Datasets:
hackint0sh
/
paraquet_

Dataset card Data Studio Files Community
text
stringlengths
928
309k
## Protocol Section ### Identification Module **NCT ID:** NCT02205879 **Brief Title:** Pregabalin for Alcohol Dependence **Official Title:** Double Blind Placebo Controlled Randomized Clinical Trial of Pregabalin for Alcohol Dependence #### Organization Study ID Info **ID:** BRPI-PGBL-A01 #### Organization **Class:** OTHER **Full Name:** St. Petersburg Bekhterev Research Psychoneurological Institute ### Status Module #### Completion Date **Date:** 2019-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-04-07 **Type:** ACTUAL **Last Update Submit Date:** 2020-04-04 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-12 **Type:** ACTUAL #### Start Date **Date:** 2013-01 **Type:** ACTUAL **Status Verified Date:** 2020-04 #### Study First Post Date **Date:** 2014-07-31 **Type:** ESTIMATED **Study First Submit Date:** 2014-07-30 **Study First Submit QC Date:** 2014-07-30 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** St.-Petersburg Bekhterev Research Psychoneurological Institute, Russian Federation #### Lead Sponsor **Class:** OTHER **Name:** St. Petersburg Bekhterev Research Psychoneurological Institute #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking and reducing drinking severity **Detailed Description:** This is a two cell double blind placebo controlled randomized clinical trial of pregabalin for alcohol dependence ### Conditions Module **Conditions:** - Alcoholism **Keywords:** - pregabalin - patients - treatment ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Pregabalin **Label:** pregabalin **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - pregabalin **Name:** Pregabalin **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Hamilton anxiety scale and Spielbereger State Trait Anxiety test **Measure:** Anxiety **Time Frame:** three months #### Primary Outcomes **Description:** Number of subjects retianed in treatment (not relapsed) **Measure:** Retention in treatment **Time Frame:** three months #### Secondary Outcomes **Description:** Time Line Follow Back technique **Measure:** Weekly alcohol consumption **Time Frame:** three months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Alcohol Dependence by ICD-X criteria Exclusion Criteria: * Severe co-morbid psychiatric and somatic diseases **Maximum Age:** 60 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** St.-Petersburg **Country:** Russian Federation **Facility:** St.-Petersburg Bekhterev Reserach Psychoneurological Institute **Zip:** 192019 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019973 - Term: Alcohol-Related Disorders - ID: D000019966 - Term: Substance-Related Disorders - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3783 - Name: Alcoholism - Relevance: HIGH - As Found: Alcoholism - ID: M21842 - Name: Alcohol-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M21837 - Name: Substance-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000437 - Term: Alcoholism ### Intervention Browse Module - Ancestors - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000927 - Term: Anticonvulsants - ID: D000002121 - Term: Calcium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000077264 - Term: Calcium-Regulating Hormones and Agents - ID: D000014151 - Term: Anti-Anxiety Agents - ID: D000014149 - Term: Tranquilizing Agents - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000011619 - Term: Psychotropic Drugs ### Intervention Browse Module - Browse Branches - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: Analg - Name: Analgesics - Abbrev: AntiConv - Name: Anticonvulsants - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: BDCA - Name: Bone Density Conservation Agents ### Intervention Browse Module - Browse Leaves - ID: M476 - Name: Pregabalin - Relevance: HIGH - As Found: Stage IV - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4246 - Name: Anticonvulsants - Relevance: LOW - As Found: Unknown - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M5384 - Name: Calcium Channel Blockers - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M16905 - Name: Anti-Anxiety Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069583 - Term: Pregabalin ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT05584579 **Brief Title:** the Role of Laparoscopy in Lower Gastrointestinal Surgical Emergencies in Adults. **Official Title:** the Role of Laparoscopy in Lower Gastrointestinal Surgical Emergencies in Adults. #### Organization Study ID Info **ID:** zagazig 13 #### Organization **Class:** OTHER_GOV **Full Name:** Zagazig University ### Status Module #### Completion Date **Date:** 2022-04-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-10-18 **Type:** ACTUAL **Last Update Submit Date:** 2022-10-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-04-01 **Type:** ACTUAL #### Start Date **Date:** 2017-04-01 **Type:** ACTUAL **Status Verified Date:** 2022-10 #### Study First Post Date **Date:** 2022-10-18 **Type:** ACTUAL **Study First Submit Date:** 2022-10-08 **Study First Submit QC Date:** 2022-10-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Zagazig University #### Responsible Party **Investigator Affiliation:** Zagazig University **Investigator Full Name:** Tamer.A.A.M.Habeeb **Investigator Title:** assistant professour of general and laparoscopic surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Introduction: causes of lower abdominal pain caused by various GIT emergencies, including acute appendicitis, intestinal obstruction, acute perforated diverticulitis, obstructed hernia, and iatrogenic colon perforation. The role of Laparoscopy may be of diagnostic and therapeutic value. Methods: Between April 2017 and April 2020, 793 patients were admitted to Zagazig University Hospital's emergency surgery unit with lower GIT emergencies, including acute appendicitis, acute intestine obstruction, complicated colonic diverticulum, complicated hernias, and iatrogenic colonic perforations. **Detailed Description:** An acute lower abdomen is typically caused by peritoneal irritation caused by an abdominal organ's inflammation, rupture, or a hollow organ obstruction. Patients with severe acute lower abdominal pain either proceed to the operative room or additional investigations or diagnostic Laparoscopy (DL). Laparoscopy should not be used routinely for every acute lower abdomen case due to anesthetic risks and morbidity . Most hospitals do emergency abdominal surgeries, and laparotomy in these procedures is associated with high death rates (14 to 20%) . Laparoscopic surgery has become a standard method for abdominal emergencies as a diagnostic and therapeutic tool. It has even been employed in some situations of lower abdominal crises in recent years . The general surgeon frequently faces diagnostic challenges in emergency abdominal conditions. The diagnosis is crucial for planning the appropriate abdominal incision and avoiding unnecessary surgery. Noninvasive diagnostic approaches such as radiological examinations are not always conclusive. Furthermore, they are costly and cannot be performed 24 hours a day in all hospital circumstances . A retrospective observational study was designed to analyze the outcomes of a laparoscopic technique in emergent lower GIT surgeries regarding intraoperative and postoperative outcomes. ### Conditions Module **Conditions:** - Emergencies **Keywords:** - Emergency surgery - laparoscopy - lower abdominal surgery ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 793 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** laparoscopic surgery **Name:** laparoscopic surgery **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** intraoperative complications **Time Frame:** up to 2 years #### Secondary Outcomes **Measure:** postoperative complications **Time Frame:** within 2 years of surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * \>18 years old, both sexes, and have undergone laparoscopic surgery for acute lower GIT emergencies such as acute appendicitis, acute intestine obstruction, complicated colonic diverticulum, complicated hernias, and iatrogenic colonic perforations Exclusion Criteria: * less than 18 years of age and open surgery **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Between April 2017 and April 2020, 793 patients were admitted to Zagazig University Hospital's emergency surgery unit with lower GIT emergencies, including acute appendicitis, acute intestine obstruction, complicated colonic diverticulum, complicated hernias, and iatrogenic colonic perforations. To be eligible for the study, patients must meet all of the following criteria: be \>18 years old, both sexes, and have undergone laparoscopic surgery for acute lower GIT emergencies such as acute appendicitis, acute intestine obstruction, complicated colonic diverticulum, complicated hernias, and iatrogenic colonic perforations. The exclusion criteria were less than 18 years of age and open surgery. STROBE criteria were followed when reporting the work and registered in clinical trial. ### Contacts Locations Module #### Locations **Location 1:** **City:** Zagazig **Country:** Egypt **Facility:** Tamer Alnaimy **State:** Sharkia **Zip:** 1234 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7796 - Name: Emergencies - Relevance: HIGH - As Found: Emergency - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004630 - Term: Emergencies ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02112279 **Acronym:** FMT **Brief Title:** Reduction of C-Difficile Infection Using Stool Transplant **Official Title:** Reduction of C-Difficile Infection Using Fecal Microbiota Transplant #### Organization Study ID Info **ID:** PHC059 #### Organization **Class:** OTHER **Full Name:** Providence Holy Cross Medical Center ### Status Module #### Completion Date **Date:** 2015-06 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2015-01-08 **Type:** ESTIMATED **Last Update Submit Date:** 2015-01-07 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2015-06 **Type:** ESTIMATED #### Start Date **Date:** 2014-04 **Status Verified Date:** 2015-01 #### Study First Post Date **Date:** 2014-04-11 **Type:** ESTIMATED **Study First Submit Date:** 2014-04-09 **Study First Submit QC Date:** 2014-04-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Providence Holy Cross Medical Center #### Responsible Party **Investigator Affiliation:** Providence Holy Cross Medical Center **Investigator Full Name:** Sherri Mendelson **Investigator Title:** Director Nursing Research and Magnet Program **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Clostridium-difficile (C-difficile) is a gram positive anaerobic spore-forming bacterium that can lead to severe diarrhea and pseudomembranous colitis. According to Schroeder (2005), there are approximately 3 million cases annually with a mortality rate of 1-2.5 %. It is most often associated with overuse of antibiotics. According to Bartlett \& Gerding (2008), 15-25% of anti-microbial-associated diarrhea is caused by C-difficile. The purpose of this study is to determine if donor fecal microbiota transplant via colonoscopy reduces refractory C-difficile infection better than current routine methods such as continued antibiotic treatment. Specifically, we hypothesize that fecal microbiota transplant via colonoscopy will result in a higher C-difficile cure rate in affected patients versus care as usual in a retrospective cohort. **Detailed Description:** Background Clostridium-difficile (C-difficile) is a gram positive anaerobic spore-forming bacterium that can lead to severe diarrhea and pseudomembranous colitis. According to Schroeder (2005), there are approximately 3 million cases annually with a mortality rate of 1-2.5 %. It is most often associated with overuse of antibiotics. According to Bartlett \& Gerding (2008), 15-25% of anti-microbial-associated diarrhea is caused by C-difficile. The purpose of this study is to determine if donor fecal microbiota transplant via colonoscopy reduces refractory C-difficile infection better than current routine methods such as continued antibiotic treatment. Specifically, we hypothesize that fecal microbiota transplant via colonoscopy will result in a higher C-difficile cure rate in affected patients versus care as usual in a retrospective cohort. Current concerns with C-difficile An increase in C-difficile exposure in hospital settings, especially for immune compromised patients has been noted. The long life of C-difficile spores with poor ability for cleaning agents to kill the spores is a particular concern for patients in critical care and oncology units. In addition, although C-difficile has been considered a hospital acquired disease, there has been an increase in community acquired C-difficile infection with the last few years. A concern was expressed by Muto, et al (2005) regarding the relationship between an unexpected outbreak of C-difficile infection following an increase in fluoroquinalone use. They found that exposure to levofloxacin was an independent risk factor for C-difficile-associated diarrhea and appeared to contribute substantially to the outbreak. They recommended restricted use of levofloxacin and the other implicated antibiotics to control the outbreak. In 2005 the Center for Disease Control (CDC) issued a warning regarding a new, highly toxic strain of C-difficile that was resistant to fluoroquinalone antibiotics. A study by Sethi, et al, (2010), demonstrated the difficulty in eradicating C-difficile infections. In their study of fifty-two patients with C-difficile, the bacteria were suppressed to undetectable levels in stool samples from most patients during treatment. At 1-4 weeks after treatment, 56% of patients who had samples tested were asymptomatic carriers of C-difficile. They found that skin contamination and environmental shedding of C-difficile often persist at the time of resolution of diarrhea, and recurrent shedding is common 1-4 weeks after therapy (58% for skin contamination and 50%, for environmental shedding). Treatment with fecal microbiota Microbiotas are friendly, beneficial bacteria. Microbiotas produce essential nutrients such as short-chain fatty acids; control epithelial cell growth; prevent overgrowth of infectious organisms; boost intestinal immunity; and prevent inflammation, diarrhea and other intestinal conditions. This essential ecosystem provides an important balance between health and disease in the body. The goal for fecal microbial transplant is to re-establish fecal microbial homeostasis with increased microbial diversity. Fecal microbiota transplants are a relatively new direction in treating C-difficile infections (CDI) that are refractory to accepted antibiotic treatment. In a retrospective medical record review of 70 patients with recurrent CDI who had undergone fecal transplantation performed via colonoscopy, Matilla, et al (2011) concluded that fecal transplantation through colonoscopy seems to be an effective treatment for recurrent CDI and also for recurrent CDI caused by the virulent C-difficile 027 strain. According to a systematic review of the literature, in 317 patients treated across 27 case series and reports, intestinal microbiota transplant demonstrated disease resolution in 92% of cases. Among the variables that determined procedural success were treatment prior to procedure, relationship of the donor to the patient, route of fecal microbiota instillation and amount of fecal microbiota solution delivered. (Gough, Shaikh \& Manges, 2010). A three-group study was conducted with 13 participants randomized to each group. Results demonstrated resolution rates of C-difficile were (81%) for the vancomycin group with subsequent donor fecal transplant via nasoduodenal tube; (31%) vancomycin only group; and (23%) vancomycin with bowel lavage group; p\<0.0001 (van Nood, et al; 2013). In a published report of proceedings of a Canadian Working Group to discuss the issues of fecal microbiota transplant, many important concerns were brought forward, including the need for donor screening, standardization of the donor fecal transplant material and the use of biologic material as an un-approved drug (Allen-Vercoe, et al, 2012). These issues must be addressed in any study to ensure that patient safety and study reliability are at the forefront in the determination of the effectiveness of fecal transplant to treat C-difficile infections that are refractory to approved antibiotic treatment. Methods This study is a one-group convenience sample interventional study with a qualitative component. Recruitment Active recruitment will involve one-to-one explanations with in-patients at a community hospital and out-patients presenting one of the study physicians for care of refractory C-difficile infection. Procedures I. Participants A. Patient: 1. Patients must be 18 years of age or older 2. Patient must have a positive C. difficile test within the 10 days prior to the procedure. 3. Continued symptoms of c-difficile infection 4. Patients must have failed at least two courses of appropriate antibiotic therapy for C. diff to be a candidate for this procedure. 5. Informed consent must be obtained. 6. All antibiotics must be discounted at least 72 hours prior to the infusion. The patient may continue on proton pump inhibitors (PPIs) but their use should be noted pre- and post- transplant. 7. A standard colonoscopy prep will be given the day before the procedure (Laxative regimen and clear liquids only). 8. Patient must provide a clean, dry blender that will be used to blend the stool mixture. The blender will be discarded after use and will not be re-used. B. Donor: if Familial versus purchased donor stool 1. The donor must be 18 years of age or older. 2. The closer the relationship between the donor and the recipient the better. Spouses and partners, first degree relatives, or household members are preferred. 3. Donors must have no history of Hepatitis B or C, HIV, recent communicable disease, incarceration, high-risk sexual behavior, inflammatory bowel disease, gastrointestinal malignancy or colon polyps. They may not have traveled an area known to be endemic for diarrheal illnesses in the past 6 months, taken antibiotics in the past 3 months for any reason, or be on any immunosuppressive drugs or chemotherapy. 4. Donors must test negative for Hepatitis B and C and HIV, and have stool specimens negative for C. Difficile, Campylobacter, Salmonella, Shigella, ova and parasites, other pathogenic bacteria, giardia antigen and cryptosporidium antigen within 10 days prior to the procedure. 5. Informed consent must be obtained from the donor. II. Setting A. A Gastroenterology Laboratory in an acute care 377-bed non-teaching hospital. III. Procedure A. Prior to Procedure 1. Verify physician order for Bowel Recolonization Therapy (or Fecal Bacteriotherapy) via colonoscopy. 2. Stool from donor must be brought in to the hospital in an approved container, received by hospital staff, labeled with the donors name, the recipients name and the recipients medical record number and sent to Endoscopy for preparation for procedure. a) The stool from donor should be formed and of adequate quantity. b) The stool from donor should be collected as close in time to instillation as possible, preferably within 6-8 hours of the procedure. 3. Informed consent must be obtained from the donor and the recipient. B. Preparation of donor sample <!-- --> 1. Personal protective equipment (mask, eye protection, gown and gloves) must be worn throughout the preparation procedure 2. Blend stool and non-bacteriostatic normal saline in a blender until stool reaches a liquid slurry consistency. Add more non-bacteriostatic normal saline until desired consistency achieved. The stool should be blended to the approximate consistency of a milkshake. 3. Filter stool solution into a sterile container with 6 layers of gauze pads, removing as much particulate matter as possible 4. Large volumes of 300-700 ml should be used for delivery through the colonoscope into the cecum or terminal ileum. 5. Container with fecal slurry must be labeled with recipients identification information and delivered immediately to bedside for instillation. C. Instillation via Colonoscopy 1. Stool mixture is administered into the terminal ileum and cecum through the biopsy channel of a colonoscope while the patient is sedated. 1. Equipment: (1) 5 syringes (at least 60 cc each) (2) K-Y jelly or water-soluble lubricant (3) Chux pads (4) Exam gloves 2. Complete hand hygiene. 3. Verify correct patient by using two patient identifiers. 4. Put on gloves and place a drape/chux under the patients buttocks. 5. Administer 300-700 ml of slurry through biopsy channel of colonoscope with a piston syringe. 6. Dispose of any leftover slurry into toilet. Dispose of waste. 7. Remove gloves and complete hand hygiene. 8. Document 1. Date and time of procedure 2. Amount of fecal slurry administered. 3. Results and patients response to procedure. 4. Observe patient for at least 15-30 minutes, until VS are stable. Measurement and data collection 1. All study patients will keep a stool diary for the 30 days following the transplant noting number of stools, time of passage, character of stool, and any changes in the patients quality of life. 2. All study patients will have a C. difficile toxin determination test at 14 days and 28 days after the procedure per physician order. C. difficile testing may be conducted using one of three methods: PCR, Illumegene, or EIA. 3. Recurrence of C. difficile is determined by C. difficile tests, signs and symptoms, as well as the consistency of stools produced. 4. Study patients will be contacted at 7, 14 and 28 days following the procedure for any concerns. A self-addressed envelope will be provided to the study participants to return their completed post-procedures log to the research team after 28 days. 5. Records for patients who undergo this procedure will be maintained by the research team in a secure location. Analysis Data analysis will be completed using measures of central tendency and raw percentages. Results of the post-procedure phone calls and the patient logs will be analyzed using qualitative measures based on phenomenology and measures of central tendency for quantitative aspects. ### Conditions Module **Conditions:** - C-difficile **Keywords:** - Microbiota - c-difficile - colonoscopy - stool transplant ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Close relative or purchased donor microbiota transplant will be administered via colonoscopy; Donor microbiota applied via colonoscopy **Intervention Names:** - Biological: Donor microbiota applied via colonoscopy. **Label:** Microbiota Transplant **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Microbiota Transplant **Description:** B. Preparation of donor sample 1. Instillation via Colonoscopy 1. Stool mixture is administered into the terminal ileum and cecum through the biopsy channel of a colonoscope while the patient is sedated. Administer 300-700 ml of slurry through biopsy channel of colonoscope with a piston syringe. **Name:** Donor microbiota applied via colonoscopy. **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Enrolled patients will test negative for c-difficile following application of the study intervention **Measure:** Negative c-difficile test **Time Frame:** 30 days #### Secondary Outcomes **Description:** patient report of decrease in symptoms related to c-difficile **Measure:** Relief of symptoms **Time Frame:** 30 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients must be 18 years of age or older 2. Patient must have a positive C. difficile test within the 10 days prior to the procedure 3. Continued symptoms of c-difficile infection 4. Patients must have failed at least two courses of appropriate antibiotic therapy for C. diff to be a candidate for this procedure - Exclusion Criteria: 1. Under 18 years of age 2. Negative C. difficile test within the 10 days prior to the procedure 3. No symptoms of c-difficile infection 4. Less than two courses of appropriate antibiotic therapy for C. difficile infection **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Robert B Moghimi, MD **Phone:** 818-363-7120 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Sherri Mendelson, PhD, RN **Phone:** 818-496-4390 **Role:** CONTACT #### Locations **Location 1:** **City:** Mission Hills **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sherri G Mendelson, RN, PhD - **Phone:** 818-496-4390 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Kelly Pagel, RN, BSN - **Phone:** 818-365-8051 - **Role:** CONTACT ***Contact 3:*** - **Name:** Robert Moghimi, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Providence Holy Cross Medical Center **State:** California **Status:** RECRUITING **Zip:** 91345 #### Overall Officials **Official 1:** **Affiliation:** PHCMC **Name:** Robert B Moghimi, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Providence Holy Cross Medical Center **Name:** Ellsworth Pryor, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Providence Holy Cross Medical Center **Name:** Sherri G Mendelson, RN, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT01337479 **Brief Title:** A Phase IIIb: Long-Term Outcomes for Hepatitis B (HepB) Patients in Some Previous Entecavir (ETV) Trials **Official Title:** Long-Term Assessment of Treatment Outcomes With Entecavir and Lamivudine for Chronic Hepatitis B Infection in Patients Who Have Enrolled in Phase III Entecavir Trials #### Organization Study ID Info **ID:** AI463-049 #### Organization **Class:** INDUSTRY **Full Name:** Bristol-Myers Squibb ### Status Module #### Completion Date **Date:** 2010-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2011-04-19 **Type:** ESTIMATED **Last Update Submit Date:** 2011-04-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2010-09 **Type:** ACTUAL #### Start Date **Date:** 2003-02 **Status Verified Date:** 2011-04 #### Study First Post Date **Date:** 2011-04-19 **Type:** ESTIMATED **Study First Submit Date:** 2011-04-15 **Study First Submit QC Date:** 2011-04-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bristol-Myers Squibb #### Responsible Party **Old Name Title:** Study Director **Old Organization:** Bristol-Myers Squibb ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to follow patients treated in entecavir Phase III and rollover studies for safety experience and Hepatitis B virus (HBV)-related complications. **Detailed Description:** Observational Model: Only subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027. Number of groups/cohorts: 1 (All subjects were observed in the same manner). ### Conditions Module **Conditions:** - Hepatitis B ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1097 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Those who participated in the specific Phase III entecavir studies as described; all had Hepatitis B infections **Label:** Participants of specific phase III entecavir studies ### Outcomes Module #### Primary Outcomes **Description:** defined as follows: * Hepatic cirrhosis (Diagnosis requires biopsy or imaging study) * Esophageal Varices (Grade 1 or higher on endoscopy or barium swallow) * Bleeding esophageal varices * Ascites (Present on physical exam or imaging study) * Hepatic encephalopathy (≥ Stage 2) * Hepatocellular carcinoma * Spontaneous bacterial peritonitis * Gastric varices * Bleeding gastric varices * Hepatorenal syndrome **Measure:** The proportion of subjects who have newly reported hepatitis B-related complications during AI463049 (reported by Phase III treatment groups) **Time Frame:** data is collected every 6 months #### Secondary Outcomes **Measure:** To determine the proportion of subjects who have a HBV Deoxyribonucleic acid (DNA) by Polymerase chain reaction (PCR) of < 300 copies/mL over the AI463049 follow-up period by the phase III treatment group **Time Frame:** Every 6 months **Measure:** To determine the proportion of subjects who have Alanine transaminase (ALT) ≤ 1.0 x Upper limit of normal (ULN) over the AI463049 follow-up period by the phase III treatment group **Time Frame:** Every 6 months **Measure:** To determine the proportion of subjects who were Hepatitis B e antigen (HBeAg) positive at the beginning of Phase III trials who have HBeAg loss or HBe seroconversion over the AI463049 follow-up period by the phase III treatment group **Time Frame:** Every 6 months **Measure:** To determine the number of anti-HBV medications following enrollment in AI463049 by the phase III treatment group **Time Frame:** Every 6 months **Measure:** To determine all cause mortality by the phase III treatment group **Time Frame:** Every 6 months **Measure:** To determine HBV-related mortality by the phase III treatment group **Time Frame:** Every 6 months **Measure:** To determine Non-hepatic malignancies by the phase III treatment group **Time Frame:** Every 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Only subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027. ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Bristol-Myers Squibb **Name:** Bristol-Myers Squibb **Role:** STUDY_DIRECTOR ### References Module #### See Also Links **Label:** BMS Clinical Trials Disclosure **URL:** http://www.bms.com/clinical_trials/Pages/home.aspx **Label:** For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm **URL:** http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000006525 - Term: Hepatitis, Viral, Human - ID: D000014777 - Term: Virus Diseases - ID: D000007239 - Term: Infections - ID: D000004769 - Term: Enterovirus Infections - ID: D000010850 - Term: Picornaviridae Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000086982 - Term: Blood-Borne Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000018347 - Term: Hepadnaviridae Infections - ID: D000004266 - Term: DNA Virus Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M9592 - Name: Hepatitis A - Relevance: HIGH - As Found: Hepatitis - ID: M9595 - Name: Hepatitis B - Relevance: HIGH - As Found: Hepatitis B - ID: M21609 - Name: Hepatitis B, Chronic - Relevance: LOW - As Found: Unknown - ID: M9591 - Name: Hepatitis - Relevance: HIGH - As Found: Hepatitis - ID: M9607 - Name: Hepatitis, Chronic - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M9610 - Name: Hepatitis, Viral, Human - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M7930 - Name: Enterovirus Infections - Relevance: LOW - As Found: Unknown - ID: M13745 - Name: Picornaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M2593 - Name: Blood-Borne Infections - Relevance: LOW - As Found: Unknown - ID: M20487 - Name: Hepadnaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M7442 - Name: DNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006506 - Term: Hepatitis A - ID: D000006509 - Term: Hepatitis B - ID: D000006505 - Term: Hepatitis ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21243 - Name: Lamivudine - Relevance: LOW - As Found: Unknown - ID: M211592 - Name: Entecavir - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT05202379 **Brief Title:** CC-42344 Safety Study in Healthy Participants **Official Title:** A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single-Ascending and Multiple-Ascending Doses of the Influenza A Virus Replication Inhibitor CC-42344 #### Organization Study ID Info **ID:** CC-42344-P1-001 #### Organization **Class:** INDUSTRY **Full Name:** Cocrystal Pharma, Inc. ### Status Module #### Completion Date **Date:** 2023-03-29 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-06-01 **Type:** ACTUAL **Last Update Submit Date:** 2023-05-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-03-29 **Type:** ACTUAL #### Start Date **Date:** 2022-02-11 **Type:** ACTUAL **Status Verified Date:** 2023-05 #### Study First Post Date **Date:** 2022-01-21 **Type:** ACTUAL **Study First Submit Date:** 2022-01-10 **Study First Submit QC Date:** 2022-01-10 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Cocrystal Pharma Australia Pty Ltd. **Class:** INDUSTRY **Name:** Linear Clinical Research #### Lead Sponsor **Class:** INDUSTRY **Name:** Cocrystal Pharma, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** CC-42344 Phase 1 study with single-ascending dose (SAD) and multiple-ascending dose (MAD) parts. **Detailed Description:** This study is testing the safety, tolerability, and pharmacokinetics (PK, the amount of study drug in the blood) of a new drug called CC-42344.Up to 78 healthy men or women aged between 18-55 are planned to be enrolled in this study in two parts. Part 1 will involve a single-ascending (increasing) dose (SAD) where 32 participants (4 groups of 8) will be assigned randomly to receive a single oral dose of the study drug or placebo. The placebo will look the same as the study drug but will not contain any medicine. An additional 6 participants will receive a single oral dose of CC-42344 to help further understand the effect of food on the uptake of the drug. Part 2: will involve a multiple-ascending dose (MAD) where 40 participants (5 groups of 8) will be randomized to receive an oral dose of study drug or placebo given once a day for 14 days, once a day for 5 days, or twice a day for 5 days. The placebo will look the same as the study drug but will not contain any medicine. ### Conditions Module **Conditions:** - Influenza A ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** 4 cohorts for SAD, with food cohort; 5 cohorts for MAD; 6 active and 2 placebo per cohort; 6 additional active in food cohort ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** active and placebo capsules identical visually. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** first dose level with 6 active and 2 placebo healthy participants **Intervention Names:** - Drug: CC-42344 - Drug: Placebo **Label:** SAD cohort 1A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** second dose level with 6 active and 2 placebo healthy participants **Intervention Names:** - Drug: CC-42344 - Drug: Placebo **Label:** SAD cohort 1B **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** third dose level with 12 active and 2 placebo healthy participants; food-effect cohort **Intervention Names:** - Drug: CC-42344 - Drug: Placebo **Label:** SAD cohort 1C **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** fourth dose level with 6 active and 2 placebo healthy participants **Intervention Names:** - Drug: CC-42344 - Drug: Placebo **Label:** SAD cohort 1D **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** first dose level with 6 active and 2 placebo healthy participants dose x 14 days **Intervention Names:** - Drug: CC-42344 - Drug: Placebo **Label:** MAD cohort 2A **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** second dose level with 6 active and 2 placebo healthy participants dose x 14 days **Intervention Names:** - Drug: CC-42344 - Drug: Placebo **Label:** MAD cohort 2B **Type:** EXPERIMENTAL #### Arm Group 7 **Description:** third dose level with 6 active and 2 placebo healthy participants dose x 14 days **Intervention Names:** - Drug: CC-42344 - Drug: Placebo **Label:** MAD cohort 2C **Type:** EXPERIMENTAL #### Arm Group 8 **Description:** forth dose level with 6 active and 2 placebo healthy participants dose x 5 days **Intervention Names:** - Drug: CC-42344 - Drug: Placebo **Label:** MAD cohort 2D **Type:** EXPERIMENTAL #### Arm Group 9 **Description:** forth dose level with 6 active and 2 placebo healthy participants dose x 5 days **Intervention Names:** - Drug: CC-42344 - Drug: Placebo **Label:** MAD cohort 2E **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - MAD cohort 2A - MAD cohort 2B - MAD cohort 2C - MAD cohort 2D - MAD cohort 2E - SAD cohort 1A - SAD cohort 1B - SAD cohort 1C - SAD cohort 1D **Description:** CC-42344 capsules **Name:** CC-42344 **Other Names:** - Active **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - MAD cohort 2A - MAD cohort 2B - MAD cohort 2C - MAD cohort 2D - MAD cohort 2E - SAD cohort 1A - SAD cohort 1B - SAD cohort 1C - SAD cohort 1D **Description:** Placebo capsules **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** number of participants with treatment-emergent adverse events **Measure:** treatment emergent adverse events **Time Frame:** Day 1 to 7 days after last dose **Description:** number of participants with clinically significant laboratory abnormalities **Measure:** laboratory abnormalities **Time Frame:** Day 1 to 7 days after last dose **Description:** number of participants with clinically significant changes from baseline in vital signs **Measure:** vital signs **Time Frame:** Day 1 to 7 days after last dose **Description:** number of participants with clinically significant changes from baseline in ECGs **Measure:** ECG **Time Frame:** Day 1 to 7 days after last dose #### Secondary Outcomes **Description:** measurement of maximum plasma concentration (Cmax) **Measure:** maximum plasma concentration **Time Frame:** Day 1 to 7 days after last dose **Description:** measurement of time of maximum plasma concentration (Tmax) **Measure:** time of maximum plasma concentration **Time Frame:** Day 1 to 7 days after last dose **Description:** measurement of area under the plasma concentration-time curve (AUC) **Measure:** area under the plasma concentration-time curve **Time Frame:** Day 1 to 7 days after last dose **Description:** measurement of elimination rate constant **Measure:** elimination rate constant **Time Frame:** Day 1 to 7 days after last dose **Description:** measurement of terminal elimination half-life (t1/2) **Measure:** terminal elimination half-life **Time Frame:** Day 1 to 7 days after last dose ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria (main): * Healthy males or healthy, non-pregnant, non-lactating females * Body weight of at least 50 kg * Body mass index between ≥18.0 and ≤32.0 kg/m2 * Good state of health (mentally and physically) * Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test, if required and per site policy Exclusion Criteria (main): * Have received any investigational drug in a clinical research study within the previous 30 days before screening * Have received any vaccine within 7 days prior to randomization * History of any drug or alcohol abuse in the past 2 years * Females of childbearing potential who are pregnant or lactating or planning to become pregnant during the study * Clinically significant abnormal biochemistry, hematology, coagulation, or urinalysis as judged by the investigator **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Nedlands **Country:** Australia **Facility:** Linear Clinical Research **State:** Western Australia **Zip:** 6009 #### Overall Officials **Official 1:** **Affiliation:** Linear Clinical Research **Name:** Sam Salman, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000009976 - Term: Orthomyxoviridae Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10295 - Name: Influenza, Human - Relevance: HIGH - As Found: Influenza - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M12902 - Name: Orthomyxoviridae Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007251 - Term: Influenza, Human ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02056379 **Acronym:** BUDEXA **Brief Title:** Comparison Between Budesonide and Dexamethasone Treatments for Respiratory Discomfort After Extubation on Children **Official Title:** Comparison Between Inhaled Budesonide and Intravenous Dexamethasone Treatments for Postextubation Stridor in Children #### Organization Study ID Info **ID:** 508177 #### Organization **Class:** OTHER **Full Name:** Hospital Israelita Albert Einstein ### Status Module #### Completion Date **Date:** 2016-03 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2014-02-06 **Type:** ESTIMATED **Last Update Submit Date:** 2014-02-04 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2015-03 **Type:** ESTIMATED #### Start Date **Date:** 2014-03 **Status Verified Date:** 2014-02 #### Study First Post Date **Date:** 2014-02-06 **Type:** ESTIMATED **Study First Submit Date:** 2014-01-23 **Study First Submit QC Date:** 2014-02-04 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Hospital M'Boi Mirim #### Lead Sponsor **Class:** OTHER **Name:** Hospital Israelita Albert Einstein #### Responsible Party **Investigator Affiliation:** Hospital Israelita Albert Einstein **Investigator Full Name:** Daniela Nasu Monteiro Medeiros **Investigator Title:** MD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study aims to analyze and compare the clinical effects of using inhaled budesonide or intravenous dexamethasone in the treatment of postextubation stridor on children admitted to the pediatric intensive care units at Hospital Municipal do M´Boi Mirim and Hospital Albert Einstein. **Detailed Description:** The investigators propose to perform a prospective, randomized, controlled and double-blind non inferiority study enrolling 70 children with postextubation stridor. The population will be divided in two groups: group 1 will receive inhaled budesonide and IV NS (intravenous normal saline) and group 2 will receive IV (intravenous) dexamethasone and inhaled normal saline. The study aims to analyze and compare (I would just say compare) the clinical effects of using inhaled budesonide or IV dexamethasone in the treatment of postextubation stridor on children admitted to the pediatric intensive care units at Hospital Municipal do M´Boi Mirim and Hospital Albert Einstein. ### Conditions Module **Conditions:** - Stridor **Keywords:** - stridor - laryngitis - budesonide - dexamethasone - children ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 70 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 2 mg of nebulized budesonide at 12/12 hours and 8 cc of intravenous normal saline. **Intervention Names:** - Drug: Budesonide **Label:** Budesonide **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** This group will receive 0,15 mg/kg/dose of intravenous dexamethasone at 6/6 hours and 8 cc of nebulized normal saline at 12/12 hours. **Intervention Names:** - Drug: Dexamethasone **Label:** Dexamethasone **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Budesonide **Description:** The subjects will receive a 5 ml normal saline inhalation right after extubation and will be re-evaluated in 5 to 10 minutes. The ones who develop upper airway obstruction and stridor with a Downes-Raphaelly score of 2 or higher will receive 0.5 ml/kg of inhaled epinephrine 1:1000 diluted to a final volume of 5 ml with a maximum dose of 2.5 ml in children up to 4 years and 5 ml in children with 5 years and above, as recommended by the American Academy of Pediatrics. The subjects who do not show an improvement after the epinephrine treatment will then be randomized to receive 2 mg of inhaled budesonide and 3 ml of IV normal saline. If there is an improvement the following maintenance therapy will be instituted for 48 hs and the subjects will receive 2 mg of budesonide q12hs and 3 ml of IV NS q6hs. **Name:** Budesonide **Other Names:** - Pulmicort **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Dexamethasone **Description:** The subjects will receive a 5 ml normal saline inhalation right after extubation and will be re-evaluated in 5 to 10 minutes. The ones who develop upper airway obstruction and stridor with a Downes-Raphaelly score of 2 or higher will receive 0.5 ml/kg of inhaled epinephrine 1:1000 diluted to a final volume of 5 ml with a maximum dose of 2.5 ml in children up to 4 years and 5 ml in children with 5 years and above, as recommended by the American Academy of Pediatrics. The subjects who do not show an improvement after the epinephrine treatment will then be randomized to receive 8 ml of inhaled normal saline and 0.6 mg/kg of IV dexamethasone. The dexamethasone group will receive 8 ml of inhaled NS q12hs and 0.15 mg/kg/dose of dexamethasone q6hs. **Name:** Dexamethasone **Other Names:** - Decadron, Hexadrol, Maxidex **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The investigators will use the Downes-Raphaelly score as an objective measurement tool of degree of respiratory discomfort. The decrease of Downes-Raphaelly score will be considered as an improvement of patient condition. **Measure:** The decrease of stridor and respiratory discomfort **Time Frame:** 6 hours #### Secondary Outcomes **Description:** The investigators will consider hypertension, hyperglycemia, gastrointestinal hemorrhage as adverse events of the usage of dexamethasone. **Measure:** Number of patients with adverse events **Time Frame:** 1 day **Description:** The investigators will study if budesonide has the same time frame improvement treating stridor and respiratory discomfort. **Measure:** The time frame of stridor's and respiratory discomfort's improvements **Time Frame:** 1 hour **Description:** Extubation failure will be considered as a need for re-intubation during de 48 hours after extubation. **Measure:** The number of patients that will have extubation failure at each arm **Time Frame:** 2 days **Description:** The inhaled epinephrine will be used as rescue therapy to absence of improvement. The number of inhaled epinephrine dosage used on each patient will be a measure of efficacy of budesonide or dexamethasone. **Measure:** The number of inhaled epinephrine doses used in each arms. **Time Frame:** 2 days **Description:** The non invasive mechanical ventilation and Heliox are rescue therapies. The number of patients treated with those rescue therapies will be a measure of efficacy of budesonide or dexamethasone. **Measure:** The number of patients who need for non invasive mechanical ventilation or Heliox **Time Frame:** 2 days **Description:** The bronchoscopy will demonstrate the non-inflammatory causes of stridor, such as: vocal cord paralysis, granuloma formation, subglottic stenosis, cricoarytenoid joint disfunction. In these cases, neither dexamethasone nor budesonide will improve clinical conditions. **Measure:** The numbers of bronchoscopies **Time Frame:** 2 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients intubated for periods longer than 24hs * age between 28 days and than 15 years * post extubation stridor must be clinically diagnosticated by a MD * informed consent must be obtained Exclusion Criteria: * patients under palliative care * presence of neuromuscular disease * previous airway pathologies * epiglottitis, aspiration of foreign bodies * viral laryngitis * former airway surgery * patients previously included in the study within the same hospital admission * corticosteroid use in the 48hs preceding extubation **Maximum Age:** 19 Years **Minimum Age:** 1 Month **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Daniela NM Medeiros **Phone:** 5511973347555 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Eduardo J Troster **Phone:** 551121511233 **Role:** CONTACT #### Locations **Location 1:** **City:** São Paulo **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Daniela NM Medeiros - **Phone:** 5511873347555 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Eduardo J Troster - **Phone:** 551121511233 - **Role:** CONTACT **Country:** Brazil **Facility:** Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP) **Zip:** 05652-000 #### Overall Officials **Official 1:** **Affiliation:** Hospital Israelita Albert Einstein **Name:** Daniela NM Medeiros **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Klassen TP, Feldman ME, Watters LK, Sutcliffe T, Rowe PC. Nebulized budesonide for children with mild-to-moderate croup. N Engl J Med. 1994 Aug 4;331(5):285-9. doi: 10.1056/NEJM199408043310501. **PMID:** 8022437 **Citation:** Johnson DW, Jacobson S, Edney PC, Hadfield P, Mundy ME, Schuh S. A comparison of nebulized budesonide, intramuscular dexamethasone, and placebo for moderately severe croup. N Engl J Med. 1998 Aug 20;339(8):498-503. doi: 10.1056/NEJM199808203390802. **PMID:** 9709042 **Citation:** Geelhoed GC, Macdonald WB. Oral and inhaled steroids in croup: a randomized, placebo-controlled trial. Pediatr Pulmonol. 1995 Dec;20(6):355-61. doi: 10.1002/ppul.1950200604. **PMID:** 8649914 **Citation:** Sinha A, Jayashree M, Singhi S. Aerosolized L-epinephrine vs budesonide for post extubation stridor: a randomized controlled trial. Indian Pediatr. 2010 Apr;47(4):317-22. doi: 10.1007/s13312-010-0060-z. Epub 2009 Sep 3. **PMID:** 19736368 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012818 - Term: Signs and Symptoms, Respiratory ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases ### Condition Browse Module - Browse Leaves - ID: M27137 - Name: Respiratory Aspiration - Relevance: LOW - As Found: Unknown - ID: M10843 - Name: Laryngitis - Relevance: LOW - As Found: Unknown - ID: M6653 - Name: Croup - Relevance: LOW - As Found: Unknown - ID: M14972 - Name: Respiratory Sounds - Relevance: HIGH - As Found: Stridor - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012135 - Term: Respiratory Sounds ### Intervention Browse Module - Ancestors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000000932 - Term: Antiemetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000000970 - Term: Antineoplastic Agents - ID: D000001993 - Term: Bronchodilator Agents - ID: D000018927 - Term: Anti-Asthmatic Agents - ID: D000019141 - Term: Respiratory System Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: VaCoAg - Name: Vasoconstrictor Agents ### Intervention Browse Module - Browse Leaves - ID: M7102 - Name: Dexamethasone - Relevance: HIGH - As Found: Children - ID: M21711 - Name: Budesonide - Relevance: HIGH - As Found: Laboratory - ID: M7992 - Name: Epinephrine - Relevance: LOW - As Found: Unknown - ID: M235549 - Name: Dexamethasone acetate - Relevance: LOW - As Found: Unknown - ID: M199152 - Name: BB 1101 - Relevance: LOW - As Found: Unknown - ID: M30371 - Name: Racepinephrine - Relevance: LOW - As Found: Unknown - ID: M211043 - Name: Epinephryl borate - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4251 - Name: Antiemetics - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M5269 - Name: Bronchodilator Agents - Relevance: LOW - As Found: Unknown - ID: M20963 - Name: Anti-Asthmatic Agents - Relevance: LOW - As Found: Unknown - ID: M21137 - Name: Respiratory System Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003907 - Term: Dexamethasone - ID: D000019819 - Term: Budesonide ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02945579 **Brief Title:** Eliminating Surgery or Radiotherapy After Systemic Therapy in Treating Patients With HER2 Positive or Triple Negative Breast Cancer **Official Title:** Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy #### Organization Study ID Info **ID:** 2016-0046 #### Organization **Class:** OTHER **Full Name:** M.D. Anderson Cancer Center #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2016-01929 **Type:** REGISTRY **Domain:** M D Anderson Cancer Center **ID:** 2016-0046 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-01-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-03-07 **Type:** ACTUAL **Last Update Submit Date:** 2024-03-05 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-01-31 **Type:** ESTIMATED #### Start Date **Date:** 2017-01-20 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2016-10-26 **Type:** ESTIMATED **Study First Submit Date:** 2016-10-24 **Study First Submit QC Date:** 2016-10-24 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** M.D. Anderson Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This clinical trial studies eliminating surgery and how well radiation therapy after systemic therapy works in treating patients with HER2 positive or triple negative breast cancer when image-guided biopsy shows no residual cancer. Patients then receive standard breast radiotherapy. **Detailed Description:** PRIMARY OBJECTIVES: I. Cohort A1 and A2: To determine the 6 mo, 1, 2, 3, 5, 7, and 10 year biopsy confirmed ipsilateral breast tumor recurrence rate (IBTR, invasive and/or in situ) among patients who do not undergo surgery. II. Cohort B: To determine the pCR rate 6 or 12 months after radiation therapy based on image-guided biopsy. III. Cohort C: To determine the 6 mo, 1, 2, 3, 5, 7 and 10-year ipsilateral breast tumor recurrence rate among patients who undergo surgery alone without radiation. SECONDARY OBJECTIVES: I. Cohort B: To determine the 6 mo, 1, 2, 3, 5, 7 and 10--year biopsy confirmed ipsilateral breast tumor recurrence rate (IBTR, invasive and/or in situ) among patients who do not undergo surgery. II. To determine the number (%) of patients where final biopsy reveals residual disease and quantify the residual disease (residual cancer burden, RCB) determined by routine pathologic examination of surgery specimens. III. To assess baseline, 6 months, 1, 3, 5, 7, and 10 years decisional comfort of clinical trial participation using the Decisional Regret Scale (DRS). IV. To determine patient-reported cosmetic outcome, breast pain, and functional status using the Breast Cancer Treatment Outcomes Scale (BCTOS) at baseline, 6 months, 1, 3, 5, 7, and 10 years. V. To determine the 6 mo, 1, 2, 3, 5, 7, and 10 years incidence of ipsilateral breast and nodal recommendation and performance of biopsy based on breast imaging follow-up. VI. Correlate "liquid biopsy" analyses (after standard routine NST, 6 months and one year post-radiotherapy or surgery) among protocol participants with pCR, utilizing circulating tumor cells (CTCs) and circulating tumor-DNA (ctDNA). VII. Among patients who decide to proceed with routine surgery, record the results of final biopsy compared with routine pathologic examination of surgery specimens. VIII. To determine patient-reported quality of life using the FACT B+4 instrument at baseline, 6 months, 1, 3, 5, 7, and 10 years after treatment. IX. To explore if radiation genomic sensitivity scores and Oncotype performed on the initial diagnostic core biopsy specimen correlate with pCR rates in Cohort B. X. To determine if changes in blood-based RNA Sequencing are elicited with radiation in Cohort B, measured at baseline, at the first 4-6 week follow-up after radiation, and at the 6 month post-radiation follow-up. XI. In Cohort B to determine the 3-year rate of tumor control/ progression free survival (PFS). XII. In Cohort C to determine whether nanomechanical biomarkers or quantification of stromal and tumor TILS can predict for low risk of local recurrence in exceptional responders who omit radiation therapy. XIII. In Cohorts A/B/C: To record 6 mo, 1, 2, 3, 5, 7, and 10 year breast cancer disease-free and overall survival. OUTLINE: For Cohorts A and B, within 12 weeks of completing neoadjuvant systemic therapy, patients undergo whole breast irradiation over 15-25 fractions on consecutive days. Patients then undergo external beam radiation therapy (EBRT) boost over 7 fractions on consecutive days beginning the day following completion of whole breast irradiation. After completion of study treatment, patients are followed up every 6 months for 5 years. ### Conditions Module **Conditions:** - Estrogen Receptor Negative - HER2 Positive Breast Carcinoma - HER2/Neu Negative - Invasive Breast Carcinoma - Progesterone Receptor Negative - Stage I Breast Cancer AJCC v7 - Stage IA Breast Cancer AJCC v7 - Stage IB Breast Cancer AJCC v7 - Stage II Breast Cancer AJCC v6 and v7 - Stage IIA Breast Cancer AJCC v6 and v7 - Stage IIB Breast Cancer AJCC v6 and v7 - Triple-Negative Breast Carcinoma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** * Neoadjuvant chemotherapy therapy * Biopsy: if no disease remaining - stay on the study and receive radiation (skip breast surgery) * H\&P and Imaging every 6 months Treatment (whole breast irradiation, EBRT) Within 12 weeks of completing neoadjuvant systemic therapy, patients undergo whole breast irradiation over 15-25 fractions on consecutive days. Patients then undergo EBRT boost over 7 fractions on consecutive days beginning the day following completion of whole breast irradiation. **Intervention Names:** - Radiation: External Beam Radiation Therapy - Other: Laboratory Biomarker Analysis - Other: Quality-of-Life Assessment - Other: Questionnaire Administration - Radiation: Whole Breast Irradiation **Label:** Cohort A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** * Neoadjuvant endocrine therapy for 6 months * Radiation if there is less than 25% tumor increase * Biopsy: if negative - additional endocrine therapy under the guidance of medical oncologist (skip breast surgery) * H\&P and Imaging every 6 months Cohort B Radiation: Treatment (Stereotactic ablative radiotherapy -SABR) Following 3-6 months of endocrine therapy, if less than 25% tumor increase, patients undergo SABR irradiation over 10 fractions every other business day. **Intervention Names:** - Radiation: External Beam Radiation Therapy - Other: Laboratory Biomarker Analysis - Other: Quality-of-Life Assessment - Other: Questionnaire Administration - Radiation: Whole Breast Irradiation **Label:** Cohort B **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** * Optional biopsy for nanomechanical biomarker assessment * Neoadjuvant chemotherapy therapy * Surgery (\& optional biopsy nanomechanical biomarker assessment): if no disease remaining - stay on the study and skip radiation * H\&P and Imaging every 6 months **Intervention Names:** - Other: Laboratory Biomarker Analysis - Other: Quality-of-Life Assessment - Other: Questionnaire Administration **Label:** Cohort C **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cohort A - Cohort B **Description:** Undergo EBRT **Name:** External Beam Radiation Therapy **Other Names:** - Definitive Radiation Therapy - EBRT - External Beam Radiotherapy - External Beam RT - external radiation - External Radiation Therapy - external-beam radiation **Type:** RADIATION #### Intervention 2 **Arm Group Labels:** - Cohort A - Cohort B - Cohort C **Description:** Correlative studies **Name:** Laboratory Biomarker Analysis **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Cohort A - Cohort B - Cohort C **Description:** Ancillary studies **Name:** Quality-of-Life Assessment **Other Names:** - Quality of Life Assessment **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Cohort A - Cohort B - Cohort C **Description:** Ancillary studies **Name:** Questionnaire Administration **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Cohort A - Cohort B **Description:** Undergo whole breast irradiation **Name:** Whole Breast Irradiation **Type:** RADIATION ### Outcomes Module #### Other Outcomes **Description:** Biomarkers in blood and plasma, specifically CTC and cDNA, will be assessed by exploratory data analysis and graphical methods, which will be applied to examine distributions and to identify data errors and outliers. Linear mixed effect models for repeated measures analysis will be employed to assess the change of the data over time with multi-covariates including disease characteristics (tumor stage, site, pathology), and other patient prognostic factors. **Measure:** Change in biomarkers in blood and plasma **Time Frame:** Baseline, 6 months, 12 months **Description:** The FACT-B+4 will assess the general quality of life of the patient. **Measure:** Quality of Life measured by FACT-B+4 questionnaire **Time Frame:** Baseline, 6 months, 12 months, 36 months, 60 months **Description:** The Breast Cancer Treatment Outcome Scale (BCTOS) will assess patient-reported cosmetic outcome, breast pain, and functional status by comparing the affected breast with her unaffected breast. **Measure:** Quality of Life measured by BCTOS questionnaire **Time Frame:** Baseline, 6 months, 12 months, 36 months, 60 months **Description:** The Decisional Regret Scale (DRS) questionnaire will assess the decisional comfort of the clinical trial participant. Question answers range : Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, or Strongly Agree **Measure:** Quality of Life measured by DRS questionnaire **Time Frame:** Baseline, 6 months, 12 months, 36 months, 60 months **Description:** Multivariable logistic regression analysis using generalized estimating equations to take the intra-patient correlation into account will be used to determine factors significantly associated with the outcome. **Measure:** Incidence of ipsilateral breast and nodal recommendation and performance of biopsy based on breast imaging follow-up **Time Frame:** Up to 5 years **Description:** Will be assessed by biopsy and routine surgery. Descriptive statistics will be used. The final biopsy will be compared with the response status determined by routine pathologic examination of surgery specimens using McNemar test. **Measure:** Residual cancer burden (RCB) **Time Frame:** Up to 5 years #### Primary Outcomes **Description:** Will monitor IBT-RFS using the method of Thall et al. Will be estimated using the Kaplan-Meier method log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis. **Measure:** Ipsilateral breast tumor recurrence-free survival (IBT-RFS) **Time Frame:** From confirmation of pathologic complete response (pCR) to the time of ipsilateral breast tumor recurrence or death, whichever occurs first or the time of last contact, assessed for up to 5 years **Description:** Will be estimated using the Kaplan-Meier method log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis. **Measure:** Overall survival **Time Frame:** Up to 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Cohort A1 and A2 • Conditions for patient eligibility: Patients on this portion of the study can receive radiation treatment at any MD Anderson Cancer Center or any outside hospital and may be enrolled prior to, during, or following neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below: 1. Pathologically confirmed unicentric invasive breast cancer defined as radiologic clinical stage T1 or T2 (≤ 5 cm), N0 or N1 (≤ 4 abnormal axillary nodes on initial ultrasound), clinical stage M0. 2. HER2 positive (IHC 3+ and or FISH amplified) or triple receptor negative (TN, ER/PR\< 10% HER2 negative (IHC 1+ or 2+ FISH non-amplified) receiving any standard routine clinical NST regimen. 3. Patient desires breast conserving therapy. 4. Age 40 years or older. This age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences \[124, 125\]. 5. Female sex. 6. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer. 7. Patient must have an initial nodal ultrasound that does not demonstrate more than four suspicious lymph nodes, any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present. * Cohort B1 and B2 • Conditions for patient eligibility: Patients on this portion of the study will be limited to receive radiation treatment at MD Anderson Cancer Center or other approved locations and must be enrolled prior to any neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below: 1. ER and/or PR positive, HER2 negative 2. Clinical stage T1N0M0, unicentric non-lobular breast cancer, no lymphovascular space invasion, 3. At least 40 years of age. 4. Oncotype ≤ 25 if age ≥ 50 years 5. Oncotype 0-20 and tumor size ≤ 1.5cm if age 40-49 years. 6. Patient agrees to take anti-estrogen therapy and is interested in breast conservation 7. Female sex. 8. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer. 9. No history of prior radiation to the area of the breast that would require protocol-mandated treatment * Cohort C * Conditions for patient eligibility: Patients on this portion of the study can receive surgical treatment at any MD Anderson Cancer Center or any outside hospital and may be enrolled prior to or following neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below: 1. Pathologically confirmed invasive breast cancer defined as radiologic clinical stage T1 or T2 (≤ 5 cm), N0, clinical stage M0 and HER2 positive (IHC 3+ and or FISH amplified) receiving any standard routine clinical NST regimen containing her-2 directed therapy OR Pathologically confirmed invasive breast cancer defined as radiologic clinical stage T1 (≤ 2 cm), N0, clinical stage M0 and triple negative, receiving any standard routine clinical NST regimen. 2. For cohort C patients participating in the optional pretreatment biopsy, the patient should be able undergo biopsy or surgery of the primary tumor site of suspected or proven invasive breast cancer and should be planned to receive neoadjuvant systemic therapy. 3. Patient desires breast conserving therapy. 4. Age 30 years or older if HER2 positive. Age 50 or older if HER2 negative (triple negative). 5. Female sex. 6. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer. 7. Patient must have an initial nodal ultrasound that does not demonstrate suspicious lymph nodes; any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present. 8. Patient must have no evidence of residual invasive tumor or DCIS on pathologic review of the lumpectomy surgical specimen 9. Patient must have no evidence of metastatic disease involving the lymph nodes on pathologic review of the lymph node surgical specimen. 10. Unifocal disease or limited multifocal disease that can be excised in a single lumpectomy specimen Exclusion Criteria: 1. Radiologic evidence for a stage T3 or clinical stage T4 breast cancer in Cohort A1/A2/C; radiologic evidence for a stage T2-T3 or clinical stage T4 breast cancer in Cohort B1/B2. 2. Clinical or pathologic evidence for distant metastases. 3. Prior diagnosis of invasive or ductal carcinoma in situ breast cancer in the ipsilateral breast. 4. Clinical evidence of progression of disease \>20% in the breast or new evidence of nodal metastases. 5. Patient is known to be pregnant. 6. Patient is participating in a NST protocol in which surgical excision of the breast and or lymph nodes are required in Cohort A1/A2/B1/B2. **Minimum Age:** 30 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Henry Kuerer **Phone:** 713-745-5043 **Role:** CONTACT #### Locations **Location 1:** **City:** Phoenix **Country:** United States **Facility:** Banner Health/Banner Research **State:** Arizona **Status:** ACTIVE_NOT_RECRUITING **Zip:** 85006 **Location 2:** **City:** Jacksonville **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Beth A. Lesnikoski - **Role:** CONTACT ***Contact 2:*** - **Name:** Beth A. Lesnikoski - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Baptist MD Anderson Cancer Center **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 32207 **Location 3:** **City:** Honolulu **Country:** United States **Facility:** Queen's Medical Center **State:** Hawaii **Status:** COMPLETED **Zip:** 96813 **Location 4:** **City:** Rochester **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Judy C. Boughey - **Phone:** 507-284-2511 - **Role:** CONTACT ***Contact 2:*** - **Name:** Judy C. Boughey - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Mayo Clinic **State:** Minnesota **Status:** RECRUITING **Zip:** 55905 **Location 5:** **City:** Voorhees **Country:** United States **Facility:** MD Anderson Cancer Center at Cooper-Voorhees **State:** New Jersey **Status:** ACTIVE_NOT_RECRUITING **Zip:** 08043 **Location 6:** **City:** Charlotte **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Richard L. White - **Phone:** 980-442-6358 - **Role:** CONTACT ***Contact 2:*** - **Name:** Richard L. White - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Carolinas Medical Center/Levine Cancer Institute **State:** North Carolina **Status:** RECRUITING **Zip:** 28203 **Location 7:** **City:** Pittsburgh **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Emilia J. Diego - **Phone:** 412-641-3083 - **Role:** CONTACT ***Contact 2:*** - **Name:** Emilia J. Diego - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Pittsburgh Cancer Institute (UPCI) **State:** Pennsylvania **Status:** RECRUITING **Zip:** 15232 **Location 8:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Henry M. Kuerer - **Phone:** 713-745-5043 - **Role:** CONTACT ***Contact 2:*** - **Name:** Henry M. Kuerer - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** M D Anderson Cancer Center **State:** Texas **Status:** RECRUITING **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** M.D. Anderson Cancer Center **Name:** Henry M Kuerer **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Kuerer HM, Smith BD, Krishnamurthy S, Yang WT, Valero V, Shen Y, Lin H, Lucci A, Boughey JC, White RL, Diego EJ, Rauch GM; Exceptional Responders Clinical Trials Group. Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2022 Dec;23(12):1517-1524. doi: 10.1016/S1470-2045(22)00613-1. Epub 2022 Oct 25. **PMID:** 36306810 **Citation:** Hariharan N, Rao TS, Rajappa S, Naidu CCK. Precision medicine - A new era in multidisciplinary care. Cancer Treat Res Commun. 2022;32:100577. doi: 10.1016/j.ctarc.2022.100577. Epub 2022 May 17. No abstract available. **PMID:** 35617923 #### See Also Links **Label:** MD Anderson Cancer Center **URL:** http://www.mdanderson.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M30373 - Name: Triple Negative Breast Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000001943 - Term: Breast Neoplasms ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02511379 **Brief Title:** Clinical Evaluation of Systane® Balance in Dry Eye Subjects **Official Title:** Clinical Evaluation of Systane® Balance on Corneal Staining in Indian Subjects With Dry Eye #### Organization Study ID Info **ID:** EXJ821-P001 (C-13-039) #### Organization **Class:** INDUSTRY **Full Name:** Alcon Research #### Secondary ID Infos **Domain:** CTRI **ID:** CTRI/2015/10/006320 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2016-06-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-10-31 **Type:** ACTUAL **Last Update Submit Date:** 2018-10-03 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2016-06-20 **Type:** ACTUAL #### Results First Post Date **Date:** 2018-09-05 **Type:** ACTUAL **Results First Submit Date:** 2017-12-15 **Results First Submit QC Date:** 2017-12-15 #### Start Date **Date:** 2015-11-26 **Type:** ACTUAL **Status Verified Date:** 2018-10 #### Study First Post Date **Date:** 2015-07-30 **Type:** ESTIMATED **Study First Submit Date:** 2015-07-28 **Study First Submit QC Date:** 2015-07-28 **Why Stopped:** Discontinuation of product development ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Alcon Research #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye. **Detailed Description:** This study was conducted in India. ### Conditions Module **Conditions:** - Dry Eye ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 14 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days **Intervention Names:** - Other: Propylene Glycol 0.6% eye drops **Label:** Systane Balance **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Systane Balance **Name:** Propylene Glycol 0.6% eye drops **Other Names:** - Systane® Balance **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15). **Measure:** Change From Baseline in Corneal Staining Total Score **Time Frame:** Baseline (Day 0), Day 45, Day 90 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Sign informed consent and willing and able to attend all study visits; * Dry eye in both eyes diagnosed by an ophthalmologist; * Other protocol-specified inclusion criteria may apply. Exclusion Criteria: * Women of childbearing potential who are pregnant or breastfeeding; * Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study; * Ocular surgery or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening; * Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening; * Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening; * Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study; * Other protocol-specified exclusion criteria may apply. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Alcon Research **Name:** Alcon Research, Ltd **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007766 - Term: Lacrimal Apparatus Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000007637 - Term: Keratoconjunctivitis - ID: D000003231 - Term: Conjunctivitis - ID: D000003229 - Term: Conjunctival Diseases - ID: D000007634 - Term: Keratitis - ID: D000003316 - Term: Corneal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M18040 - Name: Dry Eye Syndromes - Relevance: HIGH - As Found: Dry Eye - ID: M10664 - Name: Keratoconjunctivitis Sicca - Relevance: HIGH - As Found: Dry Eye - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10663 - Name: Keratoconjunctivitis - Relevance: LOW - As Found: Unknown - ID: M10786 - Name: Lacrimal Apparatus Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M6455 - Name: Conjunctivitis - Relevance: LOW - As Found: Unknown - ID: M6453 - Name: Conjunctival Diseases - Relevance: LOW - As Found: Unknown - ID: M10660 - Name: Keratitis - Relevance: LOW - As Found: Unknown - ID: M6539 - Name: Corneal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015352 - Term: Dry Eye Syndromes - ID: D000007638 - Term: Keratoconjunctivitis Sicca ### Intervention Browse Module - Ancestors - ID: D000019999 - Term: Pharmaceutical Solutions ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M12814 - Name: Ophthalmic Solutions - Relevance: HIGH - As Found: Cerebral - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000009883 - Term: Ophthalmic Solutions ### Misc Info Module #### Removed Countries - Country: India - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Systane Balance **Deaths Num At Risk:** 14 **Description:** Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days **ID:** EG000 **Other Num at Risk:** 14 **Serious Number At Risk:** 14 **Title:** Systane Balance **Frequency Threshold:** 0 **Time Frame:** Adverse events were collected for the duration of participation, an average of 90 days. ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 14 **Units:** Participants ### Group **ID:** BG000 **Title:** Systane Balance **Description:** Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 14 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 8 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 6 **Category Title:** Male **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement **Restrictive Agreement:** True ### Point of Contact **Email:** [email protected] **Organization:** Alcon, A Novartis Division **Phone:** 1-888-451-3937 **Title:** Study Director Med Affairs ## Results Section - Outcome Measures Module ### Outcome Measure 1 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -8 - **Spread:** - **Upper Limit:** 1 - **Value:** -3.1 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 14 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -11 - **Spread:** - **Upper Limit:** -1 - **Value:** -4.8 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 13 **Units:** Participants ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15). **Dispersion Type:** Full Range **Parameter Type:** MEAN **Population Description:** Analysis includes all participants with data present. Analysis was based on the eye with the higher corneal staining total score at screening or the right eye when both eyes have same corneal staining total score at screening, as observed. **Reporting Status:** POSTED **Time Frame:** Baseline (Day 0), Day 45, Day 90 **Title:** Change From Baseline in Corneal Staining Total Score **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days **ID:** OG000 **Title:** Systane Balance ### Participant Flow Module #### Group **Description:** Propylene Glycol 0.6% eye drops, 1 drop QID (4 times/day) (with the last dose of each day at bedtime) in each eye for 90 days **ID:** FG000 **Title:** Systane Balance #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 14 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 14 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 **Recruitment Details:** Participants were enrolled from 4 study sites located in India. **Has Results:** True
## Protocol Section ### Identification Module **NCT ID:** NCT01167179 **Brief Title:** Nurse-led Follow-up Care for Head and Neck Cancer Patients **Official Title:** Nurse-led Follow-up Care for Head and Neck Cancer Patients: a Quasi-experimental Study #### Organization Study ID Info **ID:** JDL-001-TVA #### Organization **Class:** OTHER **Full Name:** Radboud University Medical Center ### Status Module #### Completion Date **Date:** 2012-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-12-15 **Type:** ACTUAL **Last Update Submit Date:** 2017-05-16 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2012-05 **Type:** ACTUAL #### Results First Post Date **Date:** 2017-12-15 **Type:** ACTUAL **Results First Submit Date:** 2012-12-06 **Results First Submit QC Date:** 2017-05-16 #### Start Date **Date:** 2008-12 **Status Verified Date:** 2017-05 #### Study First Post Date **Date:** 2010-07-22 **Type:** ESTIMATED **Study First Submit Date:** 2010-07-19 **Study First Submit QC Date:** 2010-07-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Radboud University Medical Center #### Responsible Party **Investigator Affiliation:** Radboud University Medical Center **Investigator Full Name:** Jacqueline de Leeuw **Investigator Title:** MSc **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to conduct an early evaluation of a nurse-led follow up intervention added to the usual medically oriented follow up care. Besides evaluating the feasibility and acceptability to patients, the effect on psychosocial adjustment and quality of life of patients is determined. **Detailed Description:** Background: After treatment for cancer, follow-up surveillance is regarded important. In head and neck cancer patients however, increasing research evidence shows that at least the goal of detecting recurrence of cancer during routine control visits in an asymptomatic stage is not achieved. Other goals of follow-up such as management of treatment complications and helping patients and families cope and adjust remain important and ask for an accurate, effective but tailored and sensitive approach. Increasingly, nurses are mentioned as care providers best suited to perform this task. Aim: The purpose of this study is to conduct an early evaluation of a nurse-led follow up intervention added to the usual medically oriented follow up care. Besides evaluating the feasibility and acceptability to patients, the effect on psychosocial adjustment and quality of life of patients is determined. Methods and design: A quasi-experimental prospective design is used. Two groups of patients are enrolled consecutively (n=160) and patient data are collected at baseline (T0), at 6(T1) and at 12(T2) months respectively. The duration of the intervention is defined to the first year of follow up. Participating nurses are trained prior to the recruitment of the intervention group and receive supervision and individual coaching during the entire duration of the intervention phase. Outcome measures: Primary outcome, psychosocial adjustment to illness. Secondary outcomes, health related quality of life, psychosocial problems, and usage of care. ### Conditions Module **Conditions:** - Head and Neck Cancer **Keywords:** - head and neck cancer - nurse-led care - follow-up care - professional-patient relations - psychosocial adjustment - quasi-experimental - prospective - quality of life ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 160 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Usual care Participants in the comparison group receive the usual care which consists of a 5 year medical routine control schedule based on the national guidelines, and - if appropriate - involvement of the dietician and the speech language therapist.During years one to five the routine control appointments are planned at a minimum of every 2, 3, 4, 6 and 12 months respectively. Most patients who undergo a total laryngectomy have additional contact with an oncology nurse during their 6-8 weekly medical control visits at the outpatient clinic for approximately the first year of follow-up. All other head and neck cancer patients have no structured follow-up contact with an oncology nurse. **Label:** comparison group **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Interventional care Year 1 follow-up: 2-monthly medical control visit + 30 minute nursing consultation, to a minimum of 6 in year 1. No restrictions with regard to cancer stage, site or treatment modality. Intervention consist of standardised nursing consultations comprising a thorough needs assessment, supportive counseling, adequate referral to other care providers if necessary and improvement of the continuity of follow-up care. Goals: helping patients (and their partners) cope with the physical and psychosocial consequences of treatment and help them to gradually adjust to 'the life after', and into survivorship. **Intervention Names:** - Behavioral: nurse-led consultation **Label:** nurse-led consultation **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - nurse-led consultation **Description:** Content of the intervention The intervention consists of structured and standardised nursing follow up consultations comprising a thorough needs assessment, supportive counseling, adequate referral to other care providers if necessary and improvement of the continuity of follow-up care. The goals of nursing follow-up care are summarised as helping patients (and often their partners too) to cope with the physical and psychosocial consequences of treatment and help them to gradually adjust to 'the life after', and into survivorship. **Name:** nurse-led consultation **Other Names:** - nurse-led follow-up care **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The adaptive psychosocial response of an individual to a significant life change was assessed using the Psychosocial Adjustment to Illness Scale -Self Report (PAIS-SR), a 46-item self-report measure that assesses changes in seven domains. A mean PAIS-SR T-score of 50 is the average score for each domain, meaning that patients with this score adjusted neither better nor worse than a mixed cancer reference group, whereas a score lower than 50 indicates better adjustment. The total scale range for the T score is 21-80. The PAIS-SR is well validated and has been used in previous studies of HNC patients.Here, we used the validated Dutch translation. **Measure:** Psychosocial Adjustment to Illness-Scale **Time Frame:** baseline, 6 mo, 12mo #### Secondary Outcomes **Description:** Quality of Life(QoL)was measured with the EORTC QLQ-C30 and QLQ-H\&N35.The EORTC QLQ-C30 contains five functioning scales, a global health status/QoL scale, and nine symptom scales. The QLQ-H\&N35 contains 18 disease-specific symptom scales. All scores in both the EORTC QLQ-C30 and QLQ-H\&N35 were transformed to a 0-100 scale following instructions in the scoring manual, with higher scores representing better quality of life and less disease-specific symptoms. **Measure:** Quality of Life **Time Frame:** baseline, 6 mo, 12 mo ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosed with a primary head and neck tumour * Absence of other cancers diagnosed * Treatment with curative intent, all treatment modalities * Treatment and 12 month follow-up planned in Radboud University Nijmegen Medical Centre * Able to speak, write and understand Dutch * Cognitively able to give informed consent Exclusion Criteria: * Actual psychiatric disease * Actual alcohol addiction * Known life expectancy of \< 6 months **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Nijmegen **Country:** Netherlands **Facility:** Radboud University Nijmegen Medical Centre **Zip:** 6500 HB #### Overall Officials **Official 1:** **Affiliation:** Radboud University Medical Center **Name:** T van Achterberg, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** de Leeuw J, Prins JB, Teerenstra S, Merkx MA, Marres HA, van Achterberg T. Nurse-led follow-up care for head and neck cancer patients: a quasi-experimental prospective trial. Support Care Cancer. 2013 Feb;21(2):537-47. doi: 10.1007/s00520-012-1553-1. Epub 2012 Aug 4. **PMID:** 22864472 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: HIGH - As Found: Head and Neck Cancer - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006258 - Term: Head and Neck Neoplasms ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Usual Care **Description:** The participants in the comparison group received usual care that consisted of a 5-year routine control schedule with six bimonthly 10-minute visits to a head and neck surgeon in the first year posttreatment in accordance with national guidelines.19 Nursing follow-up care consisted of ad hoc problem-based contacts except for patients who underwent a laryngectomy, who received standard nursing consultations during the first 6 months posttreatment in parallel with the medical control visits. Patients who were treated with surgery alone all had one standard wound control visit with a nurse; patients who were treated with radiotherapy had one to six ad hoc nursing contacts during the first 6 months posttreatment. For the duration of the study, there were no changes in conventional care. **ID:** EG000 **Other Num at Risk:** 80 **Serious Number At Risk:** 80 **Title:** Usual Care **Group ID:** EG001 **Title:** Intervention **Description:** The intervention consisted of six 30-minute nursing follow-up consultations in the first year posttreatment. A standardized protocol was used for this purpose. Nursing consultations were conducted in parallel with and preceding the medical routine control visits and included a needs assessment based upon the biopsychosocial model. The aim of consultation was to give advice and support to patients (and their partners) addressing the physical and psychosocial consequences of treatment. To increase patient focus and active participation during consultations, patients completed a 13-item checklist prior to each consultation.Every 3 months, patients were screened for psychosocial problem areas using a specific questionnaire.During the consultations, the nurses also performed simple medical checks including inspection of the tracheal stoma, cannula and speech valve (if applicable), and oral cavity, and palpation of the neck and lymph nodes. **ID:** EG001 **Other Num at Risk:** 80 **Serious Number At Risk:** 80 **Title:** Intervention **Frequency Threshold:** 0 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 80 **Group ID:** BG001 **Value:** 80 **Group ID:** BG002 **Value:** 160 **Units:** Participants ### Group **ID:** BG000 **Title:** Usual Care **Description:** The participants in the comparison group received usual care that consisted of a 5-year routine control schedule with six bimonthly 10-minute visits to a head and neck surgeon in the first year posttreatment in accordance with national guidelines.19 Nursing follow-up care consisted of ad hoc problem-based contacts except for patients who underwent a laryngectomy, who received standard nursing consultations during the first 6 months posttreatment in parallel with the medical control visits. Patients who were treated with surgery alone all had one standard wound control visit with a nurse; patients who were treated with radiotherapy had one to six ad hoc nursing contacts during the first 6 months posttreatment. For the duration of the study, there were no changes in conventional care. ### Group **ID:** BG001 **Title:** Intervention **Description:** The intervention consisted of six 30-minute nursing follow-up consultations in the first year posttreatment. A standardized protocol was used for this purpose. Nursing consultations were conducted in parallel with and preceding the medical routine control visits and included a needs assessment based upon the biopsychosocial model. The aim of consultation was to give advice and support to patients (and their partners) addressing the physical and psychosocial consequences of treatment. To increase patient focus and active participation during consultations, patients completed a 13-item checklist prior to each consultation.Every 3 months, patients were screened for psychosocial problem areas using a specific questionnaire.During the consultations, the nurses also performed simple medical checks including inspection of the tracheal stoma, cannula and speech valve (if applicable), and oral cavity, and palpation of the neck and lymph nodes. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 68 #### Measurement **Group ID:** BG001 **Value:** 69 #### Measurement **Group ID:** BG002 **Value:** 137 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 12 #### Measurement **Group ID:** BG001 **Value:** 11 #### Measurement **Group ID:** BG002 **Value:** 23 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 13.0 **Value:** 58.4 #### Measurement **Group ID:** BG001 **Spread:** 12.3 **Value:** 59.2 #### Measurement **Group ID:** BG002 **Spread:** 11.8 **Value:** 58.8 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 20 #### Measurement **Group ID:** BG001 **Value:** 26 #### Measurement **Group ID:** BG002 **Value:** 46 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 60 #### Measurement **Group ID:** BG001 **Value:** 54 #### Measurement **Group ID:** BG002 **Value:** 114 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 80 #### Measurement **Group ID:** BG001 **Value:** 80 #### Measurement **Group ID:** BG002 **Value:** 160 **Class Title:** Netherlands ### Measure #### Measurement **Group ID:** BG000 **Spread:** 12 **Value:** 46 #### Measurement **Group ID:** BG001 **Spread:** 11 **Value:** 50 #### Measurement **Group ID:** BG002 **Spread:** 12 **Value:** 49 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 17 **Value:** 76 #### Measurement **Group ID:** BG001 **Spread:** 23 **Value:** 64 #### Measurement **Group ID:** BG002 **Spread:** 19 **Value:** 72 **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ### Measure 5 **Description:** Psychosocial Adjustment to Illness Scale - Self Report (PAIS-SR), a 46-item self-report measure that assesses changes in seven domains. The Dutch validated questionnaire was used.HRQOL was measured with the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire with additional Head \& Neck Module (EORTC QLQ-C30 and QLQ-H\&N35). **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Psychosocial adjustment **Unit of Measure:** units on a scale ### Measure 6 **Description:** Quality of Life(QoL)was measured with the EORTC QLQ-C30 and QLQ-H\&N35.The EORTC QLQ-C30 contains five functioning scales, a global health status/QoL scale, and nine symptom scales. The QLQ-H\&N35 contains 18 disease-specific symptom scales. All scores in both the EORTC QLQ-C30 and QLQ-H\&N35 were transformed to a 0-100 scale following instructions in the scoring manual, with higher scores representing better quality of life and less disease-specific symptoms. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Quality of Life **Unit of Measure:** units on a scale ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Limitations and Caveats **Description:** A historical control group being the comparison group was the 'usual care' group that included participants who were enrolled during the study and received usual care, as described. Lack of randomization may have been a confounding factor. ### Point of Contact **Email:** [email protected] **Organization:** Radboud University Nijmegen Medical Center **Phone:** +31243614925 **Title:** Jacqueline de Leeuw MSc ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 17 - **Upper Limit:** - **Value:** 76 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 23 - **Upper Limit:** - **Value:** 64 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 18 - **Upper Limit:** - **Value:** 80 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 16 - **Upper Limit:** - **Value:** 77 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 17 - **Upper Limit:** - **Value:** 80 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 18 - **Upper Limit:** - **Value:** 81 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 43 - **Spread:** 12 - **Upper Limit:** 60 - **Value:** 46 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 11 - **Upper Limit:** - **Value:** 50 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 12 - **Upper Limit:** - **Value:** 44 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 13 - **Upper Limit:** - **Value:** 44 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 12 - **Upper Limit:** - **Value:** 42 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 13 - **Upper Limit:** - **Value:** 43 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Quality of Life(QoL)was measured with the EORTC QLQ-C30 and QLQ-H\&N35.The EORTC QLQ-C30 contains five functioning scales, a global health status/QoL scale, and nine symptom scales. The QLQ-H\&N35 contains 18 disease-specific symptom scales. All scores in both the EORTC QLQ-C30 and QLQ-H\&N35 were transformed to a 0-100 scale following instructions in the scoring manual, with higher scores representing better quality of life and less disease-specific symptoms. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** ITT analyses. Linear mixed model for repeated measurements.Intervention an time (as well as their interaction), and adjustment factors tumor location, size of the tumor,treatment modality, living without a partner, and education (high vs. other) were included in the model as fixed effects. An unstructured covariance matrix was fitted **Reporting Status:** POSTED **Time Frame:** baseline, 6 mo, 12 mo **Title:** Quality of Life **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** The participants in the comparison group received usual care that consisted of a 5-year routine control schedule with six bimonthly 10-minute visits to a head and neck surgeon in the first year posttreatment in accordance with national guidelines.19 Nursing follow-up care consisted of ad hoc problem-based contacts except for patients who underwent a laryngectomy, who received standard nursing consultations during the first 6 months posttreatment in parallel with the medical control visits. Patients who were treated with surgery alone all had one standard wound control visit with a nurse; patients who were treated with radiotherapy had one to six ad hoc nursing contacts during the first 6 months posttreatment. For the duration of the study, there were no changes in conventional care. **ID:** OG000 **Title:** Usual Care ##### Group **Description:** The intervention consisted of six 30-minute nursing follow-up consultations in the first year posttreatment. A standardized protocol was used for this purpose. Nursing consultations were conducted in parallel with and preceding the medical routine control visits and included a needs assessment based upon the biopsychosocial model. The aim of consultation was to give advice and support to patients (and their partners) addressing the physical and psychosocial consequences of treatment. To increase patient focus and active participation during consultations, patients completed a 13-item checklist prior to each consultation.Every 3 months, patients were screened for psychosocial problem areas using a specific questionnaire.During the consultations, the nurses also performed simple medical checks including inspection of the tracheal stoma, cannula and speech valve (if applicable), and oral cavity, and palpation of the neck and lymph nodes. **ID:** OG001 **Title:** Intervention #### Outcome Measure 2 **Description:** The adaptive psychosocial response of an individual to a significant life change was assessed using the Psychosocial Adjustment to Illness Scale -Self Report (PAIS-SR), a 46-item self-report measure that assesses changes in seven domains. A mean PAIS-SR T-score of 50 is the average score for each domain, meaning that patients with this score adjusted neither better nor worse than a mixed cancer reference group, whereas a score lower than 50 indicates better adjustment. The total scale range for the T score is 21-80. The PAIS-SR is well validated and has been used in previous studies of HNC patients.Here, we used the validated Dutch translation. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** ITT analyses. Linear mixed model for repeated measurements.Intervention an time (as well as their interaction), and adjustment factors tumor location, size of the tumor,treatment modality, living without a partner, and education (high vs. other) were included in the model as fixed effects. An unstructured covariance matrix was fitted **Reporting Status:** POSTED **Time Frame:** baseline, 6 mo, 12mo **Title:** Psychosocial Adjustment to Illness-Scale **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** The participants in the comparison group received usual care that consisted of a 5-year routine control schedule with six bimonthly 10-minute visits to a head and neck surgeon in the first year posttreatment in accordance with national guidelines.19 Nursing follow-up care consisted of ad hoc problem-based contacts except for patients who underwent a laryngectomy, who received standard nursing consultations during the first 6 months posttreatment in parallel with the medical control visits. Patients who were treated with surgery alone all had one standard wound control visit with a nurse; patients who were treated with radiotherapy had one to six ad hoc nursing contacts during the first 6 months posttreatment. For the duration of the study, there were no changes in conventional care. **ID:** OG000 **Title:** Usual Care ##### Group **Description:** The intervention consisted of six 30-minute nursing follow-up consultations in the first year posttreatment. A standardized protocol was used for this purpose. Nursing consultations were conducted in parallel with and preceding the medical routine control visits and included a needs assessment based upon the biopsychosocial model. The aim of consultation was to give advice and support to patients (and their partners) addressing the physical and psychosocial consequences of treatment. To increase patient focus and active participation during consultations, patients completed a 13-item checklist prior to each consultation.Every 3 months, patients were screened for psychosocial problem areas using a specific questionnaire.During the consultations, the nurses also performed simple medical checks including inspection of the tracheal stoma, cannula and speech valve (if applicable), and oral cavity, and palpation of the neck and lymph nodes. **ID:** OG001 **Title:** Intervention ### Participant Flow Module #### Group **Description:** The participants in the usual care group received care that consisted of a 5-year routine control schedule with six bimonthly 10-minute visits to a head and neck surgeon in the first year posttreatment in accordance with national guidelines.19 Nursing follow-up care consisted of ad hoc problem-based contacts except for patients who underwent a laryngectomy, who received standard nursing consultations during the first 6 months posttreatment in parallel with the medical control visits. Patients who were treated with surgery alone all had one standard wound control visit with a nurse; patients who were treated with radiotherapy had one to six ad hoc nursing contacts during the first 6 months posttreatment. For the duration of the study, there were no changes in usual care. **ID:** FG000 **Title:** Usual Care #### Group **Description:** The intervention consisted of six 30-minute nursing follow-up consultations in the first year posttreatment. A standardized protocol was used for this purpose. Nursing consultations were conducted in parallel with and preceding the medical routine control visits and included a needs assessment based upon the biopsychosocial model.The aim of consultation was to give advice and support to patients (and their partners) addressing the physical and psychosocial consequences of treatment. To increase patient focus and active participation during consultations, patients completed a 13-item checklist prior to each consultation. Every 3 months, patients were screened for psychosocial problem areas using a specific questionnaire. During the consultations, the nurses also performed simple medical checks including inspection of the tracheal stoma, cannula and speech valve (if applicable), and oral cavity, and palpation of the neck and lymph nodes. **ID:** FG001 **Title:** Intervention #### Period **Title:** Overall Study ##### Withdraw **Type:** disease recurrence ###### Reason **Group ID:** FG000 **Number of Subjects:** 4 ###### Reason **Group ID:** FG001 **Number of Subjects:** 4 ##### Withdraw **Type:** Death ###### Reason **Group ID:** FG000 **Number of Subjects:** 4 ###### Reason **Group ID:** FG001 **Number of Subjects:** 10 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Withdraw **Type:** diverse ###### Reason **Group ID:** FG000 **Number of Subjects:** 6 ###### Reason **Group ID:** FG001 **Number of Subjects:** 5 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 80 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 80 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 65 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 59 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 15 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 21 **Pre-Assignment Details:** The eligibility criteria for the study were as follows: informed of a HNC diagnosis (but no other cancer); to be treated with curative intent; to be able to speak, write and understand Dutch; and be cognitively able to provide informed consent. Exclusion criteria included overt psychopathology, alcohol addiction, life expectancy of less than 6 mo. **Recruitment Details:** Recruitment period: November 2007 to February 2010. Setting: outpatient oncology clinic **Has Results:** True
## Protocol Section ### Identification Module **NCT ID:** NCT01106079 **Acronym:** TICOPA **Brief Title:** TIght COntrol of Psoriatic Arthritis **Official Title:** A Randomised Controlled Trial to Compare Intensive Management vs Standard Care in Early Psoriatic Arthritis #### Organization Study ID Info **ID:** RR07/8350 #### Organization **Class:** OTHER **Full Name:** University of Leeds #### Secondary ID Infos **ID:** 2007-004757-28 **Type:** EUDRACT_NUMBER **Domain:** Arthritis Research UK **ID:** 18825 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2013-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-05-28 **Type:** ESTIMATED **Last Update Submit Date:** 2015-05-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2012-07 **Type:** ACTUAL #### Start Date **Date:** 2008-05 **Status Verified Date:** 2015-05 #### Study First Post Date **Date:** 2010-04-19 **Type:** ESTIMATED **Study First Submit Date:** 2010-04-15 **Study First Submit QC Date:** 2010-04-16 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Arthritis Research UK **Class:** INDUSTRY **Name:** Pfizer #### Lead Sponsor **Class:** OTHER **Name:** Julia Brown #### Responsible Party **Investigator Affiliation:** University of Leeds **Investigator Full Name:** Julia Brown **Investigator Title:** Director of CTRU **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to investigate whether tight control of patients with newly diagnosed psoriatic arthritis (consisting of regular 4 weekly objective assessment of disease activity and protocol-led intensive treatment) can improve outcome as opposed to standard care (usually 3 monthly reviews with no objective outcome measures and no protocol for treatment). The principle hypothesis of this study is that tight control of inflammation in psoriatic arthritis using a treatment protocol and pre-defined objective targets for treatment will lead to an improvement in patients' disease activity and a reduction in radiological joint damage. **Detailed Description:** The TICOPA trial is designed as a randomised, controlled, parallel group, open label, multi-centre clinical trial of 206 patients with recent onset psoriatic arthritis. Patients will be randomised on a 1:1 basis to receive either standard care (12 weekly review) or tight control (4 weekly review) for a period of 48 weeks. The hypothesis is that tight control of inflammation will lead to a better outcome in terms of joint inflammation, joint damage, pain and quality of life for people with PsA. This imaging undertaken within the study will provide a further measure of joint inflammation and damage and will improve understanding of the relationships between inflammation, damage and bony proliferation in psoriatic arthritis. Those subjects randomised to the tight control arm will be reviewed every 4 weeks (by the PI at each site or a designated researcher), and will be treated according to a rapidly escalating regime, involving standard DMARDs and biologics. Initial therapy will be with oral methotrexate, increasing in dose rapidly over the first 8 weeks of the study. From the 12 week visit onwards, escalation of therapy in this arm will be performed if subjects do not meet the objective target of Minimal Disease Activity. Initial escalation will be to combination DMARD therapy. If patients in the tight control arm fail to meet the MDA criteria and fulfil the NICE criteria for the use of TNF blockers in psoriatic arthritis at 24 weeks, then they will be offered treatment with these medications. Therapy will continue to be modified throughout the 48 week follow-up until a state of minimal disease activity is reached. The control group will be seen every 12 weeks in a general rheumatology clinic and will receive standard care, involving standard DMARDs and biologics as appropriate. Treatment will be prescribed as felt appropriate by the treating physicians with no set protocol and no restrictions. All subjects will be treated and followed-up for 48 weeks from randomisation according to their treatment allocation and will have 12 weekly clinical disease assessments throughout this period by a fully trained, blinded assessor. This will include measures of disease activity in all of the five aspects of PsA (joint disease, skin disease, enthesitis, dactylitis and spinal disease). ### Conditions Module **Conditions:** - Psoriatic Arthritis **Keywords:** - Early psoriatic arthritis - Tight control - Intensive management ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 206 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Intensive management or Tight control **Label:** Intensive management **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Standard management - Control group **Label:** Standard management **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intensive management **Description:** Those subjects randomised to the intensive management or tight control arm will be reviewed every 4 weeks (by the Principal Investigator at each site or a designated researcher) and will be treated according to a rapidly escalating regime, involving standard DMARDs and biologics. Initial therapy will be with oral methotrexate, increasing in dose rapidly over the first 8 weeks of the study. From the 12 week visit onwards, escalation of therapy in this arm will be performed if subjects do not meet the objective target of Minimal Disease Activity. Initial escalation will be to combination DMARD therapy. If patients in the tight control arm fail to meet the MDA criteria and fulfil the NICE criteria for the use of TNF blockers in psoriatic arthritis at 24 weeks, then they will be offered treatment with these medications. Therapy will continue to be modified throughout the 48 week follow-up until a state of minimal disease activity is reached. **Name:** Intensive management or Tight control **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Standard management **Description:** The control group will be seen every 12 weeks in a general rheumatology clinic and will receive standard care, involving standard DMARDs and biologics as appropriate. Treatment will be prescribed as felt appropriate by the treating physicians with no set protocol and no restrictions. **Name:** Standard management - Control group **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To compare intensive management with standard care in terms of the proportion of patients achieving an ACR20 response at 48 weeks post-randomisation, in order to determine whether intensive management has superior clinical efficacy. **Measure:** Proportion of patients achieving an ACR20 response. **Time Frame:** 48 weeks #### Secondary Outcomes **Description:** To compare intensive management with standard care in terms of additional clinical efficacy outcomes at 24 and 48 weeks, including: * ACR20 (24 weeks), ACR50 and ACR70 * PASI 20, PASI 75 and PASI 90 * Change in Sharp-van der Heijde Score * ASAS 20 and ASAS 40 * Change in enthesitis score * Change in dactylitis score * Change in mNAPSI * Change in HAQ * Change in other scores (including BASDAI, tender and swollen joint counts, patient and clinician VAS scores) * MDA score **Measure:** Additional clinical efficacy outcomes **Time Frame:** 24 weeks **Description:** To compare intensive management with standard care in terms of Quality of Life (QoL),using PsAQoL between intensive management and standard care at baseline, 24 and 48 weeks **Measure:** Comparison between intensive management and standard care in terms of Quality of Life (QoL),using PsAQoL **Time Frame:** 24 weeks **Description:** To compare intensive management with standard care in terms of cost effectiveness at 12, 24 and 48 weeks **Measure:** To compare intensive management with standard care in terms of cost effectiveness **Time Frame:** 12 weeks **Description:** To compare intensive management with standard care in terms of safety outcomes over the course of the treatment until 52 weeks **Measure:** Number of participants with adverse events as a measure of safety and tolerability **Time Frame:** From baseline until 52 weeks **Description:** To compare intensive management with standard care in terms of imaging efficacy outcomes including change in Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) and ultrasound assessment of disease at 48 weeks in order to assess inflammation and damage. **Measure:** Imaging efficacy: PsAMRIS and ultrasound assessment of disease **Time Frame:** 48 weeks **Description:** To compare intensive management with standard care in terms of additional clinical efficacy outcomes at 24 and 48 weeks, including: * ACR20 (24 weeks), ACR50 and ACR70 * PASI 20, PASI 75 and PASI 90 * Change in Sharp-van der Heijde Score * ASAS 20 and ASAS 40 * Change in enthesitis score * Change in dactylitis score * Change in mNAPSI * Change in HAQ * Change in other scores (including BASDAI, tender and swollen joint counts, patient and clinician VAS scores) * MDA score **Measure:** Additional clinical efficacy outcomes **Time Frame:** 48 weeks **Description:** To compare intensive management with standard care in terms of Quality of Life (QoL),using PsAQoL between intensive management and standard care at baseline, 24 and 48 weeks. **Measure:** Comparison between intensive management and standard care in terms of Quality of Life (QoL),using PsAQoL **Time Frame:** 48 weeks **Description:** To compare intensive management with standard care in terms of cost effectiveness at 12, 24 and 48 weeks **Measure:** To compare intensive management with standard care in terms of cost effectiveness **Time Frame:** 24 weeks **Description:** To compare intensive management with standard care in terms of cost effectiveness at 12, 24 and 48 weeks **Measure:** To compare intensive management with standard care in terms of cost effectiveness **Time Frame:** 48 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with a diagnosis of psoriatic arthritis by a consultant Rheumatologist with less than 24 months disease duration. * Active disease defined by at least one tender or swollen joint or active enthesitis. * Age ≥18 years at the time of signing the informed consent form and either male or female patients. * Patient understands the objectives of the study and is able and willing to sign the Informed Consent Form. * Men and women of child bearing potential (WCBP) must use at least one adequate birth control measure for the duration of the study and should continue such precautions for 6 months after receiving the last dose of protocol treatment. * Adequate full blood count within 28 days before randomisation: * Haemoglobin count \> 8.5 g/dL * White blood count (WBC) \> 3.5 x 10\*9/L * Absolute neutrophil count (ANC) \> 1.5 x 10\*9/L * Platelet count \> 100 x 10\*9/L * Adequate hepatobiliary function within 28 days before randomisation: \*ALT and/or AST levels must be within 3 times the upper limit of normal range (ULN) for the laboratory conducting the test. * The patient must be able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: * Previous treatment for articular disease with disease modifying drugs (DMARDs) including, but not limited to, methotrexate, sulfasalazine, leflunomide, * Women who are pregnant, lactating or planning pregnancy within 6 months of their last dose of protocol treatment. * Use of any investigational agents within 4 weeks or within 5 half-lives of the investigational agent, whichever is longer, prior to randomisation. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Leeds **Country:** United Kingdom **Facility:** Chapel Allerton Hospital **State:** West Yorkshire **Zip:** LS7 4SA **Location 2:** **City:** Bradford **Country:** United Kingdom **Facility:** St Luke's Hospital **Location 3:** **City:** York **Country:** United Kingdom **Facility:** York District Hospital #### Overall Officials **Official 1:** **Affiliation:** University of Leeds **Name:** Philip Helliwell **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Coates LC, Mahmood F, Emery P, Conaghan PG, Helliwell PS. The dynamics of response as measured by multiple composite outcome tools in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) trial. Ann Rheum Dis. 2017 Oct;76(10):1688-1692. doi: 10.1136/annrheumdis-2017-211137. Epub 2017 Jun 12. **PMID:** 28606970 **Citation:** O'Dwyer JL, Meads DM, Hulme CT, Mcparland L, Brown S, Coates LC, Moverley AR, Emery P, Conaghan PG, Helliwell PS. Cost-Effectiveness of Tight Control of Inflammation in Early Psoriatic Arthritis: Economic Analysis of a Multicenter Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Mar;70(3):462-468. doi: 10.1002/acr.23293. Epub 2018 Jan 30. **PMID:** 28544822 **Citation:** Coates LC, Moverley AR, McParland L, Brown S, Navarro-Coy N, O'Dwyer JL, Meads DM, Emery P, Conaghan PG, Helliwell PS. Effect of tight control of inflammation in early psoriatic arthritis (TICOPA): a UK multicentre, open-label, randomised controlled trial. Lancet. 2015 Dec 19;386(10012):2489-98. doi: 10.1016/S0140-6736(15)00347-5. Epub 2015 Oct 1. **PMID:** 26433318 **Citation:** Freeston JE, Coates LC, Nam JL, Moverley AR, Hensor EM, Wakefield RJ, Emery P, Helliwell PS, Conaghan PG. Is there subclinical synovitis in early psoriatic arthritis? A clinical comparison with gray-scale and power Doppler ultrasound. Arthritis Care Res (Hoboken). 2014 Mar;66(3):432-9. doi: 10.1002/acr.22158. **PMID:** 24022986 **Citation:** Coates LC, Navarro-Coy N, Brown SR, Brown S, McParland L, Collier H, Skinner E, Law J, Moverley A, Pavitt S, Hulme C, Emery P, Conaghan PG, Helliwell PS. The TICOPA protocol (TIght COntrol of Psoriatic Arthritis): a randomised controlled trial to compare intensive management versus standard care in early psoriatic arthritis. BMC Musculoskelet Disord. 2013 Mar 21;14:101. doi: 10.1186/1471-2474-14-101. **PMID:** 23517506 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000025242 - Term: Spondylarthropathies - ID: D000025241 - Term: Spondylarthritis - ID: D000013166 - Term: Spondylitis - ID: D000013122 - Term: Spinal Diseases - ID: D000001847 - Term: Bone Diseases - ID: D000011565 - Term: Psoriasis - ID: D000017444 - Term: Skin Diseases, Papulosquamous - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC01 - Name: Infections - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4476 - Name: Arthritis - Relevance: HIGH - As Found: Arthritis - ID: M18178 - Name: Arthritis, Psoriatic - Relevance: HIGH - As Found: Psoriatic Arthritis - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M23036 - Name: Spondylarthropathies - Relevance: LOW - As Found: Unknown - ID: M15961 - Name: Spondylitis - Relevance: LOW - As Found: Unknown - ID: M23035 - Name: Spondylarthritis - Relevance: LOW - As Found: Unknown - ID: M15919 - Name: Spinal Diseases - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M14422 - Name: Psoriasis - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M19713 - Name: Skin Diseases, Papulosquamous - Relevance: LOW - As Found: Unknown - ID: T5412 - Name: Spondylarthropathy - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001168 - Term: Arthritis - ID: D000015535 - Term: Arthritis, Psoriatic ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents ### Intervention Browse Module - Browse Leaves - ID: M11703 - Name: Methotrexate - Relevance: LOW - As Found: Unknown - ID: M2052 - Name: Tumor Necrosis Factor Inhibitors - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT00615979 **Brief Title:** Far Forward Battlefield Telemedicine: Evaluation of Handheld Ultrasound **Official Title:** Far Forward Battlefield Telemedicine:Ultrasound Guidance System (UGS) #### Organization Study ID Info **ID:** 5279 #### Organization **Class:** OTHER **Full Name:** The Cleveland Clinic #### Secondary ID Infos **Domain:** USAMRMC **ID:** DAMD17-02-2-0040 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2009-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-01-27 **Type:** ESTIMATED **Last Update Submit Date:** 2017-01-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2008-12 **Type:** ACTUAL #### Start Date **Date:** 2002-10 **Type:** ACTUAL **Status Verified Date:** 2017-01 #### Study First Post Date **Date:** 2008-02-14 **Type:** ESTIMATED **Study First Submit Date:** 2007-12-26 **Study First Submit QC Date:** 2008-02-13 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** United States Department of Defense #### Lead Sponsor **Class:** OTHER **Name:** The Cleveland Clinic #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this study is to improve survival of battlefield trauma through ultrasound telemedicine and remotely guided therapeutics. **Detailed Description:** Specific aims to meet to improve the survival of battlefield trauma are 1)validation of portable ultrasound for diagnosis of various medical and surgical emergencies, ie cardiac tamponade, intraabdominal hemorrhage, 2)Extension of our expertise in digital echocardiography and local telemedicine to support other centers in such procedures as TEE 3)development of wireless telemedicine systems for rapid relay of ultrasonic images from portable ultrasound system to a remote review station. 4)development of a precision guide for diagnostic and therapeutic percutaneous procedures using ultrasound guidance 5)combining wireless telemetry with the guided percutaneous access tool to permit remotely guided emergency procedures 6)augmenting this work(2D/echo) with 3D/echo. ### Conditions Module **Conditions:** - Thoracic Injuries **Keywords:** - trauma - portable ultrasound - telemedicine - Department of Defense ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 120 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Diagnostic capabilities Wireless transfer **Intervention Names:** - Device: Miniature echo machine **Label:** Miniature echo machine ### Interventions #### Intervention 1 **Arm Group Labels:** - Miniature echo machine **Description:** Images captured and real-time and store-and-forward file transfers performed **Name:** Miniature echo machine **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** paired t-testing and linear regression will be used to test the hypothesis that the small system is equivalent to the full-featured one (mean difference in values not different from 0 and slope of the regression line not different **Measure:** Validation of small portable ultrasound units **Time Frame:** single time point ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-80 yrs old * Scheduled for clinical echocardiogram Exclusion Criteria: * None **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients scheduled for clinical echocardiographic study Patients with possible diagnosis of cardiac tamponade ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** The Cleveland Clinic **Name:** James Thomas, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M16657 - Name: Thoracic Injuries - Relevance: HIGH - As Found: Thoracic Injuries ### Condition Browse Module - Meshes - ID: D000013898 - Term: Thoracic Injuries ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT05617079 **Acronym:** SoNeT **Brief Title:** The State of Nebulizer Therapy in Russian Federation **Official Title:** The State of Nebulizer Therapy in Russian Federation: a National Survey Among Medicine Physicians #### Organization Study ID Info **ID:** FARCT0004 #### Organization **Class:** OTHER **Full Name:** Russian Federation of Anesthesiologists and Reanimatologists ### Status Module #### Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-02-06 **Type:** ACTUAL **Last Update Submit Date:** 2024-02-03 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-07-01 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2022-11-15 **Type:** ACTUAL **Study First Submit Date:** 2022-11-07 **Study First Submit QC Date:** 2022-11-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Russian Federation of Anesthesiologists and Reanimatologists #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** It is known that the inhalation (nebulizer) use of drugs is of great importance in the intensive care of patients with acute and chronic respiratory failure of various origins. Searching PubMed data for the last 5 years (2017-2022) for the keywords "nebulizer therapy" revealed 533 publications, and "mesh nebulizer therapy" - only 25 sources. During the same period, the national database (E-Library) has 75 publications for the keywords "nebulizer therapy", and 4 sources for "mesh nebulizer therapy". It should be noted that almost all publications are devoted to the use of nebulizers for specific diseases and pathological syndromes. There are no works evaluating the adherence of specialists, systemic indications and actually used methods. The aim of trial is to study the current state of the use of nebulizer therapy in medical organizations and identify ways to improve its effectiveness This study is planned to be carried out using a questionnaire using a database based on the Internet electronic survey form. **Detailed Description:** We intend to involve at least 3 medical organizations in the subjects of the Russian Federation with a population of up to 1 million people; at least 5 medical organizations in the constituent entities of the Russian Federation with a population level of 1 to 3 million people, at least 7 organizations with a population level of more than 3 million people. In cities of the Russian Federation with a population of 1 million people or more - at least 5 medical organizations, and in the cities of Moscow and St. Petersburg - at least 10 medical organizations. ### Conditions Module **Conditions:** - Survey - Respiratory Failure - Respiratory Disease ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 370 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Anesthesiologists, intensive care specialists, heads of departments of anesthesiology and intensive care, deputy chief physicians for anesthesiology and intensive care (heads of centers), employees of the department of anesthesiology and intensive care, pulmonologists working in medical organizations that use nebulizer therapy. **Intervention Names:** - Other: Survey **Label:** Medicine physicians ### Interventions #### Intervention 1 **Arm Group Labels:** - Medicine physicians **Description:** an electronic survey will be conducted **Name:** Survey **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Registration of the structure and indications for nebulizer therapy **Measure:** Structure of indications, methods and frequency of use of nebulizer therapy **Time Frame:** up to 1 month after inclusion #### Secondary Outcomes **Description:** Registration of drugs used for nebulizer therapy **Measure:** Drugs and frequency of their use during nebulizer therapy **Time Frame:** up to 6 month after inclusion **Description:** Frequency of use of nebulizer therapy for various types of respiratory support **Measure:** The frequency of use of nebulizer therapy for high-flow oxygen therapy, non-invasive ventilation and mechanical ventilation **Time Frame:** up to 6 month after inclusion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Medical physicians Exclusion Criteria: * Lack of experience in conducting nebulizer therapy. Lack of technical capability for nebulizer therapy in a medical organization. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Medicine physicians (VMP) practicing in the hospital and in the community settings. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alexey Gritsan, MD **Phone:** +79039205304 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Nikita Trembach, MD **Phone:** +79528589299 **Role:** CONTACT #### Locations **Location 1:** **City:** Krasnoyarsk **Contacts:** ***Contact 1:*** - **Name:** Alexey Gritsan - **Role:** CONTACT **Country:** Russian Federation **Facility:** Alexey Gritsan **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Krasnoyarsk State Medical University n.a. prof. V.F. Voyno-Yasenetsky **Name:** Alexey Gritsan, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14968 - Name: Respiratory Insufficiency - Relevance: HIGH - As Found: Respiratory Failure - ID: M14957 - Name: Respiration Disorders - Relevance: HIGH - As Found: Respiratory Disease - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: HIGH - As Found: Respiratory Disease ### Condition Browse Module - Meshes - ID: D000012131 - Term: Respiratory Insufficiency - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000012120 - Term: Respiration Disorders ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02975479 **Brief Title:** Intralymphatic Immunotherapy in Increasing Doses, Substudy **Official Title:** Intralymphatic Immunotherapy in Increasing Doses up to 10 000 SQ-U - a Human Randomized Clinical Trial. Substudy. #### Organization Study ID Info **ID:** 2015-001259-63 substudy #### Organization **Class:** OTHER **Full Name:** Karolinska Institutet ### Status Module #### Completion Date **Date:** 2022-06-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-06-24 **Type:** ACTUAL **Last Update Submit Date:** 2022-06-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-06-20 **Type:** ACTUAL #### Start Date **Date:** 2016-05 **Status Verified Date:** 2020-10 #### Study First Post Date **Date:** 2016-11-29 **Type:** ESTIMATED **Study First Submit Date:** 2016-11-24 **Study First Submit QC Date:** 2016-11-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Skane University Hospital **Class:** OTHER **Name:** Karolinska University Hospital #### Lead Sponsor **Class:** OTHER **Name:** Karolinska Institutet #### Responsible Party **Investigator Affiliation:** Karolinska Institutet **Investigator Full Name:** Lars Olaf Cardell **Investigator Title:** Professor, Head of Division, M.D. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients with allergy to grass or birch will be treated with three intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo. \*\*\*IMPORTANT INFORMATION!\*\*\* The up-dosing protocol is changed due to adverse events at 5000 SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse events.) New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U. **Detailed Description:** 40 patients with seasonal allergic rhinitis will be recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch. Injections are given with 4-5 (-7) weeks interval. ### Conditions Module **Conditions:** - Rhinitis, Allergic, Seasonal **Keywords:** - Hay fever - Pollen allergy - Allergic rhinitis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** ALK Diluent, ATC-code V07AB. 3 injections with 4-7 weeks interval. **Intervention Names:** - Drug: ALK Diluent **Label:** Intralymphatic placebo injections **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** ATC-code V01AA02. 3 injections with 4-7 weeks interval in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U, 10000 SQ-U. \*\*\*IMPORTANT INFORMATION! The up-dosing protocol is changed due to an adverse event at the last injection. New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U. \*\*\* **Intervention Names:** - Drug: ALK Alutard SQ 5-grasses or ALK Alutard Birch **Label:** Intralymphatic active injections **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intralymphatic placebo injections **Name:** ALK Diluent **Other Names:** - 0,3% human albumin. ATC-code V07AB **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Intralymphatic active injections **Description:** Depot formulation of relevant allergen adsorbed to aluminium hydroxide in a suspension. **Name:** ALK Alutard SQ 5-grasses or ALK Alutard Birch **Other Names:** - Allergen, grass pollen. ATC-code V01AA02 or V01AA05 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale) and medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids). **Measure:** Mean combined daily symptoms-and-medications-score **Time Frame:** Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment). #### Secondary Outcomes **Description:** Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale) **Measure:** Mean total daily symptoms score **Time Frame:** Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment). **Description:** Daily scoring of medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids). **Measure:** Mean total daily medications score **Time Frame:** Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment). **Description:** The study subjects will be intranasally challenged with allergen and symptom score questionnaires are filled out pre-provocation and 5, 10 and 30 min post-provocation. **Measure:** Change in subjective allergic symptoms following nasal allergen provocation **Time Frame:** Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment. **Description:** Juniper Rhinitis quality of life questionnaire (RQLQ) questionnaires **Measure:** Effects on quality of life **Time Frame:** During peak pollen season which will be up to 6 months after completed treatment. **Description:** Skin prick test **Measure:** Short term change of skin reactivity **Time Frame:** Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment. **Measure:** S-IgE Grass or Birch **Time Frame:** Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment **Measure:** S-IgG4 Grass or Birch **Time Frame:** Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment **Measure:** Registration of adverse event **Time Frame:** From the first injection to 30 days after the last injections has been given ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Seasonal allergic symptoms for birch and/or grass verified by skin prick test, * Accepted informed consent Exclusion Criteria: * Pregnancy or nursing * Autoimmune or collagen disease (known) * Cardiovascular disease * Perennial pulmonary disease * Hepatic disease * Renal disease * Cancer * Any medication with a possible side-effect of interfering with the immune response * Previous immuno- or chemotherapy * Chronic diseases * Other upper airway disease (non-allergic sinusitis, nasal polyps, chronic obstructive and restrictive lung disease) * Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers) * Major metabolic disease * Known or suspected allergy to the study product * Alcohol or drug abuse * Mental incapability of coping with the study * Withdrawal of informed consent **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Lund **Country:** Sweden **Facility:** Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Lund **Zip:** 221 85 **Location 2:** **City:** Stockholm **Country:** Sweden **Facility:** ENT-department, Karolinska University Hospital Huddinge (ENT-department B51) **Zip:** 141 86 #### Overall Officials **Official 1:** **Affiliation:** Karolinska Institutet **Name:** Lars-Olaf Cardell, Professor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Hellkvist L, Hjalmarsson E, Weinfeld D, Dahl A, Karlsson A, Westman M, Lundkvist K, Winqvist O, Georen SK, Westin U, Cardell LO. High-dose pollen intralymphatic immunotherapy: Two RDBPC trials question the benefit of dose increase. Allergy. 2022 Mar;77(3):883-896. doi: 10.1111/all.15042. Epub 2021 Aug 29. **PMID:** 34379802 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000009668 - Term: Nose Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M15049 - Name: Rhinitis - Relevance: HIGH - As Found: Rhinitis - ID: M30545 - Name: Rhinitis, Allergic - Relevance: HIGH - As Found: Rhinitis, Allergic - ID: M2454 - Name: Hyperthermia - Relevance: LOW - As Found: Unknown - ID: M8464 - Name: Fever - Relevance: LOW - As Found: Unknown - ID: M9345 - Name: Rhinitis, Allergic, Seasonal - Relevance: HIGH - As Found: Rhinitis, Allergic, Seasonal - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M12604 - Name: Nose Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012220 - Term: Rhinitis - ID: D000065631 - Term: Rhinitis, Allergic - ID: D000006255 - Term: Rhinitis, Allergic, Seasonal ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M3877 - Name: Aluminum Hydroxide - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT03321279 **Acronym:** MOVE IT **Brief Title:** Social Incentives to Increase Mobility **Official Title:** Social Incentives to Increase Mobility Among Hospitalized Patients: The MOVE IT Randomized Trial #### Organization Study ID Info **ID:** 826974 #### Organization **Class:** OTHER **Full Name:** University of Pennsylvania ### Status Module #### Completion Date **Date:** 2019-09-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-07-30 **Type:** ACTUAL **Last Update Submit Date:** 2020-07-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-09-09 **Type:** ACTUAL #### Start Date **Date:** 2018-01-11 **Type:** ACTUAL **Status Verified Date:** 2020-07 #### Study First Post Date **Date:** 2017-10-25 **Type:** ACTUAL **Study First Submit Date:** 2017-10-04 **Study First Submit QC Date:** 2017-10-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Pennsylvania #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to assess the effectiveness of a social incentive-based gamification intervention to increase physical activity in the 3 months after hospital discharge. **Detailed Description:** This study aims to assess the effectiveness of a social incentive-based gamification intervention to increase physical activity in the 3 months after hospital discharge. To do this, the investigators will conduct a two-arm randomized, controlled trial during the 3-months after hospital discharge comparing a control group that uses a wearable device to track physical activity to an intervention group that uses the same wearable devices and receives a supportive social incentive-based gamification intervention to adhere to a step goal program. Patients will be enrolled during hospitalization from medicine and oncology floors into three phases. In phase 1 (hospitalization), patients inpatient step counts will be monitored. In phase 2 (week 1 post-discharge), patients will have a baseline step count estimated. In phase 3 (weeks 2-13 post-discharge), patients will be randomly assigned to the control or intervention group. Patients will be considered enrolled in the trial if they complete the run-in periods (phases 1 and 2) and then are randomized into phase 3. The enrollment phase will be part of another randomized trial which evaluates the impact of three recruitment strategies on patient enrollment. This trial will be completed and unmasked to patients before they begin the phase 1 of our study. The investigators will also explore patients' physical activity while in the hospital and if that differs across floors that have or have not deployed a nursing mobility protocol. Changes in patient functional decline and 30-day hospital readmission will also be explored. ### Conditions Module **Conditions:** - Pneumonia - Diabetes - Congestive Heart Failure - Chronic Obstructive Pulmonary Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 233 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants' daily step counts will be for weeks 2-13 after hospital discharge. Participants will be asked to complete surveys at 5, 9 and 13 weeks post-discharge. **Label:** Control **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Participants' daily step counts will be monitored for weeks 2-13 after hospital discharge. Participants will have a weekly step goal that increases from baseline by 10% each week of the intervention (12 weeks). Participants will engage in a social incentive-based gamification based on points and levels that leverages loss aversion, which has been demonstrated to motivate behavior change more effectively with losses than gains. Participants will receive daily feedback for the step counts and weekly feedback for levels. Participants will be asked to identify a support partner, who will receive weekly reports with the the participant's points and levels balance. **Intervention Names:** - Behavioral: Social Incentive **Label:** Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** Participants in the intervention arm will receive social incentives as part of the intervention. See arm descriptions for more detail. **Name:** Social Incentive **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome variable is the change in mean daily step count from the baseline period (week 1 post-discharge) to the intervention period (weeks 2-13 post-discharge). This will be measured using the Nokia Steel wearable device. . **Measure:** Change in mean daily step count from the baseline period to the intervention period, using a wearable pedometer (Nokia Steel) to measure step count. **Time Frame:** 13 weeks #### Secondary Outcomes **Description:** A secondary outcome variable is 30-day hospital readmission post-discharge, which will be obtained from the state-based registry. **Measure:** 30-day hospital readmission post-discharge, using the state's hospital database **Time Frame:** 13 weeks **Description:** A secondary outcome variable is functional decline from admission to 3 months post-discharge, which will be obtained from information collected through validated survey assessments. **Measure:** Functional decline from admission to 3 months post-discharge, measured using validated survey assessments. **Time Frame:** 13 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18 or older * Admitted to medicine or oncology floor in the hospital Exclusion Criteria: * Inability to provide informed consent * Does not have daily access to a smartphone compatible with the wearable device * Already enrolled in another physical activity program * Inpatient mobility score of 0 or 1 indicating that physical activity is not appropriate for the patient * Any other medical conditions that would prohibit participation in a 3-month physical activity program * Unable to complete the run-in phases (e.g. not discharged from the hospital within 60 days of enrolling; not willing to use the wearable device for the 3-month post-discharge intervention). **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Philadelphia **Country:** United States **Facility:** University of Pennsylvania **State:** Pennsylvania **Zip:** 19104 #### Overall Officials **Official 1:** **Affiliation:** University of Pennsylvania **Name:** Ryan Greysen, MD, MHS, MA **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Pennsylvania **Name:** Mitesh Patel, MD, MBA, MS **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Greysen SR, Waddell KJ, Patel MS. Exploring Wearables to Focus on the "Sweet Spot" of Physical Activity and Sleep After Hospitalization: Secondary Analysis. JMIR Mhealth Uhealth. 2022 Apr 27;10(4):e30089. doi: 10.2196/30089. **PMID:** 35476034 **Citation:** Greysen SR, Changolkar S, Small DS, Reale C, Rareshide CAL, Mercede A, Snider CK, Greysen HM, Trotta R, Halpern SD, Patel MS. Effect of Behaviorally Designed Gamification With a Social Support Partner to Increase Mobility After Hospital Discharge: A Randomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e210952. doi: 10.1001/jamanetworkopen.2021.0952. **PMID:** 33760089 **Citation:** Greysen HM, Reale C, Mercede A, Patel MS, Small D, Snider C, Rareshide C, Halpern SD, Greysen SR. Mobility and outcomes for validated evidence - Incentive trial (MOVE IT): Randomized clinical trial study protocol. Contemp Clin Trials. 2020 Feb;89:105911. doi: 10.1016/j.cct.2019.105911. Epub 2019 Dec 12. No abstract available. **PMID:** 31838257 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC01 - Name: Infections - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Congestive Heart Failure - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: HIGH - As Found: Obstructive Pulmonary Disease - ID: M23449 - Name: Pulmonary Disease, Chronic Obstructive - Relevance: HIGH - As Found: Chronic Obstructive Pulmonary Disease - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000029424 - Term: Pulmonary Disease, Chronic Obstructive - ID: D000006333 - Term: Heart Failure ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT05804279 **Brief Title:** Pharmacokinetics of BPDO-1603 or BPDO-16031 and BPDO-16033 Administration in Healthy Adults **Official Title:** Pharmacokinetics and Safety of BPDO-1603 or BPDO-16031 and BPDO-16033 Administration in Healthy Adults. Randomized, Open-label, Single-dose, Cross-over, Phase 1 Study #### Organization Study ID Info **ID:** HT-007-05 #### Organization **Class:** INDUSTRY **Full Name:** Hyundai Pharm ### Status Module #### Completion Date **Date:** 2023-03-14 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-04-07 **Type:** ACTUAL **Last Update Submit Date:** 2023-03-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-02-21 **Type:** ACTUAL #### Start Date **Date:** 2022-12-28 **Type:** ACTUAL **Status Verified Date:** 2023-03 #### Study First Post Date **Date:** 2023-04-07 **Type:** ACTUAL **Study First Submit Date:** 2023-03-15 **Study First Submit QC Date:** 2023-03-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Hyundai Pharm #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Pharmacokinetics and safety of BPDO-1603 or BPDO-16031 and BPDO-16033 administration in healthy adults. Randomized, open-label, single-dose, cross-over, Phase 1 study ### Conditions Module **Conditions:** - Healthy **Keywords:** - Alzheimer's disease, Dementia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 1 tablet contains memantine 20mg/donepezil 10mg **Intervention Names:** - Drug: BPDO-1603 **Label:** BPDO-1603 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 1 tablet memantine 20mg and 1 tablet donepezil 10mg **Intervention Names:** - Drug: BPDO-1603 **Label:** BPDO-16031,BPDO-16033 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - BPDO-1603 - BPDO-16031,BPDO-16033 **Description:** donepezil/mematine **Name:** BPDO-1603 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** pharmacokinetic properties **Measure:** Cmax of memantine and donpezil **Time Frame:** from baseline to day 10 #### Secondary Outcomes **Description:** pharmacokinetic properties **Measure:** AUClast of memantine and donpezil **Time Frame:** from baseline to day 10 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Healthy adults aged 19 or older and 55 or less at the time of screening tests 2. Men weigh 55 kg or more and women weigh 50 kg or more 3. Those with a body mass index of 18.5 kg/m2 or more and less than 27.0 kg/m2 Exclusion Criteria: 1. Clinically significant active chronic diseases, hepatometer (severe liver disorder, etc.), kidney (severe kidney disorder, etc.), and nervous system (hepatorespiratory tract patients). Parkinson's disease, immune system, respiratory system (asthenia, obstructive pulmonary disease, etc.), urinary system, digestive system (digestive ulcer, etc.), endocrine system, blood/tumor, cardiovascular system (cardiac infarction, heart failure, uncontrolled hypertension, atrioventricular junction disorder, etc.), or have a history. 2. A person who has a serious urinary tract infection due to renal tubular acidosis, etc. or has a history of history 3. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Hyundaipharm **Zip:** 06121 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6904 - Name: Dementia - Relevance: LOW - As Found: Unknown - ID: M3885 - Name: Alzheimer Disease - Relevance: LOW - As Found: Unknown - ID: T2192 - Name: Familial Alzheimer Disease - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: NootAg - Name: Nootropic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnDyAg - Name: Anti-Dyskinesia Agents ### Intervention Browse Module - Browse Leaves - ID: M1721 - Name: Donepezil - Relevance: LOW - As Found: Unknown - ID: M11542 - Name: Memantine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT04171479 **Acronym:** EPINAV **Brief Title:** RMN Versus Manual Epicardial Retrospective PMCF **Official Title:** A Retrospective Multicenter Post-Market Clinical Follow-up Registry Comparing Safety and Effectiveness Outcomes of Epicardial Cardiac Ablation Using Remote Navigation to Manual Techniques #### Organization Study ID Info **ID:** CLIN-024 #### Organization **Class:** INDUSTRY **Full Name:** Stereotaxis ### Status Module #### Completion Date **Date:** 2023-03-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-08-03 **Type:** ACTUAL **Last Update Submit Date:** 2023-08-01 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-03-30 **Type:** ACTUAL #### Start Date **Date:** 2020-10-02 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2019-11-21 **Type:** ACTUAL **Study First Submit Date:** 2019-04-30 **Study First Submit QC Date:** 2019-11-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Stereotaxis #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** Retrospective registry will compare subjects who've undergone a mapping and/or ablation procedure for either ischemic ventricular tachycardia or premature ventricular contraction using an epicardial approach with either manual or remote magnetic navigation. Subjects will be compared with regards to safety, efficacy and mortality. **Detailed Description:** Up to 10 centers in the European Union will be selected to conduct the trial. Once a site is a selected, receives local Ethics Committee approval, and receives Sponsor approval to enroll, the site will begin enrollment. All subjects must meet eligibility criteria and follow protocol and ethics committee requirements regarding informed consent prior to enrollment. Once a subject is enrolled, the site may begin reviewing the subject's medical records and entering data into the electronic data capture system. Once enrollment and retrospective data entry is complete at a site, a monitoring visit will occur where source data verification will occur. ### Conditions Module **Conditions:** - Ventricular Tachycardia - Premature Ventricular Contraction ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects who underwent epicardial mapping and/or ablation using a manual technique will comprise this group. **Intervention Names:** - Device: Epicardial mapping and/or ablation **Label:** Manual #### Arm Group 2 **Description:** Subjects who underwent epicardial mapping and/or ablation using a remote magnetic technique (using Stereotaxis Niobe system) will comprise this group. **Intervention Names:** - Device: Epicardial mapping and/or ablation **Label:** Remote Magnetic Navigation ### Interventions #### Intervention 1 **Arm Group Labels:** - Manual - Remote Magnetic Navigation **Description:** Either catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach. **Name:** Epicardial mapping and/or ablation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Characterize acute success rates for both groups. Acute success for VT procedures is defined as non-inducibility of clinical VT and/or other monomorphic VT at the end of the index-procedure. Acute success for PVC procedures is defined as no recurrence and non-inducibility of culprit PVC at the end of the index-procedure. **Measure:** Acute Success **Time Frame:** intra-operative **Description:** Assess rates of device-and procedure-related serious adverse events in both groups. **Measure:** Procedural Safety: rates of device-and procedure-related serious adverse events **Time Frame:** 48 hours post index procedure #### Secondary Outcomes **Description:** Characterize recurrence rates for both groups at 1 year post index procedure. **Measure:** Chronic Success **Time Frame:** 1 year post index procedure **Description:** Characterize rates of device-or procedure-related serious adverse events for both groups at 1 year post index procedure. **Measure:** Chronic Safety: rates of device-or procedure-related serious adverse events **Time Frame:** 1 year post index procedure **Description:** Assess mortality rate for both groups **Measure:** Mortality **Time Frame:** 1 year post index procedure **Description:** Characterize recurrence rates for both groups at last follow up. **Measure:** Chronic Success **Time Frame:** At last follow up visit, estimated up to 6 years post-procedure for some patients **Description:** Characterize rates of device-or procedure-related serious adverse events for both groups at last follow up. **Measure:** Chronic Safety: rates of device-or procedure-related serious adverse events **Time Frame:** At last follow up visit, estimated up to 6 years post-procedure for some patients ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years of age or older * Have undergone an epicardial RF mapping and/or ablation for a ventricular tachycardia (VT) as standard of care treatment using either the Niobe MNS or a manual approach * Index procedure was conducted between July 1, 2013-present date. Exclusion Criteria: * NA, all subjects who meet inclusion criteria may be enrolled. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Subjects who have undergone an epicardial cardiac mapping and ablation procedure using either manual or remote magnetic (using Stereotaxis Niobe system) guidance. ### Contacts Locations Module #### Locations **Location 1:** **City:** Prague **Country:** Czechia **Facility:** Na Homolce Hospital **Location 2:** **City:** Amsterdam **Country:** Netherlands **Facility:** OLVG Hospital **Location 3:** **City:** Rotterdam **Country:** Netherlands **Facility:** Erasmus Medical Center ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001145 - Term: Arrhythmias, Cardiac - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000075224 - Term: Cardiac Conduction System Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000005117 - Term: Cardiac Complexes, Premature ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M25869 - Name: Premature Birth - Relevance: LOW - As Found: Unknown - ID: M16384 - Name: Tachycardia - Relevance: HIGH - As Found: Tachycardia - ID: M19488 - Name: Tachycardia, Ventricular - Relevance: HIGH - As Found: Ventricular Tachycardia - ID: M20921 - Name: Ventricular Premature Complexes - Relevance: HIGH - As Found: Premature Ventricular Contractions - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M1472 - Name: Cardiac Conduction System Disease - Relevance: LOW - As Found: Unknown - ID: M8260 - Name: Cardiac Complexes, Premature - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013610 - Term: Tachycardia - ID: D000017180 - Term: Tachycardia, Ventricular - ID: D000018879 - Term: Ventricular Premature Complexes ### Misc Info Module #### Removed Countries - Country: Finland - Country: Romania - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT04930679 **Brief Title:** Evaluating Safety of Andiabet on Diabetes Mellitus Type II Patients, Phase I CT. **Official Title:** A Phase I, Open-label Safety Evaluation of Andiabet of Traphaco J.S.C on Diabetes Mellitus Type II #### Organization Study ID Info **ID:** TNLS/2018-03 #### Organization **Class:** OTHER **Full Name:** Centre of Clinical Pharmacology, Hanoi Medical University ### Status Module #### Completion Date **Date:** 2019-02-22 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-06-18 **Type:** ACTUAL **Last Update Submit Date:** 2021-06-11 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-02-22 **Type:** ACTUAL #### Start Date **Date:** 2018-11-24 **Type:** ACTUAL **Status Verified Date:** 2021-06 #### Study First Post Date **Date:** 2021-06-18 **Type:** ACTUAL **Study First Submit Date:** 2021-06-11 **Study First Submit QC Date:** 2021-06-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre of Clinical Pharmacology, Hanoi Medical University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This phase I clinical trial is used to evaluate the safety of Andiabet, a herbal-derived medicinal product that assists in the treatment of type 2 Diabetes (T2D). Thereby, determine efficacy of the drug on stabilizing blood glucose in T2D patients. **Detailed Description:** This is a 28-day phase I, open-label clinical trial to evaluate safety of Andiabet on . The general purpose is the evaluate safety via adverse events and tolerability of Andiabet on T2D patients, and evaluate effect of Andiabet on clinical and laboratory parameters. The study conducted on volunteering T2D patients, whose HbA1c level is =\< 7.5% and are not pregnant, had no records of addiction, allergy, hypersensitivity, and chronic diseases. The main evaluation criteria are fasting glucose, used for evaluating efficacy and safety, which evaluated based on adverse events. Ensuring quality of the data: Sponsor and CRO are supervisors. Supervision will be conducted periodically, ensuring the compliance with the research proposal, following GCP. Hanoi Medical University-Clinical center of Pharmacology is responsible for managing the data. Completed CFR are sent to the Center of Clinical Pharmacology, entered by Microsoft Excel and analysed using SPSS 16.0 Before analysing, these data will be checked randomly, avoiding errors in data entry. ### Conditions Module **Conditions:** - Diabetes Mellitus, Type 2 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** 20 diabetes type 2 patients are recruited, in which 14 took part in the study, randomly divided into 2 arms. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 14 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 1 capsule of Andiabet x 3 times/ day . Taken 30 minutes before meals in 28 days **Intervention Names:** - Drug: Andiabet **Label:** Group I **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 2 capsule of Andiabet x 3 times/ day . Taken 30 minutes before meals in 28 days **Intervention Names:** - Drug: Andiabet **Label:** Group II **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group I - Group II **Description:** Each hard capsule includes: 200mg Gynostemma Pentaphyllum Leaf, 200mg Largerstroemia Speciosa Leaf, 133mg Anemarrhena Asphodeloides Whole **Name:** Andiabet **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** 2 AEs recorded, there were changes in biochemical indices. However, these AEs are considered mild and unrelated to the investigated product. **Measure:** Adverse events **Time Frame:** 28 days **Description:** Group II is reported to have lower blood glucose compared to group I. However, the difference is efficacy is not clear between 2 groups **Measure:** Fasting blood glucose **Time Frame:** 28 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Participants must meet ALL the following criteria: * Type 2 Diabetes (T2D) patients with HbA1c lower than or equal to 7.5% * BMI range: 18-40 kg/m2 * Diagnosed with T2D or currently treating T2D (prescribed by physicians) with one or more of the following drugs: Metformin, Sulfonyl urea, dipeptidyl peptidase-4 inhibitors, or a-glucosidase inhibitors * Be able to stop using T2D drugs in 4 weeks, while maintaining diets and exercising routine. * Willing to take part in the study. Exclusion Criteria: Participants that have ONE of the following: * Diagnosed with Type 1 Diabetes. * History of complications due to Diabetes Mellitus. * History of cardiovascular diseases: hypertension, heart failure, Unstable agina, stroke or transient ischemic attack, myocardial infarction, arrhythmias, coronary artery interventions. * History of drugs, alcohol addiction. * Uncontrolled high blood pressure * Pre-study screening blood test with abnormal results in total blood compositions, urea, AST, ALT, creatinine, albumin, total bilirubin, total urine analysis. * Test positive for HIV or HbsAg * Abnormal ECG results that are clinically significant. * History of hypersensitivity to any of the ingredients in the testing product. * Female participants that are pregnant or having pregnancy intention **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hanoi **Country:** Vietnam **Facility:** Centre of Clinical Pharmacology, Hanoi Medical University #### Overall Officials **Official 1:** **Affiliation:** Center of Clinical Pharmacology, Hanoi Medical University **Name:** Dung C Nguyen, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Diabetes Mellitus, Type 2 - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT03464279 **Brief Title:** Use of a Behavioral Economic Intervention to Reduce Antibiotic Prescription for Upper Respiratory Infections **Official Title:** Use of a Behavioral Economic Intervention to Reduce Antibiotic Prescription for Upper Respiratory Infections #### Organization Study ID Info **ID:** IRB #16-000932-004 #### Organization **Class:** OTHER **Full Name:** University of California, Los Angeles ### Status Module #### Completion Date **Date:** 2018-03-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-05-02 **Type:** ACTUAL **Last Update Submit Date:** 2018-04-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-03-30 **Type:** ACTUAL #### Start Date **Date:** 2015-05-29 **Type:** ACTUAL **Status Verified Date:** 2018-04 #### Study First Post Date **Date:** 2018-03-14 **Type:** ACTUAL **Study First Submit Date:** 2018-03-07 **Study First Submit QC Date:** 2018-03-07 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** LAC+USC Medical Center **Class:** OTHER_GOV **Name:** Los Angeles County Department of Public Health #### Lead Sponsor **Class:** OTHER **Name:** University of California, Los Angeles #### Responsible Party **Investigator Affiliation:** University of California, Los Angeles **Investigator Full Name:** Catherine A. Sarkisian **Investigator Title:** Professor in Residence **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In an effort to implement Choosing Wisely guidelines and decrease patient harm, we will implement and evaluate a clinician audit-feedback and behavioral "nudge" initiative to reduce low-value antibiotics for URIs. Using a quasi-experiment (pre-post) design, antibiotic prescriptions for URI at LAC+USC Urgent Care Center (intervention site) vs. Olive View-UCLA Urgent Care Center (control site) will used to test the effects of behavioral "nudge" on antibiotic prescribing. **Detailed Description:** National prescription rates for low-value antibiotics for uncomplicated upper respiratory infections (URIs) remain unacceptably high, including at LAC+USC Medical Center-one of the largest safety net medical centers in the U.S. Using a quasi-experiment (pre-post) design, antibiotic prescriptions for URI at LAC+USC Urgent Care Center (intervention site) vs. Olive View-UCLA Urgent Care Center (control site) will be compared. A three-part intervention at LAC+USC consists of (1) the urgent care medical director emailing Choosing Wisely® guidelines and presented journal club to all 16 urgent care clinicians, and then (2) leveraging EHR performance data to provide individual clinicians with case-specific audit-feedback (both via emails and in-person while precepting nurse practitioners) on low-value antibiotic prescribing, and (3) using a behavioral "nudge", urgent care clinicians will sign a large poster committing to avoid prescribing low-value antibiotics for uncomplicated URIs, which will be displayed in the clinic. In contrast, the control site (Urgent Care Center at Olive View-Medical Center) will receive Centers for Disease Control prescription pads for non-antibiotic treatments (e.g., decongestants) that offer patients alternatives to antibiotics, in a broader health system effort to reduce antibiotic prescribing. Patient with URIs (e.g., acute bronchitis, bronchitis NOS, excluding guideline-based red flags such as COPD, HIV) will be identified using electronic health record clinical billable data and low-value antibiotic prescriptions rates per visit will be monitored at both sites. Differences in prescriptions rates will be determined using an interrupted time-series analysis comparing utilization between sites using a repeated measures logistic regression model. . ### Conditions Module **Conditions:** - Antibiotics - Upper Respiratory Infections - Safety-Net Hospitals - Behavioral Economics - Choosing Wisely ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 2500 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention Site (Urgent Care Center at LAC+USC Medical Center) will receive a three part intervention consisting of (1) Email Choosing Wisely® guidelines and presented journal club to all 16 urgent care clinicians, (2) leveraging EHR performance data to provide individual clinicians with case-specific audit-feedback (both via emails and in-person while precepting nurse practitioners) on low-value antibiotic prescribing, and (3) using a behavioral "nudge", urgent care clinicians will sign a large poster committing to avoid prescribing low-value antibiotics for uncomplicated URIs displayed in the clinic. **Intervention Names:** - Behavioral: Nudge using Behavioral Economic Interventions **Label:** Intervention Site **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control site (Urgent Care Center at Olive View-Medical Center) will receive broader health system efforts to reduce antibiotic prescribing consisting of Center for Disease Control prescription pads for non-antibiotic treatments (e.g., decongestants) that offer patients alternatives to antibiotics. **Intervention Names:** - Behavioral: Standard Practices to Reduce Health System Antibiotic Prescription **Label:** Control Site **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention Site **Name:** Nudge using Behavioral Economic Interventions **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Control Site **Name:** Standard Practices to Reduce Health System Antibiotic Prescription **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Changes in inappropriate antibiotic prescriptions rates per visit before and after implementation of intervention at both sites **Measure:** Change in Low-value antibiotic prescriptions rates per visit **Time Frame:** 1 year #### Secondary Outcomes **Description:** Change frequency of proportion of antibiotic appropriate diagnoses before intervention and after at both sites. **Measure:** Coding Shift (ie, a shift in use of diagnostic codes to conditions that are more antibiotic appropriate) in URI diagnosis **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * all patient receiving treatment for Upper Respiratory Infections (defined by ICD codes EHR billable codes) at both LAC+USC Medical Center Urgent Care or Olive View-UCLA Medical Center Exclusion Criteria: * Patients not receiving treatment for Upper Respiratory Infections at both LAC+USC Medical Center Urgent Care or Olive View-UCLA Medical Center **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Los Angeles **Country:** United States **Facility:** Los Angeles County +University of Southern California (LAC+USC) Medical Center **State:** California **Zip:** 90033 ### References Module #### References **Citation:** Meeker D, Knight TK, Friedberg MW, Linder JA, Goldstein NJ, Fox CR, Rothfeld A, Diaz G, Doctor JN. Nudging guideline-concordant antibiotic prescribing: a randomized clinical trial. JAMA Intern Med. 2014 Mar;174(3):425-31. doi: 10.1001/jamainternmed.2013.14191. **PMID:** 24474434 **Citation:** Gonzales R, Steiner JF, Lum A, Barrett PH Jr. Decreasing antibiotic use in ambulatory practice: impact of a multidimensional intervention on the treatment of uncomplicated acute bronchitis in adults. JAMA. 1999 Apr 28;281(16):1512-9. doi: 10.1001/jama.281.16.1512. **PMID:** 10227321 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M14978 - Name: Respiratory Tract Infections - Relevance: HIGH - As Found: Upper Respiratory Infection - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000012141 - Term: Respiratory Tract Infections ### Intervention Browse Module - Ancestors - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: CNSSti - Name: Central Nervous System Stimulants - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: HIGH - As Found: Initial - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M12478 - Name: Nicotine - Relevance: LOW - As Found: Unknown - ID: M7966 - Name: Ephedrine - Relevance: LOW - As Found: Unknown - ID: M27586 - Name: Pseudoephedrine - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: T242 - Name: Olive - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000900 - Term: Anti-Bacterial Agents ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02727179 **Acronym:** LapOpHuva **Brief Title:** Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases **Official Title:** Prospective and Randomized Study Comparing Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases #### Organization Study ID Info **ID:** HUVA-0515 #### Organization **Class:** OTHER **Full Name:** Hospital Universitario Virgen de la Arrixaca ### Status Module #### Completion Date **Date:** 2017-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-12-20 **Type:** ACTUAL **Last Update Submit Date:** 2017-12-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-03 **Type:** ACTUAL #### Start Date **Date:** 2005-02 **Status Verified Date:** 2017-12 #### Study First Post Date **Date:** 2016-04-04 **Type:** ESTIMATED **Study First Submit Date:** 2016-03-14 **Study First Submit QC Date:** 2016-03-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospital Universitario Virgen de la Arrixaca #### Responsible Party **Investigator Affiliation:** Hospital Universitario Virgen de la Arrixaca **Investigator Full Name:** Ricardo Robles Campos **Investigator Title:** MD, PHD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study evaluates the feasibility of laparoscopic surgery in patients diagnosed with colorectal liver metastases. Half of participants will be operated on by laparoscopic approach and the results obtained will be compared with the results from the other half of patients operated on by open approach. **Detailed Description:** The safety and efficacy of liver surgery in the treatment of colorectal liver metastases are well established for the open approach. It allows good results in terms of complications, disease free survival and overall survival, and for these reasons it has become the gold standard technique in the treatment of colorectal liver metastases. On the contrary, the role of laparoscopic liver resection in this context is not so clear nowadays. Generally, laparoscopic surgery offers some advantages such as less pain, shorter hospital stay and better aesthetic results. But the use of laparoscopic approach in liver surgery is still discussing: two international consensus conferences have been held and no strong conclusions have been made. Furthermore for colorectal liver metastases no randomized trials, comparing both techniques, have been published until now. To assess the feasibility of laparoscopic liver resection for colorectal metastases, the investigators propose this trial in which the patients suitable for laparoscopic approach are randomized to open or laparoscopic group ### Conditions Module **Conditions:** - Colorectal Liver Metastasis - Laparoscopic Liver Resection ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Liver resection performed by laparoscopic approach **Intervention Names:** - Procedure: Liver resection **Label:** Laparoscopic group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Liver resection performed by open approach **Intervention Names:** - Procedure: Liver resection **Label:** Open group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Laparoscopic group - Open group **Description:** The investigators perform an anatomical liver resections or wedge resections depending on tumour's location and tumour's characteristics **Name:** Liver resection **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Overall survival **Time Frame:** 1 year #### Secondary Outcomes **Description:** Duration of the surgical intervention **Measure:** Surgical operative time **Time Frame:** Intraoperative **Description:** Blood loss in milliliter **Measure:** Blood losses **Time Frame:** Intraoperative **Description:** Number of blood transfusions required during surgical operation **Measure:** Transfusion **Time Frame:** Intraoperative **Description:** Days between surgical operation and hospital discharge **Measure:** Hospital stay **Time Frame:** Up to 3 months **Description:** Days between surgical operation and the beginning of adjuvant chemotherapy **Measure:** Time between surgery and adjuvant chemotherapy **Time Frame:** Up to 3 months **Measure:** Mortality **Time Frame:** 90 days **Measure:** Morbidity **Time Frame:** 90 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with colorectal liver metastases; * Patients suitable for surgical treatment; * Patients eligible for laparoscopy approach. Exclusion Criteria: * Patients with high tumour load: multiples and bilobar colorectal metastases; * Patients with big liver metastases or close to major vessels; * Patients with oncological contraindications for surgery; * Cirrhotic liver * Needing for two stage liver resection; * Medical or psychiatric condition of the patient that compromises the informed consent authorization; * Refusal to participate in the study **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Murcia **Country:** Spain **Facility:** Hospital Universitario "Virgen de la Arrixaca" **Zip:** 30120 #### Overall Officials **Official 1:** **Affiliation:** Hospital Universitario Virgen de la Arrixaca **Name:** Ricardo Robles Campos, MD; PHD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Robles-Campos R, Lopez-Lopez V, Brusadin R, Lopez-Conesa A, Gil-Vazquez PJ, Navarro-Barrios A, Parrilla P. Open versus minimally invasive liver surgery for colorectal liver metastases (LapOpHuva): a prospective randomized controlled trial. Surg Endosc. 2019 Dec;33(12):3926-3936. doi: 10.1007/s00464-019-06679-0. Epub 2019 Jan 30. **PMID:** 30701365 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009385 - Term: Neoplastic Processes - ID: D000009369 - Term: Neoplasms - ID: D000010335 - Term: Pathologic Processes - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000004066 - Term: Digestive System Diseases - ID: D000008107 - Term: Liver Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: HIGH - As Found: Metastases - ID: M11113 - Name: Liver Neoplasms - Relevance: HIGH - As Found: Liver Metastases - ID: M12330 - Name: Neoplastic Processes - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009362 - Term: Neoplasm Metastasis - ID: D000008113 - Term: Liver Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT00461279 **Brief Title:** Attachment Security as Mediator and Moderator of Outcome in Major Depression **Official Title:** Attachment Security as Mediator and Moderator of Outcome in Major Depression Following Interpersonal Therapy and Cognitive Behavior Therapy #### Organization Study ID Info **ID:** 165/2006 #### Organization **Class:** OTHER **Full Name:** Centre for Addiction and Mental Health ### Status Module #### Completion Date **Date:** 2010-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2011-12-06 **Type:** ESTIMATED **Last Update Submit Date:** 2011-12-02 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2010-02 **Type:** ACTUAL #### Start Date **Date:** 2006-08 **Status Verified Date:** 2011-12 #### Study First Post Date **Date:** 2007-04-17 **Type:** ESTIMATED **Study First Submit Date:** 2007-04-13 **Study First Submit QC Date:** 2007-04-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Ontario Mental Health Foundation #### Lead Sponsor **Class:** OTHER **Name:** Centre for Addiction and Mental Health #### Responsible Party **Investigator Affiliation:** Centre for Addiction and Mental Health **Investigator Full Name:** Carolina McBride **Investigator Title:** Dr. Carolina McBride, C.Psych **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** In this study, the focus is on an individual's attachment security and its relation to treatment outcome in Major Depression.Adult attachment reflects how one seeks psychological and physical proximity to others for security and protection in times of stress. Researchers typically define four types of attachment security: one secure and three insecure (preoccupied, dismissing, and fearful). Adults with Major Depressive Disorder (MDD) will be randomly assigned to either Interpersonal Psychotherapy (IPT) or to Cognitive Behavior Therapy (CBT). The expectation is that adults with avoidant attachment styles will respond better to CBT, and adults with preoccupied attachment styles will respond better to IPT. Also, in comparison to CBT, outcome in IPT is hypothesized to be more closely related to change in attachment. **Detailed Description:** At the current rate of increase, Major Depression, it will be the 2nd most disabling condition in the world by 2020, behind heart disease. There are now a number of effective treatments for depression. However, a significant number of people either partially recover from their depression after a course of treatment, or do not recover at all. For example, between 30% and 50% of depressed individuals taking an antidepressant are partially or totally resistant to the treatment, and more than ½ of patients in psychotherapy never achieve full remission. The goal of treatment of major depression should always be full remission. Not achieving full remission from depression is problematic as lingering symptoms are a powerful predictor of relapse. One problem may be in the type of treatment that is offered to the individual. We know little about which clients benefit from which type of treatments and which clients do poorly. One individual may respond better to one type of treatment, while another individual may respond better to another type of treatment. The accurate identification of how an individual's characteristics interact with the type of treatment offered will help us match patients to the best-suited treatment for them, so we can optimize outcome. One characteristic that may be related to treatment outcome is adult attachment security. Adult attachment reflects how one seeks psychological and physical proximity to others for security and protection in times of stress. Researchers typically define four types of attachment security: one secure and three insecure (preoccupied, dismissing, and fearful). Secure adults have a good sense of self-worth and are comfortable with intimacy. Preoccupied adults have an exaggerated desire for closeness and a heightened concern about rejection. Dismissing adults deny the value of close relationships and instead value self-reliance. Finally, fearful adults have a very negative sense of self and avoid intimacy because they fear rejection. Secure attachment has been linked to positive interpersonal relationships and psychological health and insecure attachment has been linked to overall psychological distress. In this study, I focus on attachment security and its relation to treatment outcome. Adults with Major Depressive Disorder (MDD) will be randomly assigned to either Interpersonal Psychotherapy (IPT) or to Cognitive Behavior Therapy (CBT). The expectation is that adults with avoidant attachment styles will respond better to CBT, and adults with preoccupied attachment styles will respond better to IPT. Also, in comparison to CBT, outcome in IPT is hypothesized to be more closely related to change in attachment. The power of this study lies in its considered integration of three important issues at the forefront of mental health today: MDD, attachment, and treatment. MDD is a leading cause of disability worldwide and theoretically and empirically related to attachment. Attachment theory is a primary paradigm in the developmental, social/personality, and clinical literatures, and forms the theoretical cornerstone for IPT. IPT and CBT, while successful to a degree, fail or partially fail in many cases. Successful outcome in IPT depends on successfully improving a patient's attachment representations; this is not the case in CBT where change in depression is associated with change in cognition. The fact that these treatments represent contrasting approaches in the context of attachment, affords us a unique opportunity to investigate the relationships between attachment and treatment outcome for two distinct treatments, and investigate whether an individual's attachment security interacts with the type of treatment offered to yield a better response for one type of treatment versus another. This research could have a major impact on tailoring treatment to patient characteristics to optimize treatment for major depression. ### Conditions Module **Conditions:** - Major Depression **Keywords:** - attachment - depression - IPT - CBT - pharmacotherapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 134 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Cognitive Behavior Therapy **Label:** 1 **Type:** OTHER #### Arm Group 2 **Intervention Names:** - Behavioral: Interpersonal Psychotherapy **Label:** 2 **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 **Description:** Reframing and understanding cognitions of depression **Name:** Cognitive Behavior Therapy **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - 2 **Description:** Established psychotherapy for depression **Name:** Interpersonal Psychotherapy **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Measure:** HAMD **Time Frame:** baseline and completion **Measure:** BDI **Time Frame:** baseline and completion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 or older * meet the criteria for DSM-IV diagnosis of MDD based on the Structured Interview for DSM-IV, Axis I disorders (SCID-I; First et al., 1995) * score \> 16 on the 17-item HRSD (Hamilton, 1960). Exclusion Criteria: * Bipolar Disorder * Schizoaffective Disorder * Schizophrenia * Substance Abuse * Borderline or Antisocial Personality Disorder * Organic Brain Syndrome * ECT within the past 6 months * concurrent active medical illness **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Toronto **Country:** Canada **Facility:** Centre for Addiction and Mental Health **State:** Ontario **Zip:** M5T 1R8 #### Overall Officials **Official 1:** **Affiliation:** Centre for Addiction and Mental Health **Name:** Carolina McBride, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** Information about research at the Centre for Addiction and Mental Health **URL:** http://www.camh.net/research ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M7060 - Name: Depressive Disorder, Major - Relevance: HIGH - As Found: Major Depression - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder - ID: D000003865 - Term: Depressive Disorder, Major ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT04505579 **Brief Title:** The Tether™ - Vertebral Body Tethering System Post Approval Study **Official Title:** The Tether™ - Vertebral Body Tethering System Post Approval Study #### Organization Study ID Info **ID:** RAU2019-40S #### Organization **Class:** INDUSTRY **Full Name:** ZimVie ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-02-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-02-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2020-10-29 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2020-08-10 **Type:** ACTUAL **Study First Submit Date:** 2020-07-20 **Study First Submit QC Date:** 2020-08-05 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Setting Scoliosis Straight Foundation **Class:** UNKNOWN **Name:** Exponent, Inc. #### Lead Sponsor **Class:** INDUSTRY **Name:** ZimVie #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is PPSD:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study is an opportunity to provide continued reasonable assurance of the safety and probable benefit of The Tether HUD. The study will collect long term safety and efficacy information from patients who have had their idiopathic scoliosis treated via anterior vertebral body tethering (AVBT) with The Tether. **Detailed Description:** While spinal fusion remains the standard surgical treatment for progressive idiopathic scoliosis, concerns about the long-term effects of spinal fusion have led to the investigation of growth-modulation techniques. Anterior Vertebral Body Tethering (AVBT) is one such technique that utilizes growth modulation to remodel the shape of the vertebra and straighten scoliotic curves in skeletally immature individuals. In this technique, screws are inserted at each vertebral level for the length of the convex side of the curve. A strong cord is connected through the screw tulip heads and used to initially straighten the curve as each level is fixed with a set screw. Following surgery and during the growth period the spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated in areas of decreased pressure or tension (concave side). Following this principle, AVBT has been shown to alter spinal growth with the potential to correct scoliosis while maintaining spine flexibility. The objective of the study is to assess the ongoing safety and probable benefit of The Tether HUD which was approved by the FDA under an HDE. Subject enrollment and data collection will be managed by the Harms Study Group (HSG) and Setting Scoliosis Straight Foundation (SSSF) Registry. Institutions that are HSG members or affiliates, with Investigators/surgeons that are trained and approved to perform surgeries with The Tether, will participate in the registry. Ten sites from this group will be identified as study sites specific to this Tether post-approval study (PAS). Consecutive subjects from these sites, that meet the eligibility criteria of this study, will be flagged in the registry as the PAS cohort and the study endpoints will be assessed across this population. ### Conditions Module **Conditions:** - Scoliosis Idiopathic ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 5 Years ### Arms Interventions Module #### Arm Group 1 **Description:** Patients who have received The Tether HUD for treatment of idiopathic scoliosis. **Intervention Names:** - Device: Anterior Vertebral Body Tethering **Label:** Tether ### Interventions #### Intervention 1 **Arm Group Labels:** - Tether **Description:** Anterior Vertebral Body Tethering (AVBT) is a technique that utilizes growth modulation to remodel the shape of the vertebra and straighten scoliotic curves in skeletally immature individuals. In this technique, screws are inserted at each vertebral level for the length of the convex side of the curve. A strong cord is connected through the screw tulip heads and used to initially straighten the curve as each level is fixed with a set screw. Following surgery and during the growth period the spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated in areas of decreased pressure or tension (concave side). **Name:** Anterior Vertebral Body Tethering **Other Names:** - AVBT **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The primary safety endpoint is the rate of Serious Adverse Events (SAEs) and device- and/or procedure-related Adverse Events (AEs) **Measure:** Rate of SAEs and device- &/or procedure-related AEs **Time Frame:** AVBT surgery to five year post-op **Description:** The primary probable benefit endpoint is the percentage of patients with maintenance of the major Cobb angle less than or equal to 40 degrees at 60 months post-surgery **Measure:** Percentage of subjects with maintenance of the major Cobb angle less than or equal to 40 degrees at 60 months post-surgery **Time Frame:** AVBT surgery to five year post-op #### Secondary Outcomes **Description:** Rates of overall Adverse Events; relatedness, severity, time to event **Measure:** Adverse Events **Time Frame:** AVBT surgery to five year post-op **Description:** Rates and types of reoperation **Measure:** Reoperation **Time Frame:** AVBT surgery to five year post-op **Description:** Determined by radiographic assessment, defined as a new curve development with Cobb angle measurement greater than or equal to 40 degrees. **Measure:** Number of participants with new curves that develop above or below the tethered portion of the spine. **Time Frame:** AVBT surgery to five year post-op **Description:** Determined by radiographic assessment, typically defined as an increase in secondary Cobb angle measurement greater than or equal to 10 degrees, or medical intervention/ intent to treat. **Measure:** Number of participants with secondary curves that progress to the point of clinical significance. **Time Frame:** AVBT surgery to five year post-op **Measure:** Number of participants with device integrity failures including cord breakage and screw migration. **Time Frame:** AVBT surgery to five year post-op **Description:** Sagittal balance is assessed on the lateral radiograph by measuring the difference (i.e. distance) between posterosuperior aspect of the S1 vertebral body and the plumb line. **Measure:** Mean (SD) and distributions of sagittal balance (mm) from pre-op through last visit **Time Frame:** Baseline to five year post-op **Description:** Lumbar lordosis is defined as the angle at the intersection of lines perpendicular to lines parallel to the superior endplate of T12 and the superior endplate of S1. **Measure:** Mean (SD) and distributions of lumbar lordosis (degrees) from pre-op through last visit. **Time Frame:** Baseline to five year post-op **Description:** Self-reported outcomes of function, pain, self-image, mental health, and satisfaction. Mean score; 5 (Best) - 1 (Worst) **Measure:** Mean score of Scoliosis Research Society 22r Patient Questionnaire **Time Frame:** Baseline to five year post-op **Description:** Comparison of the measured lung function (forced expiratory volume (FEV1), forced vital capacity (FVC) and FEV1/FVC) to predicted values, lower and upper limits of normal to determine if lung function is within the limits of the normal population. **Measure:** Number of participants with compromised lung function **Time Frame:** Baseline to five year post-op **Description:** Measurements of trunk shape or rib hump will be collected preoperatively and at each follow-up visit. A standard scoliometer device will be used to measure the rib hump in the thoracic and/or lumbar regions of the spine, as applicable. The scoliometer is laid across the curve at right angles with the 0° mark at the spinous process and resting gently on the skin, not pressed down. The degrees of rotation are read and recorded. **Measure:** Measurement (degrees rotation) of trunk shape by scoliometer device. Mean (SD) [min, max] will be reported. **Time Frame:** Baseline to five year post-op **Measure:** Trunk flexibility as determined by distance (cm) of flexion and lateral bend using fingertip to floor method. **Time Frame:** Baseline to five year post-op ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of progressive idiopathic scoliosis * Skeletally immature, based on both Risser (\<5) and Sanders (\<8) assessments * Major Cobb angle ≥30° and ≤65° * Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging * Failed or intolerant to bracing Exclusion Criteria: * Presence of any systemic infection, local infection, or skin compromise at the surgical site * Prior spinal surgery at the level(s) to be treated * Documented poor bone quality, defined as a T-score -1.5 or less * Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions * Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent * Unwillingness to sign Informed Consent Form and participate in study procedures **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The Tether™ - Vertebral Body Tethering System is indicated for skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or be intolerant to brace wear. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Monica Barascout, BS **Phone:** 1-303-465-8960 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Kim Martinez **Phone:** 1-303-465-8960 **Role:** CONTACT #### Locations **Location 1:** **City:** San Diego **Contacts:** ***Contact 1:*** - **Name:** Peter O Newton, MD - **Phone:** 858-966-6789 - **Role:** CONTACT **Country:** United States **Facility:** Rady Children's Hospital **State:** California **Status:** RECRUITING **Zip:** 92123 **Location 2:** **City:** Aurora **Contacts:** ***Contact 1:*** - **Name:** Mark Erickson, MD - **Role:** CONTACT **Country:** United States **Facility:** Children's Hospital Colorado **State:** Colorado **Status:** RECRUITING **Zip:** 80045 **Location 3:** **City:** Jacksonville **Country:** United States **Facility:** Nemours Children's Health **State:** Florida **Status:** ACTIVE_NOT_RECRUITING **Zip:** 32207 **Location 4:** **City:** Atlanta **Contacts:** ***Contact 1:*** - **Name:** Joshua Murphy, MD - **Role:** CONTACT **Country:** United States **Facility:** Children's Healthcare of Atlanta **State:** Georgia **Status:** RECRUITING **Zip:** 30342 **Location 5:** **City:** New Orleans **Contacts:** ***Contact 1:*** - **Name:** Lawrence Haber, MD - **Role:** CONTACT **Country:** United States **Facility:** Ochsner Health **State:** Louisiana **Status:** RECRUITING **Zip:** 70121 **Location 6:** **City:** Rochester **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** A. Noelle Larson, MD - **Phone:** 507-284-3660 - **Role:** CONTACT **Country:** United States **Facility:** Mayo Clinic **State:** Minnesota **Status:** RECRUITING **Zip:** 55905 **Location 7:** **City:** Columbia **Contacts:** ***Contact 1:*** - **Name:** Daniel Hoernschemeyer, MD - **Phone:** 573-882-2663 - **Role:** CONTACT **Country:** United States **Facility:** University of Missouri - Columbia **State:** Missouri **Status:** RECRUITING **Zip:** 65201 **Location 8:** **City:** New York **Contacts:** ***Contact 1:*** - **Name:** Baron Lonner, MD - **Role:** CONTACT **Country:** United States **Facility:** Mount Sinai **State:** New York **Status:** RECRUITING **Zip:** 10029 **Location 9:** **City:** Philadelphia **Contacts:** ***Contact 1:*** - **Name:** Amer F Samdani - **Role:** CONTACT **Country:** United States **Facility:** Shriners Children's Hopital **State:** Pennsylvania **Status:** RECRUITING **Zip:** 19140 **Location 10:** **City:** Seattle **Contacts:** ***Contact 1:*** - **Name:** Burt Yaszay, MD - **Role:** CONTACT **Country:** United States **Facility:** Seattle Children's **State:** Washington **Status:** RECRUITING **Zip:** 98105 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013121 - Term: Spinal Curvatures - ID: D000013122 - Term: Spinal Diseases - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15417 - Name: Scoliosis - Relevance: HIGH - As Found: Scoliosis - ID: M15918 - Name: Spinal Curvatures - Relevance: LOW - As Found: Unknown - ID: M15919 - Name: Spinal Diseases - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012600 - Term: Scoliosis ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT04088279 **Brief Title:** Novel Quantitative Magnetic Resonance Imaging (MRI) Measures in the Assessment and Follow-up of Patients With Pulmonary Hypertension (PH) **Official Title:** Novel Quantitative Magnetic Resonance Imaging (MRI) Measures in the Assessment and Follow-up of Patients With Pulmonary Hypertension (PH) #### Organization Study ID Info **ID:** 246688 #### Organization **Class:** OTHER **Full Name:** Royal Brompton & Harefield NHS Foundation Trust ### Status Module #### Completion Date **Date:** 2021-06 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2019-09-12 **Type:** ACTUAL **Last Update Submit Date:** 2019-09-11 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2020-12 **Type:** ESTIMATED #### Start Date **Date:** 2018-11-19 **Type:** ACTUAL **Status Verified Date:** 2019-09 #### Study First Post Date **Date:** 2019-09-12 **Type:** ACTUAL **Study First Submit Date:** 2019-07-31 **Study First Submit QC Date:** 2019-09-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Royal Brompton & Harefield NHS Foundation Trust #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** A prospective study of the use of two novel MRI techniques (oxygen-enhanced and fourier decomposition MRI) in the initial diagnosis and follow-up of patients with Pulmonary Hypertension. The investigators believe these techniques may present a novel set of imaging biomarkers that may be used for risk stratification, prediction of treatment response and longitudinal disease monitoring. The reserach MRI is in addition to standard of care and will not affect treatment decisions. ### Conditions Module **Conditions:** - Pulmonary Hypertension **Keywords:** - MRI - oxygen enhanced - fourier decomposition ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Oxygen enhanced and fourier decomposition MRI **Name:** MRI **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Measure:** Delta pO2 max (mmHg) **Time Frame:** Baseline and 3-6 months **Measure:** Wash in and wash out time constants (min) **Time Frame:** Baseline and 3-6months **Measure:** Signal Intensity Change (%) **Time Frame:** Baseline and 3-6months **Measure:** Fractions (% area of lung imaged) **Time Frame:** Baseline and 3-6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Confirmed diagnosis of Pulmonary Hypertension. * Age 18 and over. Exclusion Criteria: * Standard contra-indications to MRI (as per NHS MRI safety questionnaire). * Not medically fit for transfer to MRI. * Patient judged inappropriate for involvement in study by clinical team e.g. secondary to emotional burden of recent diagnosis. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Patrik Pettersson **Phone:** 0330 128 8736 **Role:** CONTACT #### Locations **Location 1:** **City:** London **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sobi Sathianandan, MBBS - **Role:** CONTACT **Country:** United Kingdom **Facility:** Royal Brompton Hospital **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Royal Brompton & Harefield NHS Foundation Trust **Name:** Simon Padley **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M10027 - Name: Hypertension, Pulmonary - Relevance: HIGH - As Found: Pulmonary Hypertension - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006976 - Term: Hypertension, Pulmonary - ID: D000006973 - Term: Hypertension ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT00903279 **Acronym:** TOPS-MRSA **Brief Title:** Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery **Official Title:** Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery (TOPS-MRSA) #### Organization Study ID Info **ID:** TOPS2009 #### Organization **Class:** FED **Full Name:** Bay Pines VA Healthcare System ### Status Module #### Completion Date **Date:** 2010-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2017-01-31 **Type:** ESTIMATED **Last Update Submit Date:** 2017-01-30 **Overall Status:** WITHDRAWN #### Start Date **Date:** 2009-08 **Status Verified Date:** 2009-05 #### Study First Post Date **Date:** 2009-05-18 **Type:** ESTIMATED **Study First Submit Date:** 2009-05-14 **Study First Submit QC Date:** 2009-05-14 **Why Stopped:** Funding ### Sponsor Collaborators Module #### Lead Sponsor **Class:** FED **Name:** Bay Pines VA Healthcare System #### Responsible Party **Old Name Title:** David P. Johnson, MD **Old Organization:** Bay Pines VAHCS ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The investigators anticipate that utilization of retapamulin preoperatively will eliminate MRSA colonization among patients who are colonized in their nares. **Detailed Description:** Enhanced characterization of MRSA strains carried by patients and their eradication prior to surgery will significantly reduce healthcare costs to the VA by reducing the number of MRSA positive patients who need to be isolated and or closely monitored, and allow healthcare providers to better predict the patient's requirements. In addition, the application of molecular methods will facilitate faster tracking of MRSA postoperative infections. ### Conditions Module **Conditions:** - Orthopedic Procedures - Methicillin-resistant Staphylococcus Aureus **Keywords:** - MRSA colonization - Orthopedic Surgery - Altabax - Placebo ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Intervention Names:** - Drug: Altabax (retapamulin) **Label:** Altabax **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Placebo **Description:** Placebo will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery. **Name:** Placebo **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Altabax **Description:** Retapamulin 1% ointment will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery. **Name:** Altabax (retapamulin) **Other Names:** - Retapamulin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization **Time Frame:** 30 days #### Secondary Outcomes **Measure:** Identify a predominant clone among the MRSA isolates in this study **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who are admitted for an orthopedic surgical procedure * All patients will be screened and admitted to the study prior to surgery regardless of eventual culture results for MRSA Exclusion Criteria: * Pregnancy * Serious systemic illness due to renal, cardiac or hepatic disease * Inability to complete follow-up assessments * Allergy or intolerance to retapamulin * BMI \> 30 * Uncontrolled diabetes, severe anemia, thrombocytopenia or an underlying hematopoietic disorder or malignancy * Patients with serious life-threatening illnesses and those with terminal illness not expected to survive for two years or more will not be enrolled * Antibiotics administered during the course of the study will be recorded (name, dose and dates) **Healthy Volunteers:** True **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bay Pines **Country:** United States **Facility:** Bay Pines VAHCS **State:** Florida **Zip:** 33744 #### Overall Officials **Official 1:** **Affiliation:** Bay Pines VAHCS **Name:** Suzane Silbert, PhD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000016908 - Term: Gram-Positive Bacterial Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M15996 - Name: Staphylococcal Infections - Relevance: HIGH - As Found: Methicillin-resistant Staphylococcus Aureus - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M19252 - Name: Gram-Positive Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013203 - Term: Staphylococcal Infections ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M97132 - Name: Retapamulin - Relevance: HIGH - As Found: Competition - ID: M11688 - Name: Methicillin - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000508887 - Term: Retapamulin ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT06246279 **Brief Title:** Disease Management in Adolescents With Type 1 Diabetes **Official Title:** The Effect of the Education Program Prepared in Line With Transition Theory on Adaptation to Adolescence and Disease Management in Adolescents With Type 1 Diabetes: Randomized Controlled Study #### Organization Study ID Info **ID:** AdolescentswithType1Diabete #### Organization **Class:** OTHER **Full Name:** Akdeniz University ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-02-08 **Type:** ACTUAL **Last Update Submit Date:** 2024-02-06 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2022-12-01 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-02-07 **Type:** ACTUAL **Study First Submit Date:** 2024-01-30 **Study First Submit QC Date:** 2024-01-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Akdeniz University #### Responsible Party **Investigator Affiliation:** Akdeniz University **Investigator Full Name:** Ceren Calik **Investigator Title:** Master of Science, specialist nurse **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Adolescence period; It is a transition period of rapid growth, development and maturation in biochemical, physical, social and spiritual terms, which lasts from the beginning of puberty to young adulthood. Adolescence is a predictable developmental transition period for the individual. They also encounter unpredictable situations (such as childhood illnesses). One of these conditions is Type 1 Diabetes Mellitus, which is the most common metabolic endocrine system disease in adolescents. Type 1 diabetes is an important health/disease transition in the life of a child and adolescent. Therefore, this study aimed to determine the effect of the "Adaptation to Adolescence and Type 1 Diabetes Management Training Programme", prepared in line with Meleis's Transition Theory, on the adolescent's developmental transition adaptation, self-efficacy for diabetes management and glycemic control. ### Conditions Module **Conditions:** - type1diabetes - Adolescent Behavior - Self Efficacy **Keywords:** - Type 1 Diabetes - Transition Theory - Diabetes Management - Pediatric Nurse - Randomized Controlled Trial ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In addition to the routine diabetes training of the institution, the "Adaptation to Adolescence and Type 1 Diabetes Management Training Program" prepared in line with Meleis's Transition Theory will be administered online to adolescents via Microsoft Teams Program in groups of 10 people, for a total of 10 sessions in 2 months. **Intervention Names:** - Behavioral: Adaptation to Adolescence and Type 1 Diabetes Management Training Program **Label:** Experimental group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The routinely planned diabetes education of the institution will be given by the training nurse. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group **Description:** The content of the Training Program was created by researchers based on Transition Theory, in line with high-level research results and international guides. Then, the necessary arrangements were made by taking the opinions of 10 experts (child health and disease nursing faculty member, child and adolescent mental health specialist, child endocrinologist, child development specialist, nutrition and dietetics specialist, sports training specialist). The content was finalized in line with the comments received. **Name:** Adaptation to Adolescence and Type 1 Diabetes Management Training Program **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Reynolds Adjustment Screening Inventory has four subscales. These; emotional distress (10 items), antisocial behavior (8 items), positive self (6 items related to self-confidence and socialization) and anger control problems (8 items). The Cronbach alpha value of the scale is stated as 0.91. The lowest score of the scale is 32 and the highest score is 165. **Measure:** Reynolds Adjustment Screening Inventory for Adolescents **Time Frame:** This scale will be applied three times at beginning, 3rd and 6th months. #### Secondary Outcomes **Description:** The scale is used to determine the educational needs of adolescents or to evaluate the effectiveness of diabetes education programs. The scale consists of 26 items ranging from 1 (completely agree) to 5 (strongly disagree). The lowest total score that can be obtained from the scale is 26 and the highest is 130. A higher score indicates less self-efficacy. The Cronbach's alpha coefficient of the scale was found to be 0.85. **Measure:** Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes **Time Frame:** This scale will be applied three times at beginning, 3rd and 6th months. **Description:** Glycemic control was assessed by HbA1C level. In Type 1 Diabetes, Hb A1C level is one of the basic control parameters checked in the clinic in adolescents. It is repeated routinely every 3 months when the child comes to the outpatient clinic for control for Type 1 Diabetes. **Measure:** Glycemic Control - Hemoglobin A1C **Time Frame:** This scale will be applied three times at beginning, 3rd and 6th months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Having been diagnosed with type 1 diabetes in the last 6 months * HbA1c level \>7.5 Exclusion Criteria: * presence of a diagnosis of intellectual disability, autism spectrum disorder and psychotic disorder **Maximum Age:** 18 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ceren Calik **Phone:** +90 507 606 0057 **Role:** CONTACT #### Locations **Location 1:** **City:** Antalya **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ceren Calik - **Phone:** +90 507 606 0057 - **Role:** CONTACT **Country:** Turkey **Facility:** Akdeniz Univercity **Status:** RECRUITING **Zip:** 07100 #### Overall Officials **Official 1:** **Affiliation:** Akdeniz Univercity **Name:** Ceren Calik **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Type 1 Diabetes - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003922 - Term: Diabetes Mellitus, Type 1 ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT03421379 **Brief Title:** A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus **Official Title:** A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients With Diabetes Mellitus #### Organization Study ID Info **ID:** 16962 #### Organization **Class:** INDUSTRY **Full Name:** Eli Lilly and Company #### Secondary ID Infos **Domain:** Eli Lilly and Company **ID:** I8R-JE-IGBJ **Type:** OTHER ### Status Module #### Completion Date **Date:** 2018-08-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-10-08 **Type:** ACTUAL **Last Update Submit Date:** 2019-09-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-08-20 **Type:** ACTUAL #### Results First Post Date **Date:** 2019-10-08 **Type:** ACTUAL **Results First Submit Date:** 2019-08-14 **Results First Submit QC Date:** 2019-09-18 #### Start Date **Date:** 2018-02-21 **Type:** ACTUAL **Status Verified Date:** 2019-09 #### Study First Post Date **Date:** 2018-02-05 **Type:** ACTUAL **Study First Submit Date:** 2018-01-30 **Study First Submit QC Date:** 2018-01-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Eli Lilly and Company #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to determine the efficacy and safety of nasal glucagon compared to intramuscular (IM) glucagon for treatment of insulin-induced hypoglycemia in Japanese participants with diabetes mellitus. ### Conditions Module **Conditions:** - Diabetes Mellitus ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 75 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally. **Intervention Names:** - Drug: Glucagon Nasal Powder **Label:** Glucagon Nasal Powder **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM) **Intervention Names:** - Drug: Glucagon Hydrochloride Solution **Label:** Glucagon Hydrochloride Solution **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Glucagon Nasal Powder **Description:** Administered intranasally **Name:** Glucagon Nasal Powder **Other Names:** - LY900018 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Glucagon Hydrochloride Solution **Description:** Administered IM **Name:** Glucagon Hydrochloride Solution **Other Names:** - GlucaGen® **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Percentage of participants who achieved treatment success during the controlled insulin-induced hypoglycemia in participants with type 1 diabetes mellitus (T1DM) and participants with type 2 diabetes mellitus (T2DM).Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration. **Measure:** Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia **Time Frame:** Pre-dose up to 30 minutes post each glucagon administration #### Secondary Outcomes **Description:** PD assessment measured the change from Baseline in maximal blood glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride intramuscular (IM). **Measure:** Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) **Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration **Description:** PD assessment measured the time to maximal concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM. **Measure:** PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM **Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration **Description:** PK assessment measured the change from baseline in the area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of Glucagon Nasal Powder and Glucagon Hydrochloride IM. **Measure:** Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM **Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration **Description:** PK assessment measured the change from baseline in maximal concentration (Cmax) of glucagon nasal powder and glucagon hydrochloride IM. **Measure:** PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM **Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration **Description:** PK assessment measured the change from baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM. **Measure:** PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM **Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D) * Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or 18.5 to 35.0 kg/m2 for T2D * Hemoglobin A1c (HbA1c) ≤10% Exclusion Criteria: * Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month * Have received a total daily dose of insulin \>1.2 units per kilogram (U/kg) **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Fukuoka **Country:** Japan **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Zip:** 812-0025 **Location 2:** **City:** Tokyo **Country:** Japan **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Zip:** 130-0004 **Location 3:** **City:** Tokyo **Country:** Japan **Facility:** For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. **Zip:** 162-0053 **Location 4:** **City:** Tokyo **Country:** Japan **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Zip:** 169-0073 #### Overall Officials **Official 1:** **Affiliation:** Eli Lilly and Company **Name:** Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. **Description:** Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. **Info Types:** - STUDY_PROTOCOL - SAP - CSR **IPD Sharing:** YES **Time Frame:** Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting. **URL:** https://www.clinicalstudydatarequest.com ## Document Section ### Large Document Module #### Large Docs - Date: 2017-12-05 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 684592 - Type Abbrev: Prot - Upload Date: 2019-07-10T15:01 - Date: 2018-02-02 - Filename: SAP_001.pdf - Has ICF: False - Has Protocol: False - Has SAP: True - Label: Statistical Analysis Plan - Size: 444216 - Type Abbrev: SAP - Upload Date: 2019-07-10T15:01 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M10053 - Name: Hypoglycemia - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus ### Intervention Browse Module - Ancestors - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000054795 - Term: Incretins ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M9043 - Name: Glucagon - Relevance: HIGH - As Found: Cluster - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M26997 - Name: Glucagon-Like Peptide 1 - Relevance: HIGH - As Found: Cluster - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M27905 - Name: Incretins - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000005934 - Term: Glucagon - ID: D000052216 - Term: Glucagon-Like Peptide 1 ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** All randomized participants who received at least one dose of study drug. #### Event Groups **Group ID:** EG000 **Title:** Glucagon Nasal Powder **Deaths Num At Risk:** 71 **Description:** A single dose of 3 mg glucagon nasal powder was administered intranasally **ID:** EG000 **Other Num Affected:** 15 **Other Num at Risk:** 71 **Serious Number At Risk:** 71 **Title:** Glucagon Nasal Powder **Group ID:** EG001 **Title:** Glucagon Hydrochloride Solution **Deaths Num At Risk:** 70 **Description:** A single dose of 1 mg glucagon hydrochloride solution was administered IM **ID:** EG001 **Other Num Affected:** 13 **Other Num at Risk:** 70 **Serious Number Affected:** 1 **Serious Number At Risk:** 70 **Title:** Glucagon Hydrochloride Solution **Frequency Threshold:** 0 #### Other Events **Term:** Ear pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Ear and labyrinth disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Eye pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Eye pruritus **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Lacrimation increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Diarrhoea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Nausea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Toothache **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Vomiting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Feeling abnormal **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Cystitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 **Term:** Blood pressure decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 18.1 **Term:** Blood pressure increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 18.1 **Term:** Back pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Headache **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Nasal congestion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Nasal pruritus **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Oropharyngeal pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Rhinalgia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Cold sweat **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Hot flush **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Hypertension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 18.1 **Term:** Peripheral coldness **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 18.1 #### Serious Events **Term:** Vertigo positional **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Ear and labyrinth disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 71 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 70 **Num Events:** 1 **Time Frame:** From Baseline to End of Follow-up (Up to 2 Months) ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 33 **Group ID:** BG001 **Value:** 39 **Group ID:** BG002 **Value:** 72 **Units:** Participants ### Group **ID:** BG000 **Title:** Glucagon Nasal Powder/Glucagon Hydrochloride Solution **Description:** A single dose of 3 mg glucagon nasal powder was administered intranasally ### Group **ID:** BG001 **Title:** Glucagon Hydrochloride Solution/Glucagon Nasal Powder **Description:** A single dose of 1 mg glucagon hydrochloride solution was administered IM ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 11.6 **Value:** 41.7 #### Measurement **Group ID:** BG001 **Spread:** 9.2 **Value:** 57.5 #### Measurement **Group ID:** BG002 **Spread:** 13.0 **Value:** 50.2 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 13 #### Measurement **Group ID:** BG001 **Value:** 9 #### Measurement **Group ID:** BG002 **Value:** 22 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 20 #### Measurement **Group ID:** BG001 **Value:** 30 #### Measurement **Group ID:** BG002 **Value:** 50 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 33 #### Measurement **Group ID:** BG001 **Value:** 39 #### Measurement **Group ID:** BG002 **Value:** 72 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 33 #### Measurement **Group ID:** BG001 **Value:** 39 #### Measurement **Group ID:** BG002 **Value:** 72 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 33 #### Measurement **Group ID:** BG001 **Value:** 39 #### Measurement **Group ID:** BG002 **Value:** 72 **Class Title:** Japan **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants **Population Description:** All randomized participants who received at least one dose of study drug. ## Results Section - More Information Module ### Certain Agreement **Restriction Type:** GT60 **Restrictive Agreement:** True ### Point of Contact **Email:** [email protected] **Organization:** Eli Lilly and Company **Phone:** 800-545-5979 **Title:** Chief Medical Officer ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** -1.47 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.47 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** The pre-defined non-inferiority margin is (10%) **Non-Inferiority Type:** NON_INFERIORITY **Other Analysis Description:** **P-Value:** **P-Value Comment:** **Parameter Type:** Treatment Difference Wald's Method **Parameter Value:** 0.00 **Statistical Comment:** **Statistical Method:** **Tested Non-Inferiority:** ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ### Outcome Measure 6 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 32 - **Upper Limit:** - **Value:** 113 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 33 - **Upper Limit:** - **Value:** 119 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.50 - **Spread:** - **Upper Limit:** 4.02 - **Value:** 1.00 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.67 - **Spread:** - **Upper Limit:** 4.00 - **Value:** 1.50 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 89 - **Upper Limit:** - **Value:** 4830 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 32 - **Upper Limit:** - **Value:** 3240 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 103 - **Upper Limit:** - **Value:** 9520 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 37 - **Upper Limit:** - **Value:** 3290 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.17 - **Spread:** - **Upper Limit:** 0.67 - **Value:** 0.25 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.08 - **Spread:** - **Upper Limit:** 0.67 - **Value:** 0.17 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Percentage of participants who achieved treatment success during the controlled insulin-induced hypoglycemia in participants with type 1 diabetes mellitus (T1DM) and participants with type 2 diabetes mellitus (T2DM).Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration. **Parameter Type:** NUMBER **Population Description:** All randomized participant who completed both treatment visits and had evaluable treatment success data. **Reporting Status:** POSTED **Time Frame:** Pre-dose up to 30 minutes post each glucagon administration **Title:** Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **Description:** A single dose of 3 mg glucagon nasal powder was administered intranasally **ID:** OG000 **Title:** Glucagon Nasal Powder ##### Group **Description:** A single dose of 1 mg glucagon hydrochloride solution was administered IM **ID:** OG001 **Title:** Glucagon Hydrochloride Solution #### Outcome Measure 2 **Description:** PD assessment measured the change from Baseline in maximal blood glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride intramuscular (IM). **Dispersion Type:** Geometric Coefficient of Variation **Parameter Type:** GEOMETRIC_MEAN **Population Description:** All randomized patients who receive at least 1 dose of the study drug and have evaluable PD data. **Reporting Status:** POSTED **Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration **Title:** Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) **Type:** SECONDARY **Unit of Measure:** milligram/deciliter (mg/dL) ##### Group **Description:** A single dose of 3 mg glucagon nasal powder was administered intranasally **ID:** OG000 **Title:** Glucagon Nasal Powder ##### Group **Description:** A single dose of 1 mg glucagon hydrochloride solution was administered IM **ID:** OG001 **Title:** Glucagon Hydrochloride Solution #### Outcome Measure 3 **Description:** PD assessment measured the time to maximal concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM. **Dispersion Type:** Full Range **Parameter Type:** MEDIAN **Population Description:** All randomized participants who received at least one dose of study drug and had evaluable PD data. **Reporting Status:** POSTED **Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration **Title:** PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM **Type:** SECONDARY **Unit of Measure:** hour ##### Group **Description:** A single dose of 3 mg glucagon nasal powder was administered intranasally **ID:** OG000 **Title:** Glucagon Nasal Powder ##### Group **Description:** A single dose of 1 mg glucagon hydrochloride solution was administered IM **ID:** OG001 **Title:** Glucagon Hydrochloride Solution #### Outcome Measure 4 **Description:** PK assessment measured the change from baseline in the area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of Glucagon Nasal Powder and Glucagon Hydrochloride IM. **Dispersion Type:** Geometric Coefficient of Variation **Parameter Type:** GEOMETRIC_MEAN **Population Description:** All randomized participants who received at least one dose of study drug and had evaluable PK data. **Reporting Status:** POSTED **Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration **Title:** Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM **Type:** SECONDARY **Unit of Measure:** Picogram*hour/milliliter (pg*h/mL) ##### Group **Description:** A single dose of 3 mg glucagon nasal powder was administered intranasally **ID:** OG000 **Title:** Glucagon Nasal Powder ##### Group **Description:** A single dose of 1 mg glucagon hydrochloride solution was administered IM **ID:** OG001 **Title:** Glucagon Hydrochloride Solution #### Outcome Measure 5 **Description:** PK assessment measured the change from baseline in maximal concentration (Cmax) of glucagon nasal powder and glucagon hydrochloride IM. **Dispersion Type:** Geometric Coefficient of Variation **Parameter Type:** GEOMETRIC_MEAN **Population Description:** All randomized participants who received at least one dose of study drug and had evaluable PK data. **Reporting Status:** POSTED **Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration **Title:** PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM **Type:** SECONDARY **Unit of Measure:** picogram/milliliter (pg/mL) ##### Group **Description:** A single dose of 3 mg glucagon nasal powder was administered intranasally **ID:** OG000 **Title:** Glucagon Nasal Powder ##### Group **Description:** A single dose of 1 mg glucagon hydrochloride solution was administered IM **ID:** OG001 **Title:** Glucagon Hydrochloride Solution #### Outcome Measure 6 **Description:** PK assessment measured the change from baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM. **Dispersion Type:** Full Range **Parameter Type:** MEDIAN **Population Description:** All randomized participants who received at least one dose of study drug and had evaluable PK data. **Reporting Status:** POSTED **Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration **Title:** PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM **Type:** SECONDARY **Unit of Measure:** hour (h) ##### Group **Description:** A single dose of 3 mg glucagon nasal powder was administered intranasally **ID:** OG000 **Title:** Glucagon Nasal Powder ##### Group **Description:** A single dose of 1 mg glucagon hydrochloride solution was administered IM **ID:** OG001 **Title:** Glucagon Hydrochloride Solution ### Participant Flow Module #### Group **Description:** A single dose of 3 milligram (mg) glucagon nasal powder was administered intranasally in period 1 then 1 mg single dose intramuscular glucagon hydrochloride solution was administered in period 2. **ID:** FG000 **Title:** Glucagon Nasal Powder/Glucagon Hydrochloride #### Group **Description:** A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM) in period 1 then 3 mg single dose glucagon nasal powder was administered in period 2. **ID:** FG001 **Title:** Glucagon Hydrochloride Solution/Glucagon Nasal Powder #### Period **Title:** Period 1 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Withdraw **Type:** Physician Decision ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Withdraw **Type:** Did not receive treatment ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 34 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 41 ##### Milestone **Type:** Received at Least One Dose of Study Drug ###### Achievement **Group ID:** FG000 **Number of Subjects:** 33 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 39 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 32 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 37 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 4 #### Period **Title:** Washout Period (3 to 14 Days) ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 32 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 37 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 32 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 37 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 #### Period **Title:** Period 2 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 32 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 37 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 32 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 37 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 **Pre-Assignment Details:** Participants were randomized to receive either nasal glucagon or intramuscular (IM) glucagon in the first period, followed by the alternate treatment in the second period. **Has Results:** True
## Protocol Section ### Identification Module **NCT ID:** NCT05065879 **Brief Title:** Evaluation of Immunogenicity and Safety of COVID-19 Vaccine (Produced in Beijing) in Patients With Hypertension and/or Diabetes **Official Title:** A Post-marketing Clinical Study of the Inactivated SARS-CoV-2 Vaccine (Vero Cells) (Produced in Beijing): Immunogenicity and Safety Assessments in Patients With Hypertension and/or Diabetes #### Organization Study ID Info **ID:** COVAX (HT/DM)-Beijing #### Organization **Class:** INDUSTRY **Full Name:** China National Biotec Group Company Limited ### Status Module #### Completion Date **Date:** 2022-01-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-01-10 **Type:** ACTUAL **Last Update Submit Date:** 2022-01-05 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-01-05 **Type:** ACTUAL #### Start Date **Date:** 2021-10-05 **Type:** ACTUAL **Status Verified Date:** 2022-01 #### Study First Post Date **Date:** 2021-10-04 **Type:** ACTUAL **Study First Submit Date:** 2021-09-28 **Study First Submit QC Date:** 2021-10-01 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Hunan Provincial Center for Disease Control and Prevention **Class:** OTHER **Name:** Guizhou Center for Disease Control and Prevention **Class:** OTHER **Name:** Center for Disease Control and Prevention, Fujian **Class:** INDUSTRY **Name:** Beijing Institute of Biological Products Co Ltd. #### Lead Sponsor **Class:** INDUSTRY **Name:** China National Biotec Group Company Limited #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To evaluate the post-marketing immunogenicity and safety of the inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (Vero cells) in patients aged 60 years or older with hypertension and/or diabetes, thus to further collect the immunogenicity and safety data of this product in special populations. **Detailed Description:** After giving informed consent, patients with hypertension, patients with diabetes, patients with both diseases, and healthy controls, all aged 60 years or older, were given two doses of the inactivated SARS-CoV-2 vaccine (Vero cells). Venous blood samples were collected before the first dose and on day 28 after the second dose to evaluate the immunogenicity of the vaccine. Adverse events were actively recorded on a diary card once daily from day 0 to day 7 and once from day 8 to day 21 after the first dose and the second dose. Within 3 months after immunization with the second dose and collection of diary cards, the subjects were followed up by phone once a month as well as self-report to collect serious adverse events. ### Conditions Module **Conditions:** - COVID-19 Pneumonia ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** Serum testing technicians will be masked. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 1440 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Hypertension group will enroll 330 subjects with hypertension (aged 60 years or older). **Intervention Names:** - Biological: COVAX **Label:** Hypertension group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Diabetes group will enroll 330 subjects with diabetes (aged 60 years or older). **Intervention Names:** - Biological: COVAX **Label:** Diabetes group **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Combined Diseases group will enroll 300 subjects with both hypertension and diabetes (aged 60 years or older). **Intervention Names:** - Biological: COVAX **Label:** Combined Diseases group **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Healthy people group will enroll 480 subjects with no medical history of hypertension or diabetes (aged 60 years or older). **Intervention Names:** - Biological: COVAX **Label:** Healthy people group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Combined Diseases group - Diabetes group - Healthy people group - Hypertension group **Description:** 2 doses of Covid-19 vaccine **Name:** COVAX **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** the rate of positive seroconversion against coronavirus **Measure:** Seroconversion rate **Time Frame:** Up to 28 days after the second dose **Description:** neutralizing antibody level against coronavirus **Measure:** Neutralizing antibody level **Time Frame:** Up to 28 days after the second dose #### Secondary Outcomes **Description:** analyse the incidence of adverse events following immunization, both solicited and unsolicited **Measure:** Adverse events following vaccination **Time Frame:** up to 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ≥60 years old individuals with full civil capacity. * Clinically confirmed body temperature of \<37.3°C before enrolling in this study. * Able and willing to participate in the study plan during the entire study and follow-up period. * Capable of understanding the study procedures, willing to sign the informed consent form, and able to comply with the requirements of the clinical study protocol. * Inclusion criteria for patients with hypertension and/or diabetes: Hypertension and/or diabetes definitively diagnosed by a community-level or higher medical institution. Patients with hypertension: systolic pressure \<160 mmHg and diastolic pressure \<100 mmHg on the day of immunization achieved by lifestyle adjustment and/or drug treatment; patients with diabetes: fasting glucose ≤13.9 mmol/L on the day of (or within 3 days before) immunization achieved by lifestyle adjustment and/or drug treatment. Exclusion Criteria: * Previously confirmed or asymptomatic COVID-19 patient. * Has been immunized with a SARS-CoV-2 vaccine. * Illiterate. * Known allergy to any ingredient (including excipient) of this product. * Received non-specific immunoglobulin injection within 1 month before enrollment. * Received a live attenuated vaccine within 1 month before immunization or other vaccine within 14 days before immunization. * Previous serious allergy to vaccine (e.g., acute allergic reaction, urticaria, angioedema, and dyspnea). * Has uncontrolled epilepsy and other progressive neurological disorders; history of Guillain-Barré syndrome. * Severe respiratory disorders, severe hepatic and renal diseases, malignancies, and various acute diseases or acute onset of chronic diseases. * Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases. * Definitively diagnosed with thrombocytopenia or history of other coagulation disorders that may cause subcutaneous injection to be contraindicated. * Currently experiencing acute complications (ketoacidosis, hyperosmolar state, lactic acidosis, etc.) of diabetes; or within 2 weeks after recovery from these complications. * Other physical conditions judged by the investigator that render the patient unsuitable for participation in the clinical study. **Healthy Volunteers:** True **Minimum Age:** 60 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Quanzhou **Country:** China **Facility:** Nan'an Center for Disease Control and Prevention **State:** Fujian **Location 2:** **City:** Sanming **Country:** China **Facility:** Yong'an Center for Disease Control and Prevention **State:** Fujian **Location 3:** **City:** Sanming **Country:** China **Facility:** Youxi Center for Disease Control and Prevention **State:** Fujian **Location 4:** **City:** Tongren **Country:** China **Facility:** Songtao Miao Autonomous County Center for Disease Control and Prevention **State:** Guizhou **Location 5:** **City:** Changde **Country:** China **Facility:** Linli County Center for Disease Control and Prevention **State:** Hunan ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 - ID: D000006973 - Term: Hypertension ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT05399979 **Brief Title:** Fetal Heart Rate Changes and Labor Neuraxial Analgesia: a Machine Learning Approach **Official Title:** Fetal Heart Rate Changes and Labor Neuraxial Analgesia: a Machine Learning Approach #### Organization Study ID Info **ID:** 1567908 #### Organization **Class:** OTHER **Full Name:** Augusta University ### Status Module #### Completion Date **Date:** 2022-05-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2022-06-01 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-05-05 **Type:** ACTUAL #### Start Date **Date:** 2021-06-09 **Type:** ACTUAL **Status Verified Date:** 2022-06 #### Study First Post Date **Date:** 2022-06-01 **Type:** ACTUAL **Study First Submit Date:** 2022-05-27 **Study First Submit QC Date:** 2022-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Augusta University #### Responsible Party **Investigator Affiliation:** Augusta University **Investigator Full Name:** Efrain Riveros Perez, MD **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aims to perform statistical inference and prediction of changes in fetal heart rate during active labor in healthy pregnant women by comparing three different machine learning methods **Detailed Description:** Purpose: This study aims to perform statistical inference and prediction of changes in fetal heart rate during active labor in healthy pregnant women by comparing three different machine learning methods. Methods: A retrospective analysis of 1077 healthy laboring parturients receiving neuraxial analgesia was conducted. We compared a principal components regression model with treebased random forest, ridge regression, multiple regression, a general additive model, and elastic net in terms of prediction accuracy and interpretability for inference purposes. ### Conditions Module **Conditions:** - Fetal Bradycardia ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 1077 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Labor Neuraxial Analgesia **Name:** Labor Neuraxial Analgesia **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** fetal heart rate under 120 lpm for more than 10 minutes **Measure:** fetal bradycardia **Time Frame:** 15 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Older than 18 years * Pregnancy requiring labor analgesia * Active labor * Request of neuraxial analgesia per patient and/or obstetrician * Received combined spinal-epidural technique Exclusion Criteria: * Uterine tachysystole before neuraxial analgesia. * Baseline blood pressure \<90/60 mmHg. * Third trimester hemorrhage * Eclampsia * Allergies to local anesthetics or fentanyl. * Maternal fever. * Pruritus before performance of neuraxial analgesia **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** -Pregnant patients admitted to the labor and delivery unit of an academic center ### Contacts Locations Module #### Locations **Location 1:** **City:** Augusta **Country:** United States **Facility:** Augusta University Medical Center **State:** Georgia **Zip:** 30907 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001145 - Term: Arrhythmias, Cardiac - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5196 - Name: Bradycardia - Relevance: HIGH - As Found: Bradycardia - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001919 - Term: Bradycardia ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02654379 **Brief Title:** Observational Study Evaluating Rituximab Use and Use of the Patient Alert Card in Participants Receiving Rituximab Infusion for a Non-Oncology Indication at Infusion Centers in Europe **Official Title:** MabThera Drug Utilisation Study and Patient Alert Card Evaluation in Non-Oncology Patients in Europe: An Infusion Centre-Based Approach #### Organization Study ID Info **ID:** BA28478 #### Organization **Class:** INDUSTRY **Full Name:** Hoffmann-La Roche ### Status Module #### Completion Date **Date:** 2017-09-29 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-04-09 **Type:** ACTUAL **Last Update Submit Date:** 2018-04-06 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-09-29 **Type:** ACTUAL #### Start Date **Date:** 2015-12-18 **Type:** ACTUAL **Status Verified Date:** 2018-04 #### Study First Post Date **Date:** 2016-01-13 **Type:** ESTIMATED **Study First Submit Date:** 2016-01-11 **Study First Submit QC Date:** 2016-01-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Hoffmann-La Roche #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** This study is to characterize the indications for which rituximab is being used and to evaluate the use of the Patient Alert Card (PAC) in participants receiving the medication for non-oncology conditions at infusion centers. The study involves the retrospective chart review of rituximab users' medical records in non-oncology indications as well as a survey to collect information on participant characteristics, and will include questions about participant knowledge on the risk of infections, participant receipt and review of the PAC, and any actions the participant has taken as a result of receiving the PAC. ### Conditions Module **Conditions:** - Off-Label Use ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 1408 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cohort consisting of participants who are in the center to receive an infusion for rituximab for a non-oncology indication. **Intervention Names:** - Biological: Rituximab **Label:** Cohort ### Interventions #### Intervention 1 **Arm Group Labels:** - Cohort **Description:** Rituximab use in non-oncology indications **Name:** Rituximab **Other Names:** - MabThera **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Measure:** Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab **Time Frame:** Up to 10 months **Measure:** Percentage of Participants Using Rituximab Off-Label **Time Frame:** Up to 10 months #### Secondary Outcomes **Measure:** Disease Activity Score Based on 28 Joints (DAS28) for Participants with Rheumatoid Arthritis (RA) **Time Frame:** Up to 10 months **Measure:** Percentage of Participants Who Received the Patient Alert Card (PAC) **Time Frame:** Up to 10 months **Measure:** Percentage of Participants Who Read the PAC **Time Frame:** Up to 10 months **Measure:** Percentage of Participants Who Received Additional Safety-Related Materials **Time Frame:** Up to 10 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participant is in the center to receive an infusion for rituximab for a non-oncology indication during the study period * Aged 18 years or older Exclusion Criteria: * Has previously already completed the rituximab survey * Has participated in the past 12 months in a clinical trial in which rituximab was one of the treatments being evaluated. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Participants in the center to receive an infusion for rituximab for a non-oncology indication during the study period. ### Contacts Locations Module #### Locations **Location 1:** **City:** Clermont Ferrand **Country:** France **Facility:** Chu De Clermont Ferrand; Hopital Gabriel Montpied **Zip:** 63003 **Location 2:** **City:** Corbeil Essonnes **Country:** France **Facility:** Centre Hospitalier Sud Francilien **Zip:** 91106 **Location 3:** **City:** Le Mans **Country:** France **Facility:** Centre Hospitalier Le Mans **Zip:** 72037 **Location 4:** **City:** Lille **Country:** France **Facility:** Hopital Claude Huriez - CHU Lille **Zip:** 59037 **Location 5:** **City:** Montpellier **Country:** France **Facility:** Hôpital Lapeyronie **Zip:** 34295 **Location 6:** **City:** Nantes **Country:** France **Facility:** CHU NANTES - Hôtel Dieu; Pharmacy **Zip:** 44093 **Location 7:** **City:** Paris **Country:** France **Facility:** Hôpital Cochin **Zip:** 75014 **Location 8:** **City:** Pessac **Country:** France **Facility:** Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Centre François Magendie **Zip:** 33600 **Location 9:** **City:** Saint-Etienne **Country:** France **Facility:** CHU Saint-Etienne, Hopital Bellevue **Zip:** 42055 **Location 10:** **City:** Toulouse **Country:** France **Facility:** CHU de Toulouse - Hôpital Purpan **Zip:** 31059 **Location 11:** **City:** Dresden **Country:** Germany **Facility:** Krankenhaus Dresden-Friedrichstadt **Zip:** 01067 **Location 12:** **City:** Frankfurt **Country:** Germany **Facility:** CIRI - Centrum für Innovative Diagnostik und Therapie GmbH **Zip:** 60528 **Location 13:** **City:** Freiburg **Country:** Germany **Facility:** Universitaetsklinikum Freiburg; Innere Medizin II, Gastroenterologie **Zip:** 79106 **Location 14:** **City:** Halle **Country:** Germany **Facility:** Private Practice Dr. A. Liebhaber **Zip:** 06128 **Location 15:** **City:** Heidelberg **Country:** Germany **Facility:** Universitätsklinikum Heidelberg **Zip:** 69120 **Location 16:** **City:** Lübeck **Country:** Germany **Facility:** Universitätsklinikum Schleswig-Holstein; Campus Lübeck **Zip:** 23538 **Location 17:** **City:** Mainz **Country:** Germany **Facility:** Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz **Zip:** 55101 **Location 18:** **City:** Ratingen **Country:** Germany **Facility:** Rheumazentrum Ratingen - Studienambulanz **Zip:** 40878 **Location 19:** **City:** Vogelsang-Gommern **Country:** Germany **Facility:** Fachkrankenhaus Vogelsang **Zip:** 39245 **Location 20:** **City:** Ferrara **Country:** Italy **Facility:** Azienda Ospedaliera Universitaria Arcispedale S. Anna **State:** Emilia-Romagna **Zip:** 44100 **Location 21:** **City:** Roma **Country:** Italy **Facility:** IDI-Istituto Dermopatico dell'Immacolata IRCCS **State:** Lazio **Zip:** 00167 **Location 22:** **City:** Milano **Country:** Italy **Facility:** Asst Centro Specialistico Ortopedico Traumato-Logico Gaetano Pini/Cto **State:** Lombardia **Zip:** 20122 **Location 23:** **City:** Milano **Country:** Italy **Facility:** Ospedale San Raffaele **State:** Lombardia **Zip:** 20132 **Location 24:** **City:** Torino **Country:** Italy **Facility:** Ospedale San Giovanni Bosco **State:** Piemonte **Zip:** 10154 **Location 25:** **City:** Cagliari **Country:** Italy **Facility:** Azienda Ospedaliera Giuseppe Brotzu **State:** Sardegna **Zip:** 09131 **Location 26:** **City:** Firenze **Country:** Italy **Facility:** Azienda Ospedaliera Universitaria Careggi **State:** Toscana **Zip:** 50141 **Location 27:** **City:** Pisa **Country:** Italy **Facility:** Azienda Ospedaliero Universitaria Pisana **State:** Toscana **Zip:** 56100 **Location 28:** **City:** Siena **Country:** Italy **Facility:** A.O.U. Senese Policlinico Santa Maria Alle Scotte **State:** Toscana **Zip:** 53100 **Location 29:** **City:** Sabadell **Country:** Spain **Facility:** Corporacio Sanitaria Parc Tauli **State:** Barcelona **Zip:** 08208 **Location 30:** **City:** A Coruña **Country:** Spain **Facility:** Complejo Hospitalario Universitario A Coruña **State:** LA Coruña **Zip:** 15006 **Location 31:** **City:** Málaga **Country:** Spain **Facility:** Hospital Regional Universitario de Malaga; Servicio de Reumatologia **State:** Malaga **Zip:** 29009 **Location 32:** **City:** Vigo **Country:** Spain **Facility:** Hospital Meixoeiro **State:** Pontevedra **Zip:** 36214 **Location 33:** **City:** Seville **Country:** Spain **Facility:** Hospital Universitario Virgen Macarena **State:** Sevilla **Zip:** 41071 **Location 34:** **City:** Barcelona **Country:** Spain **Facility:** Hospital de la Santa Creu i Sant Pau **Zip:** 08041 **Location 35:** **City:** Barcelona **Country:** Spain **Facility:** Hospital Universitari de Bellvitge; Servicio de Reumatologia **Zip:** 08907 **Location 36:** **City:** Granada **Country:** Spain **Facility:** Hospital Universitario San Cecilio **Zip:** 18012 **Location 37:** **City:** Madrid **Country:** Spain **Facility:** Hospital Universitario Clínico San Carlos **Zip:** 28040 **Location 38:** **City:** Madrid **Country:** Spain **Facility:** Hospital Universitario 12 de Octubre **Zip:** 28041 **Location 39:** **City:** Valladolid **Country:** Spain **Facility:** Hospital Clinico Universitario Valladolid **Zip:** 47005 **Location 40:** **City:** Bristol **Country:** United Kingdom **Facility:** Bristol Royal Infirmary **Zip:** BS2 8HW **Location 41:** **City:** Cambridge **Country:** United Kingdom **Facility:** Addenbrooke's Hospital **Zip:** CB2 0QQ **Location 42:** **City:** Colchester **Country:** United Kingdom **Facility:** Southend University Hospital **Zip:** C03 3NB **Location 43:** **City:** Exeter **Country:** United Kingdom **Facility:** Royal Devon and Exeter Hospital (Wonford) **Zip:** EX2 5DW **Location 44:** **City:** Plymouth **Country:** United Kingdom **Facility:** Derriford Hospital **Zip:** PL6 8DH **Location 45:** **City:** Salford **Country:** United Kingdom **Facility:** Salford Royal **Zip:** M6 8HD **Location 46:** **City:** Torquay **Country:** United Kingdom **Facility:** Torbay Hospital **Zip:** TQ2 7AA **Location 47:** **City:** Truro **Country:** United Kingdom **Facility:** Royal Cornwall Hospital **Zip:** TR1 3LQ **Location 48:** **City:** Wolverhampton **Country:** United Kingdom **Facility:** New Cross Hospital **Zip:** WV10 0QP #### Overall Officials **Official 1:** **Affiliation:** Hoffmann-La Roche **Name:** Clinical Trials **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Sarsour K, Beckley-Kartey S, Melega S, Odueyungbo A, Kirchner P, Khalife N, Bangs J. Rituximab utilization for approved and off-label nononcology indications and patients' experiences with the Patient Alert Card. Pharmacol Res Perspect. 2020 Jan 3;8(1):e00555. doi: 10.1002/prp2.555. eCollection 2020 Feb. **PMID:** 31911839 ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018501 - Term: Antirheumatic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M373 - Name: Rituximab - Relevance: HIGH - As Found: Healthy - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069283 - Term: Rituximab ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT04909879 **Brief Title:** Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome **Official Title:** Treatment of Non-COVID-19 Acute Respiratory Distress Syndrome: A Phase 2 Study of the Efficacy and Safety of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells #### Organization Study ID Info **ID:** MSC-ARDS-201 #### Organization **Class:** INDUSTRY **Full Name:** Sorrento Therapeutics, Inc. ### Status Module #### Completion Date **Date:** 2022-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2021-09-24 **Type:** ACTUAL **Last Update Submit Date:** 2021-09-17 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2022-02 **Type:** ESTIMATED #### Start Date **Date:** 2021-09 **Type:** ESTIMATED **Status Verified Date:** 2021-09 #### Study First Post Date **Date:** 2021-06-02 **Type:** ACTUAL **Study First Submit Date:** 2021-05-29 **Study First Submit QC Date:** 2021-05-29 **Why Stopped:** Replaced by a different protocol. ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Sorrento Therapeutics, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** This is a Phase 2 randomized study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection. **Detailed Description:** This is a Phase 2, randomized controlled, multicenter study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection. Subjects will be randomized 2:1 to receive COVI-MSC or placebo. COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4. ### Conditions Module **Conditions:** - Acute Respiratory Distress Syndrome - Ards **Keywords:** - ARDS ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects will receive intravenous infusions of COVI-MSC (two vials or a total of ≈ 30 million cells) on Day 0, Day 2, and Day 4 **Intervention Names:** - Biological: COVI-MSC **Label:** COVI-MSC **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4 **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - COVI-MSC **Description:** COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells **Name:** COVI-MSC **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Excipient solution **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** All-cause mortality rate at Day 28 **Measure:** All-cause mortality rate at Day 28 **Time Frame:** Baseline to Day 28 #### Secondary Outcomes **Description:** All-cause mortality rate at Days 60 and 90 **Measure:** All-cause mortality rate at Days 60 and 90 **Time Frame:** Baseline to Day 60 and Day 90 **Description:** Number of ventilator-free days through Day 28 **Measure:** Number of ventilator-free days through Day 28 **Time Frame:** Baseline through Day 28 **Description:** Number of ICU days through Day 28 **Measure:** Number of ICU days through Day 28 **Time Frame:** Baseline through Day 28 **Description:** Clinical status as assessed using the Ordinal Scale for Clinical Improvement (0-8 scale, where lower score means better outcome) **Measure:** Clinical status at Day 28 **Time Frame:** Baseline to Day 28 **Description:** Change in oxygenation at Days 2, 4, 6, 14, and 28 as measured using PaO2:FiO2 ratio. **Measure:** Change in oxygenation **Time Frame:** Baseline to Day 2, Day 4, Day 6, Day 14, Day 28 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Negative for SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen * Hospitalized with non-COVID-19-induced ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300 * Requires oxygen supplementation at Screening * Willing to follow contraception guidelines Exclusion Criteria: * Current standard of care treatments for ARDS appear to be working and the subject is clinically improving * A previous stem cell infusion unrelated to this trial * Pregnant or breast feeding or planning for either during the study * Suspected uncontrolled active bacterial, fungal, viral, or other infection * History of a splenectomy, lung transplant or lung lobectomy * Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable) * Expected survival or time to withdrawal of life-sustaining treatments expected to be \< 7 days **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Sorrento Therapeutics, Inc. **Name:** Mike Royal, MD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000012120 - Term: Respiration Disorders - ID: D000007235 - Term: Infant, Premature, Diseases - ID: D000007232 - Term: Infant, Newborn, Diseases - ID: D000055370 - Term: Lung Injury ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: LOW - As Found: Unknown - ID: M14965 - Name: Respiratory Distress Syndrome - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: M14964 - Name: Respiratory Distress Syndrome, Newborn - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M28144 - Name: Acute Lung Injury - Relevance: HIGH - As Found: Acute Respiratory Distress Syndrome - ID: M28143 - Name: Lung Injury - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M25869 - Name: Premature Birth - Relevance: LOW - As Found: Unknown - ID: M10279 - Name: Infant, Premature, Diseases - Relevance: LOW - As Found: Unknown - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: T4927 - Name: Respiratory Distress Syndrome, Infant - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: T192 - Name: Acute Respiratory Distress Syndrome - Relevance: HIGH - As Found: Acute Respiratory Distress Syndrome - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012128 - Term: Respiratory Distress Syndrome - ID: D000012127 - Term: Respiratory Distress Syndrome, Newborn - ID: D000055371 - Term: Acute Lung Injury - ID: D000013577 - Term: Syndrome ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT00251979 **Brief Title:** A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer **Official Title:** A Randomised, Double-blind, Parallel-group, Placebo Controlled Study of Esomeprazole i.v. (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour) Administered for 72 Hours to Assess Prevention of Rebleeding in Subjects That Have Undergone Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer - the PUB Study. #### Organization Study ID Info **ID:** D961DC00001 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2007-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2011-06-17 **Type:** ESTIMATED **Last Update Submit Date:** 2011-05-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2007-12 **Type:** ACTUAL #### Results First Post Date **Date:** 2011-06-17 **Type:** ESTIMATED **Results First Submit Date:** 2008-12-12 **Results First Submit QC Date:** 2011-05-18 #### Start Date **Date:** 2005-10 **Status Verified Date:** 2011-05 #### Study First Post Date **Date:** 2005-11-11 **Type:** ESTIMATED **Study First Submit Date:** 2005-11-09 **Study First Submit QC Date:** 2005-11-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca ### Description Module **Brief Summary:** This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment. ### Conditions Module **Conditions:** - Gastrointestinal Hemorrhage ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 1312 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Esomeprazole **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo **Time Frame:** Within 72 hours #### Secondary Outcomes **Measure:** Clinically Significant Rebleeding Within 7 Days **Time Frame:** Within 7 days **Measure:** Clinically Significant Rebleeding Within 30 Days **Time Frame:** Within 30 days **Measure:** Death Within 72 Hours **Time Frame:** Within 72 hours **Measure:** Death Within 30 Days **Time Frame:** Within 30 days **Measure:** Death Related to Rebleeding Within 30 Days as Judged by the EpC **Time Frame:** Within 30 days **Measure:** Requirement for Surgery Within 72 Hours **Time Frame:** Within 72 hours **Measure:** Requirement for Surgery Within 30 Days **Time Frame:** Within 30 days **Measure:** Requirement for Endoscopic Re-treatment Within 72 Hours **Time Frame:** Within 72 hours **Measure:** Requirement for Endoscopic Re-treatment Within 30 Days **Time Frame:** Within 30 days **Measure:** Number of Blood Units Transfused Within 72 Hours **Time Frame:** Within 72 hours **Measure:** Number of Blood Units Transfused Within 30 Days **Time Frame:** within 30 days **Measure:** Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period **Time Frame:** Within 30 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Signs of a bleeding in the stomach * One endoscopically confirmed bleeding ulcer in the stomach or duodenum Exclusion Criteria: * Malignancy or other advanced disease. * Major cardiovascular event. * Severe hepatic disease **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Braunau/Inn **Country:** Austria **Facility:** Research Site **Location 2:** **City:** Feldbach **Country:** Austria **Facility:** Research Site **Location 3:** **City:** Graz **Country:** Austria **Facility:** Research Site **Location 4:** **City:** Krems **Country:** Austria **Facility:** Research Site **Location 5:** **City:** Wels **Country:** Austria **Facility:** Research Site **Location 6:** **City:** Wien **Country:** Austria **Facility:** Research Site **Location 7:** **City:** Aalborg **Country:** Denmark **Facility:** Research Site **Location 8:** **City:** Amager **Country:** Denmark **Facility:** Research Site **Location 9:** **City:** Glostrup **Country:** Denmark **Facility:** Research Site **Location 10:** **City:** Holstebro **Country:** Denmark **Facility:** Research Site **Location 11:** **City:** Kobenhavn **Country:** Denmark **Facility:** Research Site **Location 12:** **City:** Odense **Country:** Denmark **Facility:** Research Site **Location 13:** **City:** Randers **Country:** Denmark **Facility:** Research Site **Location 14:** **City:** Slagelse **Country:** Denmark **Facility:** Research Site **Location 15:** **City:** Helsinki **Country:** Finland **Facility:** Research Site **Location 16:** **City:** Kuopio **Country:** Finland **Facility:** Research Site **Location 17:** **City:** Amiens **Country:** France **Facility:** Research Site **Location 18:** **City:** Bordeaux **Country:** France **Facility:** Research Site **Location 19:** **City:** Clermont-Ferrand CEDEX 1 **Country:** France **Facility:** Research Site **Location 20:** **City:** Lille **Country:** France **Facility:** Research Site **Location 21:** **City:** Nice Cedex 3 **Country:** France **Facility:** Research Site **Location 22:** **City:** Paris Cedex 12 **Country:** France **Facility:** Research Site **Location 23:** **City:** Paris Cedex 13 **Country:** France **Facility:** Research Site **Location 24:** **City:** Rouen **Country:** France **Facility:** Research Site **Location 25:** **City:** Berlin **Country:** Germany **Facility:** Research Site **Location 26:** **City:** Bochum **Country:** Germany **Facility:** Research Site **Location 27:** **City:** Celle **Country:** Germany **Facility:** Research Site **Location 28:** **City:** Dresden **Country:** Germany **Facility:** Research Site **Location 29:** **City:** Karlsruhe **Country:** Germany **Facility:** Research Site **Location 30:** **City:** Leipzig **Country:** Germany **Facility:** Research Site **Location 31:** **City:** Ludwigshafen **Country:** Germany **Facility:** Research Site **Location 32:** **City:** Magdeburg **Country:** Germany **Facility:** Research Site **Location 33:** **City:** Weimar **Country:** Germany **Facility:** Research Site **Location 34:** **City:** Athens **Country:** Greece **Facility:** Research Site **Location 35:** **City:** Thessaloniki **Country:** Greece **Facility:** Research Site **Location 36:** **City:** Hong Kong **Country:** Hong Kong **Facility:** Research Site **Location 37:** **City:** Arnhem **Country:** Netherlands **Facility:** Research Site **Location 38:** **City:** Dordrecht **Country:** Netherlands **Facility:** Research Site **Location 39:** **City:** Hengelo **Country:** Netherlands **Facility:** Research Site **Location 40:** **City:** Nieuwegein **Country:** Netherlands **Facility:** Research Site **Location 41:** **City:** Rotterdam **Country:** Netherlands **Facility:** Research Site **Location 42:** **City:** Zwolle **Country:** Netherlands **Facility:** Research Site **Location 43:** **City:** Alesund **Country:** Norway **Facility:** Research Site **Location 44:** **City:** Drammen **Country:** Norway **Facility:** Research Site **Location 45:** **City:** Kristiansand **Country:** Norway **Facility:** Research Site **Location 46:** **City:** Lorenskog **Country:** Norway **Facility:** Research Site **Location 47:** **City:** Oslo **Country:** Norway **Facility:** Research Site **Location 48:** **City:** Tonsberg **Country:** Norway **Facility:** Research Site **Location 49:** **City:** Bucharest **Country:** Romania **Facility:** Research Site **Location 50:** **City:** Craiova **Country:** Romania **Facility:** Research Site **Location 51:** **City:** Iasi **Country:** Romania **Facility:** Research Site **Location 52:** **City:** Tg. Mures **Country:** Romania **Facility:** Research Site **Location 53:** **City:** Timisoara **Country:** Romania **Facility:** Research Site **Location 54:** **City:** Moscow **Country:** Russian Federation **Facility:** Research Site **Location 55:** **City:** Saint Petersburg **Country:** Russian Federation **Facility:** Research Site **Location 56:** **City:** Bloemfontein **Country:** South Africa **Facility:** Research Site **Location 57:** **City:** Cape Town **Country:** South Africa **Facility:** Research Site **Location 58:** **City:** Pietermaritzburg **Country:** South Africa **Facility:** Research Site **Location 59:** **City:** Barcelona **Country:** Spain **Facility:** Research Site **Location 60:** **City:** Madrid **Country:** Spain **Facility:** Research Site **Location 61:** **City:** Sabadell **Country:** Spain **Facility:** Research Site **Location 62:** **City:** Santiago **Country:** Spain **Facility:** Research Site **Location 63:** **City:** Goteborg **Country:** Sweden **Facility:** Research Site **Location 64:** **City:** Karlstad **Country:** Sweden **Facility:** Research Site **Location 65:** **City:** Kristianstad **Country:** Sweden **Facility:** Research Site **Location 66:** **City:** Linköping **Country:** Sweden **Facility:** Research Site **Location 67:** **City:** Norrkoping **Country:** Sweden **Facility:** Research Site **Location 68:** **City:** Ostersund **Country:** Sweden **Facility:** Research Site **Location 69:** **City:** Skövde **Country:** Sweden **Facility:** Research Site **Location 70:** **City:** Stockholm **Country:** Sweden **Facility:** Research Site **Location 71:** **City:** Sundsvall **Country:** Sweden **Facility:** Research Site **Location 72:** **City:** Trollhättan **Country:** Sweden **Facility:** Research Site **Location 73:** **City:** Ankara **Country:** Turkey **Facility:** Research Site **Location 74:** **City:** Bursa **Country:** Turkey **Facility:** Research Site **Location 75:** **City:** Izmir **Country:** Turkey **Facility:** Research Site **Location 76:** **City:** Izmit **Country:** Turkey **Facility:** Research Site **Location 77:** **City:** Birmingham **Country:** United Kingdom **Facility:** Research Site **Location 78:** **City:** Derby **Country:** United Kingdom **Facility:** Research Site **Location 79:** **City:** Leeds **Country:** United Kingdom **Facility:** Research Site #### Overall Officials **Official 1:** **Affiliation:** AstraZeneca **Name:** AstraZeneca Nexium Medical Sciences Director **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Chinese University of Hong Kong **Name:** Joseph Sung, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Lau J, Lind T, Persson T, Eklund S. Effect of baseline characteristics on response to proton pump inhibitors in patients with peptic ulcer bleeding. J Dig Dis. 2017 Feb;18(2):99-106. doi: 10.1111/1751-2980.12447. **PMID:** 28070941 **Citation:** Kuipers EJ, Sung JJ, Barkun A, Mossner J, Jensen D, Stuart R, Lau JY, Ahlbom H, Lind T, Kilhamn J. Safety and tolerability of high-dose intravenous esomeprazole for prevention of peptic ulcer rebleeding. Adv Ther. 2011 Feb;28(2):150-9. doi: 10.1007/s12325-010-0095-5. Epub 2010 Dec 15. **PMID:** 21181319 **Citation:** Barkun AN, Adam V, Sung JJ, Kuipers EJ, Mossner J, Jensen D, Stuart R, Lau JY, Naucler E, Kilhamn J, Granstedt H, Liljas B, Lind T. Cost effectiveness of high-dose intravenous esomeprazole for peptic ulcer bleeding. Pharmacoeconomics. 2010;28(3):217-30. doi: 10.2165/11531480-000000000-00000. **PMID:** 20151726 **Citation:** Sung JJ, Barkun A, Kuipers EJ, Mossner J, Jensen DM, Stuart R, Lau JY, Ahlbom H, Kilhamn J, Lind T; Peptic Ulcer Bleed Study Group. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):455-64. doi: 10.7326/0003-4819-150-7-200904070-00105. Epub 2009 Feb 16. **PMID:** 19221370 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000004378 - Term: Duodenal Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000013272 - Term: Stomach Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: HIGH - As Found: Hemorrhage - ID: M17206 - Name: Ulcer - Relevance: LOW - As Found: Unknown - ID: M9557 - Name: Gastrointestinal Hemorrhage - Relevance: HIGH - As Found: Gastrointestinal Hemorrhage - ID: M13348 - Name: Peptic Ulcer - Relevance: HIGH - As Found: Peptic Ulcer - ID: M13349 - Name: Peptic Ulcer Hemorrhage - Relevance: HIGH - As Found: Bleeding Peptic Ulcers - ID: M7552 - Name: Duodenal Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010437 - Term: Peptic Ulcer - ID: D000006471 - Term: Gastrointestinal Hemorrhage - ID: D000010438 - Term: Peptic Ulcer Hemorrhage - ID: D000006470 - Term: Hemorrhage ### Intervention Browse Module - Ancestors - ID: D000000897 - Term: Anti-Ulcer Agents - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000054328 - Term: Proton Pump Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Coag - Name: Coagulants ### Intervention Browse Module - Browse Leaves - ID: M30204 - Name: Esomeprazole - Relevance: HIGH - As Found: Risk of - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M4188 - Name: Antacids - Relevance: LOW - As Found: Unknown - ID: M4219 - Name: Anti-Ulcer Agents - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M27630 - Name: Proton Pump Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000064098 - Term: Esomeprazole ### Misc Info Module #### Removed Countries - Country: Argentina - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Esomeprazole **Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** EG000 **Other Num Affected:** 87 **Other Num at Risk:** 375 **Serious Number Affected:** 61 **Title:** Esomeprazole **Group ID:** EG001 **Title:** Placebo **Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** EG001 **Other Num Affected:** 129 **Other Num at Risk:** 389 **Serious Number Affected:** 68 **Title:** Placebo **Frequency Threshold:** 2 #### Other Events **Term:** ABDOMINAL PAIN **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 **Term:** ABDOMINAL PAIN UPPER **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 **Term:** ANAEMIA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 10.0 **Term:** CONSTIPATION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 **Term:** CYSTITIS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 10.0 **Term:** DIARRHOEA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 **Term:** DIZZINESS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 10.0 **Term:** DYSPNOEA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 10.0 **Term:** HEADACHE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 10.0 **Term:** HYPERTENSION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 10.0 **Term:** HYPOKALAEMIA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 10.0 **Term:** INSOMNIA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 10.0 **Term:** NAUSEA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 **Term:** PHLEBITIS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 10.0 **Term:** PYREXIA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 10.0 **Term:** URINARY TRACT INFECTION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 10.0 #### Serious Events **Term:** ACUTE MYOCARDIAL INFARCTION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 389 **Term:** ACUTE PSYCHOSIS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** ADENOCARCINOMA PANCREAS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** ANGINA PECTORIS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** ANGINA UNSTABLE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** ATRIAL FIBRILLATION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 389 **Term:** BENIGN GASTRIC NEOPLASM **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** BRADYCARDIA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** CARDIAC FAILURE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** CHOLECYSTITIS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** CHRONIC OBSTRUCTIVE PULMONARY DISEASE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** COLONIC POLYP **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** CONSTIPATION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** DIABETES MELLITUS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** DIABETES MELLITUS INADEQUATE CONTROL **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** DISCOMFORT **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** DISLOCATION OF JOINT PROSTHESIS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** DIZZINESS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** DUODENAL PERFORATION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** DUODENAL ULCER HAEMORRHAGE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 16 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 21 **Num At Risk:** 389 **Term:** DUODENAL ULCER PERFORATION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** ERYSIPELAS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** FATIGUE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** GASTRIC CANCER **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** GASTRIC ULCER HAEMORRHAGE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 7 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 13 **Num At Risk:** 389 **Term:** GASTRIC ULCER PERFORATION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** GASTROENTERITIS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Congenital, familial and genetic disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** GASTROINTESTINAL HAEMORRHAGE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** GASTROINTESTINAL STROMAL TUMOUR **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** GOUT **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** GOUTY ARTHRITIS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 389 **Term:** HAEMOGLOBIN DECREASED **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** HIP FRACTURE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** HYPONATRAEMIA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** LOWER RESPIRATORY TRACT INFECTION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** LUNG DISORDER **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** LUNG INFECTION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** LUNG INFILTRATION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** MELAENA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** MYOCARDIAL INFARCTION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 5 **Num At Risk:** 389 **Term:** OSTEOLYSIS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** PANCREATITIS ACUTE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** PEPTIC ULCER PERFORATION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** PERIPHERAL NERVE LESION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** PERITONITIS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** PHLEBITIS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** PLEURAL EFFUSION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** PNEUMONIA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** PNEUMOTHORAX TRAUMATIC **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** PRESYNCOPE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** PULMONARY EMBOLISM **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 389 **Term:** PULMONARY OEDEMA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** PYREXIA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** RECTAL CANCER **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** RECTAL HAEMORRHAGE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** RENAL FAILURE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** RESPIRATORY FAILURE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** RESPIRATORY TRACT INFECTION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** SHOCK **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** SUBDURAL HAEMORRHAGE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** SYNCOPE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** TESTICULAR CANCER METASTATIC **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** THROMBOSIS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Num At Risk:** 389 **Term:** TRANSIENT ISCHAEMIC ATTACK **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** URINARY TRACT INFECTION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 375 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 389 **Term:** URTICARIA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Term:** UVEITIS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 **Term:** VENOUS THROMBOSIS LIMB **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 10.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 375 **Group ID:** EG001 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 375 **Group ID:** BG001 **Value:** 389 **Group ID:** BG002 **Value:** 764 **Units:** Participants ### Group **ID:** BG000 **Title:** Esomeprazole **Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days ### Group **ID:** BG001 **Title:** Placebo **Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 182 #### Measurement **Group ID:** BG001 **Value:** 210 #### Measurement **Group ID:** BG002 **Value:** 392 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 193 #### Measurement **Group ID:** BG001 **Value:** 179 #### Measurement **Group ID:** BG002 **Value:** 372 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 121 #### Measurement **Group ID:** BG001 **Value:** 121 #### Measurement **Group ID:** BG002 **Value:** 242 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 254 #### Measurement **Group ID:** BG001 **Value:** 268 #### Measurement **Group ID:** BG002 **Value:** 522 **Category Title:** Male **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement **Other Details:** AstraZeneca shall have a period of 30 days from receipt of the proposed final manuscript for any publication or other disclosure to review it and may within such time require that submission for publication or disclosure of the manuscript be delayed. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Email:** [email protected] **Organization:** AstraZeneca **Title:** Gerard Lynch ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ### Outcome Measure 6 ### Outcome Measure 7 ### Outcome Measure 8 ### Outcome Measure 9 ### Outcome Measure 10 ### Outcome Measure 11 ### Outcome Measure 12 ### Outcome Measure 13 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 22 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 40 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 27 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 50 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 29 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 53 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 8 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 9 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 10 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 21 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 16 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 32 **Title:** #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 24 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 45 **Title:** #### Outcome Measure 11 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 492 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 738 **Title:** #### Outcome Measure 12 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 589 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 935 **Title:** #### Outcome Measure 13 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 284 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 500 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Within 72 hours **Title:** Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG000 **Title:** Esomeprazole ##### Group **Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG001 **Title:** Placebo #### Outcome Measure 2 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Within 7 days **Title:** Clinically Significant Rebleeding Within 7 Days **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG000 **Title:** Esomeprazole ##### Group **Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG001 **Title:** Placebo #### Outcome Measure 3 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Within 30 days **Title:** Clinically Significant Rebleeding Within 30 Days **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG000 **Title:** Esomeprazole ##### Group **Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG001 **Title:** Placebo #### Outcome Measure 4 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Within 72 hours **Title:** Death Within 72 Hours **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG000 **Title:** Esomeprazole ##### Group **Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG001 **Title:** Placebo #### Outcome Measure 5 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Within 30 days **Title:** Death Within 30 Days **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG000 **Title:** Esomeprazole ##### Group **Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG001 **Title:** Placebo #### Outcome Measure 6 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Within 30 days **Title:** Death Related to Rebleeding Within 30 Days as Judged by the EpC **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG000 **Title:** Esomeprazole ##### Group **Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG001 **Title:** Placebo #### Outcome Measure 7 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Within 72 hours **Title:** Requirement for Surgery Within 72 Hours **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG000 **Title:** Esomeprazole ##### Group **Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG001 **Title:** Placebo #### Outcome Measure 8 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Within 30 days **Title:** Requirement for Surgery Within 30 Days **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG000 **Title:** Esomeprazole ##### Group **Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG001 **Title:** Placebo #### Outcome Measure 9 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Within 72 hours **Title:** Requirement for Endoscopic Re-treatment Within 72 Hours **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG000 **Title:** Esomeprazole ##### Group **Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG001 **Title:** Placebo #### Outcome Measure 10 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Within 30 days **Title:** Requirement for Endoscopic Re-treatment Within 30 Days **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG000 **Title:** Esomeprazole ##### Group **Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG001 **Title:** Placebo #### Outcome Measure 11 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Within 72 hours **Title:** Number of Blood Units Transfused Within 72 Hours **Type:** SECONDARY **Unit of Measure:** blood units ##### Group **Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG000 **Title:** Esomeprazole ##### Group **Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG001 **Title:** Placebo #### Outcome Measure 12 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** within 30 days **Title:** Number of Blood Units Transfused Within 30 Days **Type:** SECONDARY **Unit of Measure:** blood units ##### Group **Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG000 **Title:** Esomeprazole ##### Group **Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG001 **Title:** Placebo #### Outcome Measure 13 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Within 30 days **Title:** Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period **Type:** SECONDARY **Unit of Measure:** days ##### Group **Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG000 **Title:** Esomeprazole ##### Group **Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** OG001 **Title:** Placebo ### Participant Flow Module #### Group **Description:** Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** FG000 **Title:** Esomeprazole #### Group **Description:** Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days **ID:** FG001 **Title:** Placebo #### Period **Title:** Overall Study ##### Withdraw **Type:** Protocol Violation ###### Reason **Group ID:** FG000 **Number of Subjects:** 3 ###### Reason **Group ID:** FG001 **Number of Subjects:** 5 ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 11 ###### Reason **Group ID:** FG001 **Number of Subjects:** 17 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 13 ###### Reason **Group ID:** FG001 **Number of Subjects:** 7 ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 8 ###### Reason **Group ID:** FG001 **Number of Subjects:** 6 ##### Withdraw **Type:** Death ###### Reason **Group ID:** FG000 **Number of Subjects:** 3 ###### Reason **Group ID:** FG001 **Number of Subjects:** 5 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 375 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 389 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 337 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 349 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 38 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 40 **Has Results:** True
## Protocol Section ### Identification Module **NCT ID:** NCT04655079 **Acronym:** STIM-PSP **Brief Title:** Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) in Progressive Supranuclear Palsy (PSP) (STIM-PSP) **Official Title:** Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) on Motor and Cognitive Symptoms in Progressive Supranuclear Palsy (PSP) (STIM-PSP) #### Organization Study ID Info **ID:** tDCS 01-2020 #### Organization **Class:** OTHER **Full Name:** University of Salerno ### Status Module #### Completion Date **Date:** 2022-05-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-08-02 **Type:** ACTUAL **Last Update Submit Date:** 2023-08-01 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-05-11 **Type:** ACTUAL #### Start Date **Date:** 2021-02-01 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2020-12-04 **Type:** ACTUAL **Study First Submit Date:** 2020-11-27 **Study First Submit QC Date:** 2020-11-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Salerno #### Responsible Party **Investigator Affiliation:** University of Salerno **Investigator Full Name:** Marina Picillo **Investigator Title:** Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a double-blind, randomized, sham-controlled clinical trial that aim to verify the safety and the efficacy of anodal transcranial direct current stimulation (tDCS) on cognitive and motor symptoms in Progressive Supranuclear Palsy (PSP) over the left dorsolateral prefrontal cortex (dlPFC). **Detailed Description:** Progressive Supranuclear Palsy (PSP) is a rapidly progressive neurodegenerative disease characterized by deposition of tau and motor, cognitive and behavioral symptoms. Since no effective treatment is available, non-invasive brain stimulation techniques, such as tDCS, could be a valid complementary therapeutic approach. The tDCS modulates the spontaneous activity of the neural network by applying a direct current flow on the cortical brain areas (anodic or cathodic stimulation). Despite its efficacy in psychiatric disorders, the therapeutic use of tDCS in neurodegenerative diseases requires more systematic studies. The aim of this study is to verify the safety and efficacy of tDCS in PSP on motor, cognitive and behavioral symptoms. ### Conditions Module **Conditions:** - Progressive Supranuclear Palsy - Motor and Cognitive Symptoms **Keywords:** - Progressive Supranuclear Palsy (PSP) - Transcranial direct current stimulation (tDCS) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants will be recruited and randomized in two parallel group: group 1 will receive anodal left dlPFC tDCS (real tDCS) and group 2 will receive sham stimulation for 5 days/week for 2 consecutive weeks, in a 2:1 ratio, respectively. Each participant will undergo a clinical evaluation at baseline (T0), immediately after 2 weeks of either real or sham tDCS (T1), at 45-day (T2) and at 3-month follow up (T3) from baseline. PSP phenotypes will be uniformly distributed between treatment arms (ie, =Richardson's syndrome versus non-Richardson's syndrome=1:1). ##### Masking Info **Masking:** TRIPLE **Masking Description:** Randomization, monitoring and data management will be performed locally. Randomization will be performed using an online list randomizer (random.org). The study coordinator will generate the random allocation sequence before enrollment. Then, one sub-investigator will perform clinical evaluations and another one will administer the treatment. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants receive anodal tDCS on the left dlPFC for 5 days/week for 2 weeks **Intervention Names:** - Device: Anodal transcranial direct current stimulation (a-tDCS) **Label:** Real tDCS group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants receive sham stimulation on the left dlPFC for 5 days/week for 2 weeks **Intervention Names:** - Device: Sham Condition **Label:** Sham group **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Real tDCS group **Description:** tDCS is delivered by a battery-driven constant current stimulator thought a pair of saline soaked surface sponge electrodes. The active electrode (anode) is placed on the scalp over the left dlPFC (F3) according to the 10 to 20 international electroencephalogram coordinates) and the cathode is placed over the right deltoid muscle. During real stimulation a constant current of 2mA (milli Ampere) is applied for 20 minutes. **Name:** Anodal transcranial direct current stimulation (a-tDCS) **Other Names:** - Active tDCS **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Sham group **Description:** For the sham condition the electrode placement is the same of active tDCS but the electric current is ramped down 5 seconds after the beginning of the stimulation. **Name:** Sham Condition **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** fluency in verbal names **Measure:** Change from baseline to 3-month follow up in verbal fluency task **Time Frame:** Baseline (T0); At 3-month (T3) #### Secondary Outcomes **Description:** movements recorded with digital sensors (gait and other tasks) **Measure:** Change from baseline to 3-month follow in motor symptoms as assessed with sensor recordings (OPAL system) **Time Frame:** Baseline (T0); At 3-month (T3) **Description:** Cognitive status assessed with Montreal Cognitive Assessment (MOCA). The cut off is 15,5. The minimum value is 0 and the maximum is 30. Higher scores mean a better outcome. **Measure:** Change from baseline to 3-month follow up in cognitive symptoms as assessed with Montreal Cognitive Assessment (MOCA) **Time Frame:** Baseline (T0); At 3-month (T3) **Description:** depression symptoms, apathy, neuropsychiatric symptoms assessed with Neuropshychiatric Inventory (NPI) . The minimum value of distress is 0 and the maximum is 5. Higher scores mean a worse outcome. **Measure:** Change from baseline to 3-month follow up in caregiver distress as assessed with Neuropshychiatric Inventory (NPI) **Time Frame:** Baseline (T0); At 3-month (T3) **Description:** Executive function assessed with Frontal Assessment Battery (FAB). The cut off is 13,4. The minimum value is 0 and the maximum is 18. Higher scores mean a better outcome. **Measure:** Change from baseline to 3-month follow up in executive function as assessed with Frontal Assessment Battery (FAB) **Time Frame:** Baseline (T0); At 3-month (T3) **Description:** Attention assessed with Frontal Assessment Battery (FAB). The cut off is 13,4. The minimum value is 0 and the maximum is 18. Higher scores mean a better outcome. **Measure:** Change from baseline to 3-month follow up in attention as assessed with Frontal Assessment Battery (FAB) **Time Frame:** Baseline (T0); At 3-month (T3) **Description:** Caregiver distress assessed with Zarit Carer Burden Burden Interview (ZBI). The minimum value is 0 and the maximum is 88. The cut off is 46. Higher scores mean a worse outcome. **Measure:** Change from baseline to 3-month follow up in caregiver distress as assessed with Zarit Carer Burden Burden Interview (ZBI) **Time Frame:** Baseline (T0); At 3-month (T3) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of PSP according with Movement Disorder Society (MDS) criteria (Hoglinger et al., 2017); * Age \> 40 and \< 89 years; * Presence of a caregiver supportive the patient for all study procedure; * Ability to walk for at least 5 steps either independently or with a minimum support (another patients holding patient's arm or with a walker) Exclusion Criteria: * Presence of electrical stimulators (for example, pacemaker, Deep Brain Stimulation, DBS) * Difficult in understanding Italian language * Presence of severe sensory deficits (for example, visual or hearing impairments) * Education level \<5 years * History of drug abuse * History of severe psychiatric disorders * History of transient ischemic attacks * Cortical or sub-cortical vascular lesions * Seizures or severe heart problems and previous neurosurgical operations * Absence of subjective cognitive deficits * MMSE (Mini-Mental State Examination) score \<20 * Left-handedness **Maximum Age:** 89 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Salerno **Country:** Italy **Facility:** Centro per le Malattie Neurodegenerative (CEMAND) Dipartimento di Medicina e chirurgia, Sezione Neuroscienze, Università di Salerno ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000009886 - Term: Ophthalmoplegia - ID: D000015835 - Term: Ocular Motility Disorders - ID: D000003389 - Term: Cranial Nerve Diseases - ID: D000024801 - Term: Tauopathies - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13157 - Name: Paralysis - Relevance: HIGH - As Found: Palsy - ID: M21826 - Name: Neurobehavioral Manifestations - Relevance: HIGH - As Found: Cognitive Symptoms - ID: M16275 - Name: Supranuclear Palsy, Progressive - Relevance: HIGH - As Found: Progressive Supranuclear Palsy - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M12817 - Name: Ophthalmoplegia - Relevance: LOW - As Found: Unknown - ID: M18386 - Name: Ocular Motility Disorders - Relevance: LOW - As Found: Unknown - ID: M6605 - Name: Cranial Nerve Diseases - Relevance: LOW - As Found: Unknown - ID: M23002 - Name: Tauopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: T4741 - Name: Progressive Supranuclear Palsy - Relevance: HIGH - As Found: Progressive Supranuclear Palsy ### Condition Browse Module - Meshes - ID: D000010243 - Term: Paralysis - ID: D000013494 - Term: Supranuclear Palsy, Progressive - ID: D000019954 - Term: Neurobehavioral Manifestations ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT03498079 **Brief Title:** Prevalence of Mullerian Anomalies in Infertile Women **Official Title:** Prevalence of Mullerian Anomalies and PCO in Egyptian Women #### Organization Study ID Info **ID:** mullerian anomalies #### Organization **Class:** OTHER **Full Name:** Aljazeera Hospital ### Status Module #### Completion Date **Date:** 2019-04-25 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2019-01-09 **Type:** ACTUAL **Last Update Submit Date:** 2019-01-08 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2019-04-20 **Type:** ESTIMATED #### Start Date **Date:** 2018-04-16 **Type:** ACTUAL **Status Verified Date:** 2019-01 #### Study First Post Date **Date:** 2018-04-13 **Type:** ACTUAL **Study First Submit Date:** 2018-04-07 **Study First Submit QC Date:** 2018-04-12 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Kasr El Aini Hospital **Class:** OTHER **Name:** National Research Centre, Egypt **Class:** UNKNOWN **Name:** misr Infertility centre ,Alaqsor #### Lead Sponsor **Class:** OTHER **Name:** Aljazeera Hospital #### Responsible Party **Investigator Affiliation:** Aljazeera Hospital **Investigator Full Name:** Mahmoud Alalfy **Investigator Title:** Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** * Mullerian anomalies are congenital structural anomalies in the uterus . * Its prevalence is not uncommon . **Detailed Description:** * PCO is very common in gynecological practice * Women with mullerian anomalies should be properly evaluated for other gynecological and urological problems ### Conditions Module **Conditions:** - Mullerian Anomaly of Uterus ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 250 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 4 Weeks ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** 3D ultrasound will be done to females complaining from primary infertility with mullerian anomalies **Name:** 3D ultrasound **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** diagnosis of PCO by US and by FSH and LH levels **Measure:** the number of participants who will prove to have PCO **Time Frame:** within 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * females with age between 20-42 years with primary infertility Exclusion Criteria: * females with age above 42 years or below 20 years females with secondary infertility **Gender Based:** True **Gender Description:** females with primary infertility **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 20 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** - females with age between 20-42 years with primary infertility ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mahmoud Alalfy **Phone:** 01002611058 **Role:** CONTACT #### Locations **Location 1:** **City:** Giza **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mahmoud Alalfy, master - **Phone:** +201002611058 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ahmed Elgazzar, M.D - **Phone:** +201014005959 - **Role:** CONTACT ***Contact 3:*** - **Name:** Mahmoud Alalfy, master - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Egypt **Facility:** Algazeerah **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt **Name:** Mahmoud Alalfy **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** we will publish the results which will be obtained from this study **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M10290 - Name: Infertility - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: HIGH - As Found: Anomalies ### Condition Browse Module - Meshes - ID: D000000013 - Term: Congenital Abnormalities ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT03500679 **Brief Title:** A Study to Evaluate Safety and Immunogenicity of the ExPEC4V Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Participants Aged 18 Years and Older **Official Title:** A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Immunogenicity of the ExPEC4V (JNJ-63871860) Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Subjects Aged 18 Years and Older #### Organization Study ID Info **ID:** CR108447 #### Organization **Class:** INDUSTRY **Full Name:** Janssen Research & Development, LLC #### Secondary ID Infos **Domain:** Janssen Research & Development, LLC **ID:** 63871860BAC2003 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2019-06-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-11-26 **Type:** ACTUAL **Last Update Submit Date:** 2019-11-06 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-11-05 **Type:** ACTUAL #### Results First Post Date **Date:** 2019-11-26 **Type:** ACTUAL **Results First Submit Date:** 2019-11-06 **Results First Submit QC Date:** 2019-11-06 #### Start Date **Date:** 2018-05-09 **Type:** ACTUAL **Status Verified Date:** 2019-11 #### Study First Post Date **Date:** 2018-04-18 **Type:** ACTUAL **Study First Submit Date:** 2018-04-10 **Study First Submit QC Date:** 2018-04-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Janssen Research & Development, LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate the safety/reactogenicity of the ExPEC4V clinical trial material (CTM) after the first vaccination and to evaluate the immunogenicity of the ExPEC4V CTM, as measured by the enzyme-linked immunosorbent assay (ELISA), 14 days after the first vaccination (on Day 15). ### Conditions Module **Conditions:** - Healthy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 100 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive vaccination of ExPEC4V dose as an intramuscular (IM) injection into deltoid muscle on Days 1 and 181. The ExPEC4V doses contain polysaccharide antigen (4:4:4:8 microgram \[mcg\]) from the ExPEC4V serotypes O1A, O2, O6A, and O25B. **Intervention Names:** - Biological: ExPEC4V **Label:** Group 1: ExPEC4V (JNJ-63871860) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive placebo matching to ExPEC4V as an IM injection on Days 1 and 181. **Intervention Names:** - Biological: Placebo **Label:** Group 2: Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group 1: ExPEC4V (JNJ-63871860) **Description:** Participants will receive ExPEC4V vaccine as an IM injection on Days 1 and 181. **Name:** ExPEC4V **Other Names:** - JNJ-63871860 **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Group 2: Placebo **Description:** Participants will receive placebo as an IM injection on Days 1 and 181. **Name:** Placebo **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. **Measure:** Percentage of Participants With Solicited Local Adverse Events (AEs) After First Vaccination **Time Frame:** 14 days after first vaccination (Day 1 to Day 15) **Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever. **Measure:** Percentage of Participants With Solicited Systemic Adverse Events After First Vaccination **Time Frame:** 14 days after first vaccination (Day 1 to Day 15) **Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary. **Measure:** Percentage of Participants With Unsolicited Adverse Events After First Vaccination **Time Frame:** 29 days after first vaccination (Day 1 to Day 30) **Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product. **Measure:** Number of Participants With Serious Adverse Events (SAEs) After First Vaccination **Time Frame:** Up to Day 180 **Description:** Immunoglobulin G (IgG) antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 1 were reported. **Measure:** Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1 **Time Frame:** Day 1 **Description:** IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 15 were reported. **Measure:** ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15 **Time Frame:** Day 15 **Description:** IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported. **Measure:** ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 **Time Frame:** Day 15/Day 1 **Description:** Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Day 15 were reported. **Measure:** Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 **Time Frame:** Day 15 #### Secondary Outcomes **Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. **Measure:** Percentage of Participants With Solicited Local Adverse Events After Second Vaccination **Time Frame:** 14 days after second vaccination (Day 181 to Day 195) **Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever. **Measure:** Percentage of Participants With Solicited Systemic Adverse Events After Second Vaccination **Time Frame:** 14 days after second vaccination (Day 181 to Day 195) **Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary. **Measure:** Percentage of Participants With Unsolicited Adverse Events After Second Vaccination **Time Frame:** 29 days after second vaccination (Day 181 to Day 210) **Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product. **Measure:** Number of Participants With Serious Adverse Events After Second Vaccination **Time Frame:** Day 181 until Day 360 **Description:** Specific functional antibacterial antibodies were measured by OPKA. GMTs for serotypes O1A, O2, O6A and O25B at Days 1 and 15 were reported. **Measure:** Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 **Time Frame:** Days 1 and 15 **Description:** Specific functional antibacterial antibodies were measured by OPKA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported. **Measure:** OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 **Time Frame:** Day 15/Day 1 **Description:** Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by OPKA at Day 15 were reported. **Measure:** Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 **Time Frame:** Day 15 **Description:** IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A, O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Days 181 and 195 were reported. **Measure:** ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 **Time Frame:** Days 181 and 195 **Description:** IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 181/Day 1 and Day 195/Day 1) was reported. **Measure:** ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 **Time Frame:** Day 181/Day 1 and Day 195/Day 1 **Description:** Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Days 181 and 195 were reported. **Measure:** Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 **Time Frame:** Days 181 and 195 **Description:** Specific functional antibacterial antibodies were measured by OPKA. GMTs for serotypes O1A, O2, O6A and O25B at Days 181 and 195 were reported. **Measure:** OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 **Time Frame:** Days 181 and 195 **Description:** Specific functional antibacterial antibodies were measured by OPKA. GMR for serotypes O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 were reported. **Measure:** OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 **Time Frame:** Day 181/Day 1 and Day 195/Day 1 **Description:** Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by OPKA at Days 181 and 195 were reported. **Measure:** Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 **Time Frame:** Days 181 and 195 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants who provides written informed consent and signs the informed consent form (ICF) indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study * Participant is medically stable as confirmed by documented medical history, physical examination and vital signs. Participant may have underlying illnesses such as hypertension, diabetes, or ischemic heart disease, as long as their symptoms/signs are medically controlled. If he/she is on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination * Participant must have a body mass index (BMI) of less than or equal to (\<=)35.0 kilogram per square meter (kg/m\^2) * Contraceptive (birth control) use by woman should be consistent with local regulations regarding the acceptable methods of contraception for participant participating in clinical studies * All females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) at pregnancy test on Visit 1 (pre-vaccination) and Visit 4 (prior to the second vaccination) Exclusion Criteria: * Participant with contraindication to intramuscular (IM) injections and blood draws, for example, bleeding disorders * Participant with known allergies, hypersensitivity, or intolerance to ExPEC4V or its excipients * Participant with abnormal function of the immune system resulting from: a) clinical conditions (for example, autoimmune disease or immunodeficiency); b) chronic or recurrent use of systemic corticosteroids; c) administration of antineoplastic and immunomodulating agents or radiotherapy * Participant has a history of neoplastic disease (excluding non-melanoma skin cancer or carcinoma in situ of the cervix that was successfully treated) within the past 1 year or a history of any hematological malignancy * Participant with history of acute polyneuropathy (for example, Guillain-Barre syndrome) * Participant who has a history of an underlying clinically significant acute or (uncontrolled) chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Wichita **Country:** United States **Facility:** Heartland Clinical Research **State:** Kansas **Zip:** 67207 **Location 2:** **City:** Knoxville **Country:** United States **Facility:** VGR & NOCCR - Knoxville **State:** Tennessee **Zip:** 37920 #### Overall Officials **Official 1:** **Affiliation:** Janssen Research & Development, LLC **Name:** Janssen Research & Development, LLC Clinical Trial **Role:** STUDY_DIRECTOR ## Document Section ### Large Document Module #### Large Docs - Date: 2017-12-19 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 1191591 - Type Abbrev: Prot - Upload Date: 2019-11-06T09:39 - Date: 2019-05-22 - Filename: SAP_001.pdf - Has ICF: False - Has Protocol: False - Has SAP: True - Label: Statistical Analysis Plan - Size: 865145 - Type Abbrev: SAP - Upload Date: 2019-11-06T09:39 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. #### Event Groups **Group ID:** EG000 **Title:** ExPEC4V **Deaths Num At Risk:** 75 **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** EG000 **Other Num Affected:** 54 **Other Num at Risk:** 75 **Serious Number Affected:** 2 **Serious Number At Risk:** 75 **Title:** ExPEC4V **Group ID:** EG001 **Title:** Placebo **Deaths Num At Risk:** 25 **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** EG001 **Other Num Affected:** 17 **Other Num at Risk:** 25 **Serious Number Affected:** 1 **Serious Number At Risk:** 25 **Title:** Placebo **Frequency Threshold:** 3 #### Other Events **Term:** Bradycardia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA Version 21.1 **Term:** Nausea **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA Version 21.1 **Term:** Erythema **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA Version 21.1 **Term:** Fatigue **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA Version 21.1 **Term:** Pain/Tenderness **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA Version 21.1 **Term:** Herpes Zoster **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA Version 21.1 **Term:** Blood Pressure Diastolic Increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA Version 21.1 **Term:** Blood Pressure Systolic Increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA Version 21.1 **Term:** Respiratory Rate Increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA Version 21.1 **Term:** Gout **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA Version 21.1 **Term:** Myalgia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA Version 21.1 **Term:** Headache **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA Version 21.1 **Term:** Oropharyngeal Pain **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA Version 21.1 **Term:** Diastolic Hypertension **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA Version 21.1 **Term:** Systolic Hypertension **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA Version 21.1 #### Serious Events **Term:** Osteoarthritis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA Version 21.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 75 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 25 **Term:** Breast Cancer **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA Version 21.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 75 **Group ID:** EG001 **Num At Risk:** 25 **Term:** Deep Vein Thrombosis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA Version 21.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 75 **Group ID:** EG001 **Num At Risk:** 25 **Time Frame:** Up to Day 360 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 75 **Group ID:** BG001 **Value:** 25 **Group ID:** BG002 **Value:** 100 **Units:** Participants ### Group **ID:** BG000 **Title:** ExPEC4V **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. ### Group **ID:** BG001 **Title:** Placebo **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 18.86 **Value:** 55.7 #### Measurement **Group ID:** BG001 **Spread:** 17.56 **Value:** 56.4 #### Measurement **Group ID:** BG002 **Spread:** 18.45 **Value:** 55.9 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 39 #### Measurement **Group ID:** BG001 **Value:** 13 #### Measurement **Group ID:** BG002 **Value:** 52 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 36 #### Measurement **Group ID:** BG001 **Value:** 12 #### Measurement **Group ID:** BG002 **Value:** 48 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 5 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 6 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 69 #### Measurement **Group ID:** BG001 **Value:** 23 #### Measurement **Group ID:** BG002 **Value:** 92 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 6 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 8 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 63 #### Measurement **Group ID:** BG001 **Value:** 22 #### Measurement **Group ID:** BG002 **Value:** 85 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 3 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 6 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 8 **Class Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 **Class Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 7 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 9 **Class Title:** Other #### Measurement **Group ID:** BG000 **Value:** 61 #### Measurement **Group ID:** BG001 **Value:** 21 #### Measurement **Group ID:** BG002 **Value:** 82 **Class Title:** White Non-Hispanic ### Measure #### Measurement **Group ID:** BG000 **Value:** 75 #### Measurement **Group ID:** BG001 **Value:** 25 #### Measurement **Group ID:** BG002 **Value:** 100 **Class Title:** UNITED STATES **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race/Ethnicity, Customized **Unit of Measure:** Participants ### Measure 6 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Region of Enrollment **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement **Other Details:** If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Email:** [email protected] **Organization:** Janssen Research & Development, LLC **Phone:** 844-434-4210 **Title:** Senior Director ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ### Outcome Measure 6 ### Outcome Measure 7 ### Outcome Measure 8 ### Outcome Measure 9 ### Outcome Measure 10 ### Outcome Measure 11 ### Outcome Measure 12 ### Outcome Measure 13 ### Outcome Measure 14 ### Outcome Measure 15 ### Outcome Measure 16 ### Outcome Measure 17 ### Outcome Measure 18 ### Outcome Measure 19 ### Outcome Measure 20 ### Outcome Measure 21 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 27.64 - **Spread:** - **Upper Limit:** 50.62 - **Value:** 38.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 6.83 - **Spread:** - **Upper Limit:** 40.70 - **Value:** 20.0 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 37.58 - **Spread:** - **Upper Limit:** 61.14 - **Value:** 49.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 6.83 - **Spread:** - **Upper Limit:** 40.70 - **Value:** 20.0 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 20.53 - **Spread:** - **Upper Limit:** 42.38 - **Value:** 30.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 14.95 - **Spread:** - **Upper Limit:** 53.50 - **Value:** 32.0 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2412.54 - **Spread:** - **Upper Limit:** 4185.68 - **Value:** 3177.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1910.56 - **Spread:** - **Upper Limit:** 5074.63 - **Value:** 3113.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2865.83 - **Spread:** - **Upper Limit:** 4517.54 - **Value:** 3598.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2182.46 - **Spread:** - **Upper Limit:** 7805.05 - **Value:** 4127.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 664.08 - **Spread:** - **Upper Limit:** 1125.58 - **Value:** 864.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 473.94 - **Spread:** - **Upper Limit:** 1411.46 - **Value:** 817.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 285.25 - **Spread:** - **Upper Limit:** 493.69 - **Value:** 375.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 288.87 - **Spread:** - **Upper Limit:** 1050.27 - **Value:** 550.8 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 13048.22 - **Spread:** - **Upper Limit:** 22227.66 - **Value:** 17030.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1749.61 - **Spread:** - **Upper Limit:** 4604.01 - **Value:** 2838.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 33459.35 - **Spread:** - **Upper Limit:** 59729.66 - **Value:** 44704.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2129.94 - **Spread:** - **Upper Limit:** 6643.37 - **Value:** 3761.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 6241.05 - **Spread:** - **Upper Limit:** 10791.06 - **Value:** 8206.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 444.10 - **Spread:** - **Upper Limit:** 1253.75 - **Value:** 746.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 4280.78 - **Spread:** - **Upper Limit:** 8784.88 - **Value:** 6132.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 249.47 - **Spread:** - **Upper Limit:** 874.61 - **Value:** 467.1 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 4.142 - **Spread:** - **Upper Limit:** 6.568 - **Value:** 5.22 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.799 - **Spread:** - **Upper Limit:** 1.040 - **Value:** 0.91 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 9.221 - **Spread:** - **Upper Limit:** 15.771 - **Value:** 12.06 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.682 - **Spread:** - **Upper Limit:** 1.149 - **Value:** 0.89 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 6.515 - **Spread:** - **Upper Limit:** 11.379 - **Value:** 8.61 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.817 - **Spread:** - **Upper Limit:** 1.079 - **Value:** 0.94 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 8.460 - **Spread:** - **Upper Limit:** 17.090 - **Value:** 12.02 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.658 - **Spread:** - **Upper Limit:** 1.159 - **Value:** 0.87 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 71.47 - **Spread:** - **Upper Limit:** 90.16 - **Value:** 82.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 45.41 - **Spread:** - **Upper Limit:** 69.03 - **Value:** 57.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 82.96 - **Spread:** - **Upper Limit:** 96.92 - **Value:** 91.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 73.05 - **Spread:** - **Upper Limit:** 91.21 - **Value:** 83.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 74.64 - **Spread:** - **Upper Limit:** 92.23 - **Value:** 84.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 63.86 - **Spread:** - **Upper Limit:** 84.68 - **Value:** 75.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 79.54 - **Spread:** - **Upper Limit:** 95.15 - **Value:** 89.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 63.86 - **Spread:** - **Upper Limit:** 84.68 - **Value:** 75.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 33.45 - **Spread:** - **Upper Limit:** 58.12 - **Value:** 45.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.11 - **Spread:** - **Upper Limit:** 21.12 - **Value:** 4.2 **Title:** #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 36.22 - **Spread:** - **Upper Limit:** 60.97 - **Value:** 48.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 12.62 - **Spread:** - **Upper Limit:** 51.09 - **Value:** 29.2 **Title:** #### Outcome Measure 11 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 5.22 - **Spread:** - **Upper Limit:** 21.87 - **Value:** 11.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1.03 - **Spread:** - **Upper Limit:** 27.00 - **Value:** 8.3 **Title:** #### Outcome Measure 12 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** #### Outcome Measure 13 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 131.76 - **Spread:** - **Upper Limit:** 186.53 - **Value:** 156.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 116.55 - **Spread:** - **Upper Limit:** 256.69 - **Value:** 173.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 74 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 535.33 - **Spread:** - **Upper Limit:** 1010.75 - **Value:** 735.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 111.87 - **Spread:** - **Upper Limit:** 244.12 - **Value:** 165.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 73 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 167.79 - **Spread:** - **Upper Limit:** 255.74 - **Value:** 207.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 179.18 - **Spread:** - **Upper Limit:** 485.64 - **Value:** 295.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 74 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1896.34 - **Spread:** - **Upper Limit:** 3751.64 - **Value:** 2667.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 156.39 - **Spread:** - **Upper Limit:** 373.80 - **Value:** 241.8 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 73 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 229.09 - **Spread:** - **Upper Limit:** 405.46 - **Value:** 304.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 217.04 - **Spread:** - **Upper Limit:** 667.59 - **Value:** 380.7 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 74 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 632.29 - **Spread:** - **Upper Limit:** 1018.16 - **Value:** 802.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 241.48 - **Spread:** - **Upper Limit:** 908.80 - **Value:** 468.5 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 73 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 54.64 - **Spread:** - **Upper Limit:** 86.65 - **Value:** 68.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 39.08 - **Spread:** - **Upper Limit:** 90.08 - **Value:** 59.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 74 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 141.11 - **Spread:** - **Upper Limit:** 252.78 - **Value:** 188.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 35.59 - **Spread:** - **Upper Limit:** 75.63 - **Value:** 51.9 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 73 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants #### Outcome Measure 14 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.687 - **Spread:** - **Upper Limit:** 4.479 - **Value:** 3.47 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.959 - **Spread:** - **Upper Limit:** 1.009 - **Value:** 0.98 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 7.943 - **Spread:** - **Upper Limit:** 14.631 - **Value:** 10.78 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.629 - **Spread:** - **Upper Limit:** 1.132 - **Value:** 0.84 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.989 - **Spread:** - **Upper Limit:** 3.120 - **Value:** 2.49 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.834 - **Spread:** - **Upper Limit:** 1.816 - **Value:** 1.23 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.892 - **Spread:** - **Upper Limit:** 2.976 - **Value:** 2.37 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.739 - **Spread:** - **Upper Limit:** 1.034 - **Value:** 0.87 **Title:** #### Outcome Measure 15 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 52.31 - **Spread:** - **Upper Limit:** 75.25 - **Value:** 64.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 29.71 - **Spread:** - **Upper Limit:** 53.23 - **Value:** 41.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 76.25 - **Spread:** - **Upper Limit:** 93.23 - **Value:** 86.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 60.91 - **Spread:** - **Upper Limit:** 82.39 - **Value:** 72.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 34.80 - **Spread:** - **Upper Limit:** 58.63 - **Value:** 46.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1.03 - **Spread:** - **Upper Limit:** 27.00 - **Value:** 8.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 14.19 - **Spread:** - **Upper Limit:** 34.65 - **Value:** 23.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1.03 - **Spread:** - **Upper Limit:** 27.00 - **Value:** 8.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 34.80 - **Spread:** - **Upper Limit:** 58.63 - **Value:** 46.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 13.08 - **Spread:** - **Upper Limit:** 33.14 - **Value:** 21.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** #### Outcome Measure 16 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 7931.32 - **Spread:** - **Upper Limit:** 13755.33 - **Value:** 10445.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1968.83 - **Spread:** - **Upper Limit:** 5351.07 - **Value:** 3245.8 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 10821.68 - **Spread:** - **Upper Limit:** 19020.91 - **Value:** 14347.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1987.00 - **Spread:** - **Upper Limit:** 5200.52 - **Value:** 3214.6 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 20310.07 - **Spread:** - **Upper Limit:** 37909.76 - **Value:** 27748.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2866.53 - **Spread:** - **Upper Limit:** 9388.63 - **Value:** 5187.8 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 26020.58 - **Spread:** - **Upper Limit:** 46653.16 - **Value:** 34841.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2980.81 - **Spread:** - **Upper Limit:** 9255.68 - **Value:** 5252.6 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3592.36 - **Spread:** - **Upper Limit:** 6042.17 - **Value:** 4658.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 596.31 - **Spread:** - **Upper Limit:** 1725.64 - **Value:** 1014.4 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 6034.01 - **Spread:** - **Upper Limit:** 9868.80 - **Value:** 7716.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 635.59 - **Spread:** - **Upper Limit:** 1760.42 - **Value:** 1057.8 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1488.57 - **Spread:** - **Upper Limit:** 2931.67 - **Value:** 2089.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 286.50 - **Spread:** - **Upper Limit:** 1021.82 - **Value:** 541.1 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3010.69 - **Spread:** - **Upper Limit:** 5893.61 - **Value:** 4212.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 281.44 - **Spread:** - **Upper Limit:** 1005.88 - **Value:** 532.1 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants #### Outcome Measure 17 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.694 - **Spread:** - **Upper Limit:** 4.046 - **Value:** 3.30 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.915 - **Spread:** - **Upper Limit:** 1.188 - **Value:** 1.04 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.571 - **Spread:** - **Upper Limit:** 5.466 - **Value:** 4.42 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.914 - **Spread:** - **Upper Limit:** 1.166 - **Value:** 1.03 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 5.965 - **Spread:** - **Upper Limit:** 10.154 - **Value:** 7.78 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1.097 - **Spread:** - **Upper Limit:** 1.359 - **Value:** 1.22 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 7.608 - **Spread:** - **Upper Limit:** 12.832 - **Value:** 9.88 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1.085 - **Spread:** - **Upper Limit:** 1.330 - **Value:** 1.20 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.879 - **Spread:** - **Upper Limit:** 6.070 - **Value:** 4.85 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.999 - **Spread:** - **Upper Limit:** 1.453 - **Value:** 1.20 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 6.631 - **Spread:** - **Upper Limit:** 10.183 - **Value:** 8.22 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1.018 - **Spread:** - **Upper Limit:** 1.464 - **Value:** 1.22 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.229 - **Spread:** - **Upper Limit:** 5.966 - **Value:** 4.39 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.853 - **Spread:** - **Upper Limit:** 1.132 - **Value:** 0.98 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 6.153 - **Spread:** - **Upper Limit:** 11.773 - **Value:** 8.51 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.867 - **Spread:** - **Upper Limit:** 1.076 - **Value:** 0.97 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants #### Outcome Measure 18 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 51.53 - **Spread:** - **Upper Limit:** 75.53 - **Value:** 64.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.11 - **Spread:** - **Upper Limit:** 21.12 - **Value:** 4.2 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 69.54 - **Spread:** - **Upper Limit:** 89.92 - **Value:** 81.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 25.80 - **Spread:** - **Upper Limit:** 49.99 - **Value:** 37.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.00 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 44.82 - **Spread:** - **Upper Limit:** 70.06 - **Value:** 57.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 74.26 - **Spread:** - **Upper Limit:** 92.60 - **Value:** 85.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 86.91 - **Spread:** - **Upper Limit:** 99.02 - **Value:** 95.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 60.90 - **Spread:** - **Upper Limit:** 83.24 - **Value:** 73.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 71.32 - **Spread:** - **Upper Limit:** 91.10 - **Value:** 82.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.0 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 67.43 - **Spread:** - **Upper Limit:** 88.08 - **Value:** 79.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1.03 - **Spread:** - **Upper Limit:** 27.00 - **Value:** 8.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 86.91 - **Spread:** - **Upper Limit:** 99.02 - **Value:** 95.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1.03 - **Spread:** - **Upper Limit:** 27.00 - **Value:** 8.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 47.00 - **Spread:** - **Upper Limit:** 71.51 - **Value:** 59.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.11 - **Spread:** - **Upper Limit:** 21.12 - **Value:** 4.2 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 66.03 - **Spread:** - **Upper Limit:** 87.49 - **Value:** 78.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.11 - **Spread:** - **Upper Limit:** 21.12 - **Value:** 4.2 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 53.06 - **Spread:** - **Upper Limit:** 76.85 - **Value:** 65.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 74.98 - **Spread:** - **Upper Limit:** 93.36 - **Value:** 85.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 31.22 - **Spread:** - **Upper Limit:** 55.96 - **Value:** 43.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 54.31 - **Spread:** - **Upper Limit:** 78.41 - **Value:** 67.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants #### Outcome Measure 19 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 234.11 - **Spread:** - **Upper Limit:** 420.81 - **Value:** 313.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 104.05 - **Spread:** - **Upper Limit:** 225.12 - **Value:** 153.1 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 317.40 - **Spread:** - **Upper Limit:** 585.52 - **Value:** 431.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 103.91 - **Spread:** - **Upper Limit:** 220.32 - **Value:** 151.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 800.61 - **Spread:** - **Upper Limit:** 1638.42 - **Value:** 1145.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 142.75 - **Spread:** - **Upper Limit:** 367.06 - **Value:** 228.9 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 981.63 - **Spread:** - **Upper Limit:** 1901.43 - **Value:** 1366.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 138.74 - **Spread:** - **Upper Limit:** 350.58 - **Value:** 220.5 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 298.21 - **Spread:** - **Upper Limit:** 464.89 - **Value:** 372.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 202.09 - **Spread:** - **Upper Limit:** 519.30 - **Value:** 324.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 459.19 - **Spread:** - **Upper Limit:** 672.64 - **Value:** 555.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 200.93 - **Spread:** - **Upper Limit:** 535.47 - **Value:** 328.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 75.68 - **Spread:** - **Upper Limit:** 123.23 - **Value:** 96.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 37.78 - **Spread:** - **Upper Limit:** 87.00 - **Value:** 57.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 108.32 - **Spread:** - **Upper Limit:** 194.65 - **Value:** 145.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 35.96 - **Spread:** - **Upper Limit:** 84.27 - **Value:** 55.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants #### Outcome Measure 20 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.473 - **Spread:** - **Upper Limit:** 2.139 - **Value:** 1.77 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.842 - **Spread:** - **Upper Limit:** 1.043 - **Value:** 0.94 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.849 - **Spread:** - **Upper Limit:** 2.798 - **Value:** 2.27 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.838 - **Spread:** - **Upper Limit:** 1.025 - **Value:** 0.93 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.703 - **Spread:** - **Upper Limit:** 6.704 - **Value:** 4.98 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.717 - **Spread:** - **Upper Limit:** 0.943 - **Value:** 0.82 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 4.576 - **Spread:** - **Upper Limit:** 7.785 - **Value:** 5.97 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.694 - **Spread:** - **Upper Limit:** 0.905 - **Value:** 0.79 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.022 - **Spread:** - **Upper Limit:** 1.522 - **Value:** 1.25 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.660 - **Spread:** - **Upper Limit:** 1.036 - **Value:** 0.83 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.403 - **Spread:** - **Upper Limit:** 2.234 - **Value:** 1.77 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.676 - **Spread:** - **Upper Limit:** 1.037 - **Value:** 0.84 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.142 - **Spread:** - **Upper Limit:** 1.483 - **Value:** 1.30 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.870 - **Spread:** - **Upper Limit:** 1.137 - **Value:** 0.99 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.555 - **Spread:** - **Upper Limit:** 2.297 - **Value:** 1.89 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.829 - **Spread:** - **Upper Limit:** 1.101 - **Value:** 0.95 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants #### Outcome Measure 21 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 27.14 - **Spread:** - **Upper Limit:** 51.50 - **Value:** 38.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 41.75 - **Spread:** - **Upper Limit:** 67.18 - **Value:** 54.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 7.40 - **Spread:** - **Upper Limit:** 25.74 - **Value:** 14.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 20.24 - **Spread:** - **Upper Limit:** 44.06 - **Value:** 31.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 64.14 - **Spread:** - **Upper Limit:** 85.69 - **Value:** 76.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 73.14 - **Spread:** - **Upper Limit:** 92.24 - **Value:** 84.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 45.52 - **Spread:** - **Upper Limit:** 70.15 - **Value:** 58.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 49.51 - **Spread:** - **Upper Limit:** 74.30 - **Value:** 62.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 11.92 - **Spread:** - **Upper Limit:** 32.57 - **Value:** 20.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 22.95 - **Spread:** - **Upper Limit:** 47.30 - **Value:** 34.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.36 - **Spread:** - **Upper Limit:** 18.48 - **Value:** 9.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 7.76 - **Spread:** - **Upper Limit:** 26.86 - **Value:** 15.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 7.40 - **Spread:** - **Upper Limit:** 25.74 - **Value:** 14.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 25.70 - **Spread:** - **Upper Limit:** 50.49 - **Value:** 37.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.93 - **Spread:** - **Upper Limit:** 12.53 - **Value:** 4.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 8.90 - **Spread:** - **Upper Limit:** 28.68 - **Value:** 17.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 14.25 - **Value:** 0.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 64 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. **Reporting Status:** POSTED **Time Frame:** 14 days after first vaccination (Day 1 to Day 15) **Title:** Percentage of Participants With Solicited Local Adverse Events (AEs) After First Vaccination **Type:** PRIMARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 2 **Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. **Reporting Status:** POSTED **Time Frame:** 14 days after first vaccination (Day 1 to Day 15) **Title:** Percentage of Participants With Solicited Systemic Adverse Events After First Vaccination **Type:** PRIMARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 3 **Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. **Reporting Status:** POSTED **Time Frame:** 29 days after first vaccination (Day 1 to Day 30) **Title:** Percentage of Participants With Unsolicited Adverse Events After First Vaccination **Type:** PRIMARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 4 **Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. **Reporting Status:** POSTED **Time Frame:** Up to Day 180 **Title:** Number of Participants With Serious Adverse Events (SAEs) After First Vaccination **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 5 **Description:** Immunoglobulin G (IgG) antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 1 were reported. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** The per-protocol immunogenicity (PPI) analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. **Reporting Status:** POSTED **Time Frame:** Day 1 **Title:** Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1 **Type:** PRIMARY **Unit of Measure:** Titer ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 6 **Description:** IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 15 were reported. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. **Reporting Status:** POSTED **Time Frame:** Day 15 **Title:** ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15 **Type:** PRIMARY **Unit of Measure:** Titer ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 7 **Description:** IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. **Reporting Status:** POSTED **Time Frame:** Day 15/Day 1 **Title:** ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 **Type:** PRIMARY **Unit of Measure:** Ratio ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 8 **Description:** Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Day 15 were reported. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. **Reporting Status:** POSTED **Time Frame:** Day 15 **Title:** Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 **Type:** PRIMARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 9 **Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. **Reporting Status:** POSTED **Time Frame:** 14 days after second vaccination (Day 181 to Day 195) **Title:** Percentage of Participants With Solicited Local Adverse Events After Second Vaccination **Type:** SECONDARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 10 **Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. **Reporting Status:** POSTED **Time Frame:** 14 days after second vaccination (Day 181 to Day 195) **Title:** Percentage of Participants With Solicited Systemic Adverse Events After Second Vaccination **Type:** SECONDARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 11 **Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. **Reporting Status:** POSTED **Time Frame:** 29 days after second vaccination (Day 181 to Day 210) **Title:** Percentage of Participants With Unsolicited Adverse Events After Second Vaccination **Type:** SECONDARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 12 **Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. **Reporting Status:** POSTED **Time Frame:** Day 181 until Day 360 **Title:** Number of Participants With Serious Adverse Events After Second Vaccination **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 13 **Description:** Specific functional antibacterial antibodies were measured by OPKA. GMTs for serotypes O1A, O2, O6A and O25B at Days 1 and 15 were reported. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories. **Reporting Status:** POSTED **Time Frame:** Days 1 and 15 **Title:** Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 **Type:** SECONDARY **Unit of Measure:** Titer ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 14 **Description:** Specific functional antibacterial antibodies were measured by OPKA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. **Reporting Status:** POSTED **Time Frame:** Day 15/Day 1 **Title:** OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 **Type:** SECONDARY **Unit of Measure:** Ratio ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 15 **Description:** Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by OPKA at Day 15 were reported. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. **Reporting Status:** POSTED **Time Frame:** Day 15 **Title:** Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 **Type:** SECONDARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 16 **Description:** IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A, O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Days 181 and 195 were reported. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories. **Reporting Status:** POSTED **Time Frame:** Days 181 and 195 **Title:** ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 **Type:** SECONDARY **Unit of Measure:** Titer ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 17 **Description:** IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 181/Day 1 and Day 195/Day 1) was reported. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories. **Reporting Status:** POSTED **Time Frame:** Day 181/Day 1 and Day 195/Day 1 **Title:** ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 **Type:** SECONDARY **Unit of Measure:** Ratio ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 18 **Description:** Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Days 181 and 195 were reported. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories. **Reporting Status:** POSTED **Time Frame:** Days 181 and 195 **Title:** Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 **Type:** SECONDARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 19 **Description:** Specific functional antibacterial antibodies were measured by OPKA. GMTs for serotypes O1A, O2, O6A and O25B at Days 181 and 195 were reported. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories. **Reporting Status:** POSTED **Time Frame:** Days 181 and 195 **Title:** OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 **Type:** SECONDARY **Unit of Measure:** Titer ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 20 **Description:** Specific functional antibacterial antibodies were measured by OPKA. GMR for serotypes O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 were reported. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories. **Reporting Status:** POSTED **Time Frame:** Day 181/Day 1 and Day 195/Day 1 **Title:** OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 **Type:** SECONDARY **Unit of Measure:** Ratio ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo #### Outcome Measure 21 **Description:** Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by OPKA at Days 181 and 195 were reported. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories. **Reporting Status:** POSTED **Time Frame:** Days 181 and 195 **Title:** Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 **Type:** SECONDARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG000 **Title:** ExPEC4V ##### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** OG001 **Title:** Placebo ### Participant Flow Module #### Group **Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. **ID:** FG000 **Title:** ExPEC4V #### Group **Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. **ID:** FG001 **Title:** Placebo #### Period **Title:** Overall Study ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 6 ###### Reason **Group ID:** FG001 **Number of Subjects:** 3 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 3 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 75 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 25 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 66 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 22 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 9 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 3 **Has Results:** True
## Protocol Section ### Identification Module **NCT ID:** NCT06239779 **Acronym:** EFESAPQL **Brief Title:** Effects of Fibromyalgia Education on Smart Phone Addiction, Pain, and Quality of Life **Official Title:** Effects of Fibromyalgia Education on Smart Phone Addiction, Pain, and Quality of Life in Fibromyalgia Patients: A Randomized Controlled Study #### Organization Study ID Info **ID:** Antalya AtatürkStateHospital #### Organization **Class:** OTHER_GOV **Full Name:** Antalya Training and Research Hospital ### Status Module #### Completion Date **Date:** 2024-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-02-07 **Type:** ACTUAL **Last Update Submit Date:** 2024-02-06 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-19 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-02-02 **Type:** ACTUAL **Study First Submit Date:** 2024-01-26 **Study First Submit QC Date:** 2024-01-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Antalya Training and Research Hospital #### Responsible Party **Investigator Affiliation:** Antalya Training and Research Hospital **Investigator Full Name:** Selkin Yılmaz Muluk **Investigator Title:** MD, Physical Therapy and Rehabilitation specialist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study focuses on fibromyalgia, a condition characterized by chronic pain, fatigue, and associated issues like sleep disorders, depression, and anxiety. The investigators' goal is to detect smart phone addiction among fibromyalgia patients and assess potential improvements in their quality of life and smart phone addiction after receiving fibromyalgia education. Participants will report their recent exercise, social activities, sleep quality, and screen time for the past week. They will also complete the Revised Fibromyalgia Impact Questionnaire (FIQR) to measure pain and physical function and the Smart Phone Addiction Scale-Short Version (SAS-SV) to assess smart phone use. Diaries will track daily exercise, socialization, sleep, and screen time for 20 days. The intervention group will receive fibromyalgia education, covering an overview of fibromyalgia, coping strategies, and discussions on the impact of digital addictions. This education, delivered via a brief Microsoft PowerPoint program presentation by a physician, aims to help patients. After 20 days, all participants will redo the FIQR and SAS-SV assessments, and diary data will be collected. This study examines how physician-provided fibromyalgia education affects pain levels, quality of life, smart phone addiction, socialization, exercise, sleep, and screen time based on patient diaries. The results will deepen our understanding of how brief education can enhance the lives of fibromyalgia patients and aid in developing more effective strategies to manage pain and improve their quality of life. **Detailed Description:** Fibromyalgia is a rheumatological disease characterized by chronic pain, fatigue, and often accompanied by sleep disorders, depression, and anxiety. This study aims to identify smart phone addiction among fibromyalgia patients and explore potential improvements in their pain, quality of life and smart phone addiction after receiving fibromyalgia education. On the first day, all participants will be asked about their recent exercise duration, social activities, sleep quality, and average screen time over the past week. They will then complete the FIQR to assess pain, quality of life and physical function in fibromyalgia, as well as the SAS-SV to measure smart phone use. Participants will receive their SAS-SV scores and be provided with diaries to record daily exercise, socialization, sleep, and smart phone screen time for the next 20 days. Patients in the intervention group will receive fibromyalgia education, which includes an overview of fibromyalgia, coping strategies (exercise, socialization, sleep management, cognitive behavioral therapy, stress reduction), and discussions on the impact of digital addictions like smart phone addiction on quality of life and stress levels. This education, presented as a 10-minute Microsoft PowerPoint slide show, will be delivered by the researcher physician. At the 20th-day follow-up, all participants will again complete the FIQR questionnaire and SAS-SV scale, and data from their diaries will be collected for further analysis. This study aims to assess how fibromyalgia education provided by a physician affects pain levels, quality of life, smart phone addiction (measured by FIQR and SAS-SV), socialization frequency, exercise frequency, sleep quality, and daily screen time based on patient diaries. The findings will contribute to our understanding of how brief fibromyalgia education may impact the daily lives of patients and help develop more effective strategies to alleviate pain and enhance the quality of life for individuals with fibromyalgia. ### Conditions Module **Conditions:** - Fibromyalgia - Pain Syndrome - Quality of Life - Addiction, Mobile Phone **Keywords:** - fibromyalgia - education - pain - quality of life - phone addiction ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study is a randomized controlled trial with a pre-post intervention (education) evaluation. ##### Masking Info **Masking:** DOUBLE **Masking Description:** In this study, both participant and investigator masking have been implemented to minimize potential bias and maintain objectivity. Participants in the education group are unaware of the existence of the control group, and conversely, participants in the control group are unaware of the education group. Additionally, to further ensure objectivity, after data collection, a secretary anonymizes patients into groups A and B using stickers. This comprehensive masking approach prevents both participants and the investigator from being influenced by knowledge of group assignments during data analysis and interpretation, thereby enhancing research integrity. **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 112 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Education Group is comprised of study participants who receive an educational intervention aimed at enhancing their understanding and management of fibromyalgia. This group is designed to assess the impact of fibromyalgia education on various aspects of participants' well-being, including pain levels, quality of life, smart phone addiction, and daily activities. Participants in the Education Group will attend a brief educational session. The educational content covers the following key topics: an overview of fibromyalgia, coping strategies and potential harmful effects of smart phone addiction on fibromyalgia. The primary objective of the Education Group is to evaluate the influence of fibromyalgia education on pain levels, quality of life and physical function (measured using the FIQR) and smart phone addiction (measured using the SAS-SV) and socialization frequency, exercise frequency, sleep quality and daily screen time based on participant diaries. **Intervention Names:** - Other: Education **Label:** Education Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The Control Group is a vital component of this study, serving as a reference group for evaluating the impact of the Education Group's intervention. Participants in this group do not receive the structured educational intervention. Instead they follow their usual routines and receive standard care for fibromyalgia, which may include any recommendations typically offered by their healthcare providers but they are monitored similarly to the participants in the Education Group. The primary objective of the Control Group is to provide a baseline against which the effects of the educational intervention received by the Education Group can be compared. By not receiving the intervention, this group helps assess whether the educational program has a measurable impact on various aspects of participants' well-being when compared to standard care. **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Education Group **Description:** The education intervention involves a brief PowerPoint presentation delivered by a physician, covering an overview of fibromyalgia, coping strategies, and the potential impact of smart phone addiction on fibromyalgia. **Name:** Education **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** These are measured using the Fibromyalgia Impact Questionnaire - Revised Form is a widely recognized instrument for assessing the impact of fibromyalgia on patients' lives. FIQR encompasses various dimensions, including pain levels, quality of life, and physical function. It employs a scale with a minimum value of 0, a maximum value of 100, and higher scores indicating worse outcome fibromyalgia impact. The study aims to assess the impact of fibromyalgia education on pain levels, quality of life, and physical function using this questionnaire. **Measure:** Pain Levels, Quality of Life, and Physical Function **Time Frame:** This assessment is conducted at the beginning of the study (first day) and at the end of the study (20th day). Therefore, the time frame for this assessment spans from the first day to the 20th day of the study. **Description:** This is measured using the Smartphone Addiction Scale-short version. The study aims to assess the impact of fibromyalgia education on smart phone addiction using this scale. **Measure:** Smart Phone Addiction **Time Frame:** This assessment is conducted at the beginning of the study (first day) and at the end of the study (20th day). Therefore, the time frame for this assessment spans from the first day to the 20th day of the study #### Secondary Outcomes **Description:** This outcome is evaluated based on participant diaries. The study intends to determine how fibromyalgia education may affect participants' exercise habits. **Measure:** Exercise Frequency **Time Frame:** Participants start filling out the diary on the first day of the study and continue to do so every day for the entire 20-day duration of the study. The time frame for the diary entries covers the entire 20-day period. **Description:** This outcome is evaluated based on participant diaries. The study intends to determine how fibromyalgia education may affect participants' socialization. **Measure:** Socialization Frequency **Time Frame:** Participants start filling out the diary on the first day of the study and continue to do so every day for the entire 20-day duration of the study. The time frame for the diary entries covers the entire 20-day period. **Description:** This outcomes is evaluated based on participant diaries. The study intends to determine how fibromyalgia education may affect participants' sleep quality. **Measure:** Sleep Quality **Time Frame:** Participants start filling out the diary on the first day of the study and continue to do so every day for the entire 20-day duration of the study. The time frame for the diary entries covers the entire 20-day period. **Description:** This outcome is evaluated based on participant diaries. The study intends to determine how fibromyalgia education may affect participants' daily screen time on smart phone. **Measure:** Daily Screen Time **Time Frame:** Participants start filling out the diary on the first day of the study and continue to do so every day for the entire 20-day duration of the study. The time frame for the diary entries covers the entire 20-day period. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of Fibromyalgia: Participants must have received a definitive diagnosis of fibromyalgia from a specialist. This diagnosis should have been made within the last 6 -months or they should be newly diagnosed with fibromyalgia. * Ownership of a Smart Phone: Participants are required to own a smart phone as this is essential for aspects of the research related to smart phone addiction. * Ability to Collaborate: Participants must be willing to actively participate in the research process, follow data collection procedures, and collaborate with the research team. Exclusion Criteria: * Cognitive Impairment or Severe Neurological/Psychiatric Illness: Individuals with significant cognitive impairment or severe neurological or psychiatric conditions that may affect their participation are excluded. * Serious Health Conditions: Individuals with severe health conditions (e.g., cancer, chronic heart disease) that substantially affect their daily life and could confound the study outcomes are excluded. * Other Addictions: Individuals with other types of addictions (e.g., alcohol, substance addiction) are not eligible for participation. * Recent Serious Surgery or Trauma: Individuals who have undergone major surgery or experienced significant trauma recently are excluded. * Unwillingness to Participate: Individuals who are unwilling to participate in the research process or who do not consent to be part of the study are excluded. * Non-Compliance with Procedures: Individuals who are unable or unwilling to comply with data collection procedures as outlined by the research team are excluded. **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Nazlı Ölçücü, MD **Phone:** +905314905109 **Role:** CONTACT **Contact 2:** **Email:** [email protected], [email protected] **Name:** Selkin Yılmaz Muluk, MD **Phone:** +905321304062 **Role:** CONTACT #### Locations **Location 1:** **City:** Antalya **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Nazlı Ölçücü - **Phone:** +905314905109 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected], [email protected] - **Name:** Selkin Yılmaz Muluk - **Phone:** +905321304062 - **Role:** CONTACT **Country:** Turkey **Facility:** Ataturk State Hospital **Status:** RECRUITING **Zip:** 07040 #### Overall Officials **Official 1:** **Affiliation:** Physical Medicine and Rehabilitation specialist **Name:** Nazlı Ölçücü, MD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Antalya Ataturk State Hospital **Name:** Selkin Yılmaz Muluk, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Access will be granted to researchers, institutions, or organizations with a legitimate research purpose directly related to the subject matter of the shared data. All parties seeking access must sign an agreement confirming their commitment to maintaining the confidentiality of the data and using it only for research purposes. **Description:** The investigators do not plan to share questionnaires, scales, or patient diaries as they include personal data but are open to sharing the results of the data and the statistic analysis details upon reasonable request, **Info Types:** - STUDY_PROTOCOL - ICF - CSR **IPD Sharing:** YES **Time Frame:** Sharing will occur from the date of publication and continue for a period of three months thereafter. ### References Module #### References **Citation:** Arnold LM, Bennett RM, Crofford LJ, Dean LE, Clauw DJ, Goldenberg DL, Fitzcharles MA, Paiva ES, Staud R, Sarzi-Puttini P, Buskila D, Macfarlane GJ. AAPT Diagnostic Criteria for Fibromyalgia. J Pain. 2019 Jun;20(6):611-628. doi: 10.1016/j.jpain.2018.10.008. Epub 2018 Nov 16. **PMID:** 30453109 **Citation:** Winslow BT, Vandal C, Dang L. Fibromyalgia: Diagnosis and Management. Am Fam Physician. 2023 Feb;107(2):137-144. **PMID:** 36791450 **Citation:** Nikolic A, Bukurov B, Kocic I, Vukovic M, Ladjevic N, Vrhovac M, Pavlovic Z, Grujicic J, Kisic D, Sipetic S. Smartphone addiction, sleep quality, depression, anxiety, and stress among medical students. Front Public Health. 2023 Sep 6;11:1252371. doi: 10.3389/fpubh.2023.1252371. eCollection 2023. **PMID:** 37744504 **Citation:** Kulekcioglu S, Cetin A. Social media use in patients with fibromyalgia and its effect on symptom severity and sleep quality. Adv Rheumatol. 2021 Aug 23;61(1):51. doi: 10.1186/s42358-021-00210-7. **PMID:** 34425915 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000003192 - Term: Compulsive Behavior - ID: D000007175 - Term: Impulsive Behavior ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M8486 - Name: Fibromyalgia - Relevance: HIGH - As Found: Fibromyalgia - ID: M12161 - Name: Myofascial Pain Syndromes - Relevance: HIGH - As Found: Fibromyalgia - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M19100 - Name: Behavior, Addictive - Relevance: HIGH - As Found: Addiction - ID: M2355 - Name: Internet Addiction Disorder - Relevance: HIGH - As Found: Smart Phone Addiction - ID: M2684 - Name: Technology Addiction - Relevance: HIGH - As Found: Addiction, Mobile Phone - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M6418 - Name: Compulsive Behavior - Relevance: LOW - As Found: Unknown - ID: M10220 - Name: Impulsive Behavior - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000005356 - Term: Fibromyalgia - ID: D000009209 - Term: Myofascial Pain Syndromes - ID: D000016739 - Term: Behavior, Addictive - ID: D000082424 - Term: Internet Addiction Disorder - ID: D000088942 - Term: Technology Addiction ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02599779 **Acronym:** OZM-065 **Brief Title:** A Proof of Principle Study of Pembrolizumab With SBRT in TKI mRCC Patients **Official Title:** A Phase II Proof of Principle Study of the Activity of Pembrolizumab (MK-3475) in Combination With SBRT in Primary Tyrosine Kinase Inhibitor (TKI) Refractory Metastatic Kidney Cancer (mRCC) Patients #### Organization Study ID Info **ID:** OZM-065 #### Organization **Class:** OTHER **Full Name:** Sunnybrook Health Sciences Centre ### Status Module #### Completion Date **Date:** 2021-08-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-09-01 **Type:** ACTUAL **Last Update Submit Date:** 2021-08-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-08 **Type:** ACTUAL #### Start Date **Date:** 2016-12 **Status Verified Date:** 2021-08 #### Study First Post Date **Date:** 2015-11-09 **Type:** ESTIMATED **Study First Submit Date:** 2015-09-09 **Study First Submit QC Date:** 2015-11-05 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Merck Sharp & Dohme LLC **Class:** INDUSTRY **Name:** Ozmosis Research Inc. #### Lead Sponsor **Class:** OTHER **Name:** Sunnybrook Health Sciences Centre #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is designed as a phase-II proof of concept trial to investigate if a treatment strategy where stereotactic body radiation therapy (SBRT) is given with pembrolizumab is sufficiently active to warrant further investigation in randomized phase II or III studies. Metastatic renal cell cancer (mRCC) patients with PD-1 expressing immune cells are more likely to have larger more aggressive tumours and reduced survival and renal tumours that express PD-L1 are more aggressive with poorer outcome. Blocking this receptor/ligand interaction with monoclonal antibodies can restore the activity of tumour specific T-cells within the tumour with durable responses documented in early clinical trials in several tumour types including renal cell carcinoma. The study drug pembrolizumab is designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. SBRT will be given to the 1-3 most clinically significant lesions at the time of progression on pembrolizumab or at the 2nd course of pembrolizumab treatment in an effort to improve the activity of pembrolizumab. A total of 35 patients refractory to the approved first line therapy with a targeted drug (Sunitinib or Pazopanib) or untreated RCC patients with sarcomatoid differentiation will be enrolled on study. This group of patient has a poor outcome on any other 2nd line therapy and urgently need novel therapy. **Detailed Description:** A phase II proof of concept, multi-centre, safety and efficacy study with a biomarker component to investigate if a treatment strategy where stereotactic body radiation therapy (SBRT) is given with pembrolizumab is sufficiently active to warrant further investigation in randomized phase II or III studies. The study will run for approximately 3 years, including 2 year of recruitment and 1 year of follow up. There will be two study arms. Enrollment of 15 patients into arm A will occur before the start of enrollment of the next 20 patients on arm B. In arm A, pembrolizumab will be started and SBRT will be given to the 1-3 most clinically significant lesions only at the time of progression on pembrolizumab. Pembrolizumab will be continued after progression to detect if the addition of SBRT leads to stability or response in progressing lesions. After SBRT, untreated measurable disease must remain to assess the activity of continued pembrolizumab. Pembrolizumab and SBRT will continue until progression as per immune related response criteria (irRC). This cohort of patients will allow us to more clearly understand if SBRT does play a part in improving progression free survival when given in combination with pembrolizumab. In arm B, pembrolizumab will be started and SBRT given before the 2nd course of pembrolizumab to the 1-3 most clinically significant lesions. After SBRT, untreated measurable disease must remain to assess the activity of pembrolizumab. The value of a treatment strategy that combines pembrolizumab and SBRT up-front is evaluated in this arm. Giving SBRT early to the most clinically significant cancer lesions may give pembrolizumab more time to work and may improve response by generating neo-antigens. Patients will remain on study until progression as per irRC, withdrawal of consent or if they meet any of the premature withdrawal/discontinuation criteria. ### Conditions Module **Conditions:** - Stage IV Renal Cell Cancer AJCC V7 **Keywords:** - Renal cell cancer - SBRT - Pembrolizumab ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 4 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Arm-A: Pembrolizumab will be started and Stereotactic Body Radiation Therapy will be given at the time of progression on pembrolizumab and pembrolizumab will be continued. Pembrolizumab will continue until progression as per immune related response criteria (irRC). **Intervention Names:** - Drug: Pembrolizumab - Radiation: Stereotactic Body Radiation Therapy **Label:** Treatment arm A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Arm B: Pembrolizumab will be started. Stereotactic Body Radiation Therapy will be given before the 2nd course of pembrolizumab and pembrolizumab will be continued. Pembrolizumab will continue until progression as per immune related response criteria (irRC). **Intervention Names:** - Drug: Pembrolizumab - Radiation: Stereotactic Body Radiation Therapy **Label:** Treatment arm B **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment arm A - Treatment arm B **Description:** 200mg given intravenously over 30 minutes day 1 of every 3 week cycle until progression as per immune related response criteria **Name:** Pembrolizumab **Other Names:** - Keytruda, MK-3475 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Treatment arm A - Treatment arm B **Description:** Dose and duration dependent on body site. In Arm A: SBRT given at the time of progression on pembrolizumab. In Arm B: SBRT given before the 2nd course of pembrolizumab. **Name:** Stereotactic Body Radiation Therapy **Other Names:** - SBRT **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Measure:** Progression-free survival, as per irRC, for pembrolizumab, given with SBRT in metastatic RCC patients where progression is the best response to their first line therapy with a TKI, and in untreated patients with sarcomatoid differentiation. **Time Frame:** up to 36 months #### Secondary Outcomes **Measure:** Overall survival **Time Frame:** up to 36 months **Measure:** Objective response rate by immune related response criteria (irRC), and RECIST 1.1 criteria **Time Frame:** up to 36 months **Measure:** Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 **Time Frame:** up to 36 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Be willing and able to provide written informed consent for the trial. 2. Be ≥ 18 years of age on day of signing informed consent. 3. Patients with a histologic confirmation of renal cell carcinoma with a clear cell component where the best response to first line TKI therapy (sunitinib, pazopanib, axitinib etc) is progression, or untreated RCC patients with sarcomatoid differentiation. 4. Evidence of measurable metastatic kidney cancer according to RECIST 1.1 criteria. Patients should have an adequate number of non-irradiated metastatic sites in order to adequately assess the activity of the pembrolizumab therapy. 5. Karnofsky performance status of ≥80. 6. Favorable (0 risk factors), intermediate (1-2 risk factors) and poor risk (3-6 risk factors) patients by the Heng prognostic model are eligible based on the number of the following risk factors present. 7. Demonstrate adequate organ function, all screening labs should be performed within 10 working days of the first dose of trial treatment. 8. Male subjects should agree to use an adequate method of contraception starting with the first dose of trial treatment through 120 days after the last dose of trial treatment. 9. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of trial treatment. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. 10. One to three extra-cranial metastases eligible for SBRT. Exclusion Criteria: 1. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 2. Has had a prior monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 3. Has more than one previous targeted small molecule therapy, or radiation therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. * Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. * Note: If subject received major surgery, they must have recovered adequately in the opinion of the investigator from the toxicity and/or complications from the intervention prior to starting trial treatment. 4. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. 5. Has known brain metastases and/or carcinomatous meningitis. Exceptions include patients who have completed treatment for brain metastases at least 3 months prior to starting treatment with pembrolizumab and remained stable and no longer require steroids to control brain edema. 6. Diagnosis of ataxia telangiectasia or active collagen vascular disease. 7. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study. 8. Has evidence of interstitial lung disease, a history of non-infectious pneumonitis that required steroids, or current pneumonitis. 9. Has a known active infection requiring systemic therapy. 10. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 11. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 12. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment. 13. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). 14. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 15. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). 16. Has received a live vaccine within 30 days prior to the first dose of trial treatment. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Calgary **Country:** Canada **Facility:** Tom Baker Cancer Centre **State:** Alberta **Zip:** T2N 4N2 **Location 2:** **City:** Toronto **Country:** Canada **Facility:** Sunnybrook Health Sciences Centre **State:** Ontario **Zip:** M4N 3M5 **Location 3:** **City:** Toronto **Country:** Canada **Facility:** Princess Margaret Hospital **State:** Ontario **Zip:** M5G 2M9 #### Overall Officials **Official 1:** **Affiliation:** Sunnybrook Health Sciences Centre **Name:** Georg Bjarnason, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000230 - Term: Adenocarcinoma - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000007680 - Term: Kidney Neoplasms - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5548 - Name: Carcinoma, Renal Cell - Relevance: HIGH - As Found: Renal Cell Cancer - ID: M10703 - Name: Kidney Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: T4906 - Name: Renal Cell Carcinoma - Relevance: HIGH - As Found: Renal Cell Cancer ### Condition Browse Module - Meshes - ID: D000002292 - Term: Carcinoma, Renal Cell ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M349416 - Name: Pembrolizumab - Relevance: HIGH - As Found: Blind - ID: M2889 - Name: Tyrosine Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown - ID: T22 - Name: Tyrosine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000582435 - Term: Pembrolizumab ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02296879 **Brief Title:** A Multicenter, Open Label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous SAIT301 in Subjects With Advanced c-MET Positive (+) Solid Tumors Followed by Expansion in Selected Tumor Types **Official Title:** A Multicenter, Open Label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous SAIT301 in Subjects With Advanced c-MET Positive (+) Solid Tumors Followed by Expansion in Selected Tumor Types #### Organization Study ID Info **ID:** 2014-09-077 #### Organization **Class:** OTHER **Full Name:** Samsung Medical Center ### Status Module #### Completion Date **Date:** 2017-06-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-01-17 **Type:** ACTUAL **Last Update Submit Date:** 2018-01-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-03-15 **Type:** ACTUAL #### Start Date **Date:** 2015-01-20 **Type:** ACTUAL **Status Verified Date:** 2018-01 #### Study First Post Date **Date:** 2014-11-20 **Type:** ESTIMATED **Study First Submit Date:** 2014-11-18 **Study First Submit QC Date:** 2014-11-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Young Suk Park #### Responsible Party **Investigator Affiliation:** Samsung Medical Center **Investigator Full Name:** Young Suk Park **Investigator Title:** Samsung Medical Center **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** Mesenchymal epithelial transition factor (c-MET) is a receptor tyrosine kinase that, when engaged by its ligand hepatocyte growth factor (HGF), has been implicated in various cellular process including development as well as oncogenesis. SAIT301 is a novel humanized monoclonal antibody targeting the alpha chain of extracellular domain of c-MET. Binding of SAIT301 to c-MET blocks HGF binding and inhibits HGF-mediated signaling. Furthermore, SAIT301 also induces efficient c-MET internalization from the cell surface and subsequent degradation, resulting in inhibition of growth of the c-MET addicted cancer cells. The sponsor decided to enroll subjects with tumors that express c-MET (by immunohistochemistry \[IHC\]) for this study, as the subjects with no c-MET expression are unlikely to benefit from SAIT301 treatment. Stage 1 of this Phase I study is designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and anti-tumor activity of SAIT301 administered as a single IV infusion in 21 day cycles, for up to 4 cycles. Subjects without evidence of tumor progression after 4 cycles will be eligible to continue on SAIT301 treatment if there is no evidence of tumor progression for a further 4 cycles (Cycles 5 to 8). Biomarkers related to SAIT301 and/or tumor response will also be evaluated.Stage 2 will further evaluate the safety and PK profile of SAIT301 in select types of cancers. Dosing frequency may be adjusted based on the PK profile obtained during Stage 1. **Detailed Description:** The primary objectives of the study are as follows: * To evaluate the safety and tolerability of SAIT301. * To determine the MTD of SAIT301 and the dose level of SAIT301 where dose limiting toxicity (DLT) is observed in subjects with advanced solid tumors or define recommended Phase II dose (RP2D) as an alternative to establishing the MTD. Methodology: This first in man study will consist of 2 stages. Stage 1 will be a dose escalation study with a 3 + 3 design and will evaluate the safety, tolerability, PK profile, biomarkers, and preliminary anti-tumor activity of ascending doses of SAIT301 in subjects with c-MET + advanced solid tumors and define the MTD (or recommended Phase II dose \[RP2D\]) of SAIT301. If the PK trough levels exceed the minimum acceptable trough level for SAIT301 (25 μg/mL), the Safety Review Committee (SRC) may elect to terminate further dose escalation and declare a recommended Phase II dose (RP2D) and schedule as an alternative to establishing the MTD. In Stage 2 the MTD (or RP2D) defined in Stage 1 will be administered to additional subjects with selected diagnoses, 15 subjects per selected diagnosis, to further evaluate the safety and PK profile, and any evidence of anti tumor activity of SAIT301 in these populations. The tumor types to be included in Stage 2 will be defined in a protocol amendment at a time close to study execution based on information available at that time. The treatment period will consist of 21-day cycles. On Day 1 of each cycle, SAIT301 will be administered as an intravenous (IV) infusion. For dose level 1, the first subject will receive an IV infusion of SAIT301 on Cycle 1 Day 1 and will be followed for 21 days (Cycle 1). If the first subject at dose level 1 experiences a DLT during Cycle 1, 1 additional subject will be enrolled and will receive dose level 1, which is 50% of dose level 1. If this subject at dose level -1 does not experience a DLT during Cycle 1, 2 more subjects will be enrolled at dose level -1. If the first subject at dose level 1 does not experience a DLT during Cycle 1, the second and third subjects will receive SAIT301 at dose level 1 and will be followed for 21 days (Cycle 1). At the discretion of the SRC, if the first 3 subjects at dose level 1 do not experience a DLT during Cycle 1, dose level 2 may be administered in the next cohort. If one of these subjects experiences a DLT, the cohort will be expanded and evaluated as described below. For dose level 2 and each subsequent dose level, 3 subjects will receive SAIT301 on Day 1 of Cycle 1 and will be followed for 21 days (Cycle 1). If none of the 3 subjects experience a DLT, the next dose level can be administered in the next cohort. If 1 or more of the first 3 subjects experience a DLT, 3 more subjects will receive the same dose level. Dose escalation will continue until at least 2 subjects in a cohort of 3 to 6 subjects experience a DLT (i.e., ≥33% of subjects with a DLT at that dose level). Considering the possibility of relatively low efficacy, each subjects of dose level 1 and 2 can be administered with higher dose level after their first administration. This individual dose escalation can be determined by Investigators when safety data of the higher dose level are available. For both Stage 1 and 2, subjects will continue to receive the assigned dose level of SAIT301 until unacceptable toxicity, documented progression of disease, another criterion for discontinuation is met, or until 4 cycles have been completed. Subjects without evidence of tumor progression after 4 cycles may continue on SAIT301 treatment if there is no evidence of tumor progression for a further 4 cycles (Cycles 5 to 8). Subjects without evidence of tumor progression at the completion of Cycle 8 will be eligible for a follow-on protocol. Subjects who experience a DLT will be discontinued from further treatment. At the completion of the dose escalation stage, the SRC may for Stage 2 alter the dosing interval between cycles based on emerging PK data from lower SAIT301 dose levels. ### Conditions Module **Conditions:** - Solid Tumors ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 16 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** For Stage 1, subjects will be sequentially assigned to 1 of approximately 8 cohorts comprised of 3 to 6 subjects each. SAIT301 will be administered according to a modified Fibonacci sequence and following a 3 + 3 design. For Stage 2, the MTD or (RP2D) determined in the Stage 1 will be administered to additional subjects with selected diagnoses, 15 subjects per selected diagnosis. After completion of Stage 1 the SRC may elect to increase the interval between doses (i.e., increase cycle length to 28 days) based on the emerging PK data from the lower SAIT301 dose levels. **Intervention Names:** - Genetic: SAIT301 **Label:** SAIT301 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - SAIT301 **Description:** The treatment period will consist of 21-day cycles. On Day 1 of each cycle, SAIT301 will be administered as an intravenous (IV) infusion. **Name:** SAIT301 **Type:** GENETIC ### Outcomes Module #### Primary Outcomes **Description:** Adverse events will be evaluated and categorized in accordance with the CTCAE, version 4.03. **Measure:** Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) of at least Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 severity, and discontinuations due to AEs. **Time Frame:** Up to 25 weeks for each subject **Description:** The frequency of DLTs as part of the MTD determination process. **Measure:** The maximum tolerated dose (MTD) of SAIT301 and the dose level of SAIT301 where dose limiting toxicity (DLT) is observed in subjects with advanced solid tumors **Time Frame:** Up to 25 weeks for each subject **Description:** RP2D determination as an alternative to establishing the MTD **Measure:** A recommended Phase II dose (RP2D) as an alternative to establishing the MTD. **Time Frame:** Up to 25 weeks for each subject #### Secondary Outcomes **Description:** Free SAIT301 for Cycle 1 and Cycle 4 over dosing observation period of 0 to 21 days: maximum observed serum concentration (Cmax), time to maximum serum concentration (tmax), area under the serum concentration-time curve from zero to the last quantifiable concentration (AUC0-t), area under the concentration-time curve over the dosing interval (AUC0-tau). Free SAIT301 for Cycle 1, if half-life can be estimated with acceptable accuracy and/or for Cycle 4 if data collected in Cycle 4 are representative of steady state: area under the serum concentration-time curve from zero extrapolated to infinity (AUC0-inf), elimination rate constant (λz), elimination half-life (t1/2), apparent clearance from serum (CL), and volume of distribution at steady-state (VSS). **Measure:** The pharmacokinetic (PK) profile of SAIT301 **Time Frame:** Up to 25 weeks for each subject **Measure:** Objective tumor response for target lesions based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1, as assessed by repeat computerized tomography (CT) or magnetic resonance imaging (MRI). **Time Frame:** Up to 25 weeks for each subject **Description:** Development of anti-SAIT301 binding antibodies and neutralizing antibodies **Measure:** To assess the preliminary anti-tumor activity of SAIT301 when administered as a single agent in this subject population **Time Frame:** Up to 25 weeks for each subject ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Aged 18 years or older. 2. Have a histologically or cytologically confirmed advanced solid tumor that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy, or the subject is not a candidate for standard therapy. 3. Tumor positive for c-MET expression as determined by IHC. Results should be available before the subject can proceed in the study. 4. Adequate tumor biopsy material should be available for IHC and fluorescence in situ hybridization (FISH) of c-MET and biomarker analysis at the time of enrollment (formalin-fixed, paraffin-embedded tumor block or 20 fresh cut unstained slides). 5. At least 28 days must have elapsed since the subject's prior systemic therapy, radiotherapy, or any major surgery (excluding diagnostic biopsy or venous access device placement). Surgery requiring local/epidural anesthesia must be completed at least 72 hours before the first administration of SAIT301. For concomitant medications with a known half-life of less than 36 hours (e.g., tyrosine kinase inhibitors), the duration of time since prior therapy can be reduced to 14 days provided any drug-related toxicities have resolved to Grade 1 or better. Hormonal therapy for prostate or breast cancer are allowed during the study. 6. For dose levels 1 to 3, subjects must, at a minimum, have evaluable disease according to RECIST 1.1 guidelines. For dose levels above level 3, subjects must have measureable disease (≥1 cm by spiral computerized tomography \[CT\] or ≥2 cm by standard CT). 7. An ECOG performance status of \<2. 8. Life expectancy of \>12 weeks, as judged by the investigator. 9. Female subjects must not be pregnant or breastfeeding, or at risk to become pregnant during the study. Fertile male and female subjects must agree to use an effective barrier method of birth control to avoid pregnancy from the time of providing informed consent until 90 days after the last administration of SAIT301. 10. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days of the first administration of SAIT301. For the purpose of this study, female subjects of childbearing potential are defined as all female subjects after puberty unless they are postmenopausal for at least 1 year, or are surgically sterile (hysterectomy or bilateral oophorectomy or tubal ligation). 11. Adequate organ function as indicated by the laboratory test results obtained within 7 days prior to the first administration of SAIT301: Hematologic: Absolute neutrophil count ≥1.5 x 109/L, platelet count ≥100 x 109/L, and hemoglobin ≥9.0 g/dL. Liver function: Serum bilirubin \<2.0 mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3 x upper limit of normal (ULN) without liver involvement, or \<5 x ULN with liver involvement. Renal: serum creatinine ≤1.5 mg/dL. 12. Willing and able to provide written informed consent and to comply with the protocol, visit schedule, and requirements. Exclusion Criteria: Subjects will not be entered in the study for any of the following reasons: 1. Received previous treatment with SAIT301 or a previous drug with c-MET inhibitory activity. 2. Received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 28 days of the first administration of SAIT301 in this study. 3. History of prior allergic reactions to protein therapeutics. 4. Active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant. 5. Symptomatic or untreated central nervous system metastases. 6. Not recovered from acute toxicity of any therapy received prior to enrollment. 7. Received systemic treatment for bacterial infection within 7 days of screening. 8. Positive test results for human immunodeficiency virus (HIV), hepatitis B (core immunoglobulin M antibody and/or surface antigen), or hepatitis C at screening. 9. Any other serious medical condition which in the investigator's opinion would preclude safe participation in the study. 10. Likely to be non-compliant or uncooperative during the study, as judged by the investigator. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Samsung Medical Center **Zip:** 135-710 #### Overall Officials **Official 1:** **Affiliation:** Samsung Medical Center,Seoul,Korea **Name:** Park Yong Suk, MD,Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT00986479 **Brief Title:** This is a Study to Determine the Antidepressant Effects of AZD6765 **Official Title:** An Investigation of the Antidepressant Effects of an NMDA Antagonist in Treatment-Resistant Major Depression **NCT ID Aliases:** - NCT00995111 #### Organization Study ID Info **ID:** D6702C00015 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2011-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-10-21 **Type:** ESTIMATED **Last Update Submit Date:** 2014-10-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2011-12 **Type:** ACTUAL #### Results First Post Date **Date:** 2014-10-21 **Type:** ESTIMATED **Results First Submit Date:** 2014-10-15 **Results First Submit QC Date:** 2014-10-15 #### Start Date **Date:** 2009-12 **Status Verified Date:** 2014-10 #### Study First Post Date **Date:** 2009-09-30 **Type:** ESTIMATED **Study First Submit Date:** 2009-09-24 **Study First Submit QC Date:** 2009-09-29 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute of Mental Health (NIMH) #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to determine the antidepressant effects of AZD6765 compared to placebo. ### Conditions Module **Conditions:** - Treatment Resistant Major Depressive Disorder **Keywords:** - Patients ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 22 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. **Intervention Names:** - Drug: AZD6765 **Label:** AZD6765 (150 mg) / Placebo **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. **Intervention Names:** - Drug: Placebo to AZD6765 **Label:** Placebo / AZD6765 (150 mg) **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - AZD6765 (150 mg) / Placebo **Description:** Single IV infusion of 150 mg AZD6765. **Name:** AZD6765 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo / AZD6765 (150 mg) **Description:** Single IV infusion of Placebo to AZD6765 **Name:** Placebo to AZD6765 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst. **Measure:** Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. #### Secondary Outcomes **Description:** Remission defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score \<10. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst. **Measure:** The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Description:** Response defined as a \>= 50% reduction from baseline in MADRS total score. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst. **Measure:** The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response). **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Description:** Scale for Suicide Ideation (SSI) is a 19-item scale designed to quantify the intensity of current conscious suicide ideation. Each item is rated on a scale of 0 to 2 (with higher scores indicating greater suicidal ideation). The individual item scores are added together to form a total score, ranging between 0 and 38. 0 is considered the best outcome, 38 the worst. **Measure:** Scale for Suicide Ideation (SSI) Total Score. **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Description:** Hamilton Anxiety Rating Scale (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56. 0 is considered the best outcome, 56 the worst. **Measure:** Hamilton Anxiety Rating Scale (HAM-A) Total Score. **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Description:** Hamilton Depression Rating Scale-17 item (HDRS) is a scale that assesses depressive symptoms. HDRS consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher scores indicate more severe depression. **Measure:** Hamilton Depression Rating Scale-17 Item (HDRS) Total Score **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing **Description:** The Visual Analog Scale (VAS) Depressed is a 0 to 100-mm self-administered scale where patients rate their mood between "extreme sad" (0-mm) and "extreme happy" (100-mm), with a median "normal" point. **Measure:** Visual Analogue Scale (VAS) Depressed Score **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing **Description:** Clinician- Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during dissociative experiences. This scale involves a 23 questions and each is rated from 0 (not at all) to 4 (extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92. **Measure:** Clinician-Administered Dissociative States Scale (CADSS) Score. **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing **Description:** The Brief Psychiatric Rating Scale (BPRS) is a 18-item scale which measures symptoms and behaviors that are characteristic of schizophrenia. Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 18 items, resulting in a range of scores from 18-126. 18 is considered to be the best outcome, 126 the worst. **Measure:** Brief Psychiatric Rating Scale (BPRS) Score. **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Description:** Beck Depression Inventory (BDI) is a 21-question instrument for measuring the severity of depression. Each question has a set of at least four possible answer choices, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score is computed. Higher total scores indicate more severe depressive symptoms. **Measure:** Beck Depression Inventory (BDI) Score. **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Description:** Young Mania Rating Scale (YMRS) consists of 11 items, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) or from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. 0 is considered to be the best outcome, 60 the worst. **Measure:** Young Mania Rating Scale (YMRS) Score. **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Description:** The Visual Analog Scale (VAS) Anxious is a 0 to 100-mm self-administered scale where patients rate their mood between "extreme sad" (0-mm) and "extreme happy" (100-mm), with a median "normal" point. **Measure:** Visual Analogue Scale (VAS) Anxious Score. **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Description:** Brief Psychiatric Rating Scale (BPRS) Positive is a 4-item scale which measures positive symptoms of schizophrenia (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content). Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 4 items, resulting in a range of scores from 4-28. **Measure:** Brief Psychiatric Rating Scale (BPRS) Positive Score. **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with a diagnosis of Major Depressive Disorder, currently depressed without psychotic features * Females must be of non-childbearing potential. Exclusion Criteria: * Treatment with Clozapine or ECT within 3 months prior to study * Current or past history of psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bethesda **Country:** United States **Facility:** Research Site **State:** Maryland #### Overall Officials **Official 1:** **Affiliation:** National Institute of Mental Health (NIMH) **Name:** Carlos A Zarate, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3. **PMID:** 34510411 **Citation:** Lepow L, Luckenbaugh DA, Park L, Henter ID, Zarate CA Jr. Case series: Antidepressant effects of low-affinity and low-trapping NMDA receptor antagonists did not predict response to ketamine in seven subjects. J Psychiatr Res. 2017 Mar;86:55-57. doi: 10.1016/j.jpsychires.2016.10.023. Epub 2016 Nov 22. No abstract available. **PMID:** 27914292 **Citation:** Zarate CA Jr, Mathews D, Ibrahim L, Chaves JF, Marquardt C, Ukoh I, Jolkovsky L, Brutsche NE, Smith MA, Luckenbaugh DA. A randomized trial of a low-trapping nonselective N-methyl-D-aspartate channel blocker in major depression. Biol Psychiatry. 2013 Aug 15;74(4):257-64. doi: 10.1016/j.biopsych.2012.10.019. Epub 2012 Dec 1. **PMID:** 23206319 #### See Also Links **Label:** D6702C00015 Clinical Study Report Synopsis **URL:** http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=213&filename=D6702C00015_Clinical_Study_Report_Synopsis.pdf ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M7060 - Name: Depressive Disorder, Major - Relevance: HIGH - As Found: Major Depressive Disorder - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003866 - Term: Depressive Disorder - ID: D000003865 - Term: Depressive Disorder, Major ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PsychDr - Name: Psychotropic Drugs ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M4247 - Name: Antidepressive Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** AZD6765 (150 mg) **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. **ID:** EG000 **Other Num Affected:** 21 **Other Num at Risk:** 22 **Serious Number At Risk:** 22 **Title:** AZD6765 (150 mg) **Group ID:** EG001 **Title:** Placebo **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. **ID:** EG001 **Other Num Affected:** 20 **Other Num at Risk:** 20 **Serious Number At Risk:** 20 **Title:** Placebo **Frequency Threshold:** 5 #### Other Events **Term:** Bradycardia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** **Term:** Hypertension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** **Term:** Hypotension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** **Term:** Tachycardia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** **Term:** Dyspnoea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Hypoacusis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Ear and labyrinth disorders **Source Vocabulary:** **Term:** Tinnitus **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Ear and labyrinth disorders **Source Vocabulary:** **Term:** Vision blurred **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** **Term:** Eye irritation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** **Term:** Decreased apetite **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Increased apetite **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Constipation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Flatulence **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Thirst **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Nausea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Abdominal discomfort **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Faeces discoloured **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Dysgeusia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Vomiting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Weight increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Weight decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Libido increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Felt faint **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Headache **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Dental care **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Surgical and medical procedures **Source Vocabulary:** **Term:** Dry mouth **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Gingival disorder **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Salivary hypersecretion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Mouth ulceration **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Glossodynia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Oedema **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Muscle rigidity **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Myalgia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Tic **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Tremor **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Malignant dysphagia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Influenza **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** Nasal congestion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Oropharyngeal pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Anxiety **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Disturbance in attention **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Confusional state **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Depression **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Initial insomnia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Somnolence **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Terminal insomnia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Hallucination **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Sleep disorder **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Irritability **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Memory impairment **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Hypokinesia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Psychomotor activity **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Dysarthria **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Suicidal behaviour **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Suicidal ideation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Fatigue **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Skin irritation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** Hyperhidrosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** Pyrexia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Surgery **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Surgical and medical procedures **Source Vocabulary:** **Term:** Hearing impaired **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Ear and labyrinth disorders **Source Vocabulary:** **Term:** Body temperature decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Dissociation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Euphoric mood **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Social avoindant behaviour **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Abnormal behaviour **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Feeling abnormal **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Body temperature increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Energy increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Hypoaesthesia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Rash **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** Fear of falling **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Paraesthesia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Visual impairment **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** **Term:** Abnormal dreams **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** False Sensation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Dizziness **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 12 **Group ID:** BG001 **Value:** 10 **Group ID:** BG002 **Value:** 22 **Units:** Participants ### Group **ID:** BG000 **Title:** AZD6765 (150 mg)/ Placebo **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. ### Group **ID:** BG001 **Title:** Placebo/AZD6765 (150 mg) **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 10.9 **Value:** 50.7 #### Measurement **Group ID:** BG001 **Spread:** 10.5 **Value:** 52.4 #### Measurement **Group ID:** BG002 **Spread:** 10.1 **Value:** 51.5 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 7 #### Measurement **Group ID:** BG001 **Value:** 3 #### Measurement **Group ID:** BG002 **Value:** 10 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 5 #### Measurement **Group ID:** BG001 **Value:** 7 #### Measurement **Group ID:** BG002 **Value:** 12 **Category Title:** Male **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** AstraZeneca **Title:** Clinical Trial Transparency ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ### Outcome Measure 6 ### Outcome Measure 7 ### Outcome Measure 8 ### Outcome Measure 9 ### Outcome Measure 10 ### Outcome Measure 11 ### Outcome Measure 12 ### Outcome Measure 13 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.262 - **Upper Limit:** - **Value:** 26.881 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.314 - **Upper Limit:** - **Value:** 28.618 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.262 - **Upper Limit:** - **Value:** 25.381 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.314 - **Upper Limit:** - **Value:** 29.718 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.262 - **Upper Limit:** - **Value:** 25.835 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.314 - **Upper Limit:** - **Value:** 29.818 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.262 - **Upper Limit:** - **Value:** 26.517 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.314 - **Upper Limit:** - **Value:** 29.418 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.262 - **Upper Limit:** - **Value:** 27.654 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.314 - **Upper Limit:** - **Value:** 29.118 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.288 - **Upper Limit:** - **Value:** 29.161 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.314 - **Upper Limit:** - **Value:** 31.368 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.288 - **Upper Limit:** - **Value:** 30.732 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.314 - **Upper Limit:** - **Value:** 30.368 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.288 - **Upper Limit:** - **Value:** 31.447 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.342 - **Upper Limit:** - **Value:** 31.222 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.326 - **Upper Limit:** - **Value:** 0.955 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.330 - **Upper Limit:** - **Value:** 0.939 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.326 - **Upper Limit:** - **Value:** 1.137 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.330 - **Upper Limit:** - **Value:** 1.039 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.326 - **Upper Limit:** - **Value:** 1.137 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.330 - **Upper Limit:** - **Value:** 0.989 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.326 - **Upper Limit:** - **Value:** 0.864 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.330 - **Upper Limit:** - **Value:** 0.939 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.326 - **Upper Limit:** - **Value:** 1.364 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.330 - **Upper Limit:** - **Value:** 1.539 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.328 - **Upper Limit:** - **Value:** 1.236 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.330 - **Upper Limit:** - **Value:** 1.189 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.328 - **Upper Limit:** - **Value:** 1.379 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.332 - **Upper Limit:** - **Value:** 1.226 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.328 - **Upper Limit:** - **Value:** 1.379 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.332 - **Upper Limit:** - **Value:** 1.507 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.181 - **Upper Limit:** - **Value:** 16.211 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.207 - **Upper Limit:** - **Value:** 17.160 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.181 - **Upper Limit:** - **Value:** 16.666 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.198 - **Upper Limit:** - **Value:** 17.675 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.190 - **Upper Limit:** - **Value:** 16.817 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.198 - **Upper Limit:** - **Value:** 18.125 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.190 - **Upper Limit:** - **Value:** 17.055 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.198 - **Upper Limit:** - **Value:** 18.525 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.190 - **Upper Limit:** - **Value:** 18.817 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.207 - **Upper Limit:** - **Value:** 19.631 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.977 - **Upper Limit:** - **Value:** 15.930 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.008 - **Upper Limit:** - **Value:** 17.389 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.977 - **Upper Limit:** - **Value:** 14.975 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.008 - **Upper Limit:** - **Value:** 17.739 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.977 - **Upper Limit:** - **Value:** 15.475 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.008 - **Upper Limit:** - **Value:** 18.039 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.977 - **Upper Limit:** - **Value:** 16.112 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.008 - **Upper Limit:** - **Value:** 17.339 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.977 - **Upper Limit:** - **Value:** 16.748 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.008 - **Upper Limit:** - **Value:** 17.639 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.977 - **Upper Limit:** - **Value:** 16.732 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.008 - **Upper Limit:** - **Value:** 19.289 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.977 - **Upper Limit:** - **Value:** 17.732 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.008 - **Upper Limit:** - **Value:** 19.039 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.991 - **Upper Limit:** - **Value:** 18.160 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.024 - **Upper Limit:** - **Value:** 19.438 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6.137 - **Upper Limit:** - **Value:** 55.614 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 6.197 - **Upper Limit:** - **Value:** 60.562 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6.137 - **Upper Limit:** - **Value:** 58.614 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 6.197 - **Upper Limit:** - **Value:** 57.662 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6.137 - **Upper Limit:** - **Value:** 60.750 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 6.197 - **Upper Limit:** - **Value:** 59.062 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6.137 - **Upper Limit:** - **Value:** 55.614 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 6.197 - **Upper Limit:** - **Value:** 61.212 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6.137 - **Upper Limit:** - **Value:** 62.160 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 6.197 - **Upper Limit:** - **Value:** 64.762 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6.166 - **Upper Limit:** - **Value:** 65.753 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 6.197 - **Upper Limit:** - **Value:** 63.262 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6.166 - **Upper Limit:** - **Value:** 66.896 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 6.197 - **Upper Limit:** - **Value:** 63.312 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6.166 - **Upper Limit:** - **Value:** 68.467 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 6.264 - **Upper Limit:** - **Value:** 65.576 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.900 - **Upper Limit:** - **Value:** 4.104 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.921 - **Upper Limit:** - **Value:** 1.997 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.909 - **Upper Limit:** - **Value:** 3.324 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.921 - **Upper Limit:** - **Value:** 2.297 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.900 - **Upper Limit:** - **Value:** 2.831 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.921 - **Upper Limit:** - **Value:** 2.047 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.900 - **Upper Limit:** - **Value:** 1.240 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.921 - **Upper Limit:** - **Value:** 1.497 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.900 - **Upper Limit:** - **Value:** 1.013 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.921 - **Upper Limit:** - **Value:** 1.147 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.910 - **Upper Limit:** - **Value:** 1.360 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.921 - **Upper Limit:** - **Value:** 1.397 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.910 - **Upper Limit:** - **Value:** 1.456 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.921 - **Upper Limit:** - **Value:** 1.447 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.910 - **Upper Limit:** - **Value:** 1.313 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.932 - **Upper Limit:** - **Value:** 1.212 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.271 - **Upper Limit:** - **Value:** 32.191 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.314 - **Upper Limit:** - **Value:** 32.896 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.271 - **Upper Limit:** - **Value:** 30.237 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.314 - **Upper Limit:** - **Value:** 33.496 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.271 - **Upper Limit:** - **Value:** 30.555 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.314 - **Upper Limit:** - **Value:** 33.696 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.271 - **Upper Limit:** - **Value:** 30.737 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.314 - **Upper Limit:** - **Value:** 31.772 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.271 - **Upper Limit:** - **Value:** 33.418 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.314 - **Upper Limit:** - **Value:** 33.596 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.291 - **Upper Limit:** - **Value:** 32.882 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.314 - **Upper Limit:** - **Value:** 34.496 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.291 - **Upper Limit:** - **Value:** 34.168 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.314 - **Upper Limit:** - **Value:** 33.046 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.291 - **Upper Limit:** - **Value:** 35.739 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.335 - **Upper Limit:** - **Value:** 34.428 **Title:** #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.524 - **Upper Limit:** - **Value:** 21.081 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.538 - **Upper Limit:** - **Value:** 22.886 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.524 - **Upper Limit:** - **Value:** 22.217 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.546 - **Upper Limit:** - **Value:** 23.122 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.524 - **Upper Limit:** - **Value:** 21.535 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.538 - **Upper Limit:** - **Value:** 23.586 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.524 - **Upper Limit:** - **Value:** 21.126 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.538 - **Upper Limit:** - **Value:** 23.686 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.524 - **Upper Limit:** - **Value:** 22.444 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.538 - **Upper Limit:** - **Value:** 22.936 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.531 - **Upper Limit:** - **Value:** 22.923 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.538 - **Upper Limit:** - **Value:** 24.586 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.531 - **Upper Limit:** - **Value:** 23.494 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.538 - **Upper Limit:** - **Value:** 23.786 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.531 - **Upper Limit:** - **Value:** 24.447 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.546 - **Upper Limit:** - **Value:** 24.070 **Title:** #### Outcome Measure 11 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.412 - **Upper Limit:** - **Value:** 4.294 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.427 - **Upper Limit:** - **Value:** 3.626 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.412 - **Upper Limit:** - **Value:** 3.748 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.427 - **Upper Limit:** - **Value:** 3.526 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.412 - **Upper Limit:** - **Value:** 3.475 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.427 - **Upper Limit:** - **Value:** 3.526 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.412 - **Upper Limit:** - **Value:** 3.748 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.427 - **Upper Limit:** - **Value:** 3.526 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.412 - **Upper Limit:** - **Value:** 3.748 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.427 - **Upper Limit:** - **Value:** 3.326 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.419 - **Upper Limit:** - **Value:** 3.699 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.427 - **Upper Limit:** - **Value:** 3.676 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.419 - **Upper Limit:** - **Value:** 4.270 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.427 - **Upper Limit:** - **Value:** 3.476 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.419 - **Upper Limit:** - **Value:** 4.366 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.435 - **Upper Limit:** - **Value:** 4.339 **Title:** #### Outcome Measure 12 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.415 - **Upper Limit:** - **Value:** 43.898 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.479 - **Upper Limit:** - **Value:** 41.929 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.415 - **Upper Limit:** - **Value:** 44.216 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.479 - **Upper Limit:** - **Value:** 44.079 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.415 - **Upper Limit:** - **Value:** 42.853 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.479 - **Upper Limit:** - **Value:** 44.729 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.415 - **Upper Limit:** - **Value:** 44.580 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.479 - **Upper Limit:** - **Value:** 46.029 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.415 - **Upper Limit:** - **Value:** 44.989 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.479 - **Upper Limit:** - **Value:** 47.229 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.447 - **Upper Limit:** - **Value:** 44.718 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.479 - **Upper Limit:** - **Value:** 50.479 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.447 - **Upper Limit:** - **Value:** 42.623 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.479 - **Upper Limit:** - **Value:** 48.279 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.447 - **Upper Limit:** - **Value:** 50.147 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.551 - **Upper Limit:** - **Value:** 56.595 **Title:** #### Outcome Measure 13 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.264 - **Upper Limit:** - **Value:** 9.433 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.274 - **Upper Limit:** - **Value:** 8.946 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.264 - **Upper Limit:** - **Value:** 8.751 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.274 - **Upper Limit:** - **Value:** 8.996 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.264 - **Upper Limit:** - **Value:** 8.660 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.274 - **Upper Limit:** - **Value:** 8.996 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.264 - **Upper Limit:** - **Value:** 8.751 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.279 - **Upper Limit:** - **Value:** 8.666 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.264 - **Upper Limit:** - **Value:** 9.114 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.274 - **Upper Limit:** - **Value:** 9.296 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.269 - **Upper Limit:** - **Value:** 9.118 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.274 - **Upper Limit:** - **Value:** 9.296 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.269 - **Upper Limit:** - **Value:** 9.118 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.274 - **Upper Limit:** - **Value:** 9.446 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.269 - **Upper Limit:** - **Value:** 9.356 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.279 - **Upper Limit:** - **Value:** 9.338 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** ITT population including all randomized patients who were given study treatment. **Reporting Status:** POSTED **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Title:** Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. **Type:** PRIMARY **Unit of Measure:** Units on a scale ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. **ID:** OG000 **Title:** AZD6765 (150 mg) ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. **ID:** OG001 **Title:** Placebo #### Outcome Measure 2 **Description:** Remission defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score \<10. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst. **Parameter Type:** NUMBER **Population Description:** ITT population including all randomized patients who were given study treatment. **Reporting Status:** POSTED **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Title:** The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. **ID:** OG000 **Title:** AZD6765 (150 mg) ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. **ID:** OG001 **Title:** Placebo #### Outcome Measure 3 **Description:** Response defined as a \>= 50% reduction from baseline in MADRS total score. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst. **Parameter Type:** NUMBER **Population Description:** ITT population including all randomized patients who were given study treatment. **Reporting Status:** POSTED **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Title:** The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response). **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. **ID:** OG000 **Title:** AZD6765 (150 mg) ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. **ID:** OG001 **Title:** Placebo #### Outcome Measure 4 **Description:** Scale for Suicide Ideation (SSI) is a 19-item scale designed to quantify the intensity of current conscious suicide ideation. Each item is rated on a scale of 0 to 2 (with higher scores indicating greater suicidal ideation). The individual item scores are added together to form a total score, ranging between 0 and 38. 0 is considered the best outcome, 38 the worst. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** ITT population including all randomized patients who were given study treatment. **Reporting Status:** POSTED **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Title:** Scale for Suicide Ideation (SSI) Total Score. **Type:** SECONDARY **Unit of Measure:** Units on a scale ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. **ID:** OG000 **Title:** AZD6765 (150 mg) ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. **ID:** OG001 **Title:** Placebo #### Outcome Measure 5 **Description:** Hamilton Anxiety Rating Scale (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56. 0 is considered the best outcome, 56 the worst. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Reporting Status:** POSTED **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Title:** Hamilton Anxiety Rating Scale (HAM-A) Total Score. **Type:** SECONDARY **Unit of Measure:** Units on a scale ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. **ID:** OG000 **Title:** AZD6765 (150 mg) ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. **ID:** OG001 **Title:** Placebo #### Outcome Measure 6 **Description:** Hamilton Depression Rating Scale-17 item (HDRS) is a scale that assesses depressive symptoms. HDRS consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher scores indicate more severe depression. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** ITT population including all randomized patients who were given study treatment. **Reporting Status:** POSTED **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing **Title:** Hamilton Depression Rating Scale-17 Item (HDRS) Total Score **Type:** SECONDARY **Unit of Measure:** Units on a scale ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. **ID:** OG000 **Title:** AZD6765 (150 mg) ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. **ID:** OG001 **Title:** Placebo #### Outcome Measure 7 **Description:** The Visual Analog Scale (VAS) Depressed is a 0 to 100-mm self-administered scale where patients rate their mood between "extreme sad" (0-mm) and "extreme happy" (100-mm), with a median "normal" point. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** ITT population including all randomized patients who were given study treatment. **Reporting Status:** POSTED **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing **Title:** Visual Analogue Scale (VAS) Depressed Score **Type:** SECONDARY **Unit of Measure:** Scores on a scale ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. **ID:** OG000 **Title:** AZD6765 (150 mg) ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. **ID:** OG001 **Title:** Placebo #### Outcome Measure 8 **Description:** Clinician- Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during dissociative experiences. This scale involves a 23 questions and each is rated from 0 (not at all) to 4 (extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** ITT population including all randomized patients who were given study treatment. **Reporting Status:** POSTED **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing **Title:** Clinician-Administered Dissociative States Scale (CADSS) Score. **Type:** SECONDARY **Unit of Measure:** Units on a scale ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. **ID:** OG000 **Title:** AZD6765 (150 mg) ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. **ID:** OG001 **Title:** Placebo #### Outcome Measure 9 **Description:** The Brief Psychiatric Rating Scale (BPRS) is a 18-item scale which measures symptoms and behaviors that are characteristic of schizophrenia. Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 18 items, resulting in a range of scores from 18-126. 18 is considered to be the best outcome, 126 the worst. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** ITT population including all randomized patients who were given study treatment. **Reporting Status:** POSTED **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Title:** Brief Psychiatric Rating Scale (BPRS) Score. **Type:** SECONDARY **Unit of Measure:** Units on a scale ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. **ID:** OG000 **Title:** AZD6765 (150 mg) ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. **ID:** OG001 **Title:** Placebo #### Outcome Measure 10 **Description:** Beck Depression Inventory (BDI) is a 21-question instrument for measuring the severity of depression. Each question has a set of at least four possible answer choices, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score is computed. Higher total scores indicate more severe depressive symptoms. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** ITT population including all randomized patients who were given study treatment. **Reporting Status:** POSTED **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Title:** Beck Depression Inventory (BDI) Score. **Type:** SECONDARY **Unit of Measure:** Units on a scale ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. **ID:** OG000 **Title:** AZD6765 (150 mg) ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. **ID:** OG001 **Title:** Placebo #### Outcome Measure 11 **Description:** Young Mania Rating Scale (YMRS) consists of 11 items, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) or from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. 0 is considered to be the best outcome, 60 the worst. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** ITT population including all randomized patients who were given study treatment. **Reporting Status:** POSTED **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Title:** Young Mania Rating Scale (YMRS) Score. **Type:** SECONDARY **Unit of Measure:** Units on a scale ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. **ID:** OG000 **Title:** AZD6765 (150 mg) ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. **ID:** OG001 **Title:** Placebo #### Outcome Measure 12 **Description:** The Visual Analog Scale (VAS) Anxious is a 0 to 100-mm self-administered scale where patients rate their mood between "extreme sad" (0-mm) and "extreme happy" (100-mm), with a median "normal" point. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** ITT population including all randomized patients who were given study treatment. **Reporting Status:** POSTED **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Title:** Visual Analogue Scale (VAS) Anxious Score. **Type:** SECONDARY **Unit of Measure:** Units on a scale ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. **ID:** OG000 **Title:** AZD6765 (150 mg) ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. **ID:** OG001 **Title:** Placebo #### Outcome Measure 13 **Description:** Brief Psychiatric Rating Scale (BPRS) Positive is a 4-item scale which measures positive symptoms of schizophrenia (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content). Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 4 items, resulting in a range of scores from 4-28. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Reporting Status:** POSTED **Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. **Title:** Brief Psychiatric Rating Scale (BPRS) Positive Score. **Type:** SECONDARY **Unit of Measure:** Units on a scale ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. **ID:** OG000 **Title:** AZD6765 (150 mg) ##### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. **ID:** OG001 **Title:** Placebo ### Participant Flow Module #### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. **ID:** FG000 **Title:** AZD6765 (150 mg) #### Group **Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period. **ID:** FG001 **Title:** Placebo #### Period **Title:** Period 1 ##### Withdraw **Type:** Improved mood ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Withdraw **Type:** Administrative reasons ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 12 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 10 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 10 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 10 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 #### Period **Title:** Period 2 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 10 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 10 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 10 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 10 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 **Pre-Assignment Details:** Screening for eligibility and washout of restricted medications. **Recruitment Details:** A total of 27 patients were enrolled. Of these, 22 patients were randomized to either: (1) AZD6765 (150 mg) followed by placebo or (2) placebo followed by AZD6765 (150 mg) in a crossover study design. A total of 20 patients completed both treatment periods of the study. **Has Results:** True
## Protocol Section ### Identification Module **NCT ID:** NCT05938179 **Brief Title:** A Study of HS-10353 in Adult Participants With Major Depressive Disorder **Official Title:** A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study Evaluating the Efficacy and Safety of HS-10353 in Chinese Adults With Depression. #### Organization Study ID Info **ID:** HS-10353-201 #### Organization **Class:** INDUSTRY **Full Name:** Jiangsu Hansoh Pharmaceutical Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-07-11 **Type:** ACTUAL **Last Update Submit Date:** 2023-07-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-08-31 **Type:** ESTIMATED **Status Verified Date:** 2023-07 #### Study First Post Date **Date:** 2023-07-10 **Type:** ACTUAL **Study First Submit Date:** 2023-07-03 **Study First Submit QC Date:** 2023-07-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Jiangsu Hansoh Pharmaceutical Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of continuous oral administration of HS-10353 in Chinese adults with depression.HS-10353 is a new generation of GABAA receptor isomeric modulator developed by our company, which can correct the dysfunction of GABAA receptor function and restore the balance between GABA receptor and NMDA receptor. Oral administration of HS-10353 at night for 14 days is expected to reduce clinical symptoms in patients with depression. As an oral preparation of allopregnenolone analogitics, it has good bioavailability, rapid onset and high safety, and has broad clinical application prospects, which is expected to better meet the treatment needs of clinical depression in China in the future. ### Conditions Module **Conditions:** - Major Depressive Disorder (MDD) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 144 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: HS-10353 30mg oral capsules - Drug: HS-10353 50mg oral capsules **Label:** HS-10353 Capsules **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Placebo for HS-10353 30mg capsules - Drug: Placebo for HS-10353 50mg capsules **Label:** HS-10353 matched-placebo oral capsules **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HS-10353 Capsules **Description:** HS-10353 30mg oral capsules **Name:** HS-10353 30mg oral capsules **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - HS-10353 Capsules **Description:** HS-10353 50mg oral capsules **Name:** HS-10353 50mg oral capsules **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - HS-10353 matched-placebo oral capsules **Description:** Placebo for HS-10353 30mg capsules **Name:** Placebo for HS-10353 30mg capsules **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - HS-10353 matched-placebo oral capsules **Description:** Placebo for HS-10353 50mg capsules **Name:** Placebo for HS-10353 50mg capsules **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. The HAM-D total score comprises a sum of the 17 individual item scores. 8 items scored in a range of 0 to 2 include: Insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following 9 items are scored in a range of 0 to 4: Agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Total HAM-D score can range from 0 to 52, and higher scores indicate severe depression. A negative change from baseline indicates less depression. **Measure:** Change From Baseline in the 17-item HAM-D Total Score at Day 15 **Time Frame:** Baseline (BL), Day 15 #### Secondary Outcomes **Description:** The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. The HAM-D total score comprises a sum of the 17 individual item scores. 8 items scored in a range of 0 to 2 include: Insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following 9 items are scored in a range of 0 to 4: Agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Total HAM-D score can range from 0 to 52, and higher scores indicate severe depression. A negative change from baseline indicates less depression. **Measure:** Change From Baseline in the 17-item HAM-D Total Score **Time Frame:** Baseline, Days 3, 8, 21,28 **Description:** HAM-D response is defined as a ≥50% reduction in HAM-D score from baseline. The HAM-D total score comprises a sum of the 17 individual item scores. 8 items scored in a range of 0 to 2 include: Insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following 9 items are scored in a range of 0 to 4: Agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Total HAM-D score can range from 0 to 52, and higher scores indicate severe depression. **Measure:** Number of Participants Achieving HAM-D Response **Time Frame:** Days 3，8，15, 21, and 28 **Description:** HAM-D remission is defined as HAM-D total score ≤7. The HAM-D total score comprises a sum of the 17 individual item scores. 8 items scored in a range of 0 to 2 include: Insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following 9 items are scored in a range of 0 to 4: Agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Total HAM-D score can range from 0 to 52, and higher scores indicate severe depression. **Measure:** Number of Participants Achieving HAM-D Remission **Time Frame:** Days 3，8，15, 21, and 28 **Description:** The 14-item HAM-A is used to rate the severity of symptoms of anxiety. Each of the 14 items is defined by a series of symptoms and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scoring for HAM-A is calculated by assigning scores of 0 (not present) to 4 (very severe) to each item. Total HAM-A score is calculated as the sum of the 14 individual item scores with a total score range of 0 to 56, where the score of \<17 indicates mild severity, 18 to 24 indicates mild to moderate severity, and 25 to 30 indicates moderate to severe severity. A negative change from baseline indicates less severe symptoms. **Measure:** Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) **Time Frame:** Baseline, Days 15，28 **Description:** The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. Each item is rated on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). Total MADRS score, calculated as the sum of the 10 individual items, ranges from 0 to 60 with a higher score indicating more depression. A negative change from baseline indicates less severe symptoms. **Measure:** Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score **Time Frame:** Baseline, Days 3, 8, 15，21,28 **Description:** The CGI-S uses a 7-point Likert scale to rate the severity of the participant's illness relative to the clinician's past experience with participants who had the same diagnosis. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating as 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=extremely ill. A higher score indicates extreme illness/more severity. A negative change from baseline indicates less severe illness. **Measure:** Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score **Time Frame:** Baseline, Days 15，28 **Description:** An adverse event (AE) is any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. A serious TEAE is defined as a TEAE that at any dose results in death, is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or results in a congenital abnormality or birth defect. **Measure:** Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) and Serious TEAE in Treatment and FU Periods **Time Frame:** Treatment period: Up to Day 14; FU period: Day 15 to 28 **Description:** Laboratory parameters include serum chemistry- Alanine aminotransferase: \>3x upper limit of normal (ULN); Alanine aminotransferase or aspartate aminotransferase: \>3x ULN; Bilirubin: \>1.5x ULN, \>2x ULN; Calcium: \<2.0 millimoles per liter (mmol/L); Gamma Glutamyl Transferase \[units per liter (U/L)\]: \>3xULN; Potassium: \>5.4 mmol/L; Sodium: \>150 mmol/L; Hematology- Hematocrit : Male \<0.385 liter/liter (L/L) and Female \<0.345 L/L and Male \>0.55 L/L and Female \>0.49 L/L; Hemoglobin: Male \<115 grams/liter (g/L) and Female \<100 g/L; Neutrophils: \<1.5 10\^9/L. **Measure:** Number of Participants With Clinically Significant Abnormalities in Laboratory Measures in Treatment and FU Periods. **Time Frame:** Treatment period: Up to Day 14; FU period: Day 15 to 42 **Description:** Vital signs include supine and standing systolic blood pressure (SBP) \[millimeters of mercury (mmHg)\]: \<90, \>180, increase and decrease from baseline of \>=30; Supine and standing diastolic blood pressure (DBP) (mmHg): Increase and decrease from baseline \>=20; Standing heart rate (\>120 beats per minute); Orthostatic SBP (\>=20); Orthostatic DBP (\>=10); Orthostatic hypotension (SBP \>=20 and DBP \>=10, SBP \>=20 or DBP \>=10). **Measure:** Number of Participants With Clinically Significant Vital Sign Abnormalities in Treatment and FU Periods **Time Frame:** Up to Day 14; FU period: Day 15 to 28 **Description:** Supine 12-lead ECGs were performed in triplicate and the standard intervals (heart rate, PR, QRS, QT, and corrected QT interval by Fridericia \[QTcF\]) as well as any rhythm abnormalities were recorded. Criteria for clinically significant ECG abnormalities included QTcF interval (msec)- \>500，or longer than 60 msec from baseline **Measure:** Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities in Treatment and FU Periods **Time Frame:** Up to Day 14; FU period: Day 15 to 42 **Description:** Suicidality was monitored during the study using the C-SSRS scale. The C-SSRS includes 'yes' or 'no' responses for 5 questions for assessment of suicidal ideation and behavior. Any suicidal behavior: When response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: When response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. **Measure:** Number of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) in Double-blind Treatment Period **Time Frame:** Up to Day 14; FU period: Day 15 to 42 **Description:** Sleepiness as measured by the Stanford Sleepiness Scale (SSS) has at least two dimensions: activity and sleepiness. The subjects did not perceive the descriptions to be consistent in each dimension. Participants rated their current sleepiness on a scale from 1 to 7. Scores were assigned as follows: feeling energetic, well energetic but not at their best, awake but somewhat loose, having some degree of grogginess, grogginess, sleepiness, wanting to lie down, not trying to stay awake anymore, falling asleep quickly, feeling dreaming. **Measure:** Change From Baseline in SSS Scores in Double-blind Treatment Period **Time Frame:** Up to Day 14 **Description:** The PWC-20 was used to monitor for the presence of potential withdrawal symptoms following discontinuation of HS-10353. The PWC-20 was made up of a list of 20 symptoms (loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue-lethargy-lack of energy, poor coordination, restlessness-agitation, diaphoresis, tremor-tremulousness, dizziness-lightheadedness, headaches, muscle aches or stiffness, weakness, increased acuity \[sound, smell, touch, pain\], paresthesia, difficulty concentrating and remembering, depersonalization-derealization) that were rated on a scale of 0 (not present) to 3 (severe). The PWC-20 total score was derived as the sum of individual item scores, which ranges from 0 (not present) to 60 (severe). Higher scores indicate more severe withdrawal. A negative change from baseline indicates less severe withdrawal. **Measure:** Change From Baseline in the 20-item Physician Withdrawal Checklist (PWC-20) Total Score **Time Frame:** Baseline, Days 15, 21, and 28 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged between 18 and 65 years (including the threshold); * Subjects should have a full understanding of the test content, process and possible adverse reactions, and voluntarily sign an informed consent form (ICF); * Participants met the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) diagnostic criteria for recurrent depressive disorder (MDD) or single episode MDD without psychotic symptoms, and had an overall HAM-D17 score ≥22; * No antidepressant therapy has been used during the current episode; Participants who are currently taking antidepressants should be eluted for at least 1 week (or 5 half-lives, whichever is longer) before they can be included in the study. * Agree to stop using other antidepressants, antianxiety drugs, antipsychotics, mood stabilizers, benzodiazepines sedative and hypnotic drugs during the study treatment; * According to the investigators, the subjects were generally in good physical condition. During screening, no clinically significant abnormalities were found in physical examination, vital signs, 12-lead electrocardiogram (ECG), laboratory examination (blood routine, blood biochemistry, thyroid function, coagulation function, urine routine, etc.), anterolateral chest X-ray or chest CT. * Female subjects of reproductive age, serum β-hCG (β-HCG) negative at screening/baseline; * Subjects must agree to abstain from sex or use other effective contraceptive methods for 30 days from screening until the last dose; Male subjects should agree to refrain from donating sperm from the start of dosing until 6 months after stopping study treatment, and female subjects should agree to refrain from donating eggs from the start of dosing until 6 months after stopping study treatment. Exclusion Criteria: * According to the DSM-5 diagnostic criteria, the subject has a current/past history of schizophrenia spectrum or other psychosis, bipolar or related disorders, compulsive and related disorders, trauma and stress-related disorders, dissociation disorders, anorexia or bulimia nervosa, personality disorders, etc.; * Consistent with the diagnosis of treatment-resistant depression, that is, persistent depressive symptoms after sufficient doses and full courses of two antidepressants are used in a single depressive episode; * Based on the Columbia-Suicide Severity Assessment Scale (C-SSRS), subjects had a history of suicidal intent/self-harm behavior during the current depressive episode; * Use of typical/atypical antipsychotics and mood stabilizers during the current depressive episode; * Previous history of seizures (except convulsions caused by febrile convulsions in children); * Have a history of severe allergies; * A history of alcohol or drug dependence/drug abuse (including benzodiazepines, other than nicotine or caffeine) within the last 1 year, or a positive urine drug test at screening; * Take CYP3A4 suppressant or grapefruit/grapefruit juice, grapefruit/grapefruit, Sevilla orange or products rich in such substances within 14 days prior to screening (or 5 half-lives, whichever is longer); * Use of CYP inducers such as rifampin, carbamazepine, Ritonavir, enzalutamide, efavirenan, nevirapine, phenytoin, phenobarbital, or St. John's Wort within 14 days (or 5 half-lives, whichever is longer) prior to screening; * Received modified electroconvulsive therapy (MECT) during the current depressive episode; Or received transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS) within 1 week before screening; Or the investigator determines that the subject with the current seizure needs to receive the above treatment; * Have participated in any clinical trial or taken any clinical trial drug within the last 1 year; * Women in pregnancy, puerperal period, postpartum 6 months or breastfeeding period, who have planned pregnancy in the near future; * Poor blood pressure control or abnormal heart rate: at rest, systolic blood pressure (SBP) ≥140 mmHg or \< 90 mmHg, diastolic blood pressure (DBP) ≥90 mmHg or \< 60 mmHg; Heart rate \>100 bpm or \<60bpm; * The presence, in the investigator's judgment, of any surgical condition or condition that is likely to significantly affect drug absorption, distribution, metabolism, or excretion, or that is likely to pose a hazard to participants in the trial; Such as gastrointestinal surgery history (gastrectomy, gastrostomy, enterectomy, etc.), gastroenteritis, gastrointestinal ulcer, gastrointestinal bleeding history; Urinary tract obstruction or dysuria; * Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis seroreaction (TRUST), human immunodeficiency virus (HIV) antibody test positive; * Abnormal 12-lead ECG was clinically significant at screening/baseline: QT interval (QTcF) corrected by Fridericia formula had an absolute value of QTcF \>450 ms for males and \>470 ms for females; If QTcF is prolonged in the first measurement, the average value of 3 consecutive ECGs (10 minutes between each measurement) should be taken to confirm; * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 times upper limit of normal (ULN), serum creatinine (Cr) \> 1.5 times ULN; * Patients with diseases that may have clinical significance (such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal musculoskeletal system, metabolism, endocrine system, skin diseases, blood system diseases, immune diseases and tumors, etc.) are assessed by the researcher as not suitable for participation in this study; * Any other conditions assessed by the investigator that might interfere with compliance, harm the health of the subject, or interfere with the study outcome. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Peng Zhou **Phone:** 18013002767 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depressive Disorder - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M7060 - Name: Depressive Disorder, Major - Relevance: HIGH - As Found: Major Depressive Disorder - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003866 - Term: Depressive Disorder - ID: D000003863 - Term: Depression - ID: D000003865 - Term: Depressive Disorder, Major ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT00209079 **Brief Title:** Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma **Official Title:** Phase II Trial of Gleevec (Imatinib Mesylate) and Taxotere (Docetaxel) as a Combined Regimen for Advanced Gastric Adenocarcinoma #### Organization Study ID Info **ID:** 0804-2004 #### Organization **Class:** OTHER **Full Name:** Emory University ### Status Module #### Completion Date **Date:** 2007-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2007-12-31 **Type:** ESTIMATED **Last Update Submit Date:** 2007-12-27 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2007-04 **Type:** ACTUAL #### Start Date **Date:** 2004-09 **Status Verified Date:** 2007-09 #### Study First Post Date **Date:** 2005-09-21 **Type:** ESTIMATED **Study First Submit Date:** 2005-09-14 **Study First Submit QC Date:** 2005-09-14 **Why Stopped:** Terminated 4/17/07. Drug sponsor withdrew. ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Novartis #### Lead Sponsor **Class:** OTHER **Name:** Emory University #### Responsible Party **Old Name Title:** John Kauh, MD **Old Organization:** Winship Cancer Institute ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this trial is to test the combination of Gleevec® (also known as imatinib mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer. This study is being performed to see if the combination of Gleevec and Taxotere is an effective treatment for incurable stomach cancer with minimal side effects. **Detailed Description:** The purpose of this trial is to test the combination of Gleevec® (also known as imatinib mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer. Gleevec is a pill form of chemotherapy and is indicated for the treatment of adult patients with chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). It is considered experimental for the treatment of stomach cancer. Taxotere (docetaxel) is a chemotherapy which is injected into the vein. It is approved for breast and lung cancer but has been shown to shrink many different types of tumors. Taxotere has been shown to shrink stomach cancer in about 20% - 30% of patients treated with Taxotere only. This study is being performed to see if the combination of Gleevec and Taxotere is an effective treatment for incurable stomach cancer with minimal side effects. Treatment on this study consists of two drugs, Gleevec® and Taxotere. Patients will be take four tablets of Gleevec® daily throughout the study. After one week of Gleevec®, patients will then begin receiving doses of Taxotere intravenously once a week for two weeks in a row followed by one week without Taxotere. ### Conditions Module **Conditions:** - Gastric Adenocarcinoma **Keywords:** - Gastric Adenocarcinoma ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 5 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Gleevec, Taxotere **Label:** 1 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 **Description:** Gleevec taken 4 times daily, 100 mg per tablet. Taxotere intravenously once a week for two weeks. **Name:** Gleevec, Taxotere **Other Names:** - Imatinib, Mesylate, Docetaxel **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Determine if combination of Gleevec and Taxotere is effective treatment for incurable stomach cancer. **Time Frame:** 3 months #### Secondary Outcomes **Measure:** Determine toxicity of combination of Gleevec and Taxotere. **Time Frame:** 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * This study is for patients with histologically confirmed unresectable gastric adenocarcinoma and who have not received any chemotherapy other than 5-FU for adjuvant therapy either alone or in conjunction with radiation. Exclusion Criteria: * Patients may not have received any chemotherapy agents other than 5-FU. * Patients may not have received 5-FU for for therapy for metastatic gastric cancer. * Patients must be more than 5 years free of another primary malignancy except: if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed. * Patients must not have Grade III/IV cardiac problems, or any severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, or active uncontrolled infection). * Patient must not have had previously received radiotherapy to \>/= 25% of the bone marrow, or have had major surgery within 2 weeks prior to study entry * Final eligibility for a clinical trial is determined by the health professionals conducting the trial. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Atlanta **Country:** United States **Facility:** Emory University Winship Cancer Institute **State:** Georgia **Zip:** 30322 #### Overall Officials **Official 1:** **Affiliation:** Emory University Winship Cancer Institute **Name:** John Kauh, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3585 - Name: Adenocarcinoma - Relevance: HIGH - As Found: Adenocarcinoma - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000230 - Term: Adenocarcinoma ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000092004 - Term: Tyrosine Kinase Inhibitors - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M1668 - Name: Docetaxel - Relevance: HIGH - As Found: Fat - ID: M324 - Name: Imatinib Mesylate - Relevance: HIGH - As Found: Time points - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown - ID: M2889 - Name: Tyrosine Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: T22 - Name: Tyrosine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077143 - Term: Docetaxel - ID: D000068877 - Term: Imatinib Mesylate ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT00976079 **Brief Title:** The Effect of Transcutaneous Electrical Nerve Stimulation on Quadriceps Central Activation and Gait **Official Title:** The Effect of Transcutaneous Electrical Nerve Stimulation on Quadriceps Central Activation and Gait #### Organization Study ID Info **ID:** 13360 #### Organization **Class:** OTHER **Full Name:** University of Virginia ### Status Module #### Completion Date **Date:** 2009-08 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2009-09-14 **Type:** ESTIMATED **Last Update Submit Date:** 2009-09-11 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2009-05 **Type:** ACTUAL #### Start Date **Date:** 2007-11 **Status Verified Date:** 2009-09 #### Study First Post Date **Date:** 2009-09-14 **Type:** ESTIMATED **Study First Submit Date:** 2009-09-11 **Study First Submit QC Date:** 2009-09-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Virginia #### Responsible Party **Old Name Title:** Christopher D. Ingersoll, PhD **Old Organization:** University of Virginia ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Participants diagnosed with tibial femoral knee osteoarthritis will be assigned to one of three treatment groups including: active transcutaneous electrical nerve stimulation (TENS), placebo TENS, and a control group. Assignment of conditions will be concealed. All participants in each of the three groups will receive physical therapy for all 4 weeks of the intervention. Main outcome measures will include quadriceps central activation ratio, quadriceps torque production, WOMAC scores, visual analog pain scores during gait as well as knee joint kinetics and kinematics during gait. The purpose of this study is to to determine if the continuous use of TENS therapy for activities of daily living and rehabilitation will positively impact all outcome measures. ### Conditions Module **Conditions:** - Tibial Femoral Knee Osteoarthritis - Osteoarthritis **Keywords:** - Tibial femoral knee osteoarthritis - Osteoarthritis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 49 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Active TENS therapy for 4 weeks plus standard physical therapy for same time period. **Intervention Names:** - Device: Transcutaneous electrical nerve stimulation (TENS) **Label:** Active TENS **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Placebo TENS for 4 weeks plus standard physical therapy for same time period. **Intervention Names:** - Device: Placebo TENS **Label:** Placebo TENS **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** No TENS, standard physical therapy for 4 weeks. **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Active TENS **Description:** Continuous TENS use **Name:** Transcutaneous electrical nerve stimulation (TENS) **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Placebo TENS **Description:** Placebo TENS use **Name:** Placebo TENS **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Quadriceps central activation ratio **Time Frame:** 2 and 4 weeks **Measure:** Quadriceps torque production **Time Frame:** 2 and 4 weeks #### Secondary Outcomes **Measure:** WOMAC score **Time Frame:** 2 and 4 weeks **Measure:** Visual analog pain score **Time Frame:** 2 and 4 weeks **Measure:** Knee joint kinetics and kinematics **Time Frame:** 2 and 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who have been diagnosed with a Kellgren and Lawrence grade of 1- 4 for Tibial Femoral Knee OA in at least one leg or have been diagnosed with OA by a physician using evidence confirmed from imaging studies, arthroscopy, or visualization during an past surgical procedures, or have medical reports confirming OA using imaging studies, arthroscopy, or visualization during an past surgical procedures. * Patients between the ages of 18 and 80 years of age. * Patients will have a CAR less than 90%. Exclusion Criteria: * Patients who are pregnant. * Patients who have sought medical attention for a trauma to the knee injury within the past 6 months. * Patients who have had any orthopaedic lower extremity surgery in the past 6 months, or any surgery that would inhibition proper functioning of the study methodology. * Patients with a diagnosis of Rheumatoid Arthritis. * Patients with a known hypersensitivity to electrical stimulation. * Patients with any types of neuropathy. * Patients with known muscular abnormalities. * Patients with a history of a heart condition that precludes them from exercise. * The technique can not be performed on the leg that has had a total knee replacement, but if the other leg meets the inclusion criteria the subject can perform the study on the non- reconstructed leg. * Patients diagnosed with malignancy over the stimulating electrode site (thigh and knee). * Patients with serious infection near the stimulating electrode sites (thigh and knee) * Patients have not had a knee injection in the past 2 weeks. * Patients who are unable to walk a series of 30 meters without a walking assistance device. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Charlottesville **Country:** United States **Facility:** University of Virginia **State:** Virginia **Zip:** 22908 #### Overall Officials **Official 1:** **Affiliation:** University of Virginia **Name:** Christopher Ingersoll, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteoarthritis - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Knee Osteoarthritis - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT00157079 **Brief Title:** Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders **Official Title:** A Clinical Investigation to Assess the Safety and Efficacy of Immune Globulin Intravenous (Human), 10% in Subjects With Primary Immunodeficiency Disorders #### Organization Study ID Info **ID:** 160101 #### Organization **Class:** INDUSTRY **Full Name:** Takeda ### Status Module #### Completion Date **Date:** 2003-12-16 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-08-24 **Type:** ACTUAL **Last Update Submit Date:** 2021-08-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2003-12-16 **Type:** ACTUAL #### Start Date **Date:** 2002-06-25 **Type:** ACTUAL **Status Verified Date:** 2021-08 #### Study First Post Date **Date:** 2005-09-12 **Type:** ESTIMATED **Study First Submit Date:** 2005-09-08 **Study First Submit QC Date:** 2005-09-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Baxalta now part of Shire #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders. ### Conditions Module **Conditions:** - Primary Immunodeficiency Diseases (PID) - Immune Thrombocytopenic Purpura (ITP) - Kawasaki Syndrome **Keywords:** - PID - Immunodeficiency - Immune Thrombocytopenic Purpura (ITP) - Kawasaki syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 61 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Immune Globulin Intravenous (Human), 10% **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Measure:** Mean number of acute serious bacterial infections per participant per year **Time Frame:** Throughout the study period of 18 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration * Diagnosis of a PID disorder as defined by World Health Organization criteria for which the subject has been receiving a regimen of IGIV infusions every 21 to 28 days over a period of at least 4 months pre-study at a dose of 300-600 mg/kg body weight * Subjects \> 24 months of age * A negative serum pregnancy test for any female subject who is of childbearing potential. Exclusion Criteria: * Subjects sero-positive at enrollment for one or more of the following: hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus (HCV), antibodies to human immunodeficiency virus (HIV) Types 1 or 2 * Subjects with levels of alanine amino transferase (ALT) and aspartate amino transferase (AST) \> 2.5 times the upper limit of normal for the testing laboratory. An AST \> 2.5 times the upper limit of normal is allowable, if the ALT does not exceed the upper limit of the reference range for the testing laboratory * Subjects with neutropenia (defined as an ANC \>= 1,000/mm3) * Subjects with serum creatinine levels greater than two times the upper limit of normal for age and gender * Subjects with malignancy or a history of malignancy * Subjects who received any blood or blood product exposure other than an IGIV and/or immune serum globulin (ISG) preparation within the 6 months prior to study entry * Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV and/or ISG infusions * Subjects with selective complete IgA deficiency * Subjects with moderate levels of anti-IgA antibodies (\>150), or subjects with lower anti-IgA antibodies who are naive to IGIV treatment. (Subjects with lower levels of IgA antibodies, whom the investigators know to have tolerated IgA containing IGIV preparations in the past, may be included if the investigator is comfortable with this) * Subjects receiving antibiotic therapy for the treatment of infection within 30 days prior to enrollment * Subjects who receive prophylactic antibiotics as part of their care regimen * Subjects participating in another clinical study involving an investigational product or device within 30 days prior to study entry **Minimum Age:** 24 Months **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Los Angeles **Country:** United States **Facility:** Children´s Hospital Los Angeles **State:** California **Zip:** 90027 **Location 2:** **City:** Stanford **Country:** United States **Facility:** Stanford University Medical Center **State:** California **Zip:** 94304-8786 **Location 3:** **City:** Englewood **Country:** United States **Facility:** 1st Allergy and Clinical Research Center **State:** Colorado **Zip:** 80112 **Location 4:** **City:** North Palm Beach **Country:** United States **Facility:** Allergy Associates of the Palm Beaches **State:** Florida **Zip:** 33408 **Location 5:** **City:** Tampa **Country:** United States **Facility:** University of South Florida; Asthma, Allergy & Immunology CRU **State:** Florida **Zip:** 33613 **Location 6:** **City:** Chicago **Country:** United States **Facility:** Rush Presbyterian - St. Lukes Medical Center **State:** Illinois **Zip:** 60612 **Location 7:** **City:** Boston **Country:** United States **Facility:** Children´s Hospital Boston **State:** Massachusetts **Zip:** 02115 **Location 8:** **City:** Omaha **Country:** United States **Facility:** Allergy, Asthma & Immunology Assoc. **State:** Nebraska **Zip:** 68124 **Location 9:** **City:** Papillion **Country:** United States **Facility:** Asthma and Allergy Center **State:** Nebraska **Zip:** 68046 **Location 10:** **City:** Bronx **Country:** United States **Facility:** Montefiore Medical Center, Albert Einstein College of Medicine **State:** New York **Zip:** 10461 **Location 11:** **City:** Dallas **Country:** United States **Facility:** Pediatric Allergy/Immunology Associates **State:** Texas **Zip:** 75230 #### Overall Officials **Official 1:** **Affiliation:** Takeda **Name:** Study Director **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000007154 - Term: Immune System Diseases - ID: D000001778 - Term: Blood Coagulation Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000006470 - Term: Hemorrhage - ID: D000012877 - Term: Skin Manifestations - ID: D000057049 - Term: Thrombotic Microangiopathies - ID: D000013921 - Term: Thrombocytopenia - ID: D000001791 - Term: Blood Platelet Disorders - ID: D000095542 - Term: Cytopenia - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000006474 - Term: Hemorrhagic Disorders - ID: D000001327 - Term: Autoimmune Diseases - ID: D000014657 - Term: Vasculitis - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000008206 - Term: Lymphatic Diseases - ID: D000017445 - Term: Skin Diseases, Vascular - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M18945 - Name: Purpura, Thrombocytopenic, Idiopathic - Relevance: HIGH - As Found: Immune Thrombocytopenic Purpura - ID: M14547 - Name: Purpura - Relevance: HIGH - As Found: Purpura - ID: M14550 - Name: Purpura, Thrombocytopenic - Relevance: HIGH - As Found: Thrombocytopenic Purpura - ID: M10199 - Name: Immunologic Deficiency Syndromes - Relevance: HIGH - As Found: Immunodeficiency - ID: M2285 - Name: Primary Immunodeficiency Diseases - Relevance: HIGH - As Found: Primary Immunodeficiency - ID: M12039 - Name: Mucocutaneous Lymph Node Syndrome - Relevance: HIGH - As Found: Kawasaki Syndrome - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M21977 - Name: Hemostatic Disorders - Relevance: LOW - As Found: Unknown - ID: M5059 - Name: Blood Coagulation Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown - ID: M15680 - Name: Skin Manifestations - Relevance: LOW - As Found: Unknown - ID: M28682 - Name: Thrombotic Microangiopathies - Relevance: LOW - As Found: Unknown - ID: M16680 - Name: Thrombocytopenia - Relevance: LOW - As Found: Unknown - ID: M5072 - Name: Blood Platelet Disorders - Relevance: LOW - As Found: Unknown - ID: M3170 - Name: Cytopenia - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M9560 - Name: Hemorrhagic Disorders - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M17405 - Name: Vasculitis - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M19714 - Name: Skin Diseases, Vascular - Relevance: LOW - As Found: Unknown - ID: T3021 - Name: Immune Thrombocytopenia - Relevance: HIGH - As Found: Immune Thrombocytopenic Purpura - ID: T3007 - Name: Idiopathic Thrombocytopenic Purpura - Relevance: HIGH - As Found: Immune Thrombocytopenic Purpura - ID: T3211 - Name: Kawasaki Disease - Relevance: HIGH - As Found: Kawasaki Syndrome ### Condition Browse Module - Meshes - ID: D000009080 - Term: Mucocutaneous Lymph Node Syndrome - ID: D000011693 - Term: Purpura - ID: D000011696 - Term: Purpura, Thrombocytopenic - ID: D000016553 - Term: Purpura, Thrombocytopenic, Idiopathic - ID: D000081207 - Term: Primary Immunodeficiency Diseases - ID: D000007153 - Term: Immunologic Deficiency Syndromes ### Intervention Browse Module - Ancestors - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: HIGH - As Found: Cap - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: HIGH - As Found: Cap - ID: M19117 - Name: Immunoglobulins, Intravenous - Relevance: HIGH - As Found: Active exercises - ID: M8836 - Name: gamma-Globulins - Relevance: HIGH - As Found: Dronabinol - ID: M20191 - Name: Rho(D) Immune Globulin - Relevance: HIGH - As Found: Dronabinol - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007136 - Term: Immunoglobulins - ID: D000000906 - Term: Antibodies - ID: D000005719 - Term: gamma-Globulins - ID: D000016756 - Term: Immunoglobulins, Intravenous - ID: D000018029 - Term: Rho(D) Immune Globulin ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02016079 **Brief Title:** Effect of Omega-3 Supplementation on Child Behavior Problems **Official Title:** Randomized Controlled Trial of Omega-3 on Child Behavior Problems #### Organization Study ID Info **ID:** JCHP-01 #### Organization **Class:** OTHER **Full Name:** Joint Child Health Project, Mauritius #### Secondary ID Infos **Domain:** JCHP **ID:** JCHP-N3 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2011-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2013-12-19 **Type:** ESTIMATED **Last Update Submit Date:** 2013-12-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2011-12 **Type:** ACTUAL #### Start Date **Date:** 2010-03 **Status Verified Date:** 2013-12 #### Study First Post Date **Date:** 2013-12-19 **Type:** ESTIMATED **Study First Submit Date:** 2013-12-10 **Study First Submit QC Date:** 2013-12-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Joint Child Health Project, Mauritius #### Responsible Party **Investigator Affiliation:** Joint Child Health Project, Mauritius **Investigator Full Name:** Tashneem Moohamed **Investigator Title:** National Director, JCHP **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The primary purpose of this study was to assess the effectiveness of omega-3 supplementation on behavior problems in children. **Detailed Description:** This study consists of a randomized, placebo-controlled, double-blind trial of omega-3 on behavior problems in children. All behavior problem outcomes were assessed, although the primary focus was on antisocial and aggressive behavior. ### Conditions Module **Conditions:** - Antisocial - Aggressive - Externalizing Behavior Problems - Internalizing Behavior Problems **Keywords:** - randomized controlled trial - omega-3 - nutrition - behavior problems - externalizing - internalizing - antisocial - aggressive ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ACTUAL **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** a fruit drink containing omega-3 **Intervention Names:** - Dietary Supplement: omega-3 **Label:** Omega-3 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** the same fruit drink given in the experimental arm, but not containing omega-3 **Label:** Fruit drink **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Omega-3 **Description:** 200 ml fruit drink containing omega-3 **Name:** omega-3 **Other Names:** - Smartfish **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** The outcome measure assessed internalizing and externalizing behavior problems in children **Measure:** Child Behavior Checklist **Time Frame:** 6 months **Description:** A self-report measure of reactive and proactive forms of aggressive behavior **Measure:** Reactive-Proactive Aggression Questionnaire **Time Frame:** 6 months **Description:** A measure of antisocial personality, with a total score and three subscales: callous-unemotional, impulsivity, narcissism **Measure:** Antisocial Personality Screening Device **Time Frame:** 6 months #### Secondary Outcomes **Description:** estimate of IQ **Measure:** WISC **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * child * age between 8 and 16 years * residing in the community Exclusion Criteria: * fish allergy * diagnosed mental disorder * mental retardation * on medication that may modify lipid metabolism * extensive use of nutritional supplements within the previous 3 months **Maximum Age:** 16 Years **Minimum Age:** 8 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Quatre Bornes **Country:** Mauritius **Facility:** Joint Child Health Project #### Overall Officials **Official 1:** **Affiliation:** Joint Child Health Project **Name:** Tashneem Moohamed, BSc **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Action Research Program, Educational Priroity Areas, Mauritius **Name:** Cyril Dalais, MSc **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Raine A, Portnoy J, Liu J, Mahoomed T, Hibbeln JR. Reduction in behavior problems with omega-3 supplementation in children aged 8-16 years: a randomized, double-blind, placebo-controlled, stratified, parallel-group trial. J Child Psychol Psychiatry. 2015 May;56(5):509-20. doi: 10.1111/jcpp.12314. Epub 2014 Aug 22. **PMID:** 25146492 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000096762 - Term: Aberrant Motor Behavior in Dementia - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M85 - Name: Problem Behavior - Relevance: HIGH - As Found: Behavior Problem - ID: M3724 - Name: Aggression - Relevance: HIGH - As Found: Aggressive - ID: M6904 - Name: Dementia - Relevance: LOW - As Found: Unknown - ID: M3259 - Name: Aberrant Motor Behavior in Dementia - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000374 - Term: Aggression - ID: D000066553 - Term: Problem Behavior ### Intervention Browse Module - Browse Branches - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T415 - Name: Omega 3 Fatty Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT03908879 **Brief Title:** Intraosseous Catheter Confirmation Study **Official Title:** Prospective Diagnostic Accuracy Study Comparing Sensitivity and Specificity of Methods Used to Confirm Correct Placement of an Intraosseous (IO) Catheter #### Organization Study ID Info **ID:** Pro2019000600 #### Organization **Class:** OTHER **Full Name:** Rutgers, The State University of New Jersey ### Status Module #### Completion Date **Date:** 2022-05-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-09-08 **Type:** ACTUAL **Last Update Submit Date:** 2023-09-06 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-05-01 **Type:** ACTUAL #### Start Date **Date:** 2019-07-23 **Type:** ACTUAL **Status Verified Date:** 2023-09 #### Study First Post Date **Date:** 2019-04-09 **Type:** ACTUAL **Study First Submit Date:** 2019-04-04 **Study First Submit QC Date:** 2019-04-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Rutgers, The State University of New Jersey #### Responsible Party **Investigator Affiliation:** Rutgers, The State University of New Jersey **Investigator Full Name:** Yonatan Greenstein, MD **Investigator Title:** Associate Professor of Medicine, Division of Pulmonary & Critical Care Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a prospective diagnostic accuracy study investigating the sensitivity and specificity of methods used to confirm correct placement of an intraosseous (IO) catheter. Intraosseous catheters allow medical providers to rapidly administer fluids and medications to critically ill patients when intravenous (IV) access is not present or difficult to achieve. It is standard of care to confirm the correct placement of an IO catheter prior to using it to administer medications or fluids. Three IO placement confirmatory tests will be performed on all research subjects using a standardized protocol. There will be two index tests (the method utilized by most of the medical community evaluating the stability of the catheter, ability to aspirate blood or bone marrow and ability to administer fluids without visible or palpable extravasation as well as the method of demonstrating color flow Doppler only within the intraosseous space during bedside ultrasound exam) and one reference test (ability to visualized a pulsatile waveform when the IO catheter is attached to a pressure transducer). Primary outcome measures of the study will be the determination of correct or incorrect IO catheter placement from the confirmation methods. This data will be used to investigate the primary endpoints of sensitivity and specificity of the confirmation tests as well as inter-operator variability interpreting the raw data from the confirmation methods. Secondary outcomes include complications from the IO catheter. The goal of this study is to see if a more sensitive and specific method of IO catheter confirmation can reliably be performed by different physicians and reduce the amount of complications associated with the catheters. Additional subgroup analyses will be performed in regards to the research subjects BMI and the anatomic site selected for IO catheter use (proximal tibia or humeral head). ### Conditions Module **Conditions:** - Critical Illness **Keywords:** - Intraosseous catheter - Intraosseous access - Resuscitation - Diagnostic accuracy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** All study participants will undergo all confirmation tests ##### Masking Info **Masking:** NONE **Masking Description:** There is only one arm because all participants will be undergoing the same protocol. To evaluate inter-operator variability for methods 2 and 3, co-investigators will be reviewing saved images recorded by the physicians who placed the intraosseous (IO) catheter. Saved images include the color flow Doppler image for method 2 and the pressure waveform for method 3. Two co-investigators will review saved images from method 2, blinded and independently. Two other co-investigators will review saved images from method 3, blinded and independently. If the results of the two co-investigators for method 2 or method 3 is discordant then a third blinded reviewer will review the saved image for the method with discordant results. **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 34 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All patients will undergo all three confirmation methods/procedures. Method 1 is a triage test and an index test. Method 2 is an index test. Method 3 is a reference standard. None of the procedures being performed in this study are regulated by the United States Food and Drug Administration. **Intervention Names:** - Procedure: Standard intraosseous (IO) catheter confirmation procedure - Procedure: Color flow Doppler intraosseous (IO) catheter confirmation procedure - Procedure: Pressure transduction intraosseous (IO) catheter confirmation procedure **Label:** Intraosseous (IO) catheter placement confirmation methods **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intraosseous (IO) catheter placement confirmation methods **Description:** The physician will evaluate the ability or inability of the intraosseous (IO) catheter to stand upright unassisted, the ability or inability to aspirate blood or bone marrow from the IO catheter, and whether or not there is visible or palpable extravasation of infusate from the IO catheter insertion site or surrounding subcutaneous tissue during IO catheter use. **Name:** Standard intraosseous (IO) catheter confirmation procedure **Other Names:** - Method 1 **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Intraosseous (IO) catheter placement confirmation methods **Description:** The high frequency probe of a portable ultrasound with color flow Doppler is placed adjacent to the intraosseous (IO) catheter, visualizing the IO space in long or short axis. Color flow Doppler signal will be turned on during IO use and the physician will determine if the Doppler signal is in the intraosseous space or the extraosseous space. Saved data of the ultrasound image will be reviewed independently by at least two blinded reviewers. If the conclusions from the blinded reviewers are discordant then a third blinded reviewer will evaluate the saved data. **Name:** Color flow Doppler intraosseous (IO) catheter confirmation procedure **Other Names:** - Method 2 **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Intraosseous (IO) catheter placement confirmation methods **Description:** The intraosseous (IO) catheter will be attached to a pressure transducer to demonstrate a waveform on the telemetry monitor. Physicians will evaluate for the presence of a pulsatile waveform with objective measurements of a systolic pressure, diastolic pressure and mean pressure. Saved data of the waveform image will be reviewed independently by at least two blinded reviewers. If the conclusions from the blinded reviewers are discordant then a third blinded reviewer will evaluate the saved data. **Name:** Pressure transduction intraosseous (IO) catheter confirmation procedure **Other Names:** - Method 3 **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Categorical determination (yes/no) regarding correct IO catheter placement in the intraosseous space of all three confirmatory methods from the physicians placing the IO catheter **Measure:** Categorical determination of correct IO catheter placement by physicians placing the catheter **Time Frame:** Within 24 hours of intraosseous (IO) catheter insertion **Description:** Categorical determination (yes/no) regarding correct IO catheter placement in the intraosseous space for method 2 and method 3 by the blinded reviewers **Measure:** Categorical determination of correct IO catheter placement by blinded reviewers **Time Frame:** Within 1 week of ultrasound images and pressure transduction images being created by the physician placing the IO catheter #### Secondary Outcomes **Description:** Pressures measured from transducing the IO catheter: systolic pressure, diastolic pressure, mean pressure **Measure:** IO catheter pressure **Time Frame:** Within 24 hours of intraosseous (IO) catheter insertion **Description:** Pressures measured from a noninvasive blood pressure cuff or an arterial line: systolic pressure diastolic pressure mean pressure **Measure:** Systemic blood pressure **Time Frame:** Within 24 hours of intraosseous (IO) catheter insertion **Description:** Number of attempts made to place an IO catheter **Measure:** Number of attempts to place IO catheter **Time Frame:** Within 24 hours of intraosseous (IO) catheter insertion **Description:** Complications associated with the IO catheter after insertion **Measure:** Complications related to IO catheter **Time Frame:** Within 28 days of IO catheter insertion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients greater than 18 years of age * Full code * Require placement of an intraosseous catheter for emergent resuscitation due to lack of reliable intravenous access * Capable of undergoing all three intraosseous placement confirmatory methods Exclusion Criteria: * Age less than 18 years old * Pregnant patients * Prisoner/incarcerated * Patients unable to undergo all three intraosseous placement confirmatory methods **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Newark **Country:** United States **Facility:** University Hospital **State:** New Jersey **Zip:** 07103 #### Overall Officials **Official 1:** **Affiliation:** Rutgers, The State University of New Jersey **Name:** Yonatan Greenstein, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Stone MB, Teismann NA, Wang R. Ultrasonographic confirmation of intraosseous needle placement in an adult unembalmed cadaver model. Ann Emerg Med. 2007 Apr;49(4):515-9. doi: 10.1016/j.annemergmed.2006.11.009. Epub 2007 Jan 12. **PMID:** 17222940 **Citation:** Tsung JW, Blaivas M, Stone MB. Feasibility of point-of-care colour Doppler ultrasound confirmation of intraosseous needle placement during resuscitation. Resuscitation. 2009 Jun;80(6):665-8. doi: 10.1016/j.resuscitation.2009.03.009. Epub 2009 Apr 22. **PMID:** 19395142 **Citation:** Frascone RJ, Salzman JG, Ernest EV, Burnett AM. Use of an intraosseous device for invasive pressure monitoring in the ED. Am J Emerg Med. 2014 Jun;32(6):692.e3-4. doi: 10.1016/j.ajem.2013.12.029. Epub 2013 Dec 18. **PMID:** 24440591 **Citation:** Salzman JG, Loken NM, Wewerka SS, Burnett AM, Zagar AE, Griffith KR, Bliss PL, Peterson BK, Ward CJ, Frascone RJ. Intraosseous Pressure Monitoring in Healthy Volunteers. Prehosp Emerg Care. 2017 Sep-Oct;21(5):567-574. doi: 10.1080/10903127.2017.1302529. Epub 2017 Apr 18. **PMID:** 28418753 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M19010 - Name: Critical Illness - Relevance: HIGH - As Found: Critical Illness - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016638 - Term: Critical Illness ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT01627379 **Acronym:** POWER **Brief Title:** Cisplatin and 5-FU +/- Panitumumab for Patients With Nonresectable,Advanced or Metastatic Esophageal Squamous Cell Cancer **Official Title:** An Open-label, Randomized Phase III Trial of Cisplatin and 5-fluorouracil With or Without Panitumumab for Patients With Nonresectable, Advanced or Metastatic Esophageal Squamous Cell Cancer #### Organization Study ID Info **ID:** POWER / AIO-STO-0309 #### Organization **Class:** OTHER **Full Name:** AIO-Studien-gGmbH #### Secondary ID Infos **ID:** 2010-020606-15 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2017-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-03-02 **Type:** ACTUAL **Last Update Submit Date:** 2018-03-01 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2015-05 **Type:** ACTUAL #### Start Date **Date:** 2012-05 **Status Verified Date:** 2018-03 #### Study First Post Date **Date:** 2012-06-25 **Type:** ESTIMATED **Study First Submit Date:** 2012-06-13 **Study First Submit QC Date:** 2012-06-21 **Why Stopped:** Sponsor decision due to recommendation of the IDMC. ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Amgen **Class:** OTHER **Name:** Assign Data Management and Biostatistics GmbH **Class:** OTHER **Name:** Assign Clinical Research GmbH #### Lead Sponsor **Class:** OTHER **Name:** AIO-Studien-gGmbH #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** More than 50% of patients with esophageal cancer have locally advanced or metastatic disease at presentation. The use of chemotherapy for this patient group is increasing with the intention of local and distant tumor control, improving quality of life and prolongation of survival. Previous data suggested not only that EGFR antibody targeted therapy may be safely combined with cisplatin and 5-FU but also may increase the efficacy of standard cisplatin / 5-FU regime. In the present study, patients with nonresectable, advanced or metastatic esophageal squamous cell cancer (ESCC) will receive chemotherapy or chemotherapy plus panitumumab every 3 weeks until disease progression occurs. The primary objective is to demonstrate superiority of 5-FU, Cisplatin and Panitumumab over 5-FU and Cisplatin alone in terms of overall survival in esophageal cancer. **Detailed Description:** More than 50% of patients with esophageal cancer have locally advanced or metastatic disease at presentation. The use of chemotherapy for this patient group is increasing with the intention of local and distant tumor control, improving quality of life and prolongation of survival. The most frequently used agents are 5-fluorouracil, cisplatin, with or without various anthracyclines. Cisplatin plus continuous 5-fluorouracil are the standard of care regimens. Taxanes and anthracyclins are eligible agents for possible future studies, however with higher incidences of toxicities and life threatening complications. Response rates for single agents range from 15%-30%. Combination regimens usually tend to produce higher response rates and occasionally patients achieve complete responses (0%-11%). However, with the combination regimens, the median survival time remains clearly less than 10 months, mostly between 4-8 months \[Homs MY et al\]. In comparison of different chemotherapy protocols, there was no consistent benefit of any specific chemotherapy regimen. So far, cisplatin combined with 5-fluorouracil is one of the approved standard regimens in esophageal cancer world wide\[Medical Research Council Oesophageal Cancer Group\]. This so called three-weekly MRC regimen has a better toxicity profile than the four weekly CF regimen given in Central Europe with the higher Cisplatin dose\[Lorenzen S et al\], but less overall chemotherapy given per 4 months. Advances in molecular biology and new molecular technologies can possibly contribute to improvement of response to neoadjuvant or palliative therapy in ESCC patients as well. EGFR1 blockade with platinum-based chemotherapy already significantly improved response rates as well as the progression-free and overall survival compared to chemotherapy alone in patients with head and neck tumors, which are also squamous cancers\[Vermorken JB et al\]. Even more, the Arbeitsgemeinschaft Internistische Onkologie (AIO) has performed a randomized phase II study of the EGFR antibody cetuximab plus cisplatin/5-fluorouracil versus cisplatin/5-fluorouracil alone in first-line metastatic ESCC\[Lorenzen S et al\]. For a maximum of six 28-day cycles, patients received cisplatin 100 mg/m(2), day 1, plus 5-FU 1000 mg/m(2) days 1-5 (CF), either alone or in combination with cetuximab (CET-CF). The primary endpoint was tumor response. From 62 eligible patients included, 32 receiving CET-CF and 30 CF. Cetuximab weekly did not exacerbate grade 3/4 toxicity, except for rash (6% vs 0%) and diarrhea (16% vs 0%). The overall response rate according to RECIST criteria were 19% and 13% and the disease control rates, were 75% and 57% for the CET-CF and CF arms, respectively. With a median follow-up of 21.5 months, the median progression-free survival was 5.9 and 3.6 months and median overall survival 9.5 and 5.5 months for CET-CF and CF, respectively. No KRAS codon 12/13 tumor mutations were identified in the 37 evaluated samples. Thus, with respect to the AIO data and in concordance with the head and neck data by Vermorken, EGFR antibody targeted therapy may not only be safely combined with CF, but may also very likely increase the efficacy of standard CF, particularly with regard to a chosen primary endpoint of overall survival. Therefore, the aim of this study is to investigate if the overall survival of patients with squamous cell carcinoma of the esophagus can be prolonged if panitumumab is added to the standard CF chemotherapy. ### Conditions Module **Conditions:** - Esophageal Squamous Cell Cancer **Keywords:** - nonresectable - advanced - metastatic esophageal squamous cell cancer - Panitumumab ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Chemotherapy will be administered every 3 weeks until progression of disease or any other reason for treatment withdrawal is fulfilled. **Intervention Names:** - Drug: Cisplatin, 5-FU **Label:** Arm A: Cisplatin, 5-Fluorouracil **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Chemotherapy plus Panitumumab will be administered every 3 weeks until progression of disease or any other reason for treatment withdrawal is fulfilled. **Intervention Names:** - Drug: Panitumumab **Label:** Arm B: Cisplatin, 5-Fluorouracil and Panitumumab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm A: Cisplatin, 5-Fluorouracil **Description:** Arm A: Cisplatin 80 mg/m2 IV infusion over 2 hours on Day 1, followed by 5-FU 1000 mg/m2 IV daily as continuous infusion over 24 hours, Day 1-4. Chemotherapy will be administered every 3 weeks until progression of disease or any other reason for treatment withdrawal is fulfilled. **Name:** Cisplatin, 5-FU **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Arm B: Cisplatin, 5-Fluorouracil and Panitumumab **Description:** Arm B: Cisplatin 80 mg/m2 IV infusion over 2 hours on Day 1, followed by 5-FU 1000 mg/m2 IV daily as continuous infusion over 24 hours, Day 1-4. Panitumumab will be administered on Day 1 of each treatment cycle at a dose of 9 mg/kg prior to administration of chemotherapy. Each treatment cycle is defined as 21 days. Patients are treated until progression of disease occurs or any other reason for treatment withdrawal is fulfilled. **Name:** Panitumumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Kaplan-Meier estimate of the median time between date of randomization and the date of death from any cause or the date of last follow-up in case of no documentation of death. Comparison of Overall survival of treatment arms "Panitumumab + Chemotherapy" and "Chemotherapy only" in patients with nonresectable, advanced or metastatic ESCC. **Measure:** Overall Survival **Time Frame:** 3 years #### Secondary Outcomes **Description:** Kaplan-Meier estimate of the median time span between the date of randomization and the date of progression or death due to any cause. The difference in progression-free survival between the two treatment arms will be tested. Tumor assessments will be performed every 9 weeks during the treatment period. **Measure:** Progression-free survival **Time Frame:** every 9 weeks from Cycle 1 up to 3 years **Description:** The difference in 1-year survival between the two treatment arms is determined. **Measure:** 1-year survival **Time Frame:** 1 year **Description:** Best objective response is defined as the best response documented during study. To compare objective response rate between the two treatment arms. Tumor Assessments will be performed every 9 weeks during the treatment period. **Measure:** Response rate **Time Frame:** every 9 weeks from Cycle 1 up to 3 years **Description:** Throughout the treatment period until the End of treatment visit, patients will be assessed for all adverse events. CTCAE V 4.03 will be used for grading. **Measure:** Overall incidence of patients with adverse events **Time Frame:** up to 3 years **Description:** EORTC QLQ-C30 questionnaires **Measure:** Quality of life **Time Frame:** every 3 weeks for up to 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Signed written informed consent 2. Male or female ≥18 years of age 3. Histologically proven squamous cell carcinoma of the esophagus, which is not curatively resectable\* or locally recurrent disease and both not eligible\*\* for definitive radiochemotherapy, or clearly metastatic disease (Tx, Nx, M1, locally unresectable T4, Nx, M0 or TX, N3, M0)\* or residual (post-resection) disease not eligible\*\* for definitive radiochemotherapy * resectability has to be defined prior to randomization according to local standards: The tumor is considered unresectable due to: T-stage, N-stage, performance status/nutritional status, co-morbidity (pulmonary function, other), tumor location upper third of the esophagus, relation to other organs/structures), patient refusal, other reasons. * eligibility to definitive radiochemotherapy will be determined according to local standards based on the extent of disease, performance status/nutritional status, co-morbidity (pulmonary function, other), volume of neighboring organs within the radiation field, patient refusal, other reasons. 4. Measurable or non-measurable disease according to RECIST 1.1 5. ECOG 0-1 6. Women of child-bearing potential must have a negative pregnancy test 7. Laboratory requirements * Hematology: * Absolute neutrophil count ≥1.5x10\^9/L * Platelet count ≥100x10\^9/L * Leukocyte count ≥ 3.0x10\^9/L * Hemoglobin ≥ 9 g/dL or 5.59 mmol/l * Hepatic Function: * Total bilirubin ≤ 1.5 time the upper normal limit (UNL) * AST ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases * ALT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases * Renal Function: * Creatinine clearance ≥ 50 mL/min according to Cockroft-Gault formula * Metabolic Function * Magnesium ≥ 0.5 mmol/L or 1.2 mg/dL * Calcium ≥ 2 mmol/L or 8.0 mg/dL Exclusion Criteria: 1. Previous chemotherapy of esophageal cancer in the metastatic setting. Previous neoadjuvant chemotherapy or definitive radiochemotherapy with a maximum cumulative dose of 120 mg cisplatin and without recurrence of disease within 4 months after the end of treatment is allowed. 2. Concurrent radiotherapy involving target lesions used for this study. Concurrent palliative radiation for non-target lesions is allowed if other lesions are available outside the involved field. Previous pre- operative or post-operative radiotherapy is allowed. 3. Previous exposure to EGFR-targeted therapy 4. Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix or other curatively treated malignant disease without recurrence after at least 5 years of follow-up 5. Known brain metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids 6. Serious concomitant disease or medical condition that in the judgment of the investigator renders the subject at high risk of treatment complication or reduces the probability of assessing clinical effect. 7. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment 8. Inadequate pulmonary function according to the investigator's judgment, history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. 9. Hearing loss ≥ NCI-CTC V.4.03 Grade 3 10. Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. 11. Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment. 12. Contraindications to receive any platin, 5-FU or panitumumab 13. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to treatment start 14. Known drug abuse/alcohol abuse 15. Peripheral polyneuropathy ≥ NCI-CTC V 4.03 Grade 2 16. Chronic inflammatory bowels diseases 17. Social situations limiting the compliance with the study requirements. 18. History of HIV infection or chonic hepatitis B or C 19. Concurrent treatment with brivudin or sorivudin or its chemically related analogues. There must be at least a 4-week wash-out period between end of treatment with brivudin, sorivudin or its chemically related analogues and start of therapy with 5-FU. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Mainz **Country:** Germany **Facility:** Johannes-Gutenberg-Universität Mainz, I. Medizinische Klinik und Poliklinik **State:** Rheinland-Pfalz **Zip:** 55101 #### Overall Officials **Official 1:** **Affiliation:** I. Medizinische KLinik und Poliklinik, Johannes-Gutenberg-Universität Mainz **Name:** Markus Möhler, PD Dr. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656. **PMID:** 18784101 **Citation:** Lorenzen S, Schuster T, Porschen R, Al-Batran SE, Hofheinz R, Thuss-Patience P, Moehler M, Grabowski P, Arnold D, Greten T, Muller L, Rothling N, Peschel C, Langer R, Lordick F. Cetuximab plus cisplatin-5-fluorouracil versus cisplatin-5-fluorouracil alone in first-line metastatic squamous cell carcinoma of the esophagus: a randomized phase II study of the Arbeitsgemeinschaft Internistische Onkologie. Ann Oncol. 2009 Oct;20(10):1667-73. doi: 10.1093/annonc/mdp069. Epub 2009 Jun 23. **PMID:** 19549707 **Citation:** Homs MY, v d Gaast A, Siersema PD, Steyerberg EW, Kuipers EJ. Chemotherapy for metastatic carcinoma of the esophagus and gastro-esophageal junction. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD004063. doi: 10.1002/14651858.CD004063.pub2. **PMID:** 17054195 **Citation:** Medical Research Council Oesophageal Cancer Working Group. Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1727-33. doi: 10.1016/S0140-6736(02)08651-8. **PMID:** 12049861 **Citation:** Moehler M, Maderer A, Thuss-Patience PC, Brenner B, Meiler J, Ettrich TJ, Hofheinz RD, Al-Batran SE, Vogel A, Mueller L, Lutz MP, Lordick F, Alsina M, Borchert K, Greil R, Eisterer W, Schad A, Slotta-Huspenina J, Van Cutsem E, Lorenzen S. Cisplatin and 5-fluorouracil with or without epidermal growth factor receptor inhibition panitumumab for patients with non-resectable, advanced or metastatic oesophageal squamous cell cancer: a prospective, open-label, randomised phase III AIO/EORTC trial (POWER). Ann Oncol. 2020 Feb;31(2):228-235. doi: 10.1016/j.annonc.2019.10.018. Epub 2019 Dec 16. **PMID:** 31959339 #### See Also Links **Label:** Related Info **URL:** http://www.aio-portal.de ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000002277 - Term: Carcinoma - ID: D000004938 - Term: Esophageal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000004935 - Term: Esophageal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: HIGH - As Found: Squamous Cell Cancer - ID: M1733 - Name: Esophageal Squamous Cell Carcinoma - Relevance: HIGH - As Found: Esophageal Squamous Cell Cancer - ID: M20451 - Name: Neoplasms, Squamous Cell - Relevance: HIGH - As Found: Squamous Cell Cancer - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M8088 - Name: Esophageal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8085 - Name: Esophageal Diseases - Relevance: LOW - As Found: Unknown - ID: T2141 - Name: Esophageal Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000018307 - Term: Neoplasms, Squamous Cell - ID: D000002294 - Term: Carcinoma, Squamous Cell - ID: D000077277 - Term: Esophageal Squamous Cell Carcinoma ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000074322 - Term: Antineoplastic Agents, Immunological ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M8600 - Name: Fluorouracil - Relevance: LOW - As Found: Unknown - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M1822 - Name: Panitumumab - Relevance: HIGH - As Found: 2/day - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077544 - Term: Panitumumab ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT01449279 **Brief Title:** Pilot Ipilimumab in Stage IV Melanoma Receiving Palliative Radiation Therapy **Official Title:** A Pilot Study of Ipilimumab in Subjects With Stage IV Melanoma Receiving Palliative Radiation Therapy #### Organization Study ID Info **ID:** IRB-21970 #### Organization **Class:** OTHER **Full Name:** Stanford University #### Secondary ID Infos **Domain:** Stanford University **ID:** SU-08242011-8306 **Type:** OTHER **Domain:** OnCore **ID:** MEL0005 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2016-12-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-03-02 **Type:** ACTUAL **Last Update Submit Date:** 2020-02-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2015-12-31 **Type:** ACTUAL #### Results First Post Date **Date:** 2017-03-10 **Type:** ACTUAL **Results First Submit Date:** 2017-01-20 **Results First Submit QC Date:** 2017-01-20 #### Start Date **Date:** 2011-10 **Type:** ACTUAL **Status Verified Date:** 2020-02 #### Study First Post Date **Date:** 2011-10-10 **Type:** ESTIMATED **Study First Submit Date:** 2011-10-05 **Study First Submit QC Date:** 2011-10-07 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Stanford University #### Responsible Party **Investigator Affiliation:** Stanford University **Investigator Full Name:** Susan Knox **Investigator Title:** Associate Professor of Radiation Oncology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** To determine the safety of local palliative radiation therapy used in combination with anti-CTLA-4 immunotherapy. **Detailed Description:** This is a single institution, open-label, pilot study of palliative radiation therapy (RT) combined with ipilimumab in patients with stage IV melanoma. The primary objective of this study is to assess the safety of combining ipilimumab with palliative RT in patients with Stage IV melanoma. Secondary objectives are a) to assess the induction of anti-melanoma immune responses using laboratory correlative studies of T cell responses to melanoma antigens, and b) to compare tumor response rates and duration of response at unirradiated sites with responses in patients with Stage IV disease treated with ipilimumab alone on expanded access study CA184045. In this study, ipilimumab will be administered as recently approved by the FDA (3 mg/kg iv every 3 weeks for a total of 4 treatments). Palliative RT will start within 2 days of the first ipilimumab dose. Patients will be seen at least every 12 weeks for follow-up following completion of ipilimumab therapy until progression of disease by imaging criteria or increased symptomatology that requires another therapy. A total of 20 patients with previously treated unresectable metastatic melanoma requiring palliative radiation therapy will be treated on this pilot study over approximately 18 months. All subjects who receive study drug will be monitored for safety. Relevant tumor imaging studies will be obtained at baseline, 2-4 weeks following the 4th/last dose of ipilimumab, and then every 12 weeks until disease progression. This study will provide the safety data (and possibly early efficacy signals) needed to proceed with a randomized Phase II study for proof of principle. If compelling data is obtained supporting this IT + RT vaccine strategy, this approach will be extended to other solid tumor types. ### Conditions Module **Conditions:** - Melanoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 22 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1 to 2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2 to 4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease. **Intervention Names:** - Drug: Ipilimumab - Radiation: Radiation Therapy **Label:** Ipilimumab Treatment + Radiation Therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Ipilimumab Treatment + Radiation Therapy **Description:** Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. **Name:** Ipilimumab **Other Names:** - MDX-101 - Yervoy **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Ipilimumab Treatment + Radiation Therapy **Description:** Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist. **Name:** Radiation Therapy **Other Names:** - radiotherapy - radiation oncology **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Description:** Serious adverse events (SAEs) defined as untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires in subject hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization but, may jeopardize the subject or may require intervention to prevent one of the other serious outcomes listed in the definition above.) **Measure:** Safety Measurement - Percentage of Patients Experiencing Serious Adverse Events (SAEs) in the First 4 Months of Treatment. **Time Frame:** 4 months #### Secondary Outcomes **Description:** Compare tumor response rate and duration of response at unirradiated sites in patients with Stage IV melanoma with historical controls. Response assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by physical measurement; magnetic resonance imaging (MRI); computed tomography (CT), positron emission tomography (PET)-CT; and/or X-rays: * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR **Measure:** Response Rate **Time Frame:** 2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease **Description:** Median time to overall survival was calculated using the Kaplan-Meier algorithm. **Measure:** Overall Survival **Time Frame:** 2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease **Description:** The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented. **Measure:** Duration of Complete Response **Time Frame:** 2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease **Description:** Length of time between first dose of ipilimumab and a partial response according to RECIST v1.1 (see above) and immune response criteria **Measure:** Duration of Partial Response. **Time Frame:** 2 to 4 weeks after last ipilimumab and then every 3 months until disease progression. **Description:** Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements **Measure:** Stable Disease **Time Frame:** 2 to 4 weeks after last ipilimumab and then every 3 months until disease progression. **Description:** Time from the first dose of ipilimumab to the first tumor measurement showing either a complete or partial response to therapy. **Measure:** Median Time to Complete Response or Partial Response **Time Frame:** 2 to 4 weeks after last ipilimumab and then every 3 months until disease progression. **Description:** Median time to progression-free survival (PFS) was calculated using the Kaplan-Meier algorithm **Measure:** Progression-free Survival (PFS) **Time Frame:** 2 to 4 weeks after last ipilimumab and then every 3 months until disease progression. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Signed Written Informed Consent Before any study procedures are performed, subjects (or their legally acceptable representatives) will have the details of the study described to them, and they will be given a written informed consent document to read. Then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel. 2. Target Population * Histologically confirmed Stage IV melanoma. * Must have failed at least one systemic therapy for malignant melanoma or be intolerant to at least one prior systemic treatment. * Subjects with asymptomatic brain metastases are eligible. (Systemic steroids should be avoided if possible, or the subject should be stable on the lowest clinically effective dose, as steroids as they may interfere with the activity of ipilimumab if administered at the time of the first ipilimumab dose.) * Primary ocular and mucosal melanomas are allowed. * Must be at least 28 days since treatment with chemotherapy, biochemotherapy, surgery, radiation, or immunotherapy, and recovered from any clinically significant toxicity experienced during treatment. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Life expectancy of ≥ 16 weeks. * Subjects must have baseline (screening/baseline) radiographic images, (e.g. brain, chest, abdomen, pelvis, and bone scans with specific imaging tests to be determined by the attending physician) within 6 weeks of initiation of ipilimumab. * Required values for initial laboratory tests: * White blood cell (WBC) ≥ 2000/uL (\~ 2 x 10\^9/L) * Absolute neutrophil count (ANC) ≥ 1000/uL (\~ 1 x 10\^9/L) * Platelets ≥ 75 x 10\^3/uL (\~ 75 x 10\^9/L) * Hemoglobin ≥ 9 g/dL (\~ 80 g/L; may be transfused) * Creatinine \~ 2 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \~ 2.5 x ULN for subjects without liver metastasis \~ 5 times for liver metastases * Bilirubin: \~ 2.0 x ULN (except for subjects with Gilbert's Syndrome, who must have a total bilirubin of \< 3.0 mg/dL) * No active or chronic infection with HIV, Hepatitis B, or Hepatitis C. * Two or more measurable sites of disease (≥ 1.5 cm) which include the disease site that requires palliative radiation therapy as well as ≥ 1 other disease site outside of the planned radiation therapy field. 3. Age and Sex * Men and women, at least 18 years of age. * Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study \[and for up to 26 weeks after the last dose of investigational product\] in such a manner that the risk of pregnancy is minimized. * WOCBP include any female who has experienced menarche and who has undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post-menopausal is defined as: * Amenorrhea ≥ 12 consecutive months without another cause, or * For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level \> 35 mIU/mL * Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product. c) Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study \[and for up to 26 weeks after the last dose of investigational product\] in such a manner that the risk of pregnancy is minimized. Exclusion Criteria: 1. Sex and Reproductive Status * WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 8 weeks after the last dose of investigational product. * WOCBP using a prohibited contraceptive method. * Women who are pregnant or breastfeeding. * Women with a positive pregnancy test on enrollment or before investigational product administration. 2. Target Disease Exceptions * Subjects on any other systemic therapy for cancer, including any other experimental treatment. * Prior treatment with an anti-CTLA-4 antibody if treatment failure was due to adverse events (AEs). If a subject was discontinued from the prior anti-CTLA-4 treatment due to an AE or serious adverse event (SAE), regardless of the type of event, that discontinuation constitutes an exclusion criterion. If AEs were serious enough to require a subject's withdrawal from prior treatment, the subject should be excluded from this study. * A history of AEs with prior IL-2 or Interferon will not preclude subjects from entering the current study. * Subjects who relapsed in study MDX010-16 are not eligible for this study. 3. Medical History and Concurrent Diseases * Autoimmune disease: subjects with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease are excluded from this study as are subjects with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\]; systemic lupus erythematosus (SLE); autoimmune vasculitis \[eg, Wegener's Granulomatosis\]). Subjects with motor neuropathy considered of autoimmune origin (eg, Guillain-Barre Syndrome and Myasthenia Gravis) are excluded from this study. * Any subject who has a life-threatening condition that requires high-dose immunosuppressant(s) * Presence of known Hepatitis B or Hepatitis C infection, regardless of control on antiviral therapy * Subjects with melanoma who have another active, concurrent, malignant disease are not eligible for the CA184045 study, with the exception of subjects with adequately treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix. 4. Medical History and Concurrent Diseases * Prisoners or subjects who are involuntarily incarcerated. * Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. * Any underlying medical or psychiatric condition that, in the opinion of the investigator, could make the administration of ipilimumab hazardous or could obscure the interpretation of adverse events. * Any non-oncology vaccine therapy used for prevention of infectious diseases for up to 4 weeks before or after any dose of ipilimumab, with the exceptions of amantadine and flumadine. * Central nervous system (CNS) metastases that require palliative radiation therapy; prior brain irradiation is allowed providing CNS disease is stable. 5. Additional Concomitant Treatments * Any investigational agents * Any other (non-CA184045 related) CTLA-4 inhibitors or agonists * CD137 agonists * Immunosuppressive agents (unless required for treating potential AEs) * Chronic systemic corticosteroids (unless required for treating treatment emergent AEs or required for management of signs or symptoms due to brain metastases, upon discussion with BMS medical monitor). Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and to ensure that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Stanford **Country:** United States **Facility:** Stanford University School of Medicine **State:** California **Zip:** 94305 #### Overall Officials **Official 1:** **Affiliation:** Stanford University **Name:** Susan J Knox, PhD, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Hiniker SM, Reddy SA, Maecker HT, Subrahmanyam PB, Rosenberg-Hasson Y, Swetter SM, Saha S, Shura L, Knox SJ. A Prospective Clinical Trial Combining Radiation Therapy With Systemic Immunotherapy in Metastatic Melanoma. Int J Radiat Oncol Biol Phys. 2016 Nov 1;96(3):578-88. doi: 10.1016/j.ijrobp.2016.07.005. Epub 2016 Jul 15. **PMID:** 27681753 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018358 - Term: Neuroendocrine Tumors - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000018326 - Term: Nevi and Melanomas - ID: D000012878 - Term: Skin Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11528 - Name: Melanoma - Relevance: HIGH - As Found: Melanoma - ID: M20495 - Name: Neuroendocrine Tumors - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: M12448 - Name: Nevus, Pigmented - Relevance: LOW - As Found: Unknown - ID: M12446 - Name: Nevus - Relevance: LOW - As Found: Unknown - ID: M20470 - Name: Nevi and Melanomas - Relevance: LOW - As Found: Unknown - ID: M15681 - Name: Skin Neoplasms - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T4091 - Name: Neuroendocrine Tumor - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008545 - Term: Melanoma ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1348 - Name: Ipilimumab - Relevance: HIGH - As Found: While - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000074324 - Term: Ipilimumab ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Ipilimumab Treatment + Radiation Therapy **Deaths Num Affected:** 13 **Deaths Num At Risk:** 22 **Description:** Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease. Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist. **ID:** EG000 **Other Num Affected:** 22 **Other Num at Risk:** 22 **Serious Number Affected:** 11 **Serious Number At Risk:** 22 **Title:** Ipilimumab Treatment + Radiation Therapy **Frequency Threshold:** 5 #### Other Events **Term:** Diarrhea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Fatigue **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Nausea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Rash: Erythema **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Vomiting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) #### Serious Events **Term:** Pancreatitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 22 **Num Events:** 1 **Term:** Confusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 22 **Num Events:** 1 **Term:** Hemorrhage, CNS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 22 **Num Events:** 1 **Term:** Colitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 22 **Num Events:** 3 **Term:** Nausea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 22 **Num Events:** 5 **Term:** Anemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 22 **Num Events:** 1 **Term:** dehydration **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 22 **Num Events:** 1 **Term:** Diarrhea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 22 **Num Events:** 3 **Term:** Enteritis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 22 **Num Events:** 1 **Term:** INFECTION-Other: Sepsis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 22 **Num Events:** 1 **Term:** INFECTION-Systemic Inflammatory Response Syndrome (SIRS) **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 22 **Num Events:** 1 **Term:** Melena **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 22 **Num Events:** 1 **Term:** new brain lesion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 22 **Num Events:** 1 **Term:** PAIN-GASTROINTESTINAL-Abdomen NOS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 22 **Num Events:** 6 **Term:** Vomitting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 22 **Num Events:** 5 **Time Frame:** Collected form first dose of study drug until the end of active follow up. ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 22 **Units:** Participants ### Group **ID:** BG000 **Title:** Ipilimumab Treatment + Radiation Therapy **Description:** Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease. Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist. ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 18 **Upper Limit:** 89 **Value:** 59 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 6 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 16 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 22 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** FULL_RANGE **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** Years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Limitations and Caveats **Description:** This study was intended to be exploratory and had a limited sample size. Our results are based on a small sample size and further research should be done to really draw firm conclusions. ### Point of Contact **Email:** [email protected] **Organization:** Stanford Cancer Institute **Phone:** 650-725-2720 **Title:** Dr. Susan J Knox ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ### Outcome Measure 6 ### Outcome Measure 7 ### Outcome Measure 8 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 9 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 11 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 7 - **Spread:** - **Upper Limit:** 214 - **Value:** 107 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 60 - **Spread:** - **Upper Limit:** 139 - **Value:** 112 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 29 - **Spread:** - **Upper Limit:** 53 - **Value:** 40 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 26 - **Spread:** - **Upper Limit:** 76 - **Value:** 39 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 12 - **Spread:** - **Upper Limit:** 52 - **Value:** 19 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 9 - **Spread:** - **Upper Limit:** 50 - **Value:** 26 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Serious adverse events (SAEs) defined as untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires in subject hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization but, may jeopardize the subject or may require intervention to prevent one of the other serious outcomes listed in the definition above.) **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** All subjects. **Reporting Status:** POSTED **Time Frame:** 4 months **Title:** Safety Measurement - Percentage of Patients Experiencing Serious Adverse Events (SAEs) in the First 4 Months of Treatment. **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease. Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist. **ID:** OG000 **Title:** Ipilimumab Treatment + Radiation Therapy #### Outcome Measure 2 **Description:** Compare tumor response rate and duration of response at unirradiated sites in patients with Stage IV melanoma with historical controls. Response assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by physical measurement; magnetic resonance imaging (MRI); computed tomography (CT), positron emission tomography (PET)-CT; and/or X-rays: * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** All subjects. **Reporting Status:** POSTED **Time Frame:** 2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease **Title:** Response Rate **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease. Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist. **ID:** OG000 **Title:** Ipilimumab Treatment + Radiation Therapy #### Outcome Measure 3 **Description:** Median time to overall survival was calculated using the Kaplan-Meier algorithm. **Dispersion Type:** Full Range **Parameter Type:** MEDIAN **Population Description:** All subjects **Reporting Status:** POSTED **Time Frame:** 2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease **Title:** Overall Survival **Type:** SECONDARY **Unit of Measure:** weeks ##### Group **Description:** Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease. Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist. **ID:** OG000 **Title:** Ipilimumab Treatment + Radiation Therapy #### Outcome Measure 4 **Description:** The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented. **Dispersion Type:** Full Range **Parameter Type:** MEDIAN **Population Description:** all subjects **Reporting Status:** POSTED **Time Frame:** 2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease **Title:** Duration of Complete Response **Type:** SECONDARY **Unit of Measure:** weeks ##### Group **Description:** Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease. Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist. **ID:** OG000 **Title:** Ipilimumab Treatment + Radiation Therapy #### Outcome Measure 5 **Description:** Length of time between first dose of ipilimumab and a partial response according to RECIST v1.1 (see above) and immune response criteria **Dispersion Type:** Full Range **Parameter Type:** MEDIAN **Population Description:** all patients that did not have SAEs during treatment and did not have complete response. **Reporting Status:** POSTED **Time Frame:** 2 to 4 weeks after last ipilimumab and then every 3 months until disease progression. **Title:** Duration of Partial Response. **Type:** SECONDARY **Unit of Measure:** weeks ##### Group **Description:** Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease. Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist. **ID:** OG000 **Title:** Ipilimumab Treatment + Radiation Therapy #### Outcome Measure 6 **Description:** Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements **Dispersion Type:** Full Range **Parameter Type:** MEDIAN **Population Description:** All patients who did not have SAEs during treatment and did not reach complete response or partial response. **Reporting Status:** POSTED **Time Frame:** 2 to 4 weeks after last ipilimumab and then every 3 months until disease progression. **Title:** Stable Disease **Type:** SECONDARY **Unit of Measure:** weeks ##### Group **Description:** Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease. Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist. **ID:** OG000 **Title:** Ipilimumab Treatment + Radiation Therapy #### Outcome Measure 7 **Description:** Time from the first dose of ipilimumab to the first tumor measurement showing either a complete or partial response to therapy. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Population Description:** All patients who had either a complete response or partial response. **Reporting Status:** POSTED **Time Frame:** 2 to 4 weeks after last ipilimumab and then every 3 months until disease progression. **Title:** Median Time to Complete Response or Partial Response **Type:** SECONDARY **Unit of Measure:** weeks ##### Group **Description:** Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease. Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist. **ID:** OG000 **Title:** Ipilimumab Treatment + Radiation Therapy #### Outcome Measure 8 **Description:** Median time to progression-free survival (PFS) was calculated using the Kaplan-Meier algorithm **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Population Description:** All subject who did not have SAEs during treatment. **Reporting Status:** POSTED **Time Frame:** 2 to 4 weeks after last ipilimumab and then every 3 months until disease progression. **Title:** Progression-free Survival (PFS) **Type:** SECONDARY **Unit of Measure:** weeks ##### Group **Description:** Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease. Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist. **ID:** OG000 **Title:** Ipilimumab Treatment + Radiation Therapy ### Participant Flow Module #### Group **Description:** Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease. Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist. **ID:** FG000 **Title:** Ipilimumab Treatment + Radiation Therapy #### Period **Title:** Overall Study ##### Withdraw **Type:** Lack of Efficacy ###### Reason **Group ID:** FG000 **Number of Subjects:** 5 ##### Withdraw **Type:** Toxicity ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 22 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 15 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 7 **Recruitment Details:** Subjects were recruited during clinic visits at the Stanford Cancer Center clinic. Subjects were informed of all options and given time to ask questions before signing consent in a private room. **Has Results:** True
## Protocol Section ### Identification Module **NCT ID:** NCT01199679 **Acronym:** GERD **Brief Title:** Rubber Band Ligation and Mucosectomy for Gastroesophageal Reflux Disease (GERD) **Official Title:** Evaluation of Distal Esophageal and Cardia Rubber Band Ligation and Mucosectomy in the Treatment of Subjects With Gastroesophageal Reflux Disease #### Organization Study ID Info **ID:** 08-016 #### Organization **Class:** INDUSTRY **Full Name:** Cook Group Incorporated ### Status Module #### Completion Date **Date:** 2013-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-06-19 **Type:** ESTIMATED **Last Update Submit Date:** 2015-06-17 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2012-09 **Type:** ACTUAL #### Start Date **Date:** 2011-06 **Status Verified Date:** 2015-06 #### Study First Post Date **Date:** 2010-09-13 **Type:** ESTIMATED **Study First Submit Date:** 2010-09-09 **Study First Submit QC Date:** 2010-09-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Cook Group Incorporated #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** The purpose of this study is to determine the safety and effectiveness of two separate procedures to treat gastroesophageal reflux disease (GERD) also known as heartburn. The two therapies are: 1) a banding procedure alone using the Cook® 6 Shooter™ Saeed Multi-Band Ligator or 2) a banding/shaving procedure called Endoscopic Mucosal Resection (EMR) using the Cook® Duette™ Multi-Band Mucosectomy device. ### Conditions Module **Conditions:** - Gastroesophageal Reflux Disease - Heartburn - Regurgitation - Dyspepsia **Keywords:** - Gastroesophageal Reflux Disease - Heartburn - Regurgitation - Dyspepsia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: Mucosectomy **Label:** Endoscopic Mucosal Resection (EMR) Group **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Procedure: Rubber Band Ligation **Label:** Banding Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Endoscopic Mucosal Resection (EMR) Group **Description:** Endoscopic mucosal resection in the upper GI tract. **Name:** Mucosectomy **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Banding Group **Description:** Endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids. **Name:** Rubber Band Ligation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** HRQL = Health Related Quality of Life Questionnaire **Measure:** Reduction of reflux symptoms measured by GERD HRQL **Time Frame:** 6 months #### Secondary Outcomes **Measure:** Reduction in total esophageal acid exposure measured by 48 hour pH monitoring **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subject is 18 years of age or older. * Typical symptoms of heartburn and/or regurgitation requiring daily PPI therapy. * Subject agrees to participate and signs consent form. Exclusion Criteria: * Patient is pregnant. * Patient has a hiatal hernia greater than 2cm. * Presence of persistent daily solid food dysphagia, unplanned weight loss over ten pounds, esophageal bleeding, or vomiting more than once per week). * Active medical condition that would preclude the subject from finishing this study. * BMI \> 39. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Indianapolis **Country:** United States **Facility:** Indiana University Hospital **State:** Indiana **Zip:** 46202 #### Overall Officials **Official 1:** **Affiliation:** Indiana University Hospital **Name:** Glen A. Lehman, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000015154 - Term: Esophageal Motility Disorders - ID: D000003680 - Term: Deglutition Disorders - ID: D000004935 - Term: Esophageal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000004941 - Term: Esophagitis - ID: D000005759 - Term: Gastroenteritis - ID: D000010437 - Term: Peptic Ulcer - ID: D000004378 - Term: Duodenal Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000013272 - Term: Stomach Diseases - ID: D000012817 - Term: Signs and Symptoms, Digestive ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases ### Condition Browse Module - Browse Leaves - ID: M7589 - Name: Dyspepsia - Relevance: HIGH - As Found: Dyspepsia - ID: M8880 - Name: Gastroesophageal Reflux - Relevance: HIGH - As Found: Gastroesophageal Reflux - ID: M9444 - Name: Heartburn - Relevance: HIGH - As Found: Heartburn - ID: M8091 - Name: Esophagitis - Relevance: LOW - As Found: Unknown - ID: M8092 - Name: Esophagitis, Peptic - Relevance: HIGH - As Found: Gastroesophageal Reflux - ID: M17874 - Name: Esophageal Motility Disorders - Relevance: LOW - As Found: Unknown - ID: M17875 - Name: Esophageal Spasm, Diffuse - Relevance: LOW - As Found: Unknown - ID: M6882 - Name: Deglutition Disorders - Relevance: LOW - As Found: Unknown - ID: M8085 - Name: Esophageal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8875 - Name: Gastroenteritis - Relevance: LOW - As Found: Unknown - ID: M17206 - Name: Ulcer - Relevance: LOW - As Found: Unknown - ID: M13348 - Name: Peptic Ulcer - Relevance: LOW - As Found: Unknown - ID: M7552 - Name: Duodenal Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005764 - Term: Gastroesophageal Reflux - ID: D000004942 - Term: Esophagitis, Peptic - ID: D000004415 - Term: Dyspepsia - ID: D000006356 - Term: Heartburn ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT03065179 **Acronym:** RADVAX **Brief Title:** SBRT (Stereotactic Body Radiation Therapy) in Combination With Nivolumab/Ipilimumab in Renal Cell Carcinoma (RCC) / Kidney Cancer Patients **Official Title:** Phase II Trial of Stereotactic Body Radiation Therapy in Combination With Nivolumab Plus Ipilimumab in Patients With Metastatic Renal Cell Cancer #### Organization Study ID Info **ID:** STU 072016-044 #### Organization **Class:** OTHER **Full Name:** University of Texas Southwestern Medical Center ### Status Module #### Completion Date **Date:** 2020-11-17 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-03-30 **Type:** ACTUAL **Last Update Submit Date:** 2021-03-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-02-20 **Type:** ACTUAL #### Results First Post Date **Date:** 2021-03-30 **Type:** ACTUAL **Results First Submit Date:** 2020-12-28 **Results First Submit QC Date:** 2021-03-29 #### Start Date **Date:** 2017-03-01 **Type:** ACTUAL **Status Verified Date:** 2021-03 #### Study First Post Date **Date:** 2017-02-27 **Type:** ACTUAL **Study First Submit Date:** 2017-02-07 **Study First Submit QC Date:** 2017-02-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Texas Southwestern Medical Center #### Responsible Party **Investigator Affiliation:** University of Texas Southwestern Medical Center **Investigator Full Name:** Hans Hammers **Investigator Title:** Associate Professor, Internal Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a multi-institution, single-arm phase II study to determine the safety and efficacy of SBRT (up to 2 metastatic sites preferentially lung, mediastinum or bone in combination of nivolumab and ipilimumab in patients with metastatic renal cell carcinoma(with a clear-cell component and at least 1 measurable metastatic lesion that is not being irradiated). **Detailed Description:** The study is planned based on a two-stage design that allows early termination for lack of efficacy. A safety run-in phase will be included comprising the first 6 patients at minimum to ensure that the combination of nivolumab plus ipilimumab and SBRT is safe. Then, the investigators will determine whether the combination of nivolumab plus ipilimumab and SBRT yields a clinically compelling antitumor activity measured as objective response rate (ORR), and evaluate other endpoints including Thrombotic thrombocytopenic purpura (TTP), duration of response (DOR), progression free survival (PFS), overall survival (OS) and local control of irradiated sites. There is no previous experience with SBRT used concurrently with nivolumab and ipilimumab in this study population. Therefore, to ensure that the combination is safe, the first six patients will be treated and observed for toxicity for 6 weeks after radiation before continuing with further accrual. Therefore, six patients will be enrolled at the proposed dose of nivolumab and ipilimumab in combination with SBRT. If 4 out of the first 6 patients experience Grade 3/4 toxicity or a lower grade toxicity requiring immune suppressive therapy during the safety run-in observation period (defined as the first 4-cycles, 12 weeks), enrollment will cease and the study will be halted until further safety analysis of the combination regimen can be performed. If less than 4 out of the first 6 patients experience Grade 3/4 toxicities or require steroids, the investigators will proceed with additional accrual with this regimen. ### Conditions Module **Conditions:** - Kidney Cancer Metastatic - Kidney Cancer - Kidney Cancer, Stage IV ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 29 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy **Intervention Names:** - Drug: Nivolumab/Ipilimumab - Radiation: SBRT **Label:** Nivolumab/Ipilimumab plus SBRT **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Nivolumab/Ipilimumab plus SBRT **Description:** IV immunotherapy **Name:** Nivolumab/Ipilimumab **Other Names:** - Opdivo - Yervoy **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Nivolumab/Ipilimumab plus SBRT **Description:** SBRT will be delivered in conjunction with immunotherapy **Name:** SBRT **Other Names:** - stereotactic radiation **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Description:** An adverse event (AE) will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 **Measure:** Number of Participants With Treatment-related Adverse Events Grade 3 or Higher as Assessed by CTCAE v4.0 **Time Frame:** up to 35 months **Measure:** Number of Participants Needing Corticosteroids **Time Frame:** up to 35 months **Description:** The ORR is defined as the number of participants with a BOR of CR (Complete response) or PR (Partial response) divided by the number of treated participants. The BOR (Best overall response) is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of first subsequent anti-cancer therapy including radiotherapy, tumor-directed surgery, or systemic anticancer therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR assessment **Measure:** Objective Response Rate (ORR) **Time Frame:** up to 35 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Histological confirmation of RCC with a clear-cell component * Metastatic (AJCC Stage IV) RCC * Prior adjuvant or neoadjuvant therapy for localized or locally advanced RCC is allowed provided recurrence occurred = or \> 6 months after the last dose of the adjuvant or neoadjuvant therapy * Any number of prior systemic treatment regimen in the advanced/metastatic setting is allowed (cytokine, anti-angiogenic, mammalian target of rapamycin (mTOR) inhibitor or clinical trial) including previously untreated patients * Karnofsky Performance Status (KPS) of at least 70% * Life expectancy of at least 3 months * At least 2 metastatic sites of which at least 1 must be measurable as per RECIST 1.1 * Archival Formalin-fixed paraffin-embedded (FFPE) tumor tissue must be available for correlative studies (Note: Fine Needle Aspiration (FNA) and bone metastases samples are not acceptable for submission) * Patients with favorable, intermediate and poor risk categories will be eligible for the study. Patients must be categorized according to favorable versus intermediate/poor risk status at registration. International Metastatic RCC Database Consortium (IMDC) must be used to determine prognostic factors Exclusion Criteria: * Subjects with previously treated brain or CNS (Central nervous system) metastases are eligible provided that the subject has recovered from any acute effects of radiotherapy and is not requiring steroids, and any whole brain radiation therapy was completed at least 4 weeks prior to study drug administration, or any stereotactic radiosurgery was completed at least 2 weeks prior to study drug administration. Liver metastases will not be included as part of the radiated lesions to be treated. Medical History and Concurrent Diseases: * Prior treatment with an anti-Programmed cell death(PD) -1, anti-PD-L1, anti-PD-L2, anti-CD137(cluster of differentiation), or anti-CTLA-4 (cytotoxic T-lymphocyte-associated protein ) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. Prior treatment with high dose interleukin (HD IL)-2 is allowed. * Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\> 10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll. Patients with psoriasis not requiring active, systemic treatment are allowed. * Any condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease * Uncontrolled adrenal insufficiency * Requirement for anti-coagulation with Coumadin, low molecular weight heparin and anti-thrombin inhibitors will be accepted if anticoagulation has been stable for at least 4 weeks and no recent history of prior bleeding complications. * Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast or low risk Gleason 6 prostate cancer * Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) * Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection * Known medical condition (eg, a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results * Major surgery (eg, nephrectomy) less than 28 days prior to the first dose of study drug * Anti-cancer therapy less than 14 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug * Presence of any toxicities attributed to prior anti-cancer therapy, other than alopecia, that have not resolved to Grade 1 (NCI CTCAE v4) or baseline before administration of study drug Physical and Laboratory Test Findings: * Any of the following laboratory test findings: * White blood cell (WBC) \< 2,000/mm3 * Neutrophils \< 1,500/mm3 * Platelets \< 100,000/mm3 * aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x ULN (\> 5 x ULN if liver metastases are present) * Total Bilirubin \> 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL) * Serum creatinine \> 1.5 x upper limit of normal (ULN) or creatinine clearance \< 40 mL/min (measured or calculated by Cockroft-Gault formula) Allergies and Adverse Drug Reaction: * History of severe hypersensitivity reaction to any monoclonal antibody or study drug components Other Exclusion Criteria: * Prisoners or subject who are involuntarily incarcerated * Not suitable for SBRT treatment * Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Baltimore **Country:** United States **Facility:** The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins **State:** Maryland **Zip:** 21287 **Location 2:** **City:** Dallas **Country:** United States **Facility:** UT Southwestern **State:** Texas **Zip:** 75390 #### Overall Officials **Official 1:** **Affiliation:** UT Southwestern Medical Center **Name:** Hans Hammers, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2016-06-27 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 14780890 - Type Abbrev: Prot_SAP - Upload Date: 2020-11-13T09:22 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000000230 - Term: Adenocarcinoma - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5548 - Name: Carcinoma, Renal Cell - Relevance: HIGH - As Found: Kidney Cancer - ID: M10703 - Name: Kidney Neoplasms - Relevance: HIGH - As Found: Kidney Cancer - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: T4906 - Name: Renal Cell Carcinoma - Relevance: HIGH - As Found: Kidney Cancer - ID: T1341 - Name: Clear Cell Renal Cell Carcinoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007680 - Term: Kidney Neoplasms - ID: D000002292 - Term: Carcinoma, Renal Cell ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M1854 - Name: Nivolumab - Relevance: HIGH - As Found: Prospective - ID: M1348 - Name: Ipilimumab - Relevance: HIGH - As Found: While - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077594 - Term: Nivolumab - ID: D000074324 - Term: Ipilimumab ### Misc Info Module #### Submission Tracking ##### First MCP Info ###### Post Date - Date: 2021-01-22 - Type: ACTUAL - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Nivolumab/Ipilimumab Plus SBRT **Deaths Num At Risk:** 25 **Description:** Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy Nivolumab/Ipilimumab: IV immunotherapy SBRT: SBRT will be delivered in conjunction with immunotherapy **ID:** EG000 **Other Num Affected:** 25 **Other Num at Risk:** 25 **Serious Number Affected:** 9 **Serious Number At Risk:** 25 **Title:** Nivolumab/Ipilimumab Plus SBRT **Frequency Threshold:** 0 #### Other Events **Term:** Fatigue **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Rash **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** Pruritus **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** Pneumonitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Radiation Pneumonitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Diarrhea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Colitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** ALT **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** AST **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Amylase **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Creatinine **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** **Term:** Hypothyroidism **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Endocrine disorders **Source Vocabulary:** **Term:** Hyperthyroidism **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Endocrine disorders **Source Vocabulary:** **Term:** Adrenal Insufficiency **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Endocrine disorders **Source Vocabulary:** **Term:** Hypophysitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Endocrine disorders **Source Vocabulary:** **Term:** Arthritis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** #### Serious Events **Term:** Diarrhea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 25 **Term:** Colitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 25 **Term:** ALT (Alanine Transaminase) **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 25 **Term:** AST (Aspartate transaminase) **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 25 **Term:** Amylase **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 6 **Num At Risk:** 25 **Term:** Lipase **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 6 **Num At Risk:** 25 **Time Frame:** Up to 35 months ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 25 **Units:** Participants ### Group **ID:** BG000 **Title:** Nivolumab/Ipilimumab Plus SBRT **Description:** Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy Nivolumab/Ipilimumab: IV immunotherapy SBRT: SBRT will be delivered in conjunction with immunotherapy ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 35 **Upper Limit:** 84 **Value:** 57 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 2 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 23 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 1 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 1 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 23 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** FULL_RANGE **Parameter Type:** MEDIAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Point of Contact **Email:** [email protected] **Organization:** UT Southwestern Medical Center **Phone:** 214/645-7445 **Title:** Dr. Hans Hammers ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 9 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 10 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 38.7 - **Spread:** - **Upper Limit:** 78.9 - **Value:** 56 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** An adverse event (AE) will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** up to 35 months **Title:** Number of Participants With Treatment-related Adverse Events Grade 3 or Higher as Assessed by CTCAE v4.0 **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy Nivolumab/Ipilimumab: IV immunotherapy SBRT: SBRT will be delivered in conjunction with immunotherapy **ID:** OG000 **Title:** Nivolumab/Ipilimumab Plus SBRT #### Outcome Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** up to 35 months **Title:** Number of Participants Needing Corticosteroids **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy Nivolumab/Ipilimumab: IV immunotherapy SBRT: SBRT will be delivered in conjunction with immunotherapy **ID:** OG000 **Title:** Nivolumab/Ipilimumab Plus SBRT #### Outcome Measure 3 **Description:** The ORR is defined as the number of participants with a BOR of CR (Complete response) or PR (Partial response) divided by the number of treated participants. The BOR (Best overall response) is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of first subsequent anti-cancer therapy including radiotherapy, tumor-directed surgery, or systemic anticancer therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR assessment **Dispersion Type:** 90% Confidence Interval **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** up to 35 months **Title:** Objective Response Rate (ORR) **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **Description:** Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy Nivolumab/Ipilimumab: IV immunotherapy SBRT: SBRT will be delivered in conjunction with immunotherapy **ID:** OG000 **Title:** Nivolumab/Ipilimumab Plus SBRT ### Participant Flow Module #### Group **Description:** Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy Nivolumab/Ipilimumab: IV immunotherapy SBRT: SBRT will be delivered in conjunction with immunotherapy **ID:** FG000 **Title:** Nivolumab/Ipilimumab Plus SBRT #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 25 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 25 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 **Recruitment Details:** There were 4 participants who signed the informed consent and went through the screening process as part of the protocol and were screen failures. **Has Results:** True
## Protocol Section ### Identification Module **NCT ID:** NCT05064579 **Acronym:** COPA **Brief Title:** Towards an Algorithmic Approach to Asthma Management: Collaborative Definition of Algorithm Objectives With Families **Official Title:** Towards an Algorithmic Approach to Asthma Management: Collaborative Definition of Algorithm Objectives With Families #### Organization Study ID Info **ID:** APHP210819 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris #### Secondary ID Infos **Domain:** ID RCB number **ID:** 2021-A00041-40 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2023-01-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-02-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-02-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-01-30 **Type:** ACTUAL #### Start Date **Date:** 2022-01-18 **Type:** ACTUAL **Status Verified Date:** 2023-03 #### Study First Post Date **Date:** 2021-10-01 **Type:** ACTUAL **Study First Submit Date:** 2021-09-22 **Study First Submit QC Date:** 2021-09-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assistance Publique - Hôpitaux de Paris #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Using "big data" and artificial intelligence techniques, it becomes possible to envision algorithms for managing childhood asthma on a daily basis. In order to develop such tools, it is necessary to determine with asthma stakeholders (children, parents, doctors) the parameters that future algorithms should seek to maximize / minimize. The main objective of the study is to quantify the respective importance of each of the goals that children with asthma, parents, and their doctors seek to achieve when taking / supervising / prescribing a background therapy. **Detailed Description:** Using "big data" and artificial intelligence techniques, it becomes possible to envision algorithms for managing childhood asthma on a daily basis. In order to develop such tools, it is necessary to determine with asthma stakeholders (children, parents, doctors) the parameters that future algorithms should seek to maximize / minimize. The main objective of the study is to quantify the respective importance of each of the goals that children with asthma, parents, and their doctors seek to achieve when taking / supervising / prescribing a background therapy. To do this, parents and children fill out a paper questionnaire, which is completed by their doctor, when they come to the hospital for consultation, hospitalization, or to perform lung function tests. Concerning children and parents, these questionnaires include a part aimed at prioritizing each person's objectives and a second part collecting general information regarding their characteristics (age, sex, asthma history, etc.). ### Conditions Module **Conditions:** - Childhood Asthma **Keywords:** - Childhood asthma - Algorithms for managing childhood asthma - Big data - Artificial intelligence ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 307 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Children and adolescents aged 8 to 17 years old with a doctor's diagnosis of asthma and controller asthma treatment **Intervention Names:** - Other: Questionnaires **Label:** Patients with asthma #### Arm Group 2 **Description:** Holders of parental authority of patients with asthma described in group A **Intervention Names:** - Other: Questionnaires **Label:** Holders of parental authority #### Arm Group 3 **Description:** Doctors caring for patients with asthma described in group A **Intervention Names:** - Other: Questionnaires **Label:** Doctors ### Interventions #### Intervention 1 **Arm Group Labels:** - Doctors - Holders of parental authority - Patients with asthma **Description:** Questionnaire in two parts: one part on the objectives related to taking the treatment and the objectives related to the treatment modality and a second part on the general characteristics of each participant and the characteristics of the child's asthma. **Name:** Questionnaires **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Children, their parents (or holders of parental authority), and their doctors will be asked to allocate 20 points to 7 goals they want to prevent with the asthma controller treatment, and another 20 points to 5 goals regarding their treatment modality (more discreet, easier to take, etc). The score for each goal will range from 0 (objective not important to the respondent) to 20 (objective of major importance to the respondent). **Measure:** Mean score attributed to each goal **Time Frame:** Day 0 #### Secondary Outcomes **Description:** For each goal, the correlation of the scores attributed by children, their parents, and their doctors, will be calculated. **Measure:** Correlation of goals between respondents **Time Frame:** Day 0 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Minor patients aged 8 years to 17 years and 11 months inclusive with a diagnosis of asthma made by a doctor and a basic treatment for asthma * Holders of parental authority for patients meeting the above criteria * Doctors caring for children with asthma * Information and non-opposition of holders of parental authority and minor patients to participate in the study Exclusion Criteria: * Refusal to participate in the study * Difficulties in French writing and / or speaking **Minimum Age:** 8 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Participants will be recruited in hospitals in the Ile-de-france region ### Contacts Locations Module #### Locations **Location 1:** **City:** Boulogne-Billancourt **Country:** France **Facility:** Hôpital Ambroise Paré **Zip:** 92100 **Location 2:** **City:** Colombes **Country:** France **Facility:** Hôpital Louis Mourier **Zip:** 92700 **Location 3:** **City:** Paris **Country:** France **Facility:** Hôpital Trousseau-Allergologie pédiatrique **Zip:** 75012 **Location 4:** **City:** Paris **Country:** France **Facility:** Hôpital Trousseau-Pneumologie pédiatrique **Zip:** 75012 **Location 5:** **City:** Paris **Country:** France **Facility:** Hôpital Necker-Enfants Malades **Zip:** 75015 **Location 6:** **City:** Paris **Country:** France **Facility:** Hôpital Robert Debré **Zip:** 75019 #### Overall Officials **Official 1:** **Affiliation:** Assistance Publique - Hôpitaux de Paris **Name:** David Drummond, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Masrour O, Personnic J, Amat F, Abou Taam R, Prevost B, Lezmi G, Gonsard A, Nathan N, Pirojoc A, Delacourt C, Wanin S, Drummond D. Objectives for algorithmic decision-making systems in childhood asthma: Perspectives of children, parents, and physicians. Digit Health. 2024 Feb 21;10:20552076241227285. doi: 10.1177/20552076241227285. eCollection 2024 Jan-Dec. **PMID:** 38389509 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT01250379 **Brief Title:** A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA) **Official Title:** A Phase III Randomized Study Evaluating the Efficacy and Safety of Continued and Re-induced Bevacizumab in Combination With Chemotherapy for Patients With Locally Recurrent or Metastatic Breast Cancer After First-line Chemotherapy and Bevacizumab Treatment #### Organization Study ID Info **ID:** MO22998 #### Organization **Class:** INDUSTRY **Full Name:** Hoffmann-La Roche #### Secondary ID Infos **ID:** 2010-020998-16 ### Status Module #### Completion Date **Date:** 2015-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-02-11 **Type:** ESTIMATED **Last Update Submit Date:** 2016-01-12 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-12 **Type:** ACTUAL #### Results First Post Date **Date:** 2015-06-30 **Type:** ESTIMATED **Results First Submit Date:** 2015-06-05 **Results First Submit QC Date:** 2015-06-05 #### Start Date **Date:** 2011-02 **Status Verified Date:** 2016-01 #### Study First Post Date **Date:** 2010-11-30 **Type:** ESTIMATED **Study First Submit Date:** 2010-11-25 **Study First Submit QC Date:** 2010-11-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Hoffmann-La Roche #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs. ### Conditions Module **Conditions:** - Breast Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 494 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Chemotherapy **Label:** 1 **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Drug: bevacizumab [Avastin] - Drug: Chemotherapy **Label:** 2 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 2 **Description:** 10 mg/ kg iv every 2 weeks or 15 mg/kg iv every 3 weeks **Name:** bevacizumab [Avastin] **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 1 - 2 **Description:** Standard chemotherapy (doublets not allowed) **Name:** Chemotherapy **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Measure:** Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) **Time Frame:** Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years **Description:** The median time, in months, from randomization to second-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Measure:** Second-Line PFS **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years **Description:** Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Measure:** Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6 **Time Frame:** Month 6 **Description:** Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without secondline PD or death were censored at the date of last tumor assessment where non-progression was documented. **Measure:** Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12 **Time Frame:** Month 12 **Description:** Second-line PFS was defined as the time from randomization to PD or death due to any cause during their secondline of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Measure:** Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18 **Time Frame:** Month 18 **Description:** Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Measure:** Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24 **Time Frame:** Month 24 #### Secondary Outcomes **Description:** The median time, in months, from randomization to second-line PFS event according to the following baseline risk factors: hormone receptor negative, HER2 negative (triple negative), hormone receptor positive/HER-2 negative (HR-pos/HER-neg), first-line PFS less than (\<) 6 months, first-line PFS greater than or equal to (≥) 6 months, taxane chemotherapy (chemo), non-taxane chemo, vinorelbine chemo, LDH ≤ 1.5 upper limit of normal (ULN), LDH greater than (\>) 1.5 ULN, \< 65 years of age, ≥ 65 years of age, \< 70 years of age, ≥ 70 years of age, \< 3 metastatic organ sites, ≥ 3 metastatic organ sites, bevacizumab-free (B-free) interval ≤ 6 weeks, B-free \> 6 weeks, disease-free (D-free) interval ≤ 24 months, D-free \> 24 months, D-free ≤ 12 months, and D-free \> 12 months. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. PD: defined in Outcome measure 1. The 95% CI was estimated using Kaplan-Meier methodology. **Measure:** Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years **Description:** BOR was defined as a confirmed CR or PR during second-line treatment. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% Cl was determined using the Pearson-Clopper method. **Measure:** Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013) **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years **Description:** For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; stable disease was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI was determined using the Pearson-Clopper method. **Measure:** Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013) **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years **Description:** The median time, in months, from the date of the first second-line documentation of CR or PR according to RECIST v1.1 to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free. **Measure:** Duration of Second-Line Objective Response (Data Cutoff 20 December 2013) **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years **Description:** Duration of objective response was defined as the median time, in months, from the date of the first second-line documentation of CR or PR to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free. **Measure:** Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013) **Time Frame:** Months 3, 6, and 9 **Description:** Third-line PFS was defined as the time from the date of first dose of third-line bevacizumab and/or chemotherapy to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Measure:** Percentage of Participants With Third-Line PFS According to RECIST v1.1 **Time Frame:** First dose of third-line treatment until PD or death due to any cause (assessed every 8-9 weeks, over a period of approximately 14 months) **Description:** The median time, in months, from the first dose of third-line bevacizumab and/or chemotherapy to third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Measure:** Third-Line PFS **Time Frame:** First dose of third-line treatment until PD or death due to any cause (over a period of approximately 14 months) **Description:** Second- and third-line PFS was defined as the time from the date randomization to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Measure:** Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1 **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years **Description:** The median time, in months, from randomization to second-line and third-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Measure:** Second- and Third-Line PFS **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years **Description:** Second- and third-line tumor progression was defined as occurrence of third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death due to progression of disease were censored at the date of last tumor assessment where non-progression was documented. **Measure:** Percentage of Participants With Second- and Third-Line Tumor Progression **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years **Description:** The median time, in months, from randomization to second- and third-line tumor progression. Second- and third-line tumor progression was defined as third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Measure:** Time to Second- and Third-Line Tumor Progression **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years **Description:** Percentage of participants who died due to any reason were reported. **Measure:** Percentage of Participants Who Died **Time Frame:** Baseline until death (up to approximately 4 years) **Description:** OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Participants who had not died were censored at the date the patient was last known to be alive. **Measure:** Overall Survival (OS) **Time Frame:** Baseline until death (up to approximately 4 years) **Description:** OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. **Measure:** Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24 **Time Frame:** Months 6, 12, 18, and 24 **Description:** The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility (M) ("no problems"="I have no problems in walking about" to "extreme problems"="I am confined to bed"), self-care (SC) ("no problems"="I have no problems with self-care" to "extreme problems"="I am unable to wash or dress myself"), usual activities (UA) ("no problems"="I have no problems performing my usual activities" to "extreme problems"="I am unable to perform my usual activities"), pain/discomfort (P/D) ("no problems"="I have no pain or discomfort" to "extreme problems"="I have extreme pain or discomfort"), and anxiety/depression (A/D) ("no problems"="I am not anxious or depressed" to "extreme problems"='I am extremely anxious or depressed"). **Measure:** Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) **Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) **Description:** The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems). **Measure:** Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013) **Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) **Description:** The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life. **Measure:** Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013) **Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) **Description:** The participant was asked to rate their overall health on a 0-100 millimeter (mm) vertical scale, where the lowest endpoint=0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A higher value indicated a better health state. **Measure:** Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013) **Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) **Description:** The participant was asked to rate their overall health on a 0-100 mm vertical scale, where the lowest endpoint = 0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life. **Measure:** Change From Baseline in VAS Scores (Data Cutoff 20 December 2013) **Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) **Description:** The Functional Assessment of Cancer Therapy-Breast (FACT-B) is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"), as follows: physical well-being (PWB) (7 items, total score 0-28), social/family well-being (SWB) (7 items, total score 0-28), emotional well-being (EWB) (6 items, total score 0-24), functional well-being (FWB) (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B Trial Outcomes Index (TOI) score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The Functional Assessment of Cancer Therapy-General (FACT-G) total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscales scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life. **Measure:** Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years) **Description:** The FACT-B is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"), as follows: PWB (7 items, total score 0-28), SWB (7 items, total score 0-28), EWB (6 items, total score 0-24), FWB (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B TOI score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The FACT-G total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscale scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life. **Measure:** Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Female patients, \>/= 18 years of age * Histologically confirmed HER2-negative breast cancer * Disease progression during or following first-line treatment with Avastin and chemotherapy for locally recurrent or metastatic breast cancer * Avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy * ECOG performance status 0-2 * At least 28 days since prior radiation therapy or surgery and recovery from treatment Exclusion Criteria: * Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin for first-line treatment * Active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years * Inadequate renal function * Clinically relevant cardio-vascular disease * Known CNS disease except for treated brain metastases * Chronic daily treatment with high-dose aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day) * Pregnant or lactating women **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Buenos Aires **Country:** Argentina **Zip:** C1199ACI **Location 2:** **City:** Buenos Aires **Country:** Argentina **Zip:** C1280AEB **Location 3:** **City:** Buenos Aires **Country:** Argentina **Zip:** C1426ANZ **Location 4:** **City:** San Miguel de Tucuman **Country:** Argentina **Zip:** T4000IAK **Location 5:** **City:** Feldkirch **Country:** Austria **Zip:** 6807 **Location 6:** **City:** Graz **Country:** Austria **Zip:** 8036 **Location 7:** **City:** Innsbruck **Country:** Austria **Zip:** 6020 **Location 8:** **City:** Krems **Country:** Austria **Zip:** 3500 **Location 9:** **City:** Salzburg **Country:** Austria **Zip:** 5020 **Location 10:** **City:** Steyr **Country:** Austria **Zip:** 4400 **Location 11:** **City:** Villach **Country:** Austria **Zip:** 9500 **Location 12:** **City:** Wien **Country:** Austria **Zip:** 1090 **Location 13:** **City:** Goiania **Country:** Brazil **State:** GO **Zip:** 74140-050 **Location 14:** **City:** Porto Alegre **Country:** Brazil **State:** RS **Zip:** 90430-090 **Location 15:** **City:** Itajai **Country:** Brazil **State:** SC **Zip:** 88301-220 **Location 16:** **City:** Split **Country:** Croatia **Zip:** 21000 **Location 17:** **City:** Amiens **Country:** France **Zip:** 80090 **Location 18:** **City:** Angers **Country:** France **Zip:** 49933 **Location 19:** **City:** Besancon **Country:** France **Zip:** 25030 **Location 20:** **City:** Bordeaux **Country:** France **Zip:** 33000 **Location 21:** **City:** Boulogne Sur Mer **Country:** France **Zip:** 62222 **Location 22:** **City:** Brest **Country:** France **Zip:** 29609 **Location 23:** **City:** Caen **Country:** France **Zip:** 14076 **Location 24:** **City:** Clermont Ferrand **Country:** France **Zip:** 63011 **Location 25:** **City:** Dijon **Country:** France **Zip:** 21079 **Location 26:** **City:** Grenoble **Country:** France **Zip:** 38028 **Location 27:** **City:** Limoges **Country:** France **Zip:** 87039 **Location 28:** **City:** Marseille **Country:** France **Zip:** 13285 **Location 29:** **City:** Montpellier **Country:** France **Zip:** 34298 **Location 30:** **City:** Nancy **Country:** France **Zip:** 54100 **Location 31:** **City:** Nantes **Country:** France **Zip:** 44202 **Location 32:** **City:** Paris **Country:** France **Zip:** 75970 **Location 33:** **City:** Pierre Benite **Country:** France **Zip:** 69495 **Location 34:** **City:** Reims CEDEX **Country:** France **Zip:** 51056 **Location 35:** **City:** Rouen **Country:** France **Zip:** 76038 **Location 36:** **City:** Saint Gregoire **Country:** France **Zip:** 35768 **Location 37:** **City:** Saint Jean **Country:** France **Zip:** 31240 **Location 38:** **City:** St Cloud **Country:** France **Zip:** 92210 **Location 39:** **City:** St Priest En Jarez **Country:** France **Zip:** 42271 **Location 40:** **City:** St Quentin **Country:** France **Zip:** 02321 **Location 41:** **City:** Strasbourg **Country:** France **Zip:** 67010 **Location 42:** **City:** Toulouse **Country:** France **Zip:** 31076 **Location 43:** **City:** Amberg **Country:** Germany **Zip:** 92224 **Location 44:** **City:** Aschaffenburg **Country:** Germany **Zip:** 63739 **Location 45:** **City:** Berlin **Country:** Germany **Zip:** 10367 **Location 46:** **City:** Berlin **Country:** Germany **Zip:** 10719 **Location 47:** **City:** Bielefeld **Country:** Germany **Zip:** 33604 **Location 48:** **City:** Chemnitz **Country:** Germany **Zip:** 09116 **Location 49:** **City:** Dresden **Country:** Germany **Zip:** 01307 **Location 50:** **City:** Düsseldorf **Country:** Germany **Zip:** 40235 **Location 51:** **City:** Essen **Country:** Germany **Zip:** 45122 **Location 52:** **City:** Essen **Country:** Germany **Zip:** 45136 **Location 53:** **City:** Freiburg **Country:** Germany **Zip:** 79110 **Location 54:** **City:** Göttingen **Country:** Germany **Zip:** 37073 **Location 55:** **City:** Hamburg **Country:** Germany **Zip:** 20249 **Location 56:** **City:** Hannover **Country:** Germany **Zip:** 30177 **Location 57:** **City:** Heidelberg **Country:** Germany **Zip:** 69115 **Location 58:** **City:** Heidelberg **Country:** Germany **Zip:** 69120 **Location 59:** **City:** Karlsruhe **Country:** Germany **Zip:** 76135 **Location 60:** **City:** Koeln **Country:** Germany **Zip:** 50935 **Location 61:** **City:** Mannheim **Country:** Germany **Zip:** 68161 **Location 62:** **City:** Muenster **Country:** Germany **Zip:** 48149 **Location 63:** **City:** München **Country:** Germany **Zip:** 80639 **Location 64:** **City:** Naunhof **Country:** Germany **Zip:** 04683 **Location 65:** **City:** Neuss **Country:** Germany **Zip:** 41462 **Location 66:** **City:** Nordhausen **Country:** Germany **Zip:** 99734 **Location 67:** **City:** Osnabrueck **Country:** Germany **Zip:** 49076 **Location 68:** **City:** Ravensburg **Country:** Germany **Zip:** 88212 **Location 69:** **City:** Stade **Country:** Germany **Zip:** 21680 **Location 70:** **City:** Stralsund **Country:** Germany **Zip:** 18435 **Location 71:** **City:** Wiesbaden **Country:** Germany **Zip:** 65199 **Location 72:** **City:** Athens **Country:** Greece **Zip:** 11528 **Location 73:** **City:** Ioannina **Country:** Greece **Zip:** 455 00 **Location 74:** **City:** Patras **Country:** Greece **Zip:** 265 00 **Location 75:** **City:** Thessaloniki **Country:** Greece **Zip:** 546 45 **Location 76:** **City:** Budapest **Country:** Hungary **Zip:** 1122 **Location 77:** **City:** Budapest **Country:** Hungary **Zip:** 1145 **Location 78:** **City:** Szeged **Country:** Hungary **Zip:** 6720 **Location 79:** **City:** Beer Sheva **Country:** Israel **Zip:** 8410101 **Location 80:** **City:** Jerusalem **Country:** Israel **Zip:** 91120 **Location 81:** **City:** Kfar-Saba **Country:** Israel **Zip:** 4428164 **Location 82:** **City:** Petach Tikva **Country:** Israel **Zip:** 4941492 **Location 83:** **City:** Ramat Gan **Country:** Israel **Zip:** 52620-00 **Location 84:** **City:** Rehovot **Country:** Israel **Zip:** 7610001 **Location 85:** **City:** Tel Aviv **Country:** Israel **Zip:** 6423906 **Location 86:** **City:** Tel Aviv **Country:** Israel **Location 87:** **City:** Cosenza **Country:** Italy **State:** Calabria **Zip:** 87100 **Location 88:** **City:** Benevento **Country:** Italy **State:** Campania **Zip:** 82100 **Location 89:** **City:** Napoli **Country:** Italy **State:** Campania **Zip:** 80131 **Location 90:** **City:** Reggio Emilia **Country:** Italy **State:** Emilia-Romagna **Zip:** 42100 **Location 91:** **City:** Udine **Country:** Italy **State:** Friuli-Venezia Giulia **Zip:** 33100 **Location 92:** **City:** Roma **Country:** Italy **State:** Lazio **Zip:** 00168 **Location 93:** **City:** Monza **Country:** Italy **State:** Lombardia **Zip:** 20052 **Location 94:** **City:** Macerata **Country:** Italy **State:** Marche **Zip:** 62100 **Location 95:** **City:** Cagliari **Country:** Italy **State:** Sardegna **Zip:** 09121 **Location 96:** **City:** Sassari **Country:** Italy **State:** Sardegna **Zip:** 07100 **Location 97:** **City:** Catania **Country:** Italy **State:** Sicilia **Zip:** 95100 **Location 98:** **City:** Firenze **Country:** Italy **State:** Toscana **Zip:** 50134 **Location 99:** **City:** Pisa **Country:** Italy **State:** Toscana **Zip:** 56100 **Location 100:** **City:** Pontedera **Country:** Italy **State:** Toscana **Zip:** 56025 **Location 101:** **City:** Verona **Country:** Italy **State:** Veneto **Zip:** 37126 **Location 102:** **City:** Bardejov **Country:** Slovakia **Zip:** 085 01 **Location 103:** **City:** Bratislava **Country:** Slovakia **Zip:** 812 50 **Location 104:** **City:** Kosice **Country:** Slovakia **Zip:** 04001 **Location 105:** **City:** Nove Zamky **Country:** Slovakia **Zip:** 940 34 **Location 106:** **City:** Presov **Country:** Slovakia **Zip:** 080 01 **Location 107:** **City:** Santander **Country:** Spain **State:** Cantabria **Zip:** 39008 **Location 108:** **City:** San Sebastian **Country:** Spain **State:** Guipuzcoa **Zip:** 20080 **Location 109:** **City:** Palma De Mallorca **Country:** Spain **State:** Islas Baleares **Zip:** 07014 **Location 110:** **City:** La Laguna **Country:** Spain **State:** Tenerife **Zip:** 38320 **Location 111:** **City:** Barcelona **Country:** Spain **Zip:** 08035 **Location 112:** **City:** Barcelona **Country:** Spain **Zip:** 08036 **Location 113:** **City:** Barcelona **Country:** Spain **Zip:** 08041 **Location 114:** **City:** Castellon **Country:** Spain **Zip:** 12002 **Location 115:** **City:** Cordoba **Country:** Spain **Zip:** 14004 **Location 116:** **City:** Leon **Country:** Spain **Zip:** 24071 **Location 117:** **City:** Lerida **Country:** Spain **Zip:** 25198 **Location 118:** **City:** Madrid **Country:** Spain **Zip:** 28007 **Location 119:** **City:** Madrid **Country:** Spain **Zip:** 28033 **Location 120:** **City:** Madrid **Country:** Spain **Zip:** 28034 **Location 121:** **City:** Madrid **Country:** Spain **Zip:** 28040 **Location 122:** **City:** Madrid **Country:** Spain **Zip:** 28041 **Location 123:** **City:** Madrid **Country:** Spain **Zip:** 28046 **Location 124:** **City:** Madrid **Country:** Spain **Zip:** 28223 **Location 125:** **City:** Malaga **Country:** Spain **Zip:** 29010 **Location 126:** **City:** Murcia **Country:** Spain **Zip:** 30008 **Location 127:** **City:** Sevilla **Country:** Spain **Zip:** 41014 **Location 128:** **City:** Valencia **Country:** Spain **Zip:** 46009 **Location 129:** **City:** Zaragoza **Country:** Spain **Zip:** 50009 **Location 130:** **City:** Aarau **Country:** Switzerland **Zip:** 5000 **Location 131:** **City:** Chur **Country:** Switzerland **Zip:** 7000 **Location 132:** **City:** Zürich **Country:** Switzerland **Zip:** 8038 #### Overall Officials **Official 1:** **Affiliation:** Hoffmann-La Roche **Name:** Clinical Trials **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Vrdoljak E, Marschner N, Zielinski C, Gligorov J, Cortes J, Puglisi F, Aapro M, Fallowfield L, Fontana A, Inbar M, Kahan Z, Welt A, Levy C, Brain E, Pivot X, Putzu C, Gonzalez Martin A, de Ducla S, Easton V, von Minckwitz G. Final results of the TANIA randomised phase III trial of bevacizumab after progression on first-line bevacizumab therapy for HER2-negative locally recurrent/metastatic breast cancer. Ann Oncol. 2016 Nov;27(11):2046-2052. doi: 10.1093/annonc/mdw316. Epub 2016 Aug 8. **PMID:** 27502725 **Citation:** von Minckwitz G, Puglisi F, Cortes J, Vrdoljak E, Marschner N, Zielinski C, Villanueva C, Romieu G, Lang I, Ciruelos E, De Laurentiis M, Veyret C, de Ducla S, Freudensprung U, Srock S, Gligorov J. Bevacizumab plus chemotherapy versus chemotherapy alone as second-line treatment for patients with HER2-negative locally recurrent or metastatic breast cancer after first-line treatment with bevacizumab plus chemotherapy (TANIA): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1269-78. doi: 10.1016/S1470-2045(14)70439-5. Epub 2014 Sep 28. **PMID:** 25273342 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000020533 - Term: Angiogenesis Inhibitors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000006131 - Term: Growth Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M246 - Name: Bevacizumab - Relevance: HIGH - As Found: Non- - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068258 - Term: Bevacizumab ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis. #### Event Groups **Group ID:** EG000 **Title:** CT Arm **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** EG000 **Other Num Affected:** 181 **Other Num at Risk:** 238 **Serious Number Affected:** 55 **Serious Number At Risk:** 238 **Title:** CT Arm **Group ID:** EG001 **Title:** CT+BV Arm **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** EG001 **Other Num Affected:** 218 **Other Num at Risk:** 245 **Serious Number Affected:** 89 **Serious Number At Risk:** 245 **Title:** CT+BV Arm **Frequency Threshold:** 5 #### Other Events **Term:** Proteinuria **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Hypertension **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Haemorrhage **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Palmar-plantar erythrodysaesthesia syndrome **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Neutropenia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Leukopenia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Anaemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Diarrhoea **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Nausea **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Vomiting **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Fatigue **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Mucosal inflammation **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Thrombocytopenia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Abdominal pain **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Constipation **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Asthenia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Pyrexia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Urinary tract infection **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) **Term:** Decreased appetite **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Peripheral sensory neuropathy **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Epistaxis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA (17.1) #### Serious Events **Term:** Febrile neutropenia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 5 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 12 **Num At Risk:** 245 **Term:** Neutropenia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 6 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 10 **Num At Risk:** 245 **Term:** Leukopenia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 245 **Term:** Thrombocytopenia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 5 **Num At Risk:** 245 **Term:** Anaemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Pancytopenia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Infection **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 245 **Term:** Bronchitis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 245 **Term:** Pneumonia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 245 **Term:** Device related infection **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Device related sepsis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Ear infection **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Enterocolitis infectious **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Erysipelas **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Herpes zoster **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Injection site infection **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Osteomyelitis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Sepsis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 245 **Term:** Tooth infection **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Urinary tract infection **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Wound infection **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Pyrexia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 245 **Term:** Fatigue **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 245 **Term:** General physical health deterioration **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 245 **Term:** Chest discomfort **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Chest pain **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Device failure **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Mucosal inflammation **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 245 **Term:** Pain **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Sudden death **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Diarrhoea **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 245 **Term:** Vomiting **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 245 **Term:** Abdominal pain **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Anal fissure **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Diverticular perforation **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Faecaloma **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Melaena **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Nausea **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Pancreatitis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Pulmonary embolism **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 6 **Num At Risk:** 245 **Term:** Pleural effusion **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 245 **Term:** Dyspnoea **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 245 **Term:** Pneumothorax **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Ischaemic stoke **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Cerebrovascular accident **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Cerebrovascular disorder **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Convulsion **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 245 **Term:** Headache **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Motor dysfunction **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Partial seizures **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Polyneuropathy **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Spinal cord compression **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Cardiac failure **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 245 **Term:** Acute coronary syndrome **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Atrial fibrillation **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Cardiac failure congestive **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 245 **Term:** Cardiotoxicity **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Left ventricular failure **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Sinus tachycardia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Tachycardia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Bone pain **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 245 **Term:** Osteonecrosis of jaw **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 245 **Term:** Musculoskeletal pain **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Pathological fracture **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Gamma-glutamyltransferase increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Alanine aminotransferase increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Aspartate aminotransferase increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Blood bilirubin increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Blood potassium increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Hyponatraemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 245 **Term:** Hypercalcaemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Hypocalcaemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Embolism venous **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 245 **Term:** Haemorrhage **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Depression **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Confusional state **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Cholelithiasis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 245 **Term:** Cholecystitis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Endometrial adenocarcinoma **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Metastases to liver **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Obstructive uropathy **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Postrenal failure **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Menstrual disorder **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Reproductive system and breast disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Metrorrhagia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Reproductive system and breast disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Salpingo-oophorectomy **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Surgical and medical procedures **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Tooth extraction **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Surgical and medical procedures **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Foot fracture **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Skin ulcer **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Anal abscess **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Peritonitis bacterial **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Pseudomembranous colitis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Urosepsis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Femoral neck fracture **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Head injury **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Subdural haematoma **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Biopsy liver **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Hypoglycaemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Facial paresis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Pneumonia aspiration **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Angina pectoris **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Atrial tachycardia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Congestive cardiomyopathy **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Left ventricular dysfunction **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Mitral valve incompetence **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Ileus paralytic **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Subileus **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Device dislocation **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Device occlusion **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Impaired healing **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Multi-organ failure **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Cholangitis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Hepatitis toxic **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Supraventricular tachycardia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Gastrointestinal disorder **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Patient-device incompatibility **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Osteolysis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Ischaemic cardiomyopathy **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Ruptured cerebral aneurysm **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Large intestine anastomosis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Surgical and medical procedures **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 238 **Group ID:** EG001 **Num At Risk:** 245 **Term:** Embolism arterial **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Term:** Infarction **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 238 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 245 **Time Frame:** Baseline up to approximately 4 years. ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 247 **Group ID:** BG001 **Value:** 247 **Group ID:** BG002 **Value:** 494 **Units:** Participants ### Group **ID:** BG000 **Title:** CT Arm **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. ### Group **ID:** BG001 **Title:** CT+BV Arm **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 10.83 **Value:** 54.7 #### Measurement **Group ID:** BG001 **Spread:** 11.17 **Value:** 55.8 #### Measurement **Group ID:** BG002 **Spread:** 11.01 **Value:** 55.2 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 247 #### Measurement **Group ID:** BG001 **Value:** 247 #### Measurement **Group ID:** BG002 **Value:** 494 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Male **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants **Population Description:** Intent-to-treat (ITT) population: all randomized participants. ## Results Section - More Information Module ### Certain Agreement **Other Details:** The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Email:** [email protected] **Organization:** Hoffman-LaRoche **Phone:** 800-821-8590 **Title:** Medical Communications ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 #### Analysis **CI Lower Limit:** 0.65 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.97 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** The 95% confidence interval (CI) was estimated using Cox proportional hazards methodology. The stratification factors used in the analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and lactate dehydrogenase (LDH) level. **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0204 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.79 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.67 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.97 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** Unstratified analysis. **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0245 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.81 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False ### Outcome Measure 3 #### Analysis **CI Lower Limit:** 0.40 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.88 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: HR-neg **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0088 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.59 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.67 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.05 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: HR-pos/HER-neg **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.1196 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.84 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.43 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.90 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: PFS \<6 months **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0110 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.62 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.65 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.03 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: PFS ≥6 months **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0816 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.82 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.31 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.98 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: taxane chemo **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0395 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.55 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.68 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.06 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: non-taxane chemo **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.1385 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.84 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.22 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.75 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: vinorelbine chemo **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0029 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.41 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.62 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.96 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: LDH ≤ 1.5 ULN **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0171 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.77 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.46 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.16 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: LDH \> 1.5 ULN **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.1797 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.73 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.62 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.97 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: \< 65 years of age **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0229 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.77 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.51 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.16 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: ≥ 65 years of age **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.2139 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.77 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.59 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.89 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: \< 70 years of age **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0021 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.73 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.64 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 2.39 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: ≥ 70 years of age **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.5216 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 1.24 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.58 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.94 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: \< 3 metastatic organ sites **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0148 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.74 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.61 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.17 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: ≥ 3 metastatic organ sites **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.3102 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.84 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.64 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.04 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: B-free ≤ 6 weeks **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0967 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.82 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.51 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.00 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: B-free \> 6 weeks **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0489 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.72 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.41 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.92 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: D-free ≤ 24 months **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0176 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.62 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.66 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.11 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: D-free \> 24 months **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.2318 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.85 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.26 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.03 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: D-free ≤ 12 months **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0568 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.52 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.66 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.05 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Subgroup analysis: D-free \> 12 months **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.1143 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.83 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False ### Outcome Measure 4 #### Analysis **CI Lower Limit:** -4.2 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 12.4 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** The 95% CI was estimated using Hauck-Anderson methodology. **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.3457 **P-Value Comment:** **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** 4.1 **Statistical Comment:** **Statistical Method:** Chi-squared **Tested Non-Inferiority:** False ### Outcome Measure 5 ### Outcome Measure 6 #### Analysis **CI Lower Limit:** 0.51 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.99 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level. **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.9825 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 1.01 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.73 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 2.34 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** Unstratified analysis. **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.3601 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 1.31 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False ### Outcome Measure 7 ### Outcome Measure 8 ### Outcome Measure 9 #### Analysis **CI Lower Limit:** 0.59 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.06 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level. **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.1080 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.79 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.59 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.02 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** Unstratified analysis. **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0625 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.78 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False ### Outcome Measure 10 ### Outcome Measure 11 #### Analysis **CI Lower Limit:** 0.68 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.05 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level. **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.1349 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.85 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.68 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.03 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** Unstratified analysis. **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0863 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.84 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False ### Outcome Measure 12 ### Outcome Measure 13 #### Analysis **CI Lower Limit:** 0.65 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.02 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level. **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0744 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.81 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.66 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.00 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** Unstratified analysis. **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0503 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.81 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False ### Outcome Measure 14 ### Outcome Measure 15 ### Outcome Measure 16 #### Analysis **CI Lower Limit:** 0.76 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.21 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level. **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.7253 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.96 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** 0.75 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.16 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** Unstratified analysis. **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.5332 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.93 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** False ### Outcome Measure 17 ### Outcome Measure 18 ### Outcome Measure 19 ### Outcome Measure 20 ### Outcome Measure 21 ### Outcome Measure 22 ### Outcome Measure 23 ### Outcome Measure 24 ### Outcome Measure 25 ### Outcome Measure 26 ### Outcome Measure 27 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 88.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 93.9 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.9 - **Spread:** - **Upper Limit:** 5.3 - **Value:** 4.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 5.5 - **Spread:** - **Upper Limit:** 7.6 - **Value:** 6.3 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.0 - **Spread:** - **Upper Limit:** 3.9 - **Value:** 2.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 3.4 - **Spread:** - **Upper Limit:** 6.1 - **Value:** 4.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 4.2 - **Spread:** - **Upper Limit:** 6.2 - **Value:** 4.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 6.0 - **Spread:** - **Upper Limit:** 7.8 - **Value:** 6.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.3 - **Spread:** - **Upper Limit:** 4.3 - **Value:** 3.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 4.1 - **Spread:** - **Upper Limit:** 6.9 - **Value:** 5.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.9 - **Spread:** - **Upper Limit:** 6.1 - **Value:** 4.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 5.8 - **Spread:** - **Upper Limit:** 7.6 - **Value:** 6.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.7 - **Spread:** - **Upper Limit:** 5.3 - **Value:** 3.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 4.9 - **Spread:** - **Upper Limit:** 9.8 - **Value:** 6.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.9 - **Spread:** - **Upper Limit:** 5.8 - **Value:** 4.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 4.9 - **Spread:** - **Upper Limit:** 6.8 - **Value:** 6.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.8 - **Spread:** - **Upper Limit:** 4.3 - **Value:** 2.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 4.2 - **Spread:** - **Upper Limit:** 11.1 - **Value:** 6.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.9 - **Spread:** - **Upper Limit:** 6.0 - **Value:** 4.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 5.5 - **Spread:** - **Upper Limit:** 7.6 - **Value:** 6.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.7 - **Spread:** - **Upper Limit:** 3.9 - **Value:** 2.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.5 - **Spread:** - **Upper Limit:** 7.3 - **Value:** 5.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.9 - **Spread:** - **Upper Limit:** 4.7 - **Value:** 4.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 4.7 - **Spread:** - **Upper Limit:** 6.9 - **Value:** 6.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.2 - **Spread:** - **Upper Limit:** 7.8 - **Value:** 4.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 5.5 - **Spread:** - **Upper Limit:** 8.0 - **Value:** 6.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.7 - **Spread:** - **Upper Limit:** 4.6 - **Value:** 4.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 5.3 - **Spread:** - **Upper Limit:** 7.3 - **Value:** 6.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.2 - **Spread:** - **Upper Limit:** 11.9 - **Value:** 7.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 4.1 - **Spread:** - **Upper Limit:** 11.2 - **Value:** 6.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.9 - **Spread:** - **Upper Limit:** 6.1 - **Value:** 4.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 6.0 - **Spread:** - **Upper Limit:** 8.2 - **Value:** 6.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.1 - **Spread:** - **Upper Limit:** 4.9 - **Value:** 4.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 4.1 - **Spread:** - **Upper Limit:** 6.2 - **Value:** 4.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.6 - **Spread:** - **Upper Limit:** 4.6 - **Value:** 4.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 4.4 - **Spread:** - **Upper Limit:** 6.6 - **Value:** 5.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.3 - **Spread:** - **Upper Limit:** 6.3 - **Value:** 4.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 6.0 - **Spread:** - **Upper Limit:** 9.5 - **Value:** 7.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.0 - **Spread:** - **Upper Limit:** 3.9 - **Value:** 2.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 4.2 - **Spread:** - **Upper Limit:** 6.3 - **Value:** 5.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 4.0 - **Spread:** - **Upper Limit:** 6.1 - **Value:** 4.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 5.5 - **Spread:** - **Upper Limit:** 8.1 - **Value:** 6.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.3 - **Spread:** - **Upper Limit:** 5.8 - **Value:** 2.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 3.9 - **Spread:** - **Upper Limit:** 9.7 - **Value:** 5.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.9 - **Spread:** - **Upper Limit:** 5.7 - **Value:** 4.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 5.3 - **Spread:** - **Upper Limit:** 7.6 - **Value:** 6.3 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 11.7 - **Spread:** - **Upper Limit:** 22.9 - **Value:** 16.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 15.2 - **Spread:** - **Upper Limit:** 27.5 - **Value:** 20.9 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.1 - **Spread:** - **Upper Limit:** 3.9 - **Value:** 1.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.0 - **Spread:** - **Upper Limit:** 3.0 - **Value:** 0.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 10.8 - **Spread:** - **Upper Limit:** 21.7 - **Value:** 15.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 14.7 - **Spread:** - **Upper Limit:** 26.9 - **Value:** 20.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 26.8 - **Spread:** - **Upper Limit:** 40.8 - **Value:** 33.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 41.4 - **Spread:** - **Upper Limit:** 56.4 - **Value:** 48.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 33.9 - **Spread:** - **Upper Limit:** 48.5 - **Value:** 41.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 18.1 - **Spread:** - **Upper Limit:** 31.1 - **Value:** 24.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 5.0 - **Spread:** - **Upper Limit:** 13.7 - **Value:** 8.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 3.1 - **Spread:** - **Upper Limit:** 10.6 - **Value:** 6.0 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 4.4 - **Spread:** - **Upper Limit:** 16.7 - **Value:** 10.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 6.1 - **Spread:** - **Upper Limit:** 10.3 - **Value:** 8.3 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 78.6 - **Spread:** - **Upper Limit:** 99.5 - **Value:** 96.7 - **Comment:** 95% CI data was not applicable (NA) because all participants were estimated to be alive and free of disease progression at this time point. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 100.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 48.9 - **Spread:** - **Upper Limit:** 82.5 - **Value:** 69.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 55.3 - **Spread:** - **Upper Limit:** 84.4 - **Value:** 72.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 40.4 - **Spread:** - **Upper Limit:** 76.3 - **Value:** 60.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 24.6 - **Spread:** - **Upper Limit:** 56.3 - **Value:** 40.8 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 94.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 96.1 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.2 - **Spread:** - **Upper Limit:** 3.9 - **Value:** 2.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.4 - **Spread:** - **Upper Limit:** 5.1 - **Value:** 3.8 **Title:** #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 71.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 83.4 **Title:** #### Outcome Measure 11 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 9.2 - **Spread:** - **Upper Limit:** 12.5 - **Value:** 10.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 10.7 - **Spread:** - **Upper Limit:** 14.5 - **Value:** 12.8 **Title:** #### Outcome Measure 12 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 67.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 75.3 **Title:** #### Outcome Measure 13 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 9.4 - **Spread:** - **Upper Limit:** 12.7 - **Value:** 11.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 12.0 - **Spread:** - **Upper Limit:** 15.5 - **Value:** 13.3 **Title:** #### Outcome Measure 14 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 34.3 - **Spread:** - **Upper Limit:** 47.0 - **Value:** 40.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 47.7 - **Spread:** - **Upper Limit:** 60.3 - **Value:** 54.2 **Title:** #### Outcome Measure 15 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 63.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 66.0 **Title:** #### Outcome Measure 16 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 15.4 - **Spread:** - **Upper Limit:** 21.2 - **Value:** 18.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 17.6 - **Spread:** - **Upper Limit:** 21.0 - **Value:** 19.7 **Title:** #### Outcome Measure 17 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 79.9 - **Spread:** - **Upper Limit:** 89.2 - **Value:** 85.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 85.9 - **Spread:** - **Upper Limit:** 93.5 - **Value:** 90.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 62.0 - **Spread:** - **Upper Limit:** 74.3 - **Value:** 68.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 66.2 - **Spread:** - **Upper Limit:** 77.7 - **Value:** 72.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 46.0 - **Spread:** - **Upper Limit:** 59.3 - **Value:** 52.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 48.2 - **Spread:** - **Upper Limit:** 61.0 - **Value:** 54.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 31.8 - **Spread:** - **Upper Limit:** 44.9 - **Value:** 38.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 31.3 - **Spread:** - **Upper Limit:** 43.9 - **Value:** 37.6 **Title:** #### Outcome Measure 18 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 60.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 64.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 36.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 34.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 82.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 85.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 12.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 11.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 53.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 46.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 40.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 48.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 24.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 27.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 68.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 66.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 33.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 34.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 56.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 58.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 61.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 51.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 34.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 43.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 82.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 75.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 13.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 17.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 53.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 40.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 40.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 51.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 29.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 23.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 61.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 68.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 6.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 49.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 46.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 40.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 48.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 6.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 66.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 49.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 29.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 47.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 81.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 78.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 14.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 17.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 50.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 36.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 42.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 56.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 34.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 19.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 59.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 76.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 51.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 49.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 44.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 43.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 59.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 47.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 34.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 48.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 76.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 75.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 15.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 18.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 6.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 39.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 30.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 50.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 59.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 6.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 10.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 19.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 18.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 67.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 69.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 8.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 11.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 36.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 26.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 50.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 61.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 11.8 **Title:** #### Outcome Measure 19 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.6489 - **Spread:** - **Upper Limit:** 0.7122 - **Value:** 0.6806 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.6389 - **Spread:** - **Upper Limit:** 0.7061 - **Value:** 0.6725 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.6470 - **Spread:** - **Upper Limit:** 0.7437 - **Value:** 0.6953 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.6057 - **Spread:** - **Upper Limit:** 0.6973 - **Value:** 0.6515 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.7114 - **Spread:** - **Upper Limit:** 0.7879 - **Value:** 0.7496 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.6058 - **Spread:** - **Upper Limit:** 0.7010 - **Value:** 0.6534 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.5642 - **Spread:** - **Upper Limit:** 0.6938 - **Value:** 0.6290 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.4736 - **Spread:** - **Upper Limit:** 0.6370 - **Value:** 0.5553 **Title:** #### Outcome Measure 20 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0.0482 - **Spread:** - **Upper Limit:** 0.0276 - **Value:** -0.0103 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.0868 - **Spread:** - **Upper Limit:** 0.0127 - **Value:** -0.0370 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0.0025 - **Spread:** - **Upper Limit:** 0.0800 - **Value:** 0.0387 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.1038 - **Spread:** - **Upper Limit:** 0.0021 - **Value:** -0.0508 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0.1398 - **Spread:** - **Upper Limit:** -0.0371 - **Value:** -0.0884 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.1649 - **Spread:** - **Upper Limit:** -0.0107 - **Value:** -0.0878 **Title:** #### Outcome Measure 21 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 64.1 - **Spread:** - **Upper Limit:** 69.0 - **Value:** 66.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 60.8 - **Spread:** - **Upper Limit:** 65.9 - **Value:** 63.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 66.4 - **Spread:** - **Upper Limit:** 72.1 - **Value:** 69.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 63.7 - **Spread:** - **Upper Limit:** 69.2 - **Value:** 66.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 63.3 - **Spread:** - **Upper Limit:** 71.3 - **Value:** 67.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 63.2 - **Spread:** - **Upper Limit:** 69.5 - **Value:** 66.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 59.5 - **Spread:** - **Upper Limit:** 68.0 - **Value:** 63.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 57.0 - **Spread:** - **Upper Limit:** 66.5 - **Value:** 61.7 **Title:** #### Outcome Measure 22 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -4.8 - **Spread:** - **Upper Limit:** 0.9 - **Value:** -2.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.4 - **Spread:** - **Upper Limit:** 5.3 - **Value:** 2.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -4.7 - **Spread:** - **Upper Limit:** 4.3 - **Value:** -0.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.6 - **Spread:** - **Upper Limit:** 5.5 - **Value:** 2.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -9.1 - **Spread:** - **Upper Limit:** -1.0 - **Value:** -5.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -5.5 - **Spread:** - **Upper Limit:** 3.0 - **Value:** -1.3 **Title:** #### Outcome Measure 23 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 19.900 - **Spread:** - **Upper Limit:** 21.342 - **Value:** 20.621 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 19.500 - **Spread:** - **Upper Limit:** 21.006 - **Value:** 20.253 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 20.028 - **Spread:** - **Upper Limit:** 21.416 - **Value:** 20.722 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 19.923 - **Spread:** - **Upper Limit:** 21.425 - **Value:** 20.674 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 14.176 - **Spread:** - **Upper Limit:** 15.519 - **Value:** 14.847 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 14.419 - **Spread:** - **Upper Limit:** 15.704 - **Value:** 15.062 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 15.289 - **Spread:** - **Upper Limit:** 16.894 - **Value:** 16.091 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 14.951 - **Spread:** - **Upper Limit:** 16.502 - **Value:** 15.726 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 24.103 - **Spread:** - **Upper Limit:** 25.869 - **Value:** 24.986 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 23.578 - **Spread:** - **Upper Limit:** 25.198 - **Value:** 24.388 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 59.658 - **Spread:** - **Upper Limit:** 63.696 - **Value:** 61.677 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 58.365 - **Spread:** - **Upper Limit:** 62.189 - **Value:** 60.277 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 69.919 - **Spread:** - **Upper Limit:** 74.419 - **Value:** 72.169 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 69.786 - **Spread:** - **Upper Limit:** 73.942 - **Value:** 71.864 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 94.063 - **Spread:** - **Upper Limit:** 99.753 - **Value:** 96.908 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 93.485 - **Spread:** - **Upper Limit:** 98.746 - **Value:** 96.115 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 19.413 - **Spread:** - **Upper Limit:** 21.413 - **Value:** 20.413 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 18.158 - **Spread:** - **Upper Limit:** 20.153 - **Value:** 19.156 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 19.888 - **Spread:** - **Upper Limit:** 21.779 - **Value:** 20.833 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 20.245 - **Spread:** - **Upper Limit:** 21.987 - **Value:** 21.116 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 15.070 - **Spread:** - **Upper Limit:** 16.815 - **Value:** 15.943 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 15.900 - **Spread:** - **Upper Limit:** 17.441 - **Value:** 16.671 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 15.609 - **Spread:** - **Upper Limit:** 17.715 - **Value:** 16.662 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 15.180 - **Spread:** - **Upper Limit:** 17.158 - **Value:** 16.169 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 25.188 - **Spread:** - **Upper Limit:** 27.364 - **Value:** 26.276 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 24.928 - **Spread:** - **Upper Limit:** 26.839 - **Value:** 25.884 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 60.975 - **Spread:** - **Upper Limit:** 66.118 - **Value:** 63.547 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 58.811 - **Spread:** - **Upper Limit:** 63.747 - **Value:** 61.279 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 71.212 - **Spread:** - **Upper Limit:** 77.299 - **Value:** 74.255 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 70.603 - **Spread:** - **Upper Limit:** 76.184 - **Value:** 73.393 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 96.582 - **Spread:** - **Upper Limit:** 104.169 - **Value:** 100.375 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 95.667 - **Spread:** - **Upper Limit:** 102.760 - **Value:** 99.213 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 20.721 - **Spread:** - **Upper Limit:** 22.744 - **Value:** 21.733 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 18.571 - **Spread:** - **Upper Limit:** 20.688 - **Value:** 19.629 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 19.855 - **Spread:** - **Upper Limit:** 22.006 - **Value:** 20.930 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 19.829 - **Spread:** - **Upper Limit:** 21.857 - **Value:** 20.843 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 16.260 - **Spread:** - **Upper Limit:** 18.400 - **Value:** 17.330 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 15.961 - **Spread:** - **Upper Limit:** 17.650 - **Value:** 16.806 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 15.818 - **Spread:** - **Upper Limit:** 18.291 - **Value:** 17.055 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 14.787 - **Spread:** - **Upper Limit:** 17.053 - **Value:** 15.920 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 25.493 - **Spread:** - **Upper Limit:** 28.354 - **Value:** 26.923 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 24.630 - **Spread:** - **Upper Limit:** 26.880 - **Value:** 25.755 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 62.539 - **Spread:** - **Upper Limit:** 68.717 - **Value:** 65.628 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 58.309 - **Spread:** - **Upper Limit:** 63.905 - **Value:** 61.107 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 73.269 - **Spread:** - **Upper Limit:** 80.318 - **Value:** 76.794 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 70.116 - **Spread:** - **Upper Limit:** 76.421 - **Value:** 73.269 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 98.819 - **Spread:** - **Upper Limit:** 108.187 - **Value:** 103.503 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 94.865 - **Spread:** - **Upper Limit:** 102.948 - **Value:** 98.906 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 20.599 - **Spread:** - **Upper Limit:** 23.282 - **Value:** 21.940 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 17.515 - **Spread:** - **Upper Limit:** 20.416 - **Value:** 18.965 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 19.468 - **Spread:** - **Upper Limit:** 22.211 - **Value:** 20.840 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 20.192 - **Spread:** - **Upper Limit:** 22.606 - **Value:** 21.399 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 15.719 - **Spread:** - **Upper Limit:** 18.477 - **Value:** 17.098 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 15.411 - **Spread:** - **Upper Limit:** 17.436 - **Value:** 16.438 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 16.754 - **Spread:** - **Upper Limit:** 19.734 - **Value:** 18.244 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 14.861 - **Spread:** - **Upper Limit:** 17.241 - **Value:** 16.051 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 24.146 - **Spread:** - **Upper Limit:** 27.988 - **Value:** 26.067 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 23.231 - **Spread:** - **Upper Limit:** 26.033 - **Value:** 24.632 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 61.991 - **Spread:** - **Upper Limit:** 69.653 - **Value:** 65.882 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 56.548 - **Spread:** - **Upper Limit:** 63.480 - **Value:** 60.014 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 74.166 - **Spread:** - **Upper Limit:** 82.443 - **Value:** 78.305 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 69.365 - **Spread:** - **Upper Limit:** 76.801 - **Value:** 73.083 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 98.433 - **Spread:** - **Upper Limit:** 109.588 - **Value:** 104.011 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 92.995 - **Spread:** - **Upper Limit:** 102.595 - **Value:** 97.795 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 21.427 - **Spread:** - **Upper Limit:** 24.471 - **Value:** 22.949 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 18.121 - **Spread:** - **Upper Limit:** 21.250 - **Value:** 19.686 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 20.433 - **Spread:** - **Upper Limit:** 23.847 - **Value:** 22.140 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 19.645 - **Spread:** - **Upper Limit:** 22.798 - **Value:** 21.222 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 16.690 - **Spread:** - **Upper Limit:** 20.079 - **Value:** 18.385 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 15.481 - **Spread:** - **Upper Limit:** 18.028 - **Value:** 16.755 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 17.875 - **Spread:** - **Upper Limit:** 21.356 - **Value:** 19.615 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 15.585 - **Spread:** - **Upper Limit:** 18.805 - **Value:** 17.195 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 27.722 - **Spread:** - **Upper Limit:** 31.415 - **Value:** 29.568 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 24.457 - **Spread:** - **Upper Limit:** 27.869 - **Value:** 26.163 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 68.549 - **Spread:** - **Upper Limit:** 75.716 - **Value:** 72.132 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 59.199 - **Spread:** - **Upper Limit:** 66.836 - **Value:** 63.017 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 78.178 - **Spread:** - **Upper Limit:** 87.995 - **Value:** 83.087 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 70.566 - **Spread:** - **Upper Limit:** 79.191 - **Value:** 74.879 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 107.315 - **Spread:** - **Upper Limit:** 118.494 - **Value:** 112.904 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 95.302 - **Spread:** - **Upper Limit:** 106.506 - **Value:** 100.904 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 20.583 - **Spread:** - **Upper Limit:** 23.847 - **Value:** 22.215 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 18.820 - **Spread:** - **Upper Limit:** 22.440 - **Value:** 20.630 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 17.955 - **Spread:** - **Upper Limit:** 21.361 - **Value:** 19.658 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 19.146 - **Spread:** - **Upper Limit:** 22.685 - **Value:** 20.915 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 15.708 - **Spread:** - **Upper Limit:** 19.412 - **Value:** 17.560 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 13.875 - **Spread:** - **Upper Limit:** 18.259 - **Value:** 16.067 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 16.120 - **Spread:** - **Upper Limit:** 20.780 - **Value:** 18.450 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 13.901 - **Spread:** - **Upper Limit:** 19.136 - **Value:** 16.519 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 27.156 - **Spread:** - **Upper Limit:** 31.616 - **Value:** 29.386 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 21.013 - **Spread:** - **Upper Limit:** 26.625 - **Value:** 23.819 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 63.981 - **Spread:** - **Upper Limit:** 73.518 - **Value:** 68.750 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 55.065 - **Spread:** - **Upper Limit:** 66.870 - **Value:** 60.967 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 71.480 - **Spread:** - **Upper Limit:** 82.430 - **Value:** 76.955 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 68.901 - **Spread:** - **Upper Limit:** 81.568 - **Value:** 75.235 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 98.512 - **Spread:** - **Upper Limit:** 112.568 - **Value:** 105.540 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 90.613 - **Spread:** - **Upper Limit:** 107.531 - **Value:** 99.072 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 21.283 - **Spread:** - **Upper Limit:** 25.333 - **Value:** 23.308 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 18.124 - **Spread:** - **Upper Limit:** 21.943 - **Value:** 20.033 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 18.953 - **Spread:** - **Upper Limit:** 22.527 - **Value:** 20.740 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 18.310 - **Spread:** - **Upper Limit:** 22.590 - **Value:** 20.450 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 17.522 - **Spread:** - **Upper Limit:** 21.093 - **Value:** 19.308 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 15.494 - **Spread:** - **Upper Limit:** 19.045 - **Value:** 17.270 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 16.586 - **Spread:** - **Upper Limit:** 20.491 - **Value:** 18.538 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 13.949 - **Spread:** - **Upper Limit:** 18.587 - **Value:** 16.268 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 26.879 - **Spread:** - **Upper Limit:** 30.945 - **Value:** 28.912 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 22.842 - **Spread:** - **Upper Limit:** 29.632 - **Value:** 26.237 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 66.403 - **Spread:** - **Upper Limit:** 75.114 - **Value:** 70.758 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 55.941 - **Spread:** - **Upper Limit:** 69.418 - **Value:** 62.679 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 76.424 - **Spread:** - **Upper Limit:** 87.363 - **Value:** 81.894 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 67.865 - **Spread:** - **Upper Limit:** 80.458 - **Value:** 74.162 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 104.704 - **Spread:** - **Upper Limit:** 116.908 - **Value:** 110.806 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 91.294 - **Spread:** - **Upper Limit:** 109.503 - **Value:** 100.399 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 18.958 - **Spread:** - **Upper Limit:** 24.626 - **Value:** 21.792 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 17.412 - **Spread:** - **Upper Limit:** 23.184 - **Value:** 20.298 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 15.598 - **Spread:** - **Upper Limit:** 23.569 - **Value:** 19.583 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 17.629 - **Spread:** - **Upper Limit:** 24.004 - **Value:** 20.817 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 13.389 - **Spread:** - **Upper Limit:** 20.897 - **Value:** 17.143 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 12.606 - **Spread:** - **Upper Limit:** 18.823 - **Value:** 15.714 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 13.876 - **Spread:** - **Upper Limit:** 20.410 - **Value:** 17.143 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 12.633 - **Spread:** - **Upper Limit:** 20.319 - **Value:** 16.476 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 23.931 - **Spread:** - **Upper Limit:** 32.548 - **Value:** 28.240 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 21.407 - **Spread:** - **Upper Limit:** 29.512 - **Value:** 25.459 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 55.888 - **Spread:** - **Upper Limit:** 76.469 - **Value:** 66.179 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 53.524 - **Spread:** - **Upper Limit:** 70.942 - **Value:** 62.233 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 58.381 - **Spread:** - **Upper Limit:** 88.952 - **Value:** 73.667 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 62.863 - **Spread:** - **Upper Limit:** 83.746 - **Value:** 73.305 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 81.841 - **Spread:** - **Upper Limit:** 120.242 - **Value:** 101.042 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 85.368 - **Spread:** - **Upper Limit:** 112.160 - **Value:** 98.764 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 17.376 - **Spread:** - **Upper Limit:** 26.338 - **Value:** 21.857 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 19.569 - **Spread:** - **Upper Limit:** 24.209 - **Value:** 21.889 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 16.352 - **Spread:** - **Upper Limit:** 21.600 - **Value:** 18.976 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 19.417 - **Spread:** - **Upper Limit:** 25.953 - **Value:** 22.685 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 13.758 - **Spread:** - **Upper Limit:** 22.527 - **Value:** 18.143 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 14.274 - **Spread:** - **Upper Limit:** 21.503 - **Value:** 17.889 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 14.658 - **Spread:** - **Upper Limit:** 22.199 - **Value:** 18.429 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 12.890 - **Spread:** - **Upper Limit:** 19.184 - **Value:** 16.037 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 22.941 - **Spread:** - **Upper Limit:** 31.988 - **Value:** 27.464 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 22.584 - **Spread:** - **Upper Limit:** 31.194 - **Value:** 26.889 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 56.306 - **Spread:** - **Upper Limit:** 79.194 - **Value:** 67.750 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 56.516 - **Spread:** - **Upper Limit:** 73.114 - **Value:** 64.815 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 63.847 - **Spread:** - **Upper Limit:** 90.963 - **Value:** 77.405 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 68.852 - **Spread:** - **Upper Limit:** 88.148 - **Value:** 78.500 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 87.586 - **Spread:** - **Upper Limit:** 122.152 - **Value:** 104.869 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 92.415 - **Spread:** - **Upper Limit:** 118.363 - **Value:** 105.389 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 18.906 - **Spread:** - **Upper Limit:** 27.260 - **Value:** 23.083 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 16.407 - **Spread:** - **Upper Limit:** 25.593 - **Value:** 21.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 16.238 - **Spread:** - **Upper Limit:** 23.095 - **Value:** 19.667 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 14.019 - **Spread:** - **Upper Limit:** 26.067 - **Value:** 20.043 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 13.476 - **Spread:** - **Upper Limit:** 21.524 - **Value:** 17.500 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 14.130 - **Spread:** - **Upper Limit:** 22.098 - **Value:** 18.114 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 14.316 - **Spread:** - **Upper Limit:** 20.351 - **Value:** 17.333 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 11.339 - **Spread:** - **Upper Limit:** 21.518 - **Value:** 16.429 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 24.421 - **Spread:** - **Upper Limit:** 32.774 - **Value:** 28.597 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 20.250 - **Spread:** - **Upper Limit:** 30.417 - **Value:** 25.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 59.566 - **Spread:** - **Upper Limit:** 78.462 - **Value:** 69.014 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 47.031 - **Spread:** - **Upper Limit:** 74.635 - **Value:** 60.833 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 62.045 - **Spread:** - **Upper Limit:** 90.889 - **Value:** 76.467 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 57.141 - **Spread:** - **Upper Limit:** 94.030 - **Value:** 75.586 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 88.146 - **Spread:** - **Upper Limit:** 124.087 - **Value:** 106.117 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 73.196 - **Spread:** - **Upper Limit:** 121.226 - **Value:** 97.211 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -32.634 - **Spread:** - **Upper Limit:** 71.134 - **Value:** 19.250 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.487 - **Spread:** - **Upper Limit:** 33.513 - **Value:** 18.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 7.257 - **Spread:** - **Upper Limit:** 29.493 - **Value:** 18.375 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 3.434 - **Spread:** - **Upper Limit:** 36.455 - **Value:** 19.944 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -49.531 - **Spread:** - **Upper Limit:** 77.531 - **Value:** 14.000 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -3.285 - **Spread:** - **Upper Limit:** 34.752 - **Value:** 15.733 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -35.825 - **Spread:** - **Upper Limit:** 65.825 - **Value:** 15.000 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.348 - **Spread:** - **Upper Limit:** 26.015 - **Value:** 12.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.490 - **Spread:** - **Upper Limit:** 42.844 - **Value:** 21.667 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 14.172 - **Spread:** - **Upper Limit:** 35.828 - **Value:** 25.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -67.969 - **Spread:** - **Upper Limit:** 179.802 - **Value:** 55.917 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 20.085 - **Spread:** - **Upper Limit:** 90.581 - **Value:** 55.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -110.732 - **Spread:** - **Upper Limit:** 243.982 - **Value:** 66.625 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.191 - **Spread:** - **Upper Limit:** 129.831 - **Value:** 66.011 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -110.243 - **Spread:** - **Upper Limit:** 286.826 - **Value:** 88.292 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 20.313 - **Spread:** - **Upper Limit:** 161.709 - **Value:** 91.011 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** Standard deviation (SD) not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 22.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 23.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 20.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 21.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 35.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 78.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 86.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 121.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 26.000 - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 22.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -3.782 - **Spread:** - **Upper Limit:** 52.549 - **Value:** 24.383 - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 21.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 9.294 - **Spread:** - **Upper Limit:** 34.706 - **Value:** 22.000 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -7.412 - **Spread:** - **Upper Limit:** 43.412 - **Value:** 18.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 7.318 - **Spread:** - **Upper Limit:** 34.848 - **Value:** 21.083 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -46.678 - **Spread:** - **Upper Limit:** 67.678 - **Value:** 10.500 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -2.788 - **Spread:** - **Upper Limit:** 63.566 - **Value:** 30.389 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -7.266 - **Spread:** - **Upper Limit:** 56.266 - **Value:** 24.500 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 58.060 - **Spread:** - **Upper Limit:** 96.884 - **Value:** 77.472 - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 59.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 38.830 - **Spread:** - **Upper Limit:** 148.103 - **Value:** 93.467 - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 74.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 102.396 - **Spread:** - **Upper Limit:** 145.315 - **Value:** 123.856 - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 96.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 27.000 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 17.539 - **Spread:** - **Upper Limit:** 25.128 - **Value:** 21.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 26.600 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 14.147 - **Spread:** - **Upper Limit:** 26.853 - **Value:** 20.5000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 22.000 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 6.616 - **Spread:** - **Upper Limit:** 29.384 - **Value:** 18.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 22.000 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.908 - **Spread:** - **Upper Limit:** 23.908 - **Value:** 11.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 27.143 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 19.395 - **Spread:** - **Upper Limit:** 36.605 - **Value:** 28.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 76.143 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 45.778 - **Spread:** - **Upper Limit:** 74.889 - **Value:** 60.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 97.600 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -50.209 - **Spread:** - **Upper Limit:** 191.209 - **Value:** 70.500 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 124.743 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -20.209 - **Spread:** - **Upper Limit:** 221.209 - **Value:** 100.500 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 14.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 15.400 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 15.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 11.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 20.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 45.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 55.400 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 75.400 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 17.873 - **Spread:** - **Upper Limit:** 20.299 - **Value:** 19.086 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 15.977 - **Spread:** - **Upper Limit:** 18.846 - **Value:** 17.412 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 19.456 - **Spread:** - **Upper Limit:** 21.790 - **Value:** 20.623 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 20.335 - **Spread:** - **Upper Limit:** 22.639 - **Value:** 21.487 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 14.102 - **Spread:** - **Upper Limit:** 16.121 - **Value:** 15.111 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 12.872 - **Spread:** - **Upper Limit:** 15.478 - **Value:** 14.175 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 14.122 - **Spread:** - **Upper Limit:** 16.772 - **Value:** 15.447 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 13.877 - **Spread:** - **Upper Limit:** 16.593 - **Value:** 15.235 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 23.602 - **Spread:** - **Upper Limit:** 26.354 - **Value:** 24.978 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 22.989 - **Spread:** - **Upper Limit:** 25.901 - **Value:** 24.445 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 56.033 - **Spread:** - **Upper Limit:** 62.428 - **Value:** 59.230 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 53.234 - **Spread:** - **Upper Limit:** 60.770 - **Value:** 57.002 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 66.264 - **Spread:** - **Upper Limit:** 73.393 - **Value:** 69.829 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 64.384 - **Spread:** - **Upper Limit:** 72.586 - **Value:** 68.485 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 90.240 - **Spread:** - **Upper Limit:** 99.619 - **Value:** 94.930 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 87.645 - **Spread:** - **Upper Limit:** 98.320 - **Value:** 92.983 **Title:** #### Outcome Measure 24 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -2.219 - **Spread:** - **Upper Limit:** -0.344 - **Value:** -1.281 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -2.239 - **Spread:** - **Upper Limit:** -0.338 - **Value:** -1.289 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0.283 - **Spread:** - **Upper Limit:** 0.994 - **Value:** 0.356 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.226 - **Spread:** - **Upper Limit:** 1.640 - **Value:** 0.707 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0.274 - **Spread:** - **Upper Limit:** 1.089 - **Value:** 0.408 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.314 - **Spread:** - **Upper Limit:** 1.734 - **Value:** 1.024 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.043 - **Spread:** - **Upper Limit:** 0.591 - **Value:** -0.226 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.027 - **Spread:** - **Upper Limit:** 0.548 - **Value:** -0.240 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0.659 - **Spread:** - **Upper Limit:** 1.116 - **Value:** 0.228 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.121 - **Spread:** - **Upper Limit:** 1.780 - **Value:** 0.950 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -3.295 - **Spread:** - **Upper Limit:** 0.573 - **Value:** -1.361 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -2.407 - **Spread:** - **Upper Limit:** 1.693 - **Value:** -0.357 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -2.920 - **Spread:** - **Upper Limit:** 1.399 - **Value:** -0.760 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.945 - **Spread:** - **Upper Limit:** 2.684 - **Value:** 0.369 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -3.332 - **Spread:** - **Upper Limit:** 1.876 - **Value:** -0.728 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.544 - **Spread:** - **Upper Limit:** 4.229 - **Value:** 1.342 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0,733 - **Spread:** - **Upper Limit:** 1.322 - **Value:** 0.294 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -2.871 - **Spread:** - **Upper Limit:** -0.775 - **Value:** -1.823 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.411 - **Spread:** - **Upper Limit:** 0.525 - **Value:** -0.443 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.678 - **Spread:** - **Upper Limit:** 1.397 - **Value:** 0.359 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.415 - **Spread:** - **Upper Limit:** 1.979 - **Value:** 1.197 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.186 - **Spread:** - **Upper Limit:** 1.657 - **Value:** 0.921 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.666 - **Spread:** - **Upper Limit:** 0.570 - **Value:** -0.548 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.422 - **Spread:** - **Upper Limit:** 0.389 - **Value:** -0.517 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0.658 - **Spread:** - **Upper Limit:** 1.815 - **Value:** 0.578 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.423 - **Spread:** - **Upper Limit:** 1.514 - **Value:** 0.546 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -3.149 - **Spread:** - **Upper Limit:** 2.183 - **Value:** -0.483 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -4.049 - **Spread:** - **Upper Limit:** 0.586 - **Value:** -1.732 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -2.970 - **Spread:** - **Upper Limit:** 2.931 - **Value:** -0.019 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -3.494 - **Spread:** - **Upper Limit:** 1.821 - **Value:** -0.836 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -3.744 - **Spread:** - **Upper Limit:** 3.730 - **Value:** -0.007 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -3.421 - **Spread:** - **Upper Limit:** 3.167 - **Value:** -0.127 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.236 - **Spread:** - **Upper Limit:** 1.598 - **Value:** 0.181 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -3.306 - **Spread:** - **Upper Limit:** -0.685 - **Value:** -1.996 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.490 - **Spread:** - **Upper Limit:** 1.104 - **Value:** -0.193 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.001 - **Spread:** - **Upper Limit:** 2.750 - **Value:** 1.375 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0.101 - **Spread:** - **Upper Limit:** 1.834 - **Value:** 0.867 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.366 - **Spread:** - **Upper Limit:** 2.067 - **Value:** 1.217 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.405 - **Spread:** - **Upper Limit:** 1.643 - **Value:** 0.119 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.053 - **Spread:** - **Upper Limit:** 1.166 - **Value:** 0.056 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.723 - **Spread:** - **Upper Limit:** 1.647 - **Value:** -0.038 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.106 - **Spread:** - **Upper Limit:** 1.262 - **Value:** 0.078 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -3.411 - **Spread:** - **Upper Limit:** 3.853 - **Value:** 0.221 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -4.383 - **Spread:** - **Upper Limit:** 1.238 - **Value:** -1.573 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -3.066 - **Spread:** - **Upper Limit:** 4.595 - **Value:** 0.764 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -2.497 - **Spread:** - **Upper Limit:** 4.131 - **Value:** 0.817 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -4.106 - **Spread:** - **Upper Limit:** 5.693 - **Value:** 0.793 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -2.828 - **Spread:** - **Upper Limit:** 5.142 - **Value:** 1.157 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0.913 - **Spread:** - **Upper Limit:** 2.673 - **Value:** 0.880 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -2.799 - **Spread:** - **Upper Limit:** 0.329 - **Value:** -1.235 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.754 - **Spread:** - **Upper Limit:** 0.979 - **Value:** -0.388 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.209 - **Spread:** - **Upper Limit:** 3.281 - **Value:** 1.036 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0.298 - **Spread:** - **Upper Limit:** 2.426 - **Value:** 1.064 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.204 - **Spread:** - **Upper Limit:** 2.906 - **Value:** 1.555 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0.103 - **Spread:** - **Upper Limit:** 2.863 - **Value:** 1.380 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.201 - **Spread:** - **Upper Limit:** 3.471 - **Value:** 1.635 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.916 - **Spread:** - **Upper Limit:** 3.771 - **Value:** 0.928 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.435 - **Spread:** - **Upper Limit:** 2.990 - **Value:** 1.278 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.390 - **Spread:** - **Upper Limit:** 7.637 - **Value:** 3.123 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -2.522 - **Spread:** - **Upper Limit:** 5.464 - **Value:** 1.471 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.313 - **Spread:** - **Upper Limit:** 6.547 - **Value:** 2.617 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.346 - **Spread:** - **Upper Limit:** 7.740 - **Value:** 3.197 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -2.074 - **Spread:** - **Upper Limit:** 9.132 - **Value:** 3.529 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.579 - **Spread:** - **Upper Limit:** 9.370 - **Value:** 3.896 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -2.051 - **Spread:** - **Upper Limit:** 2.325 - **Value:** 0.137 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -2.930 - **Spread:** - **Upper Limit:** 1.570 - **Value:** -0.680 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -2.436 - **Spread:** - **Upper Limit:** 1.259 - **Value:** -0.589 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.590 - **Spread:** - **Upper Limit:** 3.492 - **Value:** 0.951 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.598 - **Spread:** - **Upper Limit:** 1.998 - **Value:** 0.200 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.658 - **Spread:** - **Upper Limit:** 2.754 - **Value:** 1.048 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0.562 - **Spread:** - **Upper Limit:** 3.395 - **Value:** 1.417 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.893 - **Spread:** - **Upper Limit:** 2.608 - **Value:** 0.857 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.268 - **Spread:** - **Upper Limit:** 4.058 - **Value:** 1.395 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -2.358 - **Spread:** - **Upper Limit:** 3.247 - **Value:** 0.444 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -2.496 - **Spread:** - **Upper Limit:** 7.360 - **Value:** 2.432 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -4.688 - **Spread:** - **Upper Limit:** 5.932 - **Value:** 0.622 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -3.342 - **Spread:** - **Upper Limit:** 6.231 - **Value:** 1.444 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -3.035 - **Spread:** - **Upper Limit:** 7.899 - **Value:** 2.432 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -3.950 - **Spread:** - **Upper Limit:** 7.782 - **Value:** 1.916 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -4.258 - **Spread:** - **Upper Limit:** 9.603 - **Value:** 2.673 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -2.037 - **Spread:** - **Upper Limit:** 4.627 - **Value:** 1.295 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -3.721 - **Spread:** - **Upper Limit:** 0.055 - **Value:** -1.833 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0.316 - **Spread:** - **Upper Limit:** 3.375 - **Value:** 1.529 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.083 - **Spread:** - **Upper Limit:** 5.099 - **Value:** 2.008 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.492 - **Spread:** - **Upper Limit:** 2.492 - **Value:** 1.492 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.183 - **Spread:** - **Upper Limit:** 3.603 - **Value:** 1.710 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.174 - **Spread:** - **Upper Limit:** 4.365 - **Value:** 2.269 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.872 - **Spread:** - **Upper Limit:** 4.055 - **Value:** 1.592 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.714 - **Spread:** - **Upper Limit:** 2.912 - **Value:** 0.599 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.463 - **Spread:** - **Upper Limit:** 4.258 - **Value:** 1.897 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -2.832 - **Spread:** - **Upper Limit:** 10.919 - **Value:** 4.044 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -3.691 - **Spread:** - **Upper Limit:** 7.002 - **Value:** 1.656 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.392 - **Spread:** - **Upper Limit:** 11.780 - **Value:** 6.586 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -2.596 - **Spread:** - **Upper Limit:** 9.550 - **Value:** 3.477 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.241 - **Spread:** - **Upper Limit:** 13.894 - **Value:** 7.067 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -2.391 - **Spread:** - **Upper Limit:** 13.139 - **Value:** 5.374 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -6.094 - **Spread:** - **Upper Limit:** 1.969 - **Value:** -2.063 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -3.996 - **Spread:** - **Upper Limit:** 2.944 - **Value:** -0.526 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -5.699 - **Spread:** - **Upper Limit:** 2.699 - **Value:** -1.500 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.729 - **Spread:** - **Upper Limit:** 7.796 - **Value:** 3.033 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -2.781 - **Spread:** - **Upper Limit:** 4.495 - **Value:** 0.857 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -2.190 - **Spread:** - **Upper Limit:** 4.097 - **Value:** 0.954 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -4.835 - **Spread:** - **Upper Limit:** 4.835 - **Value:** 0.000 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.511 - **Spread:** - **Upper Limit:** 10.797 - **Value:** 5.654 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -6.133 - **Spread:** - **Upper Limit:** 4.474 - **Value:** -0.830 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.291 - **Spread:** - **Upper Limit:** 4.641 - **Value:** 1.675 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -17.803 - **Spread:** - **Upper Limit:** 10.621 - **Value:** -3.591 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1.093 - **Spread:** - **Upper Limit:** 14.699 - **Value:** 6.803 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -22.930 - **Spread:** - **Upper Limit:** 14.764 - **Value:** -4.083 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -3.820 - **Spread:** - **Upper Limit:** 22.050 - **Value:** 9.115 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -29.740 - **Spread:** - **Upper Limit:** 19.138 - **Value:** -5.301 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -3.114 - **Spread:** - **Upper Limit:** 24.695 - **Value:** 10.791 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -6.733 - **Spread:** - **Upper Limit:** 6.733 - **Value:** 0.000 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.491 - **Spread:** - **Upper Limit:** 3.342 - **Value:** 0.926 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -5.182 - **Spread:** - **Upper Limit:** 1.154 - **Value:** -2.014 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.034 - **Spread:** - **Upper Limit:** 8.174 - **Value:** 3.570 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -3.537 - **Spread:** - **Upper Limit:** 3.423 - **Value:** -0.057 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.630 - **Spread:** - **Upper Limit:** 7.964 - **Value:** 3.667 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -4.531 - **Spread:** - **Upper Limit:** 4.959 - **Value:** 0.214 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -2.143 - **Spread:** - **Upper Limit:** 8.588 - **Value:** 3.222 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -7.507 - **Spread:** - **Upper Limit:** 2.912 - **Value:** -2.298 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.361 - **Spread:** - **Upper Limit:** 7.534 - **Value:** 3.086 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -17.130 - **Spread:** - **Upper Limit:** 12.963 - **Value:** -2.083 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -3.624 - **Spread:** - **Upper Limit:** 18.093 - **Value:** 7.235 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -17.855 - **Spread:** - **Upper Limit:** 14.140 - **Value:** -1.857 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -3.116 - **Spread:** - **Upper Limit:** 25.886 - **Value:** 11.385 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -24.302 - **Spread:** - **Upper Limit:** 15.993 - **Value:** -4.155 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -4.192 - **Spread:** - **Upper Limit:** 33.135 - **Value:** 14.472 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -6.045 - **Spread:** - **Upper Limit:** 10.311 - **Value:** 2.133 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -3.965 - **Spread:** - **Upper Limit:** 3.108 - **Value:** -0.429 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -5.126 - **Spread:** - **Upper Limit:** 2.710 - **Value:** -1.208 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -3.189 - **Spread:** - **Upper Limit:** 16.846 - **Value:** 6.829 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -5.042 - **Spread:** - **Upper Limit:** 3.842 - **Value:** -0.600 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.608 - **Spread:** - **Upper Limit:** 9.979 - **Value:** 4.686 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -5.341 - **Spread:** - **Upper Limit:** 5.341 - **Value:** 0.000 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.169 - **Spread:** - **Upper Limit:** 15.931 - **Value:** 7.381 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -6.531 - **Spread:** - **Upper Limit:** 5.609 - **Value:** -0.461 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -3.410 - **Spread:** - **Upper Limit:** 10.743 - **Value:** 3.667 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -12.563 - **Spread:** - **Upper Limit:** 15.907 - **Value:** 1.672 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -7.450 - **Spread:** - **Upper Limit:** 24.005 - **Value:** 8.278 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -22.161 - **Spread:** - **Upper Limit:** 21.828 - **Value:** -0.167 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.867 - **Spread:** - **Upper Limit:** 38.801 - **Value:** 18.467 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -23.085 - **Spread:** - **Upper Limit:** 25.432 - **Value:** 1.174 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -9.207 - **Spread:** - **Upper Limit:** 43.018 - **Value:** 16.906 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -30.221 - **Spread:** - **Upper Limit:** 22.721 - **Value:** -3.750 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -11.605 - **Spread:** - **Upper Limit:** 5.605 - **Value:** -3.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -34.229 - **Spread:** - **Upper Limit:** 32.479 - **Value:** -0.875 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -9.614 - **Spread:** - **Upper Limit:** 24.303 - **Value:** 7.344 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -42.119 - **Spread:** - **Upper Limit:** 34.119 - **Value:** -4.000 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -18.466 - **Spread:** - **Upper Limit:** 27.932 - **Value:** 4.733 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -64.531 - **Spread:** - **Upper Limit:** 62.531 - **Value:** -1.000 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -9.165 - **Spread:** - **Upper Limit:** 14.276 - **Value:** 2.556 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -29.128 - **Spread:** - **Upper Limit:** 17.461 - **Value:** -5.833 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -11.512 - **Spread:** - **Upper Limit:** 18.845 - **Value:** 3.667 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -77.291 - **Spread:** - **Upper Limit:** 56.124 - **Value:** -10.583 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -30.212 - **Spread:** - **Upper Limit:** 36.657 - **Value:** 3.222 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -171.100 - **Spread:** - **Upper Limit:** 151.850 - **Value:** -9.625 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -41.554 - **Spread:** - **Upper Limit:** 64.821 - **Value:** 11.633 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -153.638 - **Spread:** - **Upper Limit:** 122.722 - **Value:** -15.458 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -48.177 - **Spread:** - **Upper Limit:** 78.777 - **Value:** 15.300 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** -6.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 23.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 0.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 21.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 3.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 18.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 38.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 41.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -51.962 - **Spread:** - **Upper Limit:** 66.629 - **Value:** 7.333 - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** -3.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -23.441 - **Spread:** - **Upper Limit:** 27.808 - **Value:** 2.183 - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 1.400 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -12.706 - **Spread:** - **Upper Limit:** 12.706 - **Value:** 0.000 - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 6.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -13.535 - **Spread:** - **Upper Limit:** 26.701 - **Value:** 6.583 - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** -1.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -41.305 - **Spread:** - **Upper Limit:** 47.638 - **Value:** 3.167 - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** -3.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 11.789 - **Spread:** - **Upper Limit:** 22.378 - **Value:** 17.083 - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** -7.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 15.253 - **Spread:** - **Upper Limit:** 16.947 - **Value:** 16.100 - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 3.067 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -24.358 - **Spread:** - **Upper Limit:** 62.891 - **Value:** 19.267 - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 0.067 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 3.667 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -40.119 - **Spread:** - **Upper Limit:** 36.119 - **Value:** -2.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 4.200 - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 8.800 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 0.000 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -28.119 - **Spread:** - **Upper Limit:** 48.119 - **Value:** 10.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 8.000 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -56.962 - **Spread:** - **Upper Limit:** 61.629 - **Value:** 2.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 6.032 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -59.531 - **Spread:** - **Upper Limit:** 67.531 - **Value:** 4.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 17.698 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -156.612 - **Spread:** - **Upper Limit:** 165.279 - **Value:** 4.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 15.867 - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 29.800 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 21.898 - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 38.800 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** -11.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** -4.200 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** 5.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** -5.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** -5.000 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** -21.333 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** -15.533 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** Zero participants analyzed. - **Group ID:** OG000 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** NA - **Comment:** SD not calculated as only 1 participant was analyzed. - **Group ID:** OG001 - **Lower Limit:** NA - **Spread:** - **Upper Limit:** NA - **Value:** -20.533 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.916 - **Spread:** - **Upper Limit:** 0.174 - **Value:** -0.871 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -3.783 - **Spread:** - **Upper Limit:** -1.231 - **Value:** -2.507 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0.902 - **Spread:** - **Upper Limit:** 0.690 - **Value:** -0.106 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.788 - **Spread:** - **Upper Limit:** 0.256 - **Value:** -0.766 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.553 - **Spread:** - **Upper Limit:** 0.673 - **Value:** -0.440 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.562 - **Spread:** - **Upper Limit:** 0.546 - **Value:** -0.508 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -2.590 - **Spread:** - **Upper Limit:** -0.239 - **Value:** -1.415 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.809 - **Spread:** - **Upper Limit:** 0.263 - **Value:** -0.773 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.182 - **Spread:** - **Upper Limit:** 1.421 - **Value:** 0.120 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.878 - **Spread:** - **Upper Limit:** 1.360 - **Value:** 0.241 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -5.070 - **Spread:** - **Upper Limit:** 0.447 - **Value:** -2.311 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -5.734 - **Spread:** - **Upper Limit:** -0.273 - **Value:** -3.003 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -5.902 - **Spread:** - **Upper Limit:** 0.361 - **Value:** -2.771 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -7.941 - **Spread:** - **Upper Limit:** -1.462 - **Value:** -4.702 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -6.633 - **Spread:** - **Upper Limit:** 1.195 - **Value:** -2.719 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -8.515 - **Spread:** - **Upper Limit:** -0.366 - **Value:** -4.440 **Title:** #### Outcome Measure 25 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 12.3 - **Spread:** - **Upper Limit:** 22.2 - **Value:** 16.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 19.0 - **Spread:** - **Upper Limit:** 29.9 - **Value:** 24.2 **Title:** #### Outcome Measure 26 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 6.4 - **Spread:** - **Upper Limit:** 14.3 - **Value:** 9.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 7.4 - **Spread:** - **Upper Limit:** 15.5 - **Value:** 11.0 **Title:** #### Outcome Measure 27 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.6 - **Spread:** - **Upper Limit:** 10.2 - **Value:** 6.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 3.7 - **Spread:** - **Upper Limit:** 10.2 - **Value:** 6.5 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Parameter Type:** NUMBER **Population Description:** Intent-to-Treat (ITT) population - all randomized participants. **Reporting Status:** POSTED **Time Frame:** Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years **Title:** Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 2 **Description:** The median time, in months, from randomization to second-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Population Description:** ITT population **Reporting Status:** POSTED **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years **Title:** Second-Line PFS **Type:** PRIMARY **Unit of Measure:** months ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 3 **Description:** The median time, in months, from randomization to second-line PFS event according to the following baseline risk factors: hormone receptor negative, HER2 negative (triple negative), hormone receptor positive/HER-2 negative (HR-pos/HER-neg), first-line PFS less than (\<) 6 months, first-line PFS greater than or equal to (≥) 6 months, taxane chemotherapy (chemo), non-taxane chemo, vinorelbine chemo, LDH ≤ 1.5 upper limit of normal (ULN), LDH greater than (\>) 1.5 ULN, \< 65 years of age, ≥ 65 years of age, \< 70 years of age, ≥ 70 years of age, \< 3 metastatic organ sites, ≥ 3 metastatic organ sites, bevacizumab-free (B-free) interval ≤ 6 weeks, B-free \> 6 weeks, disease-free (D-free) interval ≤ 24 months, D-free \> 24 months, D-free ≤ 12 months, and D-free \> 12 months. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. PD: defined in Outcome measure 1. The 95% CI was estimated using Kaplan-Meier methodology. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Population Description:** ITT population. Here, Number of participants analyzed equals (=) participants evaluable for this outcome measure and number (n) = number of participants included in the analysis for the specified risk factor. **Reporting Status:** POSTED **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years **Title:** Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) **Type:** SECONDARY **Unit of Measure:** months ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 4 **Description:** BOR was defined as a confirmed CR or PR during second-line treatment. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% Cl was determined using the Pearson-Clopper method. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** ITT population; only randomized participants with measurable disease at baseline were included in the analysis. **Reporting Status:** POSTED **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years **Title:** Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013) **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 5 **Description:** For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; stable disease was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI was determined using the Pearson-Clopper method. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** ITT population; only randomized participants with measurable disease at baseline were included in the analysis. **Reporting Status:** POSTED **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years **Title:** Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013) **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 6 **Description:** The median time, in months, from the date of the first second-line documentation of CR or PR according to RECIST v1.1 to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Population Description:** ITT population; only randomized participants with a CR or PR were included in the analysis. **Reporting Status:** POSTED **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years **Title:** Duration of Second-Line Objective Response (Data Cutoff 20 December 2013) **Type:** SECONDARY **Unit of Measure:** months ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 7 **Description:** Duration of objective response was defined as the median time, in months, from the date of the first second-line documentation of CR or PR to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** ITT population; only randomized participants with a CR or PR were included in the analysis. **Reporting Status:** POSTED **Time Frame:** Months 3, 6, and 9 **Title:** Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013) **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 8 **Description:** Third-line PFS was defined as the time from the date of first dose of third-line bevacizumab and/or chemotherapy to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Parameter Type:** NUMBER **Population Description:** Third line ITT population: all randomized participants who received third-line treatment. **Reporting Status:** POSTED **Time Frame:** First dose of third-line treatment until PD or death due to any cause (assessed every 8-9 weeks, over a period of approximately 14 months) **Title:** Percentage of Participants With Third-Line PFS According to RECIST v1.1 **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 9 **Description:** The median time, in months, from the first dose of third-line bevacizumab and/or chemotherapy to third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Population Description:** Third line ITT population **Reporting Status:** POSTED **Time Frame:** First dose of third-line treatment until PD or death due to any cause (over a period of approximately 14 months) **Title:** Third-Line PFS **Type:** SECONDARY **Unit of Measure:** months ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 10 **Description:** Second- and third-line PFS was defined as the time from the date randomization to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Parameter Type:** NUMBER **Population Description:** ITT population **Reporting Status:** POSTED **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years **Title:** Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1 **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 11 **Description:** The median time, in months, from randomization to second-line and third-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Population Description:** ITT population **Reporting Status:** POSTED **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years **Title:** Second- and Third-Line PFS **Type:** SECONDARY **Unit of Measure:** months ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 12 **Description:** Second- and third-line tumor progression was defined as occurrence of third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death due to progression of disease were censored at the date of last tumor assessment where non-progression was documented. **Parameter Type:** NUMBER **Population Description:** ITT population **Reporting Status:** POSTED **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years **Title:** Percentage of Participants With Second- and Third-Line Tumor Progression **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 13 **Description:** The median time, in months, from randomization to second- and third-line tumor progression. Second- and third-line tumor progression was defined as third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Population Description:** ITT population **Reporting Status:** POSTED **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years **Title:** Time to Second- and Third-Line Tumor Progression **Type:** SECONDARY **Unit of Measure:** months ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 14 **Description:** Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** ITT population **Reporting Status:** POSTED **Time Frame:** Month 6 **Title:** Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6 **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 15 **Description:** Percentage of participants who died due to any reason were reported. **Parameter Type:** NUMBER **Population Description:** ITT population **Reporting Status:** POSTED **Time Frame:** Baseline until death (up to approximately 4 years) **Title:** Percentage of Participants Who Died **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 16 **Description:** OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Participants who had not died were censored at the date the patient was last known to be alive. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Population Description:** ITT population **Reporting Status:** POSTED **Time Frame:** Baseline until death (up to approximately 4 years) **Title:** Overall Survival (OS) **Type:** SECONDARY **Unit of Measure:** months ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 17 **Description:** OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** ITT population **Reporting Status:** POSTED **Time Frame:** Months 6, 12, 18, and 24 **Title:** Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24 **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 18 **Description:** The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility (M) ("no problems"="I have no problems in walking about" to "extreme problems"="I am confined to bed"), self-care (SC) ("no problems"="I have no problems with self-care" to "extreme problems"="I am unable to wash or dress myself"), usual activities (UA) ("no problems"="I have no problems performing my usual activities" to "extreme problems"="I am unable to perform my usual activities"), pain/discomfort (P/D) ("no problems"="I have no pain or discomfort" to "extreme problems"="I have extreme pain or discomfort"), and anxiety/depression (A/D) ("no problems"="I am not anxious or depressed" to "extreme problems"='I am extremely anxious or depressed"). **Parameter Type:** NUMBER **Population Description:** ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants completing the questionnaires at the corresponding timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) **Title:** Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 19 **Description:** The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEAN **Population Description:** ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint **Reporting Status:** POSTED **Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) **Title:** Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013) **Type:** SECONDARY **Unit of Measure:** score on a scale ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 20 **Description:** The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEAN **Population Description:** ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) **Title:** Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013) **Type:** SECONDARY **Unit of Measure:** score on a scale ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 21 **Description:** The participant was asked to rate their overall health on a 0-100 millimeter (mm) vertical scale, where the lowest endpoint=0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A higher value indicated a better health state. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEAN **Population Description:** ITT population; n=number of participants who completed the assessment at the specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) **Title:** Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013) **Type:** SECONDARY **Unit of Measure:** mm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 22 **Description:** The participant was asked to rate their overall health on a 0-100 mm vertical scale, where the lowest endpoint = 0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEAN **Population Description:** ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) **Title:** Change From Baseline in VAS Scores (Data Cutoff 20 December 2013) **Type:** SECONDARY **Unit of Measure:** mm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 23 **Description:** The Functional Assessment of Cancer Therapy-Breast (FACT-B) is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"), as follows: physical well-being (PWB) (7 items, total score 0-28), social/family well-being (SWB) (7 items, total score 0-28), emotional well-being (EWB) (6 items, total score 0-24), functional well-being (FWB) (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B Trial Outcomes Index (TOI) score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The Functional Assessment of Cancer Therapy-General (FACT-G) total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscales scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEAN **Population Description:** ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the questionnaire at the specified timepoints. **Reporting Status:** POSTED **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years) **Title:** Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) **Type:** SECONDARY **Unit of Measure:** score on a scale ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 24 **Description:** The FACT-B is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"), as follows: PWB (7 items, total score 0-28), SWB (7 items, total score 0-28), EWB (6 items, total score 0-24), FWB (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B TOI score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The FACT-G total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscale scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEAN **Population Description:** ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years) **Title:** Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) **Type:** SECONDARY **Unit of Measure:** score on a scale ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 25 **Description:** Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without secondline PD or death were censored at the date of last tumor assessment where non-progression was documented. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** ITT population **Reporting Status:** POSTED **Time Frame:** Month 12 **Title:** Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12 **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 26 **Description:** Second-line PFS was defined as the time from randomization to PD or death due to any cause during their secondline of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** ITT population **Reporting Status:** POSTED **Time Frame:** Month 18 **Title:** Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18 **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm #### Outcome Measure 27 **Description:** Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** ITT population **Reporting Status:** POSTED **Time Frame:** Month 24 **Title:** Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24 **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG000 **Title:** CT Arm ##### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** OG001 **Title:** CT+BV Arm ### Participant Flow Module #### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** FG000 **Title:** Chemotherapy (CT) Arm #### Group **Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 milligrams per kilogram (mg/kg), intravenously (IV), every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. **ID:** FG001 **Title:** Chemotherapy Plus Bevacizumab (CT+BV) Arm #### Period **Title:** Overall Study ##### Withdraw **Type:** Death ###### Reason **Group ID:** FG000 **Number of Subjects:** 141 ###### Reason **Group ID:** FG001 **Number of Subjects:** 148 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 32 ###### Reason **Group ID:** FG001 **Number of Subjects:** 20 ##### Withdraw **Type:** Physician Decision ###### Reason **Group ID:** FG000 **Number of Subjects:** 11 ###### Reason **Group ID:** FG001 **Number of Subjects:** 3 ##### Withdraw **Type:** Protocol Violation ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ###### Reason **Group ID:** FG001 **Number of Subjects:** 8 ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 9 ###### Reason **Group ID:** FG001 **Number of Subjects:** 6 ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 5 ###### Reason **Group ID:** FG001 **Number of Subjects:** 4 ##### Withdraw **Type:** Other ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 4 ##### Withdraw **Type:** Participant noncompliance ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 247 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 247 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 45 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 54 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 202 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 193 **Recruitment Details:** A total of 556 participants were screened and of these, 494 were randomized. **Has Results:** True
## Protocol Section ### Identification Module **NCT ID:** NCT03678779 **Acronym:** SIU4P **Brief Title:** Snack It Up for Parents: Interventions to Improve Children's Snacks **Official Title:** Snack It Up for Parents: Interventions to Improve Children's Snacks #### Organization Study ID Info **ID:** 1601028 #### Organization **Class:** OTHER **Full Name:** Tufts University ### Status Module #### Completion Date **Date:** 2016-08 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-09-20 **Type:** ACTUAL **Last Update Submit Date:** 2018-09-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-08 **Type:** ACTUAL #### Start Date **Date:** 2016-03 **Type:** ACTUAL **Status Verified Date:** 2018-09 #### Study First Post Date **Date:** 2018-09-20 **Type:** ACTUAL **Study First Submit Date:** 2018-07-23 **Study First Submit QC Date:** 2018-09-18 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Newman's Own Foundation **Class:** UNKNOWN **Name:** Stop & Shop Supermarket Company **Class:** UNKNOWN **Name:** Soccer4Success/America SCORES #### Lead Sponsor **Class:** OTHER **Name:** Tufts University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Influencing children's snacking habits has the potential to reap long-term rewards, yet few studies have focused on helping parents to provide healthier snacks for their children. The study tested the feasibility and preliminary effectiveness of parent interventions to improve snacks for children ages 8-12. **Detailed Description:** Objective. Influencing children's snacking habits has the potential to reap long-term rewards, yet few studies have focused on helping parents to provide healthier snacks for their children. The study tested the feasibility and preliminary effectiveness of parent interventions to improve snacks for children ages 8-12. Methods. Parents of children enrolled in an out-of-school-time soccer program in a low-income school district (n 16) were recruited. A comparison of 3 randomly-assigned interventions was conducted: 4 parents received grocery store gift cards (Incentive); 7 received nutrition education videos with tip sheets (Education); and 5 received both (Combined). The interventions were assessed qualitatively by interviewing parents and quantitatively to determine motivation (psychosocial survey) and children's snack quality (web-based 24-hour recall). ### Conditions Module **Conditions:** - Snacking **Keywords:** - child nutrition - nutrition education - parent intervention ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 17 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Each week parents received one $5 grocery store gift card per child in the household, intended for the purchase of healthy snacks, donated to the study by a partnering grocery store **Intervention Names:** - Behavioral: Incentive **Label:** Incentive **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Parents received brief weekly nutrition education videos (approximately one minute in length, uploaded on YouTube and viewable on most operating systems and on mobile devices **Intervention Names:** - Behavioral: Education **Label:** Education **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Parents received both the Incentive and Education arm interventions **Intervention Names:** - Behavioral: Combined **Label:** Combined **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Incentive **Description:** $5 grocery gift card **Name:** Incentive **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Education **Description:** Video-based brief nutrition education **Name:** Education **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Combined **Description:** Both Incentive and Education interventions received **Name:** Combined **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** grams of sugar, fruits and vegetables as snacks **Measure:** snack quality by on-line 24-hour dietary recall (ASA24) **Time Frame:** 6 weeks #### Secondary Outcomes **Description:** Parent intrinsic motivation for providing fruit and vegetable snacks; questions adapted from the Intrinsic Motivation Inventory (McAuley, E., Duncan, T., \& Tammen, V. (1989). Psychometric properties of the Intrinsic Motivation Inventory in a competitive sport setting: A confirmatory factor analysis. Research Quarterly for Exercise and Sport, 60(1), 48-58). **Measure:** Intrinsic motivation by adapted Intrinsic Motivation Inventory **Time Frame:** 6 weeks **Description:** Parent pros and cons for providing fruit and vegetable snacks to children; questions adapted from Mainvil decisional balance scale (Mainvil, L. A., Lawson, R., Horwath, C. C., McKenzie, J. E., \& Hart, I. (2010). Validated scales to assess adult decisional balance to eat more fruits and vegetables. Appetite, 55(3), 454-465. doi:10.1016/j.appet.2010.08.007) **Measure:** Decisional balance by the Mainvil Decisional Balance Scale **Time Frame:** 6 weeks **Description:** Parent self-efficacy for providing fruit and vegetable snacks; questions adapted from the self-efficacy questions in the National Cancer Institute's Food Attitudes and Behaviors Survey (Erinosho, T. O., Pinard, C. A., Nebeling, L. C., Moser, R. P., Shaikh, A. R., Resnicow, K., . . . Yaroch, A. L. (2015). Development and implementation of the National Cancer Institute's Food Attitudes and Behaviors Survey to assess correlates of fruit and vegetable intake in adults. PLoS One, 10(2), e0115017. doi:10.1371/journal.pone.0115017) **Measure:** Self-efficacy by questions adapted NCI Food Attitudes and Behaviors Survey **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 year and older * Must have a child enrolled in one of three designated soccer sites of the study and must agree to let their child take the online 24 hour recall (ASA24) * Must have a child 7 years or older participating on a soccer team * Must frequently buy groceries from Stop \& Shop (only if recruited for a study arms that involves grocery coupons) * Must be literate in English or Spanish. Exclusion Criteria: * Failure to provide informed consent **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT03435679 **Brief Title:** One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty **Official Title:** One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty. A Randomized Controlled Multicenter Trial. #### Organization Study ID Info **ID:** MLL_02_2018 #### Organization **Class:** OTHER **Full Name:** Odense University Hospital ### Status Module #### Completion Date **Date:** 2027-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-15 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-12 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03-01 **Type:** ESTIMATED #### Start Date **Date:** 2018-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2018-02-19 **Type:** ACTUAL **Study First Submit Date:** 2018-01-31 **Study First Submit QC Date:** 2018-02-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Odense Patient Data Explorative Network **Class:** OTHER **Name:** Region of Southern Denmark #### Lead Sponsor **Class:** OTHER **Name:** Odense University Hospital #### Responsible Party **Investigator Affiliation:** Odense University Hospital **Investigator Full Name:** Martin Lindberg-Larsen **Investigator Title:** Orthopaedic Surgeon, MD, PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study investigates functional outcome and safety after one-stage versus two-stage revision of the infected knee arthroplasty. Half of participants are treated with a one-stage surgical procedure, while the other half is treated with a two-stage procedure. The investigators hypothesize that the functional outcome and quality of life of the participants is superior after one-stage surgery compared to two-stage surgery. **Detailed Description:** A two-stage approach is the standard surgical procedure in the treatment of the chronically infected knee arthroplasty, but promising results have been reported after a one-stage approach from single-centre studies. The potential benefits for the patients treated with a one-stage approach are many as they only have to go through surgery and rehabilitation once with shorter total length of hospital stay. However, no randomized controlled trials comparing outcome after the procedures have been performed so far. ### Conditions Module **Conditions:** - Periprosthetic Knee Infection **Keywords:** - infection - knee arthroplasty - surgical treatment - one-stage - two-stage - outcome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 96 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** one-stage surgical treatment of the infected knee arthroplasty **Intervention Names:** - Procedure: one-stage **Label:** one-stage **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** two-stage surgical treatment of the infected knee arthroplasty with a interim period of 8-10 weeks between stages **Intervention Names:** - Procedure: two-stage **Label:** two-stage **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - one-stage **Description:** one-stage surgery **Name:** one-stage **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - two-stage **Description:** two-stage surgery **Name:** two-stage **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Area Under Curve for Oxford Knee Score **Measure:** Oxford Knee Score (AUC) **Time Frame:** preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively. #### Secondary Outcomes **Description:** Area Under Curve for Oxford Knee Score **Measure:** Oxford Knee Score (AUC) **Time Frame:** preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively. **Description:** Quality of life questionnaire **Measure:** EQ-5D-5L **Time Frame:** preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively. **Description:** re-revisions due to infection and other causes **Measure:** Re-revision rate **Time Frame:** 2 year postoperatively **Description:** postoperative mortality **Measure:** mortality **Time Frame:** 90 days postoperatively and 1 and 2 year postoperatively **Description:** postoperative readmission rate **Measure:** readmission rate **Time Frame:** 90 days postoperatively **Description:** Range of motion of the infected/operated knee **Measure:** Range of Motion **Time Frame:** 2 years postoperatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Clinical signs of periprosthetic knee infection * \> 6 weeks from previous knee arthoplasty procedure (primary or total revision procedure) * Speak and understand Danish and have given informed consent Exclusion Criteria: * Soft tissue problems requiring plastic surgery * major bone loss requiring mega/tumor-prosthesis * acute surgery due to sepsis * malignant disease with less than 2 years life expectancy * re-infection with previous two-stage procedure * bilateral knee infection **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Martin Lindberg-Larsen, MD, PhD **Phone:** 0045 25213900 **Role:** CONTACT #### Locations **Location 1:** **City:** Aalborg **Contacts:** ***Contact 1:*** - **Name:** Andreas Kappel, MD - **Role:** CONTACT **Country:** Denmark **Facility:** Aalborg University Hospital **Status:** RECRUITING **Location 2:** **City:** Arhus **Country:** Denmark **Facility:** Aarhus University Hospital **Status:** WITHDRAWN **Location 3:** **City:** Copenhagen **Contacts:** ***Contact 1:*** - **Name:** Morten Smiegalow, MD - **Role:** CONTACT **Country:** Denmark **Facility:** Bispebjerg Hospital **Status:** RECRUITING **Location 4:** **City:** Copenhagen **Contacts:** ***Contact 1:*** - **Name:** Anders Odgaard, MD, PhD - **Role:** CONTACT **Country:** Denmark **Facility:** Gentofte Hospital **Status:** RECRUITING **Location 5:** **City:** Copenhagen **Contacts:** ***Contact 1:*** - **Name:** Kirill Gromov, MD, PhD - **Role:** CONTACT **Country:** Denmark **Facility:** Hvidovre Hospital **Status:** RECRUITING **Location 6:** **City:** Copenhagen **Contacts:** ***Contact 1:*** - **Name:** Anders Odgaard, Professor - **Role:** CONTACT **Country:** Denmark **Facility:** Rigshospitalet **Status:** RECRUITING **Location 7:** **City:** Horsens **Contacts:** ***Contact 1:*** - **Name:** Jeppe Lange, MD, PhD - **Role:** CONTACT **Country:** Denmark **Facility:** Horsens Hospital **Status:** RECRUITING **Location 8:** **City:** Køge **Country:** Denmark **Facility:** Køge Hospital **Status:** WITHDRAWN **Location 9:** **City:** Næstved **Contacts:** ***Contact 1:*** - **Name:** Henrik Schrøder, MD - **Role:** CONTACT **Country:** Denmark **Facility:** Næstved Hospital **Status:** RECRUITING **Location 10:** **City:** Odense **Contacts:** ***Contact 1:*** - **Name:** Martin Lindberg-Larsen, MD, PhD - **Role:** CONTACT **Country:** Denmark **Facility:** Odense Universitets Hospital **Status:** RECRUITING **Location 11:** **City:** Silkeborg **Country:** Denmark **Facility:** Silkeborg Hospital **Status:** WITHDRAWN **Location 12:** **City:** Vejle **Contacts:** ***Contact 1:*** - **Name:** Thomas Bruno Lind-Hansen, MD, PhD - **Role:** CONTACT **Country:** Denmark **Facility:** Vejle Hospital **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Martin Lindberg-Larsen **Name:** Martin Lindberg-Larsen **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** According to local interpretation of GDPR. Blinded data can be provided upon request. **IPD Sharing:** NO ### References Module #### References **Citation:** Lindberg-Larsen M, Jorgensen CC, Bagger J, Schroder HM, Kehlet H. Revision of infected knee arthroplasties in Denmark. Acta Orthop. 2016 Aug;87(4):333-8. doi: 10.3109/17453674.2016.1148453. Epub 2016 Feb 22. **PMID:** 26900908 **Citation:** Lindberg-Larsen M, Pitter FT, Voldstedlund M, Schroder HM, Bagger J. Microbiological diagnosis in revision of infected knee arthroplasties in Denmark. Infect Dis (Lond). 2017 Nov-Dec;49(11-12):824-830. doi: 10.1080/23744235.2017.1350878. Epub 2017 Jul 8. **PMID:** 28691647 **Citation:** Masters JP, Smith NA, Foguet P, Reed M, Parsons H, Sprowson AP. A systematic review of the evidence for single stage and two stage revision of infected knee replacement. BMC Musculoskelet Disord. 2013 Jul 29;14:222. doi: 10.1186/1471-2474-14-222. **PMID:** 23895421 **Citation:** Haddad FS, Sukeik M, Alazzawi S. Is single-stage revision according to a strict protocol effective in treatment of chronic knee arthroplasty infections? Clin Orthop Relat Res. 2015 Jan;473(1):8-14. doi: 10.1007/s11999-014-3721-8. **PMID:** 24923669 **Citation:** Singer J, Merz A, Frommelt L, Fink B. High rate of infection control with one-stage revision of septic knee prostheses excluding MRSA and MRSE. Clin Orthop Relat Res. 2012 May;470(5):1461-71. doi: 10.1007/s11999-011-2174-6. Epub 2011 Nov 12. **PMID:** 22081299 **Citation:** Baker P, Petheram TG, Kurtz S, Konttinen YT, Gregg P, Deehan D. Patient reported outcome measures after revision of the infected TKR: comparison of single versus two-stage revision. Knee Surg Sports Traumatol Arthrosc. 2013 Dec;21(12):2713-20. doi: 10.1007/s00167-012-2090-7. Epub 2012 Jun 13. **PMID:** 22692517 **Citation:** Massin P, Delory T, Lhotellier L, Pasquier G, Roche O, Cazenave A, Estellat C, Jenny JY. Infection recurrence factors in one- and two-stage total knee prosthesis exchanges. Knee Surg Sports Traumatol Arthrosc. 2016 Oct;24(10):3131-3139. doi: 10.1007/s00167-015-3884-1. Epub 2015 Nov 26. **PMID:** 26611899 **Citation:** Lindberg-Larsen M, Odgaard A, Fredborg C, Schroder HM; One-stage vs Two-stage Collaboration Group. One-stage versus two-stage revision of the infected knee arthroplasty - a randomized multicenter clinical trial study protocol. BMC Musculoskelet Disord. 2021 Feb 12;22(1):175. doi: 10.1186/s12891-021-04044-8. **PMID:** 33579256 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT01568879 **Brief Title:** Evaluating the Effectiveness of a Chronic Disease Management Program for Gout **Official Title:** Evaluating the Effectiveness of a Chronic Disease Management Program for Gout #### Organization Study ID Info **ID:** CN-11RGold-02-H #### Organization **Class:** OTHER **Full Name:** Kaiser Permanente ### Status Module #### Completion Date **Date:** 2014-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-03-06 **Type:** ESTIMATED **Last Update Submit Date:** 2015-03-04 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-11 **Type:** ACTUAL #### Start Date **Date:** 2012-01 **Status Verified Date:** 2015-03 #### Study First Post Date **Date:** 2012-04-02 **Type:** ESTIMATED **Study First Submit Date:** 2012-03-28 **Study First Submit QC Date:** 2012-03-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kaiser Permanente #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The aim of this study is to test the effectiveness of a pharmacist-staffed, protocol-based chronic disease management program compared to patients receiving usual care in achieving a target serum uric acid level in patients with recurrent gout. **Detailed Description:** Gout is a chronic condition with intermittent symptoms and should be managed through an outcome-based disease management approach. Unlike other common chronic conditions, strategies for population management in gout patients have not been tested. The study will identify adult members of Kaiser Permanente (KP) Northern California with a diagnosis of gout and 3 or more outpatient or Emergency Department visits for gout over a 1-year period preceding study enrollment. These patients will be randomized to either an active management group, or to usual care. The participants will be enrolled and followed over a period of 26 weeks. The primary outcome to be measured will be the attainment and maintenance of a uric acid lowering regimen targeted to achieve serum uric acid level of 6.0 mg/dl or less. The treatment protocol will use standard treatment guidelines to lower and maintain uric acid levels to less than or equal to 6.0 mg/dl (or maximum doses of uric acid lowering medications) and provide patient education and dietary counseling. Monitoring and medication management will be carried out by a licensed clinical pharmacist under the supervision of an experienced rheumatologist. Control subjects will have regular monitoring of serum uric acid levels and will be provided with educational material and dietary counseling, but otherwise receive usual care. The demonstration that a chronic disease management approach to gout care can improve the health and reduce morbidity in patients with gout may illuminate a simple path towards improved quality of life and reduced morbidity in this growing population of patients. ### Conditions Module **Conditions:** - Recurrent or Tophaceous Gout **Keywords:** - Recurrent gout - Tophaceous gout - Gout flares - Arthritis - Joint Diseases - Rheumatic Diseases ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 104 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Gout Disease Management Program **Label:** Gout Chronic Disease Management Program **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Control **Label:** Usual Care **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Usual Care **Description:** The control group will receive care from their primary care physician that reflects the actual current care received by KPNC patients, but will not receive any treatment recommendations from the study protocol. The control subject will have regular monitoring of serum uric acid levels and will be provided with educational material and dietary counseling. **Name:** Control **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Gout Chronic Disease Management Program **Description:** The experimental group will utilize standard guidelines for the initiation of uric acid lowering treatments, and approved medications. The study protocol treatments include medication management, dietary guidelines, and basic educational materials on gout and its management. No non-formulary medications or devices will be used. The experimental procedure to be tested is the use of a structured protocol to manage and monitor standard treatments. **Name:** Gout Disease Management Program **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** attainment and maintenance of a serum uric acid level of 6.0 mg/dl or less. The outcome will be considered positive if that level is attained and the 6 month follow up value remains at the target level. **Measure:** Serum Uric Acid Level **Time Frame:** change from baseline at 6 months follow up #### Secondary Outcomes **Description:** Change in Serum Creatinine **Measure:** Serum Creatinine **Time Frame:** 0, 12, and 26 weeks **Description:** Change in serum ALT (a measure of potential toxicity) **Measure:** Serum Alanine Aminotransferase (ALT) **Time Frame:** 0, 12, and 26 weeks **Description:** Number of gout flares **Measure:** Gout flares **Time Frame:** 0, 12, and 26 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Three or more outpatient/ED visits in a 24-month period prior to selection for study with one of these primary visit diagnoses: * Gouty arthropathy * Gout, unspecified * Gout with other specified manifestations * Tophaceous gout of ear (274.81) or other sites * Gouty nephropathy At least 2 years of continuous Kaiser Foundation Hospital Plan membership Baseline uric acid level above 7.0mg/dl Exclusion Criteria: * Current cancer diagnosis with active treatment * End stage renal disease * Pregnant or lactating * Patients with a diagnosis of dementia * Terminally ill patients **Maximum Age:** 80 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** All KPNC Facilities **Country:** United States **Facility:** Kaiser Permanente Northern California Medical Facilities **State:** California #### Overall Officials **Official 1:** **Affiliation:** Kaiser Permanente **Name:** Robert Goldfien, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000070657 - Term: Crystal Arthropathies - ID: D000012216 - Term: Rheumatic Diseases - ID: D000011686 - Term: Purine-Pyrimidine Metabolism, Inborn Errors - ID: D000008661 - Term: Metabolism, Inborn Errors - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M9177 - Name: Gout - Relevance: HIGH - As Found: Gout - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: HIGH - As Found: Chronic Disease - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M630 - Name: Crystal Arthropathies - Relevance: LOW - As Found: Unknown - ID: M11641 - Name: Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M14540 - Name: Purine-Pyrimidine Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006073 - Term: Gout - ID: D000002908 - Term: Chronic Disease ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17277 - Name: Uric Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT05926479 **Brief Title:** Validation And Turkish Cross-Cultural Adaptation of Treatment Expectation Questionnaire (TEX-Q) Tool **Official Title:** Validation And Turkish Cross-Cultural Adaptation of Treatment Expectation Questionnaire (TEX-Q) Tool #### Organization Study ID Info **ID:** IstanbulBUFC #### Organization **Class:** OTHER **Full Name:** Istanbul Bilgi University ### Status Module #### Completion Date **Date:** 2023-09-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-09-28 **Type:** ACTUAL **Last Update Submit Date:** 2023-09-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-09-01 **Type:** ACTUAL #### Start Date **Date:** 2023-06-21 **Type:** ACTUAL **Status Verified Date:** 2023-09 #### Study First Post Date **Date:** 2023-07-03 **Type:** ACTUAL **Study First Submit Date:** 2023-06-21 **Study First Submit QC Date:** 2023-06-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul Bilgi University #### Responsible Party **Investigator Affiliation:** Istanbul Bilgi University **Investigator Full Name:** Furkan Çakır **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The general treatment expectations of patients play a significant role in determining the outcomes of the different treatments they undergo. When it comes to physiotherapy programs, these expectations act as non-specific treatment components, capable of triggering subjective psychological changes and eliciting mechanisms that resemble placebo effects. When theory-based, multidimensional measurement tools that evaluate patients' expectations from various treatments are examined, the Treatment Expectation Questionnaire (TEX-Q) questionnaire stands out. The aim of this study is to ensure the validity and reliability of the Turkish version of this form, which can be answered by every patient receiving various treatments, as an objective alternative and to be included among other treatment expectancy measurement tools. **Detailed Description:** This study includes the translation of the form after obtaining the relevant permissions, examining the internal consistency of the Turkish version, explanatory and confirmatory factor analysis, convergent validity and test-retest reliability processes. The Turkish version of TEX-Q was applied to 200 patients who applied to the clinic for physiotherapy in the examination of internal consistency and exploratory factor analysis of the questionnaire. For convergent validity, 46 independent participants answered the Turkish version of the TEX-Q, the Positivity Scale, and the Hospital Anxiety and Depression Scale. The test-retest reliability within a 2-weeks interval was analysed in 63 of patients seeking physiotherapy program. ### Conditions Module **Conditions:** - Physiotherapy Patients **Keywords:** - patient - expectation - validity - reliability ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 150 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Translating the Questionnaire into Turkish and Related Processes - Other: Validity - Other: Reliability **Label:** physiotherapy patient ### Interventions #### Intervention 1 **Arm Group Labels:** - physiotherapy patient **Description:** The first step is the translation from the original language to the other language. The ideal target in the translation phase is to use people who are familiar with the structure of the original language and who are familiar with the language. Two forward translation and one reverse translation methods will be applied after obtaining the written permission of the authors. After the completion of this phase, the terminological differences arising from the translators in the translation process from the original language to Turkish will be collected and discussed on the questions. The cultural adaptation study will be terminated by determining the equivalence between the Turkish version of the index and the English original. The final version of the questionnaire and the necessary changes will be arranged specific to the investigator's society and the authors of the original questionnaire will be consulted and the questionnaire will be finalized. **Name:** Translating the Questionnaire into Turkish and Related Processes **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - physiotherapy patient **Description:** The scale will be applied by face-to-face technique and convergent (moderate-high correlation with optimism measure) and distant (low correlation with depression and anxiety measures) validity will be evaluated. **Name:** Validity **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - physiotherapy patient **Description:** The reliability of the materials will be tested with Cronbach alpha. **Name:** Reliability **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** It is a 21-item questionnaire, originally called the Treatment Expectation Questionnaire, developed by Alberts et al. in 2020, in which treatment expectations for different treatments can be measured in general and comparatively. The participant is asked to mark the number between 0 and 10 that he thinks corresponds to the appropriate value for him. Treatment benefit (items 1-3), positive effect (items 4-6), adverse effects (items 7-9), negative effect (items 10-11), treatment improvement (items 12-13), and behavioral control (items 14). -15) subheadings. Items 7-11 are reverse coded. There are 6 additional items of previous treatment experience. The total score of the questionnaire for the first 15 items is 150. **Measure:** Treatment Expectancy Questionnaire **Time Frame:** Baseline #### Secondary Outcomes **Description:** Positivity Scale, directly evaluate the positivity levels of individuals. The original form of the instrument has a five-degree likert-type assessment. The Positivity Scale consists of eight items, one of which is reversed (item 6). **Measure:** Positivity Scale **Time Frame:** Baseline **Description:** The aim of the scale is to determine the severity and severity of the patient by determining the patient's susceptibility to anxiety and depression. The test has a total of 14 questions. Seven of these questions measure anxiety (odd numbers) and the remaining seven measure depression (even numbers). The cut-off points were 10 for anxiety and 7 for depression. Accordingly, those above this score are considered at risk. **Measure:** Hospital Anxiety and DepressionScale **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ages between 18-65 * who would receive physiotherapy for at least 2 weeks for any indication Exclusion Criteria: * insufficient level of Turkish * having any mental problems that would prevent participation in the study * receiving another applied treatment other than the physiotherapy program **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Individuals who apply to physiotherapy clinic and will receive treatment for any indication ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Istanbul Bilgi University **State:** Beyoglu **Zip:** 34340 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: Rare - Name: Rare Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02027779 **Brief Title:** Safety and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A **Official Title:** An Open Label Safety and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A #### Organization Study ID Info **ID:** GreenGene™ F_E_P3 #### Organization **Class:** INDUSTRY **Full Name:** GC Biopharma Corp ### Status Module #### Completion Date **Date:** 2016-02 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2014-01-06 **Type:** ESTIMATED **Last Update Submit Date:** 2014-01-03 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2015-12 **Type:** ESTIMATED #### Start Date **Date:** 2014-01 **Status Verified Date:** 2014-01 #### Study First Post Date **Date:** 2014-01-06 **Type:** ESTIMATED **Study First Submit Date:** 2014-01-02 **Study First Submit QC Date:** 2014-01-03 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Atlantic Research Group #### Lead Sponsor **Class:** INDUSTRY **Name:** Green Cross Corporation #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study primarily will address the safety and secondarily will assess efficacy of GreenGene™ F in subjects with severe hemophilia A previously treated ≥50 exposure days with a GreenGene™ F, and without presence inhibitor to FVIII (Factor VIII). ### Conditions Module **Conditions:** - Hemophilia A **Keywords:** - GreenGene™ F, Previously Treated Patients ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Hemostatic efficacy of GreenGene™ F will be assessed by its effectiveness in controlling spontaneous or traumatic bleeding episodes and by the rate of breakthrough bleeding during prophylaxis over ≥ 50 additional exposure days. **Intervention Names:** - Biological: GreenGene™ F **Label:** Prophylaxis safety and efficacy substudy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Hemostatic efficacy of GreenGene™ F will be assessed by its effectiveness in controlling spontaneous or traumatic bleeding episodes and by the rate of breakthrough bleeding in a minimum of 10 on demand treated subjects during additional 50 exposure days. **Intervention Names:** - Biological: GreenGene™ F **Label:** On-demand safety and efficacy substudy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Prophylaxis safety and efficacy substudy **Description:** Prophylaxis safety and efficacy substudy: intra venous infusion, 30 ± 10 IU/kg infusions 3 times per week with dose escalation to 45 ± 10 IU/kg if appropriate, for 50 exposure days **Name:** GreenGene™ F **Other Names:** - GreenGeneF - GreenGene F **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - On-demand safety and efficacy substudy **Description:** On-demand safety and efficacy substudy: minor bleed = 20 ± 10 IU/kg moderate bleed = 30 ± 10 IU/kg major bleed = 30 - 50 IU/kg **Name:** GreenGene™ F **Other Names:** - GreenGeneF - GreenGene F **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Development of neutralizing antibodies (inhibitors) will be followed during the regular visits, average of 3 months. **Measure:** Number of subjects with development of inhibitors **Time Frame:** every 3 months, up to 18 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subjects must have participated in the "GreenGene™ F_P3", (with Eudra CT number 2012-001445-40) or a pediatric study with GreenGene™ F 2. Have ≥50 previous exposure days to GreenGene™ F, as documented in the subject's medical records. 3. Negative assays for FVIII inhibitor at inclusion (\<0.6BU Nijmegen assay), i.e. at the end of study "GreenGene™ F_P3" for patients entering into this extension study immediately after finishing the previous phase III study. 4. Normal liver and kidney function 5. Platelet count ≥ 100,000㎕ 6. Normal prothrombin time or International Normalized Ratio (INR) \< 1.5 7. Subjects receiving therapy for human immunodeficiency virus (HIV) or hepatitis must be on a stable treatment regimen 8. Subjects must be able to withhold FVIII infusions for approximately 72 h prior to each inhibitor assay 9. Absolute CD4 lymphocyte cell count ≥ 200㎕ 10. Signed the written informed consent form or informed consent was obtained from the subject's legal guardian 11. Females must not be lactating or pregnant at screening or Baseline (as documented by a negative beta-human chorionic gonadotropin \[β-hCG\] test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG). A test was obtained more than 72 hours before the first dose of study drug 12. All females will be considered to be of childbearing potential unless they are appropriate age group and without other known or suspected cause) or have been sterilized surgically (i.e. bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least one month before dosing) 13. Willing and able to comply with all aspects of the protocol Exclusion Criteria: 1. Presence at Screening of FVIII inhibitor ≥ 0.6 BU as tested with the Nijmegen modification of the Bethesda assay. 2. Laboratory or clinical evidence of portal vein hypertension including, but not limited to, an INR \> 1.4, the presence of splenomegaly and/or spider angiomata of physical examination and/or a history of esophageal hemorrhage or documented esophageal varices 3. Uncontrolled hypertension (diastolic blood pressure \>100 mm Hg) 4. Hemoglobin \< 10 g/dL 5. Severe renal dysfunction (creatinine \> 2x upper limit of normal \[ULN\], total bilirubin \> 2x the ULN) 6. Liver disease (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] \> 3x the ULN) 7. History of diabetes or other metabolic disease 8. History of hypersensitivity or serious adverse reaction to recombinant or plasma-derived FVIII concentrates 9. History of pretreatment prior to the administration of FVIII products (e.g., antihistamines) 10. Regular use of antifibrinolytics or medications affecting platelet function 11. Hypersensitivity to hamster- or mouse derived proteins 12. Blood transfusions within 30 days of enrollment into the study 13. Current participation in another investigational drug or device study, or participated in a clinical study involving an investigational drug or device within 30 days of enrollment into the study 14. Unable or unwilling to cooperate with study procedures 15. Females who are pregnant (positive β-hCG test) or breastfeeding **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Chang Hee Lee, M.D. **Phone:** +82 31 260 9729 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Kevin Wait **Phone:** +1 540 649 5490 **Role:** CONTACT #### Locations **Location 1:** **City:** Little Rock **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Bryce Warren - **Phone:** 501-364-4003 - **Role:** CONTACT ***Contact 2:*** - **Name:** Kimo Stine, M.D. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Arkansas Children's Hospital **State:** Arkansas **Status:** RECRUITING **Zip:** 72202 **Location 2:** **City:** New Hyde Park **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Patricia Murray - **Phone:** 718-470-7380 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Lisa Patriarca - **Phone:** 718 470 7380 - **Role:** CONTACT ***Contact 3:*** - **Name:** Richard Lipton, M.D. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Long Island Jewish Medical Center - Hemophilia Treatment Center **State:** New York **Status:** RECRUITING **Zip:** 11040 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000025861 - Term: Blood Coagulation Disorders, Inherited - ID: D000001778 - Term: Blood Coagulation Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000020147 - Term: Coagulation Protein Disorders - ID: D000006474 - Term: Hemorrhagic Disorders - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9553 - Name: Hemophilia A - Relevance: HIGH - As Found: Hemophilia A - ID: M21977 - Name: Hemostatic Disorders - Relevance: LOW - As Found: Unknown - ID: M5059 - Name: Blood Coagulation Disorders - Relevance: LOW - As Found: Unknown - ID: M23095 - Name: Blood Coagulation Disorders, Inherited - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M21982 - Name: Coagulation Protein Disorders - Relevance: LOW - As Found: Unknown - ID: M9560 - Name: Hemorrhagic Disorders - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: T2710 - Name: Hemophilia - Relevance: HIGH - As Found: Hemophilia - ID: T2711 - Name: Hemophilia A - Relevance: HIGH - As Found: Hemophilia A ### Condition Browse Module - Meshes - ID: D000006467 - Term: Hemophilia A ### Intervention Browse Module - Browse Branches - Abbrev: Coag - Name: Coagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M8312 - Name: Factor VIII - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT03113279 **Brief Title:** Mechanisms of Age-Related Muscle Loss **Official Title:** Influence of Increasing Physical Activity on Body Composition, Metabolic Health and Muscle Anabolism in Old Obese Adults #### Organization Study ID Info **ID:** RG-13_183 #### Organization **Class:** OTHER **Full Name:** University of Birmingham ### Status Module #### Completion Date **Date:** 2016-08-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-04-13 **Type:** ACTUAL **Last Update Submit Date:** 2017-04-12 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-03-01 **Type:** ACTUAL #### Start Date **Date:** 2014-08-01 **Type:** ACTUAL **Status Verified Date:** 2017-04 #### Study First Post Date **Date:** 2017-04-13 **Type:** ACTUAL **Study First Submit Date:** 2017-03-28 **Study First Submit QC Date:** 2017-04-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Birmingham #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Two independent, but interrelated conditions that have a growing impact on healthy life expectancy and health care costs in developed nations are the age related loss of muscle mass (sarcopenia) and obesity. Sarcopenia affects approximately one third of adults over 60 years of age and more than 50% of those over 80 years, which is of concern when one considers that the most rapidly expanding population demographic in the UK is adults \>80 years of age. Skeletal muscle is important in regulating blood glucose and insulin sensitivity. Thus, sarcopenia may play a role in exacerbating insulin resistance and progression toward Type II diabetes (T2D). Indeed, the highest incidence of T2D in the UK has been noted to occur in adults \>65 years. Obesity is a major risk factor for chronic diseases including T2D and cardiovascular disease. Progression towards obesity is associated with a concomitant decrease in muscle mass, producing an unfavorable ratio of fat to muscle. Thus, obesity in old age may exacerbate the progression of sarcopenia. For the proposed study the investigators will conduct preliminary laboratory tests to characterize body composition, insulin sensitivity, systemic inflammation, aerobic capacity and muscle protein metabolism (in the fasted and fed state) in healthy older and obese older adults for comparison against healthy young individuals. **Detailed Description:** Twenty healthy young (aged 18-35), healthy old and obese older adults (aged ≥65) will be recruited. Old groups will be matched for age and sexual dimorphism. Obese participants will be classed as prediabetic based on a fasting A1C between 5.7 and 6.4% and impaired fasting glucose between 5.6 and 6.9 mmol/L. Obese participants will habitually take between 2000-5000 steps per day, whilst healthy young and old participants will complete \>5000 steps per day. VISIT 1 Preliminary assessments - Over a 3day period, participants will be instructed to wear a portable pedometer, to allow visual feedback on step count, and an armband accelerometer to determine habitual daily energy expenditure and the intensity of physical activity. In addition, participants will log their dietary intake. VISIT 2 Body composition and metabolic profiling After consuming a standardized meal the previous evening, participants will report to the Wellcome Trust Clinical Research Facility in a 10 hour fasted state at approximately 09.00. Participants will be weighed in light clothing and blood pressure will be measured. Thereafter, body composition will be determined using dual energy Xray absorptiometry (DXA) and resting metabolic rate (RMR) via ventilated hood and continuous gas collection. Following RMR, a catheter will be inserted into a forearm vein and a resting, fasted blood sample obtained to determine postprandial insulin sensitivity using the HOMA-IR index. VISIT 3 Muscle protein metabolism Participants will return to the lab in a 10 hour fasted-state at approximately 07.00 having refrained from strenuous exercise for 48 hours previously. Catheters will be inserted into the antecubital vein of both forearms. A primed, continuous infusion of isotopically labeled amino acid will be infused into one arm and the other will be used for frequent blood sampling. Muscle biopsies will be obtained 3 and 7 hours into the infusion to determine postabsorptive and postprandial rates of muscle protein synthesis. ### Conditions Module **Conditions:** - Sarcopenic Obesity - Muscle Weakness - Protein Metabolism Disorder - Physical Activity ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 38 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Obese older individuals **Label:** Obese older individuals #### Arm Group 2 **Description:** Lean older individuals **Label:** Lean older individuals #### Arm Group 3 **Description:** Young lean individuals **Label:** Young lean individuals ### Outcomes Module #### Primary Outcomes **Description:** Postabsorptive and postprandial myofibrillar protein synthesis rates between groups and following the activity intervention **Measure:** Myofibrillar protein synthesis rates via mass spectrometry **Time Frame:** 2 years #### Secondary Outcomes **Description:** muscle fibre type (i.e. I and II) and cross sectional area **Measure:** Muscle fibre properties via immunohistochemical staining **Time Frame:** 2 years **Description:** Intramyocellular lipid content in Type I and II fibres **Measure:** Muscle fibre lipid content immunofluorescent staining **Time Frame:** 2 years **Description:** Daily average time spent in sedentary, light, moderate or vigorous intensity activity **Measure:** Physical activity levels via accelerometry **Time Frame:** 2 years **Description:** Blood markers of inflammation, interleukin 6 and c-reactive protein **Measure:** Inflammation via plasma/insulin assays **Time Frame:** 2 years **Description:** Blood samples will be analyzed for insulin, glucose and hbA1C for indication of whole-body insulin sensitivity **Measure:** Insulin sensitivity via plasma assays **Time Frame:** 2 years **Description:** DXA-derived fat and fat free mass will be measured **Measure:** Body composition via dual x-ray absorptiometry **Time Frame:** 2 years **Description:** Western blots for phosphorylation of key anabolic signaling proteins **Measure:** Intramuscular signaling via western blot **Time Frame:** 2 years **Description:** Diet logs will be assessed for total energy and macronutrient intake **Measure:** Dietary intake via dietary logs **Time Frame:** 2 years **Description:** Average daily step count assessed via waist worn pedometer **Measure:** Daily step count by pedometer **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age: 65-85 years old for older individuals and 18-35 years for younger individuals 2. Sex: Men and women 3. BMI: 18-25 kg/m2 for healthy non-obese young and elderly control group and \>30 kg/m2 for obese older participants. 4. Diagnosis / General Health: For healthy elderly, good general health (no known cardiovascular or metabolic disease), nonsmokers, accustomed to normal levels of activity as assessed by pedometer and accelerometer devices during baseline testing (\>5000 steps per day). For obese elderly, general good health (no known cardiovascular or metabolic disease), nonsmokers, with low levels of physical activity as assessed by pedometer and accelerometer devices during baseline testing (\<4000 steps per day). Fasting blood glucose must be \<5.6 mmol/mL for healthy older adults and between 5.6 and 6.9 mmol/mL for obese older adults. Fasting concentrations of A1C should be \<5.7% for healthy and between 5.7 and 6.4% for prediabetic older adults. These values are in line with the type 2 diabetes classification listed by The American Diabetes Association (DIABETES CARE, VOLUME 33, SUPPLEMENT 1, JANUARY 2010). 5. Compliance: understands and is willing, able and likely to comply with all study procedures and restrictions. 6. Consent: demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent. Exclusion Criteria: 1. Health problems such as: heart disease, rheumatoid arthritis, diabetes, poor lung function, uncontrolled hypertension, or any health conditions that might put the participant at risk for this study. 2. Recent failure to obtain clearance for exercise participation from family physician/medical doctor. 3. Regular consumption of any analgesic or anti-inflammatory drug(s), prescription or nonprescription. 4. Taking any medications known to affect protein metabolism (i.e. b-blockers, corticosteroids, nonsteroidal anti-inflammatories, or prescription strength acne medications). Medications will be deemed inappropriate based on the Chief Investigators discretion 5. Individuals who complete fewer than 1000 steps per day (as assessed by pedometer prior to the study) or those who participate in regular structured exercise (running or strength training) more than 2 times per week. 6. Participants will be excluded if they fail to comply with the physical activity demands of the study. Exclusion will occur if the following are not met. Failure to meet the expected daily step count target on more than one occasion per week during the 21 day intervention will be deemed as failure to comply. 7. Participants who have previously (within 5 years of the present study) undergone infusion of an amino acid tracer and/or had 4 or more muscle biopsies obtained from the quadriceps region will be excluded. **Healthy Volunteers:** True **Maximum Age:** 85 Years **Minimum Age:** 65 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - OLDER_ADULT **Study Population:** * Young lean healthy inidivduals aged 18-35. * Lean healthy older individuals aged 65-85. * Obese inactive older individuals aged 65-85. ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Smeuninx B, Mckendry J, Wilson D, Martin U, Breen L. Age-Related Anabolic Resistance of Myofibrillar Protein Synthesis Is Exacerbated in Obese Inactive Individuals. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3535-3545. doi: 10.1210/jc.2017-00869. **PMID:** 28911148 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M20944 - Name: Muscle Weakness - Relevance: HIGH - As Found: Muscle Weakness - ID: M13204 - Name: Paresis - Relevance: LOW - As Found: Unknown - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: HIGH - As Found: Metabolism Disorders - ID: M4554 - Name: Asthenia - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000018908 - Term: Muscle Weakness - ID: D000008659 - Term: Metabolic Diseases ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT06216379 **Brief Title:** Sensory Processing Associated With Motor Skills **Official Title:** Is Sensory Processing Associated With Gross and Fine Motor Skills at 1-Year-Old? #### Organization Study ID Info **ID:** E-77082166-604.01.02-739050 #### Organization **Class:** OTHER **Full Name:** Gazi University ### Status Module #### Completion Date **Date:** 2023-12-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-01-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-01-11 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-08-01 **Type:** ACTUAL #### Start Date **Date:** 2023-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-01-22 **Type:** ACTUAL **Study First Submit Date:** 2024-01-11 **Study First Submit QC Date:** 2024-01-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Gazi University #### Responsible Party **Investigator Affiliation:** Gazi University **Investigator Full Name:** Ayse Simsek **Investigator Title:** Gazi University **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** In the study, sensory processing skills of 1-year-old preterm and term children will be evaluated. The relationship between sensory processing skills and gross and fine motor development will be investigated. ### Conditions Module **Conditions:** - Preterm Birth - Sensory Processing Disorder - Motor Delay ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 61 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Children born before 37 gestational weeks **Intervention Names:** - Diagnostic Test: Assessment **Label:** Preterm #### Arm Group 2 **Description:** Children born after 37 weeks of gestation **Intervention Names:** - Diagnostic Test: Assessment **Label:** Term ### Interventions #### Intervention 1 **Arm Group Labels:** - Preterm - Term **Description:** Sensory processing skills and gross and fine motor development of preterm and term born children were evaluated. **Name:** Assessment **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** The Test of Sensory Functions in Infants (TSFI) is a standardized and reliable tool designed to evaluate the sensory development of infants aged 4-18 months. Consisting of 24 items, the TSFI measures reactions in five distinct subdomains: tactile deep pressure, visual-tactile integration, adaptive motor function, ocular motor function, and reactivity to vestibular stimulation \[1\]. A specific age-normalized score is generated for each subdomain, contributing to a total score determined by the sum of all subdomains. The total score ranges from 0 to 49, with higher scores indicating more typical sensory responsiveness and lower scores suggesting behaviors associated with sensory over-responsivity \[2\]. In this study, a physiotherapist administered the TSFI to assess the sensory development of infants. **Measure:** Test of Sensory Functions in Infants TSFI **Time Frame:** 15 minutes #### Secondary Outcomes **Description:** The PDMS-2 is a widely employed and acknowledged assessment tool for evaluating a child's motor abilities. Its primary purpose is to distinguish and aid in identifying developmental delays in children aged 5 and below by comparing their performance against established norms \[3\]. The gross motor skills section includes 4 subtests: reflexes, stationary, locomotion, and object manipulation. Similarly, the fine motor skills segment consists of 2 subtests: grasping and visual-motor integration. Each item in the test is evaluated using a 3-point scoring system. **Measure:** Peabody Developmental Motor Scales-2 **Time Frame:** 30 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Premature group: Healthy children with a gestational age below 34 weeks Term group: Healthy children with gestational age between 37-41 weeks Exclusion Criteria: they had major congenital malformations, had genetic or chromosomal abnormalities, had known metabolic disorders, or had seizures. **Maximum Age:** 12 Months **Minimum Age:** 12 Months **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** Healthy children born preterm and term at 12 months of age ### Contacts Locations Module #### Locations **Location 1:** **City:** Erzurum **Country:** Turkey **Facility:** Erzurum Technical University ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007752 - Term: Obstetric Labor, Premature - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M25869 - Name: Premature Birth - Relevance: HIGH - As Found: Preterm Birth - ID: M10772 - Name: Obstetric Labor, Premature - Relevance: LOW - As Found: Unknown - ID: M10764 - Name: Obstetric Labor Complications - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000047928 - Term: Premature Birth ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT05393479 **Brief Title:** "Thinking Healthy Programme" for Perinatal Depression in Nepal **Official Title:** Feasibility, Acceptability, Appropriateness, and Preliminary Effectiveness of "Thinking Healthy Programme" for Perinatal Depression in Nepal: A Pilot Cluster Randomized Controlled Trial #### Organization Study ID Info **ID:** TPONepal #### Organization **Class:** OTHER **Full Name:** Transcultural Psychosocial Organization Nepal ### Status Module #### Completion Date **Date:** 2023-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-08-31 **Type:** ACTUAL **Last Update Submit Date:** 2023-08-30 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2023-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2022-11-15 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2022-05-26 **Type:** ACTUAL **Study First Submit Date:** 2022-04-26 **Study First Submit QC Date:** 2022-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Liverpool #### Lead Sponsor **Class:** OTHER **Name:** Transcultural Psychosocial Organization Nepal #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** As many as 1 in 3 women in Nepal suffer from perinatal depression however, they often go unidentified and untreated. Lack of knowledge limited trained human resources, and unavailability of specific maternal mental health services are some of the major barriers impeding help-seeking. To mitigate this gap, the World Health Organization recommended Thinking Healthy Programme (THP), a psychological intervention that can be delivered by non-specialists and has been proven effective for perinatal depression in a resource constrained context. The THP has already been translated and adapted to Nepali context. In this study, the investigators plan to pilot test the intervention and assess its feasibility, acceptability, appropriateness, and preliminary effectiveness when delivered by the Female Community Health Volunteers (FCHVs). The FCHVs are cadre of Nepal Government mobilized for the prevention and promotion of maternal and child health in the community level. **Detailed Description:** The Thinking Healthy Programme (THP) is a community based low-intensity psychosocial intervention tailored for perinatal depression in improving outcomes in three areas - a) mother's health, b) the mother-baby relationship, and c) the mother's relationship with others. The intervention has already been tested in other South Asian context and has been found effective in reducing depressive symptoms and promoting wellbeing even when delivered by a non-specialist with limited education. The intervention is basic and does not require prior knowledge or experience on mental health however, it is preferred that the deliverer should at least know about basics of maternal and childcare. In a resource poor country like Nepal where the investment and human resource for maternal mental health is scanty despite the high burden, the THP can be promising given its effectiveness and cost-effectiveness. The THP has already been adapted to the Nepali context. For the pilot-testing of THP, 4 health facilities will be selected. The health facilities will be randomized to intervention and control arm (2 health facilities in each arm). A list of pregnant women from the health facility's and FCHV's catchment area will be collected from the health facility's outpatient department (OPD) register and FCHV's register/logbook. Eligible women will be screened by the research assistant using the Patient Health Questionnaire (PHQ-9), a screening tool for depression consisting of 9 questions that has already been validated in Nepal. If the woman scores 10 or above in the screening tool, the research assistant will collect the baseline information within 1 week and will refer the woman to the respective FCHV from the same locality as the woman's. The FCHVs in the intervention arm will meet the woman, administer consent form regarding the "Thinking Healthy Programme" (THP). Participants providing consent will be engaged in the THP programme that will be delivered by the trained FCHV. The FCHVs in the control arm will meet the woman, provide psychoeducation, and refer to the health facility where mental health services are available. ### Conditions Module **Conditions:** - Perinatal Depression **Keywords:** - perinatal depression - psychological intervention - nonspecialist - low and middle income countries - pilot cluster randomized control trial ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The health facility is the unit of randomization. Altogether 4 health facilities will be selected for the study, where two health facilities will be allocated to each arm. The female community health volunteers (FCHVs) from the health facilities in the intervention arm will receive 10 days training on detection of perinatal depression and THP whilst the FCHVs from control arm will receive 3 days training on detection, psychoeducation, and referral. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Perinatal women identified with depression in intervention arm will be engaged in 2 modules, one during pregnancy and one during postnatal. Each module has 3 sessions each focusing on a) mother's health, b) the mother-baby relationship, and c) the mother's relationship with others. Altogether 8 sessions (including 1 introductory session, 6 THP sessions, and 1 closing session) each lasting 30 minutes to 1 hour will be provided to intervention arm participants. In the third session of each module that deals with "the mother's relationship with others", family members will be engaged as well. Questionnaire evaluation will be conducted at baseline, post-Module 1 (after 2 months from recruitment date) and at 3 months post delivery after completing Module 2 and closing session. **Intervention Names:** - Behavioral: Thinking Healthy Programme **Label:** Intervention Arm: Thinking Healthy Programme **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects in the control arm will receive usual care, where perinatal women identified with depression, are provided with psychoeducation about their condition and about the availability of services at the health facility and other health information. They will be then referred to the health facility where trained health workers are available. **Label:** Control Arm: Usual Care **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention Arm: Thinking Healthy Programme **Description:** The Thinking Healthy Programme (THP) is a psychological treatment recommended by the World Health Organization for perinatal depression. The THP is based on the basic tenets of cognitive behavioural therapy (CBT) that aims to identify unhealthy thoughts and the vicious effects it has on the emotions and behaviour of a person and transform to healthy thinking style that ultimately impacts one's emotions and behaviour, too. The intervention aims to bring positive outcomes in three areas - a) mother's health, b) the mother-baby relationship, and c) the mother's relationship with others. A randomized controlled trial (RCT) showed that the intervention was effective in reducing depressive symptoms and disability and improving functioning. Additionally, women receiving THP had higher rate of exclusive breastfeeding, and engaging more with their infants. Similarly, infants of these women were also less likely to have diarrhoeal episode and more likely to complete immunization. **Name:** Thinking Healthy Programme **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Competency of Female Community Health Volunteers will be assessed through Ensuring Quality in Psychological Support (EQUIP), an online platform consisting of a tool to assess clinical competency of mental health and psychosocial service providers. A service providers' competency is assessed in a Likert scale where 1 represents having harmful behaviour, 2 represents having any or none of the basic helping skills, 3 represents having all basic skills and 4 represents having any advanced skills. **Measure:** Change in Female Community Health Volunteers' clinical skills to provide psychological support **Time Frame:** From pre training to immediate post training **Description:** Service providers who deliver the Thinking Healthy Programme for duration of project will be asked through Focus Group Discussion and Key Informant Interviews about the feasibility of recruiting women with perinatal depression, delivering intervention in the community setting, engaging women, and their family members in the session. **Measure:** Qualitative Information: Feasibility from service providers' perspective **Time Frame:** Month 18 **Description:** Women with perinatal depression and their family members engaged in the Thinking Healthy Programme will be interviewed to explore feasibility in terms of engaging in the session, scheduling time for session, and completing tasks. **Measure:** Qualitative Information: Feasibility from service users' perspective **Time Frame:** 3 months postnatal **Description:** Service providers who deliver the Thinking Healthy Programme for duration of project will be asked through Focus Group Discussion and Key Informant Interviews about their experience delivering intervention focusing on facilitators and barriers, perceived benefits and challenges of intervention for perinatal depression, and their willingness to engage as deliver agents in the future. **Measure:** Qualitative Information: Acceptability from service providers' perspective **Time Frame:** Month 18 **Description:** Women with perinatal depression and their family members engaged in the Thinking Healthy Programme will be interviewed to explore facilitators and barriers to engage in the session, perceived benefits and challenges of receiving intervention in the home setting, and their perception of the service provider. **Measure:** Qualitative Information: Acceptability of of Thinking Healthy Programme from service users' perspective **Time Frame:** 3 months postnatal **Description:** Service providers who deliver the Thinking Healthy Programme for duration of project will be asked through Focus Group Discussion and Key Informant Interviews about their perception towards the intervention, its utility, suitability in Nepali context. **Measure:** Qualitative Information: Appropriateness of Thinking Healthy Programme from service providers' perspective **Time Frame:** Month 18 **Description:** Women with perinatal depression and their family members engaged in the Thinking Healthy Programme will be interviewed to explore their perception towards the intervention, its utility, suitability for their problem. **Measure:** Qualitative Information: Appropriateness of Thinking Healthy Programme from service users' perspective **Time Frame:** 3 months postnatal #### Secondary Outcomes **Description:** The PHQ-9 is a 9-item screening tool for depression used in various medical setting, and primary care setting. The tool has nine common symptoms of depression that should be rated by the respondent in a Likert scale where 0 stands for "not at all" to 3 "always". The symptoms are rated in relation to its occurrence and experience by the respondent in the past 2 weeks. The additional 1 question in PHQ9+1 is related to disability caused by depression. The tool has been translated and validated in a primary care population in Nepal. Symptoms severity will be assessed at baseline, 2 months post baseline and 3 months postnatal. **Measure:** Changes in Patient Health Questionnaire-9+1 **Time Frame:** Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8) **Description:** A 7-item screening tool for anxiety that is rated by the respondent in a Likert scale where 0 stands for "not at all" to 3 "nearly every day". The tool has already been used in Nepal. Symptoms severity will be assessed at baseline, 2 months post baseline and 3 months postnatal. **Measure:** Changes in Generalized Anxiety Disorder Scale **Time Frame:** Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8) **Description:** A 12-item tool that measures disability and functionality over the previous 30 days and has already been used in Nepal. Responses are rated in a scale where 1 means "none" and 5 means "extreme". Higher the score means higher the disability. **Measure:** Changes in World Health Organization's Disability Assessment Schedule **Time Frame:** Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8) **Description:** Alcohol Use Disorder Identification Test is a screening tool to identify probable alcohol dependence or alcohol misuse. The tool has 10 questions divided into 3 conceptual domains. The first domain assesses recent alcohol consumption and contains 3 questions (frequency of consumption, typical amount, and frequency of heavy consumption). The second domain assesses symptoms of dependence through 3 questions (loss of control over consumption, increased relevance of consumption, and morning consumption). The third domain assesses harmful alcohol through 4 questions (Feeling of guilt after consumption, memory gaps, alcohol-related injuries and environmental concern about consumption). The tool has been validated in Nepal and a result equal to or greater than 9 is considered indicative of alcohol dependence or alcohol misuse. **Measure:** Changes in Alcohol Use Disorder Identification Test **Time Frame:** Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8) **Description:** The brief version of Internalized Stigma of Mental Illness tool has 9-items that explores self-stigmatization of persons with mental illness. Responses are recorded from 1-4 scale where 1 means "strongly disagree" and 4 means "strongly agree". Higher the score means greater experience of stigma. The tool has been previously validated and used in other studies in Nepal. **Measure:** Changes in Internalized Stigma of Mental Illness **Time Frame:** Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8) **Description:** The Multidimensional Scale of Perceived Social Support is a 12-item instrument which measures perceived support from three sources: Family, Friends and Significant Others. It consists of 4 items for each sources and each item is graded on a 7-item likert scale where 1 means "very strongly disagree" and 7 means "very strongly agree". Higher the score in the scale means having stronger social support system. **Measure:** Changes in Multidimensional Scale of Perceived Social Support **Time Frame:** Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8) **Description:** Contains 9 structured questions in which the first 3 questions asks whether the person had suicidal thought, or plan or tried in the last 3 months. The questions only record occurrences of event with binary response options (Yes/No). Question no. 4 to 8 asks about whether medical attention was needed, whether the person has spoken to anyone, who they have spoken to, help sought, and treatment type. The last question asks about suicidal ideation at any point in their life in a yes/no option. **Measure:** Suicide Assessment **Time Frame:** Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8) **Description:** Four structured questions whether any antenatal visits were made (yes/no option), number of total visits, any health problems were seen (yes/no option), hospitalization was done (yes/no option). **Measure:** Antenatal care attendance **Time Frame:** Baseline (M0), 2 months after baseline (M2) **Description:** Three structured questions with binary option (yes/no) about any occurrences of physical, or emotional, or sexual violence in the last three months. **Measure:** Domestic violence **Time Frame:** Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8) **Description:** Four structured questions whether any postnatal visits were made (yes/no option), number of total visits, any health problems were seen (yes/no option), hospitalization was done (yes/no option). **Measure:** Postnatal care attendance **Time Frame:** 3 months postnatal (M4-M8) **Description:** Four structured questions to indicate whether exclusive breastfeeding has been done. First question asks whether the breastfeeding is done (yes/no option), milk adequacy (yes/no option), breastfeeding frequency, and use of formulas (yes/no option). **Measure:** Exclusive breastfeeding **Time Frame:** 3 months postnatal (M4-M8) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Pregnant women * Should be residing in the FCHV's catchment area * Should be between 4-7 months pregnant. * Should have no severe physical health conditions * Should have depressive symptoms (scores 10 or higher in PHQ-9). Exclusion Criteria: * Women reporting miscarriage, abortion, or still birth will be excluded from the THP intervention (but referred to the psychosocial counsellor for further care) **Gender Based:** True **Gender Description:** The subject being studied is perinatal depression i.e. women in pregnancy and postnatal period. **Healthy Volunteers:** True **Maximum Age:** 49 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Kathmandu **Country:** Nepal **Facility:** Transcultural Psychosocial Organization Nepal **State:** Bagmati **Zip:** 44616 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000007232 - Term: Infant, Newborn, Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M4545 - Name: Asphyxia Neonatorum - Relevance: HIGH - As Found: Perinatal Depression - ID: M4544 - Name: Asphyxia - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: T513 - Name: Asphyxia Neonatorum - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001238 - Term: Asphyxia Neonatorum - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT00810979 **Brief Title:** Comparison of SLx-4090 Combined With Statin Therapy Versus Statin Alone in Reducing LDL-C in Patients With Hyperlipidemia **Official Title:** A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Different Doses of SLx-4090 in Combination With a Statin vs. Statin Mono-therapy in Patients With Hyperlipidemia #### Organization Study ID Info **ID:** SLx-4090-08-06 #### Organization **Class:** INDUSTRY **Full Name:** Response Pharmaceuticals ### Status Module #### Completion Date **Date:** 2009-09 **Type:** ACTUAL #### Disp First Post Date **Date:** 2014-12-31 **Type:** ESTIMATED **Disp First Submit Date:** 2014-12-09 **Disp First Submit QC Date:** 2014-12-10 #### Expanded Access Info #### Last Update Post Date **Date:** 2023-11-18 **Type:** ACTUAL **Last Update Submit Date:** 2023-11-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2009-09 **Type:** ACTUAL #### Start Date **Date:** 2009-01 **Status Verified Date:** 2023-04 #### Study First Post Date **Date:** 2008-12-18 **Type:** ESTIMATED **Study First Submit Date:** 2008-12-17 **Study First Submit QC Date:** 2008-12-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Response Pharmaceuticals #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to determine whether SLx-4090 in combination with statin therapy will reduce LDL-C in patients with hyperlipidemia more effectively than statin therapy alone. **Detailed Description:** 1. LDL-C after 12 weeks of treatment 2. Safety and tolerability 3. Plasma levels of SLx-4090 ### Conditions Module **Conditions:** - Hyperlipidemia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 133 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** SLx-4090 dose #1 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician. **Intervention Names:** - Drug: SLx-4090 - Drug: Statin **Label:** 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** SLx-4090 dose #2 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician. **Intervention Names:** - Drug: SLx-4090 - Drug: Statin **Label:** 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Placebo in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician. **Intervention Names:** - Other: Placebo - Drug: Statin **Label:** 3 **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 **Description:** tablet **Name:** SLx-4090 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 2 **Description:** tablet **Name:** SLx-4090 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - 3 **Description:** matching tablet **Name:** Placebo **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - 1 - 2 - 3 **Description:** Subjects were dosed with the statin prescribed specifically by their prescribing physician. **Name:** Statin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Reduction in LDL-C **Time Frame:** 12 weeks #### Secondary Outcomes **Measure:** Adverse events **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * LDL-C \> or = 100 mg/dL * On stable statin therapy for at least 6 weeks Exclusion Criteria: * Coronary heart disease or risk factors for CHD **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Birmingham **Country:** United States **State:** Alabama **Zip:** 35209 **Location 2:** **City:** Tempe **Country:** United States **State:** Arizona **Zip:** 85282 **Location 3:** **City:** Tucson **Country:** United States **State:** Arizona **Zip:** 85710 **Location 4:** **City:** Jacksonville **Country:** United States **State:** Florida **Zip:** 32205 **Location 5:** **City:** Atlanta **Country:** United States **State:** Georgia **Zip:** 30342 **Location 6:** **City:** Addison **Country:** United States **State:** Illinois **Zip:** 60101 **Location 7:** **City:** Chicago **Country:** United States **State:** Illinois **Zip:** 60611 **Location 8:** **City:** Chicago **Country:** United States **State:** Illinois **Zip:** 60654 **Location 9:** **City:** Indianapolis **Country:** United States **State:** Indiana **Zip:** 46260 **Location 10:** **City:** Louisville **Country:** United States **State:** Kentucky **Zip:** 40213 **Location 11:** **City:** Edina **Country:** United States **State:** Minnesota **Zip:** 55435 **Location 12:** **City:** Saint Louis **Country:** United States **State:** Missouri **Zip:** 63141 **Location 13:** **City:** Rochester **Country:** United States **State:** New York **Zip:** 14609 **Location 14:** **City:** Raleigh **Country:** United States **State:** North Carolina **Zip:** 27609 **Location 15:** **City:** Cincinnati **Country:** United States **State:** Ohio **Zip:** 45212 **Location 16:** **City:** Cincinnati **Country:** United States **State:** Ohio **Zip:** 45219 **Location 17:** **City:** Cleveland **Country:** United States **State:** Ohio **Zip:** 44122 **Location 18:** **City:** Mount Pleasant **Country:** United States **State:** South Carolina **Zip:** 29464 **Location 19:** **City:** Richmond **Country:** United States **State:** Virginia **Zip:** 23294 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050171 - Term: Dyslipidemias - ID: D000052439 - Term: Lipid Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10000 - Name: Hyperlipidemias - Relevance: HIGH - As Found: Hyperlipidemia - ID: M10002 - Name: Hyperlipoproteinemias - Relevance: HIGH - As Found: Hyperlipidemia - ID: M26181 - Name: Dyslipidemias - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M27029 - Name: Lipid Metabolism Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006949 - Term: Hyperlipidemias - ID: D000006951 - Term: Hyperlipoproteinemias ### Intervention Browse Module - Browse Branches - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21155 - Name: Hydroxymethylglutaryl-CoA Reductase Inhibitors - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT03457779 **Brief Title:** Pilot Study To Investigate Targetable Metabolic Pathways Sustaining Triple Negative Breast Cancer **Official Title:** Pilot Study To Investigate Targetable Metabolic Pathways Sustaining Triple Negative (TN) Breast Cancer and Associated Genomic Alterations #### Organization Study ID Info **ID:** 017-396 #### Organization **Class:** OTHER **Full Name:** Baylor Research Institute ### Status Module #### Completion Date **Date:** 2020-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-10-08 **Type:** ACTUAL **Last Update Submit Date:** 2021-10-07 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-04-08 **Type:** ACTUAL #### Start Date **Date:** 2018-02-08 **Type:** ACTUAL **Status Verified Date:** 2021-10 #### Study First Post Date **Date:** 2018-03-08 **Type:** ACTUAL **Study First Submit Date:** 2018-02-08 **Study First Submit QC Date:** 2018-03-06 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Baylor Research Institute #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The primary objective is to describe and discover new insights into the glucose, amino acid, and lipid metabolic dependencies of TNBC via nuclear magnetic resonance (NMR) spectroscopy analysis of in vivo \[1,2-13C\] glucose-labeled breast cancer biopsies. The secondary objectives are to correlate the dominant metabolic dependencies of TNBCs with pathologic response to preoperative chemotherapy, and with the cancers' molecular signaling pathways assessed via NGS and RPPA. **Detailed Description:** One of the recognized hallmarks of cancer cells is deregulated cellular metabolism, characterized by enhanced metabolic autonomy compare with non-transformed cells. Tumor cells typically display an overall increase in glucose metabolism, associated with enhanced aerobic glycolysis and decreased oxidative phosphorylation, accompanied by a requirement for a high rate of protein, nucleotide, and fatty acid synthesis to provide the raw materials for cell division. 13C-glucose is a non-radioactive stable isotope tracer that has been widely used in vitro, in vivo, and in patients in a variety of disease settings to study glucose, amino acid, and lipid metabolism, at steady state and following intervention. \[1,2-13C\] glucose can provide additional information on the activity of the oxidative pentose phosphate pathway versus glycolysis. Administration of intravenous 13C-glucose is a convenient and affordable approach to analyzing the metabolomics of human cancers in their native microenvironments. The metabolic dependencies of the various breast cancer subtypes are poorly understood. Importantly, in depth analyses of the in situ metabolic processes utilized by triple-negative breast cancers (TNBCs) using state-of-the-art in vivo \[1,2-13C\]-glucose infusions in patients with TNBC has never been done. In TNBC, oncogenic activation of key signaling pathways leads to altered metabolic programming resulting in an increased dependence on exogenous nutrients such as glucose and glutamine. These data further suggest a hypothesis that TNBCs may employ a cellular mechanism called macropinocytosis to ingest and degrade interstitial albumin to accumulate glutamine. This process may then be exploited for therapeutic gain through enhanced uptake by cells that utilize macropinocytosis to meet their metabolic requirements. In this study, administration of \[1,2-13C\]-glucose to patients with TNBC will be done prior to patients undergoing a biopsy of their breast cancer as well as blood sample collection which will allow for in depth evaluation of glycolysis as well as lipid and amino acid metabolism by Joshua Rabinowitz, PhD, at Princeton University who is an international expert in cancer metabolomics. RAS and PI3K pathway and other genomic alterations as well as pathway activation status will be determined by next generation sequencing (NGS) and by reverse phase protein array (RPPA), and will be correlated with the metabolic findings, and both will be assessed in the context of the patients' response to standard preoperative chemotherapy. ### Conditions Module **Conditions:** - Triple Negative Breast Cancer ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** Patients with TNBC will receive \[1,2-13C\]-glucose IV to prior to undergoing a biopsy of their breast cancer and blood collection to allow for in depth evaluation. ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 16 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 4 patients without glucose infusion **Intervention Names:** - Dietary Supplement: Glucose **Label:** Non Glucose Arm **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 12 Patients with glucose infusion **Intervention Names:** - Dietary Supplement: Glucose **Label:** Glucose Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Glucose Arm - Non Glucose Arm **Description:** The first 4 patients enrolled on trial will undergo the research core biopsies of their TNBC without the 13C glucose infusion; these samples will serve as control tissue that will be processed identically to the tissues obtained from patients who received the glucose isotope. The following 12 patients will receive 6 grams (g) of \[1,2-13C\] glucose as an IV **Name:** Glucose **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Amount of glucose, amino acid, lipid will be measured in 16 patients with TNBC using NMR spectroscopy to see how metabolism is affected in TNBC. **Measure:** Amount of glucose, amino acid, and lipid metabolites in TNBC. **Time Frame:** 2 years #### Secondary Outcomes **Description:** A panel of key cancer cell signaling pathways will be analyzed in TNBC tissues from 16 patients using phosphoproteomic technology and next generation sequencing. The activated and deactivated pathways will be correlated with standard of care pathologic response (residual disease or no residual disease) and amount of glucose, amino acid, and lipid metabolized. **Measure:** Correlation of signaling pathways in TNBC with response and metabolites. **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: A patient will be considered for enrollment in this study if all the following criteria are met: 1. Female patients ≥18 years of age. 2. Have TNBC defined as invasive ductal cancer: ER- tumors with \<10% of tumor nuclei immunoreactive; PR- tumors with \<10% of tumor nuclei immunoreactive; HER2-negative defined as follows: 1. FISH-negative (FISH ratio \<2.0), or 2. IHC 0-1+, or 3. IHC 2+ AND FISH-negative (FISH ratio\<2.0) 3. Adequate hematologic function, defined by: 1. Absolute neutrophil count (ANC) \>1000/mm3 2. Platelet count ≥100,000/mm3 3. Hemoglobin \>9 g/dL (in the absence of red blood cell transfusion) 4. Adequate liver function, defined by: 1. AST and ALT ≤ 5 x the upper limit of normal (ULN) 2. Total bilirubin ≤1.5 x ULN 5. Adequate renal function, defined by: a. Serum creatinine ≤ 2 x ULN or calculated creatinine clearance of ≥60 ml/min 6. Have blood glucose \<250 mg/dL 7. Willing to undergo 1 mandatory core biopsy (6 passes) for research purposes. 8. All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry. Exclusion Criteria: A patient will be ineligible for inclusion in this study any of the following criteria are met: 1. Patients receiving any anti-cancer therapy (chemotherapy, immunotherapy, and/or biologic therapy). 2. Is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study. 3. Has a history of insulin-dependent diabetes. 4. Concomitant active malignancy 5. Is pregnant or breastfeeding. **Gender Based:** True **Gender Description:** Female patients ≥18 years of age. **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Dallas **Country:** United States **Facility:** Baylor University Medical Center **State:** Texas **Zip:** 75246 #### Overall Officials **Official 1:** **Affiliation:** Texas Oncology/Baylor Scott & White Health **Name:** Joyce O'Shaughnessy, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** De-Identified Data will be shared via encrypted email **Description:** For serum collection and storage at the Baylor BPM core, until they are shipped to Princeton University. The key metabolic dependency findings will be correlated with genomic and proteomic alterations assessed by NGS and RPPA, and with patients' response to preoperative chemotherapy. **Info Types:** - STUDY_PROTOCOL - SAP - CSR **IPD Sharing:** YES **Time Frame:** Data will be shared from opening of recruitment through study closure. ### References Module #### References **Citation:** Ghergurovich JM, Lang JD, Levin MK, Briones N, Facista SJ, Mueller C, Cowan AJ, McBride MJ, Rodriguez ESR, Killian A, Dao T, Lamont J, Barron A, Su X, Hendricks WPD, Espina V, Von Hoff DD, O'Shaughnessy J, Rabinowitz JD. Local production of lactate, ribose phosphate, and amino acids within human triple-negative breast cancer. Med. 2021 Jun 11;2(6):736-754. doi: 10.1016/j.medj.2021.03.009. Epub 2021 Apr 14. **PMID:** 34223403 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M30373 - Name: Triple Negative Breast Neoplasms - Relevance: HIGH - As Found: Triple Negative Breast Cancer - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms - ID: D000064726 - Term: Triple Negative Breast Neoplasms ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT00005979 **Brief Title:** Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer **Official Title:** Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence #### Organization Study ID Info **ID:** CDR0000067967 #### Organization **Class:** OTHER **Full Name:** UNICANCER #### Secondary ID Infos **ID:** FRE-FNCLCC-ACCORD-2 **ID:** FFCD-9802 **ID:** EU-20014 ### Status Module #### Completion Date **Date:** 2007-09-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-02-17 **Type:** ACTUAL **Last Update Submit Date:** 2021-02-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2005-09-26 **Type:** ACTUAL #### Start Date **Date:** 1998-07-22 **Type:** ACTUAL **Status Verified Date:** 2021-02 #### Study First Post Date **Date:** 2003-01-27 **Type:** ESTIMATED **Study First Submit Date:** 2000-07-05 **Study First Submit QC Date:** 2003-01-26 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Federation Francophone de Cancerologie Digestive #### Lead Sponsor **Class:** OTHER **Name:** UNICANCER #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan in treating patients who have stage III colon cancer. **Detailed Description:** OBJECTIVES: * Compare the effect of leucovorin calcium and fluorouracil with or without irinotecan on the 3 year survival rate and overall survival of patients with resected node positive colon cancer at high risk of recurrence. * Compare toxicities of these regimens in these patients. * Compare quality of life of these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, disease type (occlusion vs perforation vs N2 only), delay between surgery and chemotherapy (28 days or less vs over 28 days), and age (under 65 vs 65 and over). Patients are randomized to one of two treatment arms. * Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2. * Arm II: Patients receive irinotecan IV over 90 minutes on day 1 followed by leucovorin calcium and fluorouracil as in arm I. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, after 6 and 12 courses, and then at 1 year. Patients are followed every 3 months for 2 years, then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study within 3 years. ### Conditions Module **Conditions:** - Colorectal Cancer **Keywords:** - stage III colon cancer - adenocarcinoma of the colon ### Design Module #### Design Info **Allocation:** RANDOMIZED **Primary Purpose:** TREATMENT **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** FOLFIRI regimen **Type:** DRUG #### Intervention 2 **Name:** fluorouracil **Type:** DRUG #### Intervention 3 **Name:** irinotecan hydrochloride **Type:** DRUG #### Intervention 4 **Name:** leucovorin calcium **Type:** DRUG ### Eligibility Module **Eligibility Criteria:** DISEASE CHARACTERISTICS: * Histologically proven stage III adenocarcinoma of the colon that has been curatively resected within past 42 days * No metastatic disease * Node positive * No more than 4 nodes affected (Tx, N2, M0) AND/OR * N1 or N2 with perforation and/or occlusion * No prior rectal cancer within 10 cm of anal margin or that was treated with preoperative radiotherapy * No prior inflammatory disease of the intestine PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Neutrophil count at least 2,000/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin less than 1.25 times upper limit of normal (ULN) * SGOT and SGPT less than 3 times ULN * Alkaline phosphatase less than 3 times ULN Renal: * Not specified Cardiovascular: * No myocardial infarction within past 6 months * No insufficient cardiac function Other: * No other serious medical illness * No active infection * No other malignancy except skin cancer or carcinoma in situ of the cervix * No psychological or social condition that would preclude study * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics * No prior extensive intestinal resection **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Angers **Country:** France **Facility:** Centre Paul Papin **Zip:** 49036 **Location 2:** **City:** Bayonne **Country:** France **Facility:** Clinique St. Etienne **Zip:** 64100 **Location 3:** **City:** Bordeaux **Country:** France **Facility:** Institut Bergonie **Zip:** 33076 **Location 4:** **City:** Bourg-En-Bresse **Country:** France **Facility:** Centre Hospitalier de Fleyriat **Zip:** 01012 **Location 5:** **City:** Bourgoin-Jallieu **Country:** France **Facility:** Centre Hospitalier de Bourgoin - Jallieu **Zip:** 38300 **Location 6:** **City:** Brive **Country:** France **Facility:** Centre Hospitalier General **Zip:** 19101 **Location 7:** **City:** Caen **Country:** France **Facility:** Centre Regional Francois Baclesse **Zip:** 14076 **Location 8:** **City:** Creteil **Country:** France **Facility:** Centre Hospitalier Universitaire Henri Mondor **Zip:** 94010 **Location 9:** **City:** Dijon **Country:** France **Facility:** Faculte de Medecine **Zip:** 21033 **Location 10:** **City:** Dijon **Country:** France **Facility:** Hopital Du Bocage **Zip:** 21034 **Location 11:** **City:** Forbach **Country:** France **Facility:** Centre Hospitalier Maie Madeleine **Zip:** 57600 **Location 12:** **City:** Lyon **Country:** France **Facility:** Centre Leon Berard **Zip:** 69008 **Location 13:** **City:** Marseille **Country:** France **Facility:** Institut J. Paoli and I. Calmettes **Zip:** 13273 **Location 14:** **City:** Montpellier **Country:** France **Facility:** Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle **Zip:** 34298 **Location 15:** **City:** Nantes-Saint Herblain **Country:** France **Facility:** CRLCC Nantes - Atlantique **Zip:** 44805 **Location 16:** **City:** Orleans **Country:** France **Facility:** CHR D'Orleans - Hopital de la Source **Zip:** 45067 **Location 17:** **City:** Reims **Country:** France **Facility:** Institut Jean Godinot **Zip:** 51056 **Location 18:** **City:** Reims **Country:** France **Facility:** St Joseph's Medical Center **Zip:** 51056 **Location 19:** **City:** Reims **Country:** France **Facility:** Centre Hospitalier Universitaire **Zip:** 51092 **Location 20:** **City:** Rennes **Country:** France **Facility:** Centre Eugene Marquis **Zip:** 35064 **Location 21:** **City:** Rouen **Country:** France **Facility:** Hopital Charles Nicolle **Zip:** 76031 **Location 22:** **City:** Saint Cloud **Country:** France **Facility:** Centre Rene Huguenin **Zip:** 92210 **Location 23:** **City:** Strasbourg **Country:** France **Facility:** Hopitaux Universitaire de Strasbourg **Zip:** 67091 **Location 24:** **City:** Tarbes **Country:** France **Facility:** Centre Hospitalier de Tarbes **Zip:** 65013 **Location 25:** **City:** Toulouse **Country:** France **Facility:** Institut Claudius Regaud **Zip:** 31052 **Location 26:** **City:** Valence **Country:** France **Facility:** Centre Hospitalier Valence **Zip:** 26000 **Location 27:** **City:** Vandoeuvre-les-Nancy **Country:** France **Facility:** Centre Alexis Vautrin **Zip:** 54511 **Location 28:** **City:** Vannes **Country:** France **Facility:** Centre Hospitalier P. Chubert **Zip:** 56260 **Location 29:** **City:** Vichy **Country:** France **Facility:** Centre Hospitalier Regionale de Vichy **Zip:** 03201 **Location 30:** **City:** Villejuif **Country:** France **Facility:** Institut Gustave Roussy **Zip:** F-94805 #### Overall Officials **Official 1:** **Affiliation:** Institut du Cancer de Montpellier - Val d'Aurelle **Name:** Marc Ychou, MD, PhD **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Federation Francophone de Cancerologie Digestive **Name:** Jean Faivre **Role:** STUDY_CHAIR ### References Module #### References **Citation:** Ychou M, Raoul JL, Douillard JY, Gourgou-Bourgade S, Bugat R, Mineur L, Viret F, Becouarn Y, Bouche O, Gamelin E, Ducreux M, Conroy T, Seitz JF, Bedenne L, Kramar A. A phase III randomised trial of LV5FU2 + irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802). Ann Oncol. 2009 Apr;20(4):674-80. doi: 10.1093/annonc/mdn680. Epub 2009 Jan 29. **PMID:** 19179549 **Citation:** Cote JF, Kirzin S, Kramar A, Mosnier JF, Diebold MD, Soubeyran I, Thirouard AS, Selves J, Laurent-Puig P, Ychou M. UGT1A1 polymorphism can predict hematologic toxicity in patients treated with irinotecan. Clin Cancer Res. 2007 Jun 1;13(11):3269-75. doi: 10.1158/1078-0432.CCR-06-2290. Epub 2007 May 17. **PMID:** 17510208 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000015179 - Term: Colorectal Neoplasms - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M6338 - Name: Colonic Neoplasms - Relevance: HIGH - As Found: Colon Cancer - ID: M17890 - Name: Colorectal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003110 - Term: Colonic Neoplasms ### Intervention Browse Module - Ancestors - ID: D000077264 - Term: Calcium-Regulating Hormones and Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000059004 - Term: Topoisomerase I Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000000931 - Term: Antidotes - ID: D000020011 - Term: Protective Agents - ID: D000014803 - Term: Vitamin B Complex - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M6191 - Name: Leucovorin - Relevance: HIGH - As Found: Stem Cell - ID: M8600 - Name: Fluorouracil - Relevance: HIGH - As Found: According - ID: M29233 - Name: Levoleucovorin - Relevance: HIGH - As Found: Root - ID: M1671 - Name: Irinotecan - Relevance: HIGH - As Found: CT scan - ID: M5381 - Name: Calcium - Relevance: HIGH - As Found: Radiation - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M29349 - Name: Topoisomerase I Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4250 - Name: Antidotes - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: HIGH - As Found: Root - ID: T120 - Name: Cola - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002955 - Term: Leucovorin - ID: D000005472 - Term: Fluorouracil - ID: D000077146 - Term: Irinotecan - ID: D000002118 - Term: Calcium - ID: D000058766 - Term: Levoleucovorin ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT03319979 **Brief Title:** DHFR 19 bp Deletion Polymorphism and Folic Acid Utilization **Official Title:** DHFR 19 bp Deletion Polymorphism and Folic Acid Utilization #### Organization Study ID Info **ID:** ORA# 1211023 #### Organization **Class:** OTHER **Full Name:** Tufts University ### Status Module #### Completion Date **Date:** 2015-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-10-24 **Type:** ACTUAL **Last Update Submit Date:** 2017-10-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2015-03 **Type:** ACTUAL #### Start Date **Date:** 2013-02 **Status Verified Date:** 2017-10 #### Study First Post Date **Date:** 2017-10-24 **Type:** ACTUAL **Study First Submit Date:** 2017-10-20 **Study First Submit QC Date:** 2017-10-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tufts University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** A genetic variation in the gene for the protein dihydrofolate reductase (DHFR) that is necessary to utilize folic acid (a synthetic form of the B vitamin folate found in supplements and fortified food), increases the risk for breast cancer in multivitamin users and, when present in mothers who used folic acid supplements during pregnancy, increases the risk for cancer of the eye of their children. The aim of the proposed research is to understand how a common genetic variation in the gene for DHFR affects the function of this protein and the ability of the body to use folic acid. **Detailed Description:** A 19bp deletion polymorphism of intron 1 of dihydrofolate reductase (DHFR 19bpdel) increases the risk for breast cancer, and retinoblastoma of the offspring, in folic acid supplement users. Folic acid is a synthetic form of folate present in fortified foods and supplements that must be converted to tetrahydrofolate by DHFR to enter the metabolism. Individuals homozygous for DHFR 19bpdel have higher prevalence of unmetabolized folic acid in plasma and lower incorporation of folic acid into tissues. How the DHFR19bpdel (17% homozygosity in US) affects DHFR activity and folate metabolism to increase cancer risk is not understood. Studies on this topic are urgent in the light of mandatory folic acid fortification in the US and other countries. The objective of this project is to characterize the effect of DHFR 19bpdel on DHFR activity and folate pathway reactions and to determine if the effect of DHFR 19bpdel can be alleviated with folinic acid, which is a folate source that need not be converted by DHFR. The specific aims of this project are to 1\] Determine expression of DHFR mRNA and protein, splicing of intron 1 and enzyme activity in white blood cells from 3 DHFR genotypes. 2\] Determine the effect of DHFR 19bpdel and folic acid or folinic acid concentration on cell growth, and folate pathway reactions in white blood cells in homozygotes for DHFR 19bpdel and those who lack the polymorphism. Results of this study will guide measures to reduce this modifiable cancer risk associated with DHFR 19bpdel. ### Conditions Module **Conditions:** - Characterize rs70991108 Polymorphism of DHFR Gene **Keywords:** - Folate, DHFR ### Design Module #### Design Info **Observational Model:** ECOLOGIC_OR_COMMUNITY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 117 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** DHFR mRNA and protein abundance determined for the 19 bp deletion genotypes **Measure:** DHFR mRNA and protein abundance **Time Frame:** 1 year #### Secondary Outcomes **Description:** Effect of DHFR 19bp deletion on reactions of folate pathway determined in cell culture conditions **Measure:** Reactions of folate pathway **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult premenopausal women aged 21-45 in general good health, non-pregnant, minimum weight of 110 pounds. Exclusion Criteria: * Smoking, a terminal illness, any known chronic illness, rheumatoid arthritis, heart, kidney, liver or gastrointestinal disease requiring treatment, antifolate medications, metformin use. * More than 2 drinks a day. * Pregnant women have different metabolism when compared to other adults hence they will not be included in the study. * Non-English speaking subjects will be excluded since the study involves a computer based diet history questionnaire in English. The budget for this project does not include the cost of an interpreter. **Gender Based:** True **Gender Description:** Pre-menopausal women **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 21 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** Healthy pre-menopausal females aged 21-45 from Metro Boston area ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Tufts University **Name:** Ligi Paul, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT03569579 **Brief Title:** CKD-355 Drug-drug Interaction Study (CKD-355 DDI P1) **Official Title:** A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Effect of D797 on Pharmacokinetics of D324 in Healthy Volunteers #### Organization Study ID Info **ID:** 179DDI18002 #### Organization **Class:** INDUSTRY **Full Name:** Chong Kun Dang Pharmaceutical ### Status Module #### Completion Date **Date:** 2018-06-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-06-26 **Type:** ACTUAL **Last Update Submit Date:** 2018-06-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-05-21 **Type:** ACTUAL #### Start Date **Date:** 2018-04-16 **Type:** ACTUAL **Status Verified Date:** 2018-06 #### Study First Post Date **Date:** 2018-06-26 **Type:** ACTUAL **Study First Submit Date:** 2018-06-15 **Study First Submit QC Date:** 2018-06-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Chong Kun Dang Pharmaceutical #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate a pharmacokinetic drug interaction between D797 of D324 in healthy volunteers **Detailed Description:** To healthy subjects of twenty(20), following treatments are administered dosing in each period and wash-out period is a minimum of 21 days. ### Conditions Module **Conditions:** - Central Nervous System Diseases ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Period 1: Treatment A(Memantine Tab. 10mg)\*2T, QD, PO. Period 2: Treatment B(Memantine Tab. 10mg)\*2T + Donepezil Tab. 10mg)\*1T, QD, PO. Each treatment period was separated by a washout period of at least 21 dyas. **Intervention Names:** - Drug: Memantine Tab. 10mg - Drug: Memantine Tab. 10mg + Donepezil Tab. 10mg **Label:** Group 1(Treatment A/Treatment B) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Period 1: Treatment B(Memantine Tab. 10mg)\*2T + Donepezil Tab. 10mg)\*1T, QD, PO. Period 2: Treatment A(Memantine Tab. 10mg)\*1T, QD, PO. Each treatment period was separated by a washout period of at least 21 dyas. **Intervention Names:** - Drug: Memantine Tab. 10mg - Drug: Memantine Tab. 10mg + Donepezil Tab. 10mg **Label:** Group 1(Treatment B/Treatment A) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group 1(Treatment A/Treatment B) - Group 1(Treatment B/Treatment A) **Description:** Memantine Tab. 10mg\* 2T/day, QD, PO **Name:** Memantine Tab. 10mg **Other Names:** - Ebixa Tab. 10mg **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Group 1(Treatment A/Treatment B) - Group 1(Treatment B/Treatment A) **Description:** Memantine Tab. 10mg\* 2T/day + Donepezil Tab. 10mg \* 1T/day, QD, PO **Name:** Memantine Tab. 10mg + Donepezil Tab. 10mg **Other Names:** - Ebixa Tab. 10mg + Aricept Tab. 10mg **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Area under the plasma concentration of Memantine versus time curve from time zero to time of last quantifiable concentration **Measure:** AUCt of Memantine **Time Frame:** 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h **Description:** Maximum plasma concentration of Memantine **Measure:** Cmax of Memantine **Time Frame:** 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h #### Secondary Outcomes **Description:** Area under the plasma concentration of Memantine versus time curve from time zero to time infinity **Measure:** AUCinf of Memantine **Time Frame:** 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h **Description:** Time to maximum concentration of of Memantine **Measure:** Tmax of Memantine **Time Frame:** 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h **Description:** Apparent terminal half-life of Memantine **Measure:** t1/2 of Memantine **Time Frame:** 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h **Description:** Total body clearance of Memantine **Measure:** CL/F of Memantine **Time Frame:** 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h **Description:** Apparent volume of distribution of Memantine **Measure:** Vd/F of Memantine **Time Frame:** 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. A healthy adult whose age is over 19 years old when visiting for initial screening test 2. Body mass index(BMI) between 17.5\~30.5 kg/m\^2 and the body weight must be over 55kg (Body mass index (BMI) = weight (kg) / height (m)\^2) 3. A person with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area 4. Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, the electrocardiogram (ECG), and etc. 5. The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs. 6. The participants must have an ability and willingness to participate throughout the entire trials Exclusion Criteria: 1. A person who had a history or symptoms of clinically aware of blood, kidney, internal secretion, gastrointestinal, urinary system, cardiovascular, liver, mental, nercous, or allergic(except subclinical seasonal allergies that is not treated at injecion) desease. 2. Who had a gistory of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy) 3. Who had following results after examination a. ALT or AST \> twice higher than normal value 4. Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250 mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (!2%) (125 mL) = 12g) 5. Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial. 6. Whose blood pressure \< 100 or ≥140(systolic blood pressure) or \< 70 or ≥ 90(diastolic blood pressure) 7. Who had a medical history of alcohol and drug abuses. 8. Who had taken a drug that has a control of metabolic rate (activatioh or inhibithion) in 30 days before the first taking of clinical testing durg. 9. Who smokes more than 10 eigarettes per day. 10. Who took prescribed drugs or over-the-conuter durgs in 10 days before taking of very first clinical testing drug. 11. Who participated in whole blood donation in 2 months before the first taking of clinical testing drugs or platelet donations in 1 month before the first taking to clinical testing drugs. 12. Who has a potent to increase a danger by participating in the clinical trials or sho can interrupt interpretin test results by having serious or chronic medical and mental status or having issues in results of the screening examination. 13. Who has a histroy of an extreme sensitivity of drugs that contain donepezil hydrochloride, piperidine derivatives, memantine hydrochloride drugs. Who has a serious heart failure or a congestive heart failure that must be drug-treated 14. Who has a Pregnant or potentially pregnant. 15. Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders. 16. A patient with severe hepatopathy 17. A patient with moderate nephropathy. 18. A person who is not determined unsuitable to participate in this test by the researchers. **Healthy Volunteers:** True **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Jeonju **Country:** Korea, Republic of **Facility:** Chonbuk National University Hospital #### Overall Officials **Official 1:** **Affiliation:** Chonbuk National University Hospital **Name:** Kyung-Ho Jang, Professor **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5742 - Name: Central Nervous System Diseases - Relevance: HIGH - As Found: Central Nervous System Diseases ### Condition Browse Module - Meshes - ID: D000009422 - Term: Nervous System Diseases - ID: D000002493 - Term: Central Nervous System Diseases ### Intervention Browse Module - Ancestors - ID: D000002800 - Term: Cholinesterase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018678 - Term: Cholinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018697 - Term: Nootropic Agents - ID: D000000978 - Term: Antiparkinson Agents - ID: D000018726 - Term: Anti-Dyskinesia Agents - ID: D000015259 - Term: Dopamine Agents - ID: D000018691 - Term: Excitatory Amino Acid Antagonists - ID: D000018683 - Term: Excitatory Amino Acid Agents ### Intervention Browse Module - Browse Branches - Abbrev: NootAg - Name: Nootropic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnDyAg - Name: Anti-Dyskinesia Agents - Abbrev: CaAg - Name: Cardiotonic Agents ### Intervention Browse Module - Browse Leaves - ID: M1721 - Name: Donepezil - Relevance: HIGH - As Found: Unresectable - ID: M11542 - Name: Memantine - Relevance: HIGH - As Found: Portion - ID: M6040 - Name: Cholinesterase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20758 - Name: Cholinergic Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M20774 - Name: Nootropic Agents - Relevance: LOW - As Found: Unknown - ID: M4295 - Name: Antiparkinson Agents - Relevance: LOW - As Found: Unknown - ID: M7473 - Name: Dopamine - Relevance: LOW - As Found: Unknown - ID: M17962 - Name: Dopamine Agents - Relevance: LOW - As Found: Unknown - ID: M20771 - Name: Excitatory Amino Acid Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008559 - Term: Memantine - ID: D000077265 - Term: Donepezil ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT05659979 **Brief Title:** Comprehensive Geriatric Assessment in Knee Osteoarthritis **Official Title:** The Role of Comprehensive Geriatric Assessment in Older Patients Affected by Knee Osteoarthritis: an Exploratory Randomized Controlled Trial #### Organization Study ID Info **ID:** ITA7976 #### Organization **Class:** OTHER **Full Name:** University of Palermo ### Status Module #### Completion Date **Date:** 2024-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2022-12-21 **Type:** ACTUAL **Last Update Submit Date:** 2022-12-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-01-01 **Type:** ESTIMATED **Status Verified Date:** 2022-12 #### Study First Post Date **Date:** 2022-12-21 **Type:** ACTUAL **Study First Submit Date:** 2022-12-03 **Study First Submit QC Date:** 2022-12-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Charles University, Czech Republic **Class:** OTHER **Name:** Ente Ospedaliero Ospedali Galliera **Class:** OTHER **Name:** St. Marien-Hospital Düren **Class:** OTHER **Name:** Erasmus University Rotterdam #### Lead Sponsor **Class:** OTHER **Name:** University of Palermo #### Responsible Party **Investigator Affiliation:** University of Palermo **Investigator Full Name:** Nicola Veronese **Investigator Title:** Dr. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Osteoarthritis (OA) is the most common form of arthritis, and is characterized by joint pain and stiffness leading to functional decline and relevant loss in quality of life. The management of knee OA is demanded to several specialists, including general practitioners, rheumatologists, orthopedics and finally geriatricians. However, the exact role of geriatricians in the management of knee OA was poorly studied, whilst the comprehensive geriatric assessment (CGA) is widely used for preventing negative consequences in older people. **Detailed Description:** Osteoarthritis (OA) is the most common form of arthritis, and is characterized by joint pain and stiffness leading to functional decline and relevant loss in quality of life. The incidence of OA is rising due to the aging population and an increase in some risk factors, such as obesity. Knee OA is the most common OA localization, and symptomatic knee OA is highly prevalent among people aged over 50 years, affecting more than 250 million people worldwide. Knee OA is a leading cause of pain in older people, and pain of the hip and knee results in physical disability and an increased risk of all-cause mortality. Hip and knee OA together are the eleventh highest contributor to global disability: the years of life lived with OA-related disability increased by 64% from 1990 to 2010 reaching 17 million. OA is a progressive disorder, with different degrees of severity, that requires long-term management with various treatment options over the course of the disease. The goals of treatment for OA are to reduce symptoms and ultimately slow disease progression, which may in turn reduce the impact of OA on the patient's mobility and quality of life, with consequent reduction in healthcare resource needs. In 2019, the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) published recommendations for the management of knee OA in the form of a treatment algorithm that provides practical guidance for the prioritization of interventions and guides physicians through progressive, logical steps based on the severity of the knee OA signs/symptoms. The management of knee OA is therefore demanded to several specialists, including general practitioners, rheumatologists, orthopedics and finally geriatricians. However, the exact role of geriatricians in the management of knee OA was poorly studied, whilst the comprehensive geriatric assessment (CGA) is widely used for preventing negative consequences in older people, such as hospitalization or mortality. Moreover, CGA can be used across different settings, from primary care to hospital, with similar beneficial effects in older people. Finally, people affected by knee OA are usually affected by other medical (e.g., dementia, cardiovascular diseases, depression) and non-medical (e.g., loneliness) conditions that can limit the adherence to therapeutic approaches, therefore limiting the efficacy of the interventions suggested in knee OA. ### Conditions Module **Conditions:** - Osteo Arthritis Knee ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This group will receive a comprehensive geriatric assessment evaluation during the study, using the multidimensional prognostic index **Intervention Names:** - Other: Comprehensive geriatric assessment **Label:** Comprehensive Geriatric Assessment **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** This group will receive standard/usual care **Label:** Controls **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Comprehensive Geriatric Assessment **Description:** A detailed comprehensive geriatric assessment will be given to all the participants randomized to this group, including the administration of multidimensional prognostic index (MPI), a tool derived from the CGA and consisting of eight different domains. **Name:** Comprehensive geriatric assessment **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** We will use the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale. The WOMAC, that is one of the most used tool in knee OA research, measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The single items of the WOMAC will be assessed as co-primary outcomes. **Measure:** Change in pain, physical function, stiffness **Time Frame:** Baseline, 3 months, 6 months #### Secondary Outcomes **Description:** Adherence to medications suggested during the first visit will be evaluated during the follow-up period using questionnaires. **Measure:** Change in the adherence to medications **Time Frame:** Baseline, 3 months, 6 months **Description:** This outcome will be explored using the multidimensional prognostic index (MPI), a scale that measures eight different domains typical of older people. The sum of the calculated scores from the eight domains will be divided by 8 to obtain a final MPI risk score ranging from 0 = no risk to 1 = higher risk of mortality. **Measure:** Change in the severity of multidimensional frailty **Time Frame:** Baseline, 3 months, 6 months **Description:** The short form 36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the less quality of life. **Measure:** Change in the quality of life **Time Frame:** Baseline, 3 months, 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Both genders * Age \> 70 years; able to sign the informed consent * Diagnosis of knee OA according to standardized criteria in Grade 1 (doubtful narrowing of joint space and possible osteophytic lipping), Grade 2 (definite osteophytes and possible narrowing of joint space) Kellgren and Lawrence system or Grade 3 (moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends). Exclusion Criteria: * Expected life expectancy less than 6 months * Previous orthopedic surgery, in the three months before the enrolment or a planned orthopedic intervention in the next 6 months. **Minimum Age:** 70 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Nicola Veronese, MD **Phone:** 0916558519 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Palermo **Name:** Nicola Veronese, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteo Arthritis - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Osteo Arthritis Knee - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT05661279 **Brief Title:** Rhomboid Intercostal Block Versus Serratus Anterior Plane Block **Official Title:** Ultrasound Guided Rhomboid Intercostal Block Versus Serratus Anterior Plane Block for Analgesia After Thoracodorsal Artery Perforator Flap Following Partial Mastectomy #### Organization Study ID Info **ID:** zu-IRB # 10060 #### Organization **Class:** OTHER_GOV **Full Name:** Zagazig University ### Status Module #### Completion Date **Date:** 2023-10-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-09-06 **Type:** ACTUAL **Last Update Submit Date:** 2023-09-02 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2023-10-02 **Type:** ESTIMATED #### Start Date **Date:** 2022-12-30 **Type:** ACTUAL **Status Verified Date:** 2023-09 #### Study First Post Date **Date:** 2022-12-22 **Type:** ACTUAL **Study First Submit Date:** 2022-12-01 **Study First Submit QC Date:** 2022-12-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Zagazig University #### Responsible Party **Investigator Affiliation:** Zagazig University **Investigator Full Name:** Heba M Fathi **Investigator Title:** prof/Dr **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** evaluate and compare the impact of ultrasound guided rhomboid intercostal block versus serratus anterior plane block for analgesia after thoracodorsal artery perforator flap following partial mastectomy **Detailed Description:** * To assess and compare quality of post- operative analgesia in each group. * Time of performance of block in both groups. * To assess and compare post-operative hemodynamics as well as anticipated adverse effects including nausea, vomiting, itching, hemorrhage, bradycardia, hypotension. ### Conditions Module **Conditions:** - Postoperative Pain **Keywords:** - rhomboid intercostal block -serratus anterior plane block - thoracodorsal artery perforator flap ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 84 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** control group who will be given general anesthesia only **Intervention Names:** - Procedure: general anesthesia **Label:** Group C: **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Rhomboid intercostal block then general anesthesia **Intervention Names:** - Procedure: general anesthesia - Procedure: general anesthesia plus Rhomboid intercostal block **Label:** Group R: **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Serratus anterior plane block then general anesthesia **Intervention Names:** - Procedure: general anesthesia - Procedure: Serratus anterior plane block **Label:** group S **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group C: - Group R: - group S **Description:** general anesthesia **Name:** general anesthesia **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Group R: **Description:** the patients will be positioned in lateral decubitus with moving the scapula laterally by abducting the ipsilateral arm across the chest. under complete aseptic situations A high-frequency (6-12 MHz) linear US probe will be put medial to the medial border of the scapula in an oblique sagittal plane with the orientation marker directed cranially.at the T6-7 level, the tissue plain between the rhomboid major and intercostal muscles is identified, and a single injection of 25mL of bupivacaine (0.25%) will be administered via 18-gauge Tuohy advanced in plane from a superomedial to an inferolateral direction, followed by general anesthesia **Name:** general anesthesia plus Rhomboid intercostal block **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - group S **Description:** The patient will be positioned supine with his arm abducts at 90°. the US high frequency (6-12 MHz) linear probe of sonosite M turbo ultrasonography (FUJIFIM sonosite, Inc., Bothell, WA, USA) will be put in sagittal plane at the midaxillary line. identification of the fascial plane between the serratus anterior muscle and external intercostal muscles will be performed between the fourth and fifth ribs in the midaxillary area . At this point the18-gauge Tuohy needle will be advanced in plane with injection of 25mL of 0.25 %, bupivacaine. followed by general anesthesia **Name:** Serratus anterior plane block **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The amount of tramadol consumption **Measure:** tramadol consumption **Time Frame:** at 24 hours postoperative #### Secondary Outcomes **Description:** Time needed to performance the block **Measure:** Time of performance of block **Time Frame:** time from positioning of ultrasound porbe till the end of block procedure. **Description:** the first time that the patients need analgesia when VAS ≥ 3 **Measure:** Time to first dose of rescue analgesia **Time Frame:** during the first 24 hours postoperatively **Description:** nausea, vomiting, local anesthesia toxicity, needle injury **Measure:** Anticipated side effect **Time Frame:** at 24 hous post operative **Description:** Post operative patient's satisfaction using 3 point scale (1= satisfied ,2=neutral, 3=not satisfied) **Measure:** Post operative patient's satisfaction **Time Frame:** at 24 hours post operative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients aged between 21 to 60 years * Undergoing pedicled thoracodorsal artery perforator flap following breast conserving surgery -General anesthesia * Informed consents * ASA I \& II * Body mass index 25-30 kg/m2. Exclusion Criteria: * patients on anti-platelet, anticoagulant or B blocker drugs * Patients with acute decompensated heart failure, hypertension, heart block, coronary disease, Asthma, bleeding disorders, compromised renal or hepatic function * history of allergy to local anesthesia or opioid analgesia, * pregnancy. **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Heba M Fathi, M.D **Phone:** 01000143938 **Role:** CONTACT #### Locations **Location 1:** **City:** Zagazig **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Heba M Fathi, M.D - **Role:** CONTACT **Country:** Egypt **Facility:** Heba M Fathi **Status:** RECRUITING **Zip:** 44519 #### Overall Officials **Official 1:** **Affiliation:** faculty of human medicine ,zagazig university **Name:** Heba M Fathi **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Postoperative Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative ### Intervention Browse Module - Ancestors - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: HIGH - As Found: Imaging - ID: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000777 - Term: Anesthetics ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02247479 **Acronym:** CHROMA **Brief Title:** A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration **Official Title:** A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration #### Organization Study ID Info **ID:** GX29176 #### Organization **Class:** INDUSTRY **Full Name:** Hoffmann-La Roche #### Secondary ID Infos **ID:** 2014-000107-27 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2018-01-29 **Type:** ACTUAL #### Disp First Post Date **Date:** 2018-08-16 **Type:** ACTUAL **Disp First Submit Date:** 2018-08-14 **Disp First Submit QC Date:** 2018-08-14 #### Expanded Access Info #### Last Update Post Date **Date:** 2019-06-26 **Type:** ACTUAL **Last Update Submit Date:** 2019-06-17 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2018-01-29 **Type:** ACTUAL #### Results First Post Date **Date:** 2019-04-23 **Type:** ACTUAL **Results First Submit Date:** 2019-01-22 **Results First Submit QC Date:** 2019-04-19 #### Start Date **Date:** 2014-09-18 **Type:** ACTUAL **Status Verified Date:** 2019-06 #### Study First Post Date **Date:** 2014-09-25 **Type:** ESTIMATED **Study First Submit Date:** 2014-07-15 **Study First Submit QC Date:** 2014-09-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Hoffmann-La Roche #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). ### Conditions Module **Conditions:** - Geographic Atrophy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 906 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections for approximately 96 weeks. **Intervention Names:** - Drug: Lampalizumab **Label:** Lampalizumab Once in Every 4 Weeks (Q4W) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive 10 mg dose of lampalizumab administered by intravitreal injections for approximately 96 weeks. **Intervention Names:** - Drug: Lampalizumab **Label:** Lampalizumab Once in Every 6 Weeks (Q6W) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants will receive sham comparator Q4W or Q6W for 96 weeks. **Intervention Names:** - Other: Sham **Label:** Sham Comparator **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Lampalizumab Once in Every 4 Weeks (Q4W) - Lampalizumab Once in Every 6 Weeks (Q6W) **Description:** Participants will receive 10 mg dose of lampalizumab administered intravitreally. **Name:** Lampalizumab **Other Names:** - RO5490249 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Sham Comparator **Description:** A sham injection is a procedure that mimics an intravitreal injection of lampalizumab. **Name:** Sham **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression). **Measure:** Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48 **Time Frame:** Baseline, Week 48 **Description:** For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression). **Measure:** Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48 **Time Frame:** Baseline, Week 48 #### Secondary Outcomes **Description:** Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening. **Measure:** Change From Baseline in Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry at Week 48 **Time Frame:** Baseline, Week 48 **Description:** Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Measure:** Change From Baseline in Mean Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48 **Time Frame:** Baseline, Week 48 **Description:** BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Measure:** Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48 **Time Frame:** Baseline, Week 48 **Description:** Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Measure:** Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48 **Time Frame:** Week 48 **Description:** The LLVA was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. LLVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Measure:** Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48 **Time Frame:** Baseline, Week 48 **Description:** Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Measure:** Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48 **Time Frame:** Week 48 **Description:** MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Measure:** Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48 **Time Frame:** Baseline, Week 48 **Description:** MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Measure:** Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48 **Time Frame:** Baseline, Week 48 **Description:** NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health,general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Measure:** Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48 **Time Frame:** Baseline, Week 48 **Description:** NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Measure:** Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48 **Time Frame:** Baseline, Week 48 **Description:** NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Measure:** Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48 **Time Frame:** Baseline, Week 48 **Description:** The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Measure:** Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48 **Time Frame:** Baseline, Week 48 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) with no evidence of prior or active choroidal neovascularization (CNV) in both eyes Exclusion Criteria: Ocular Exclusion Criteria: Study Eye * History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD * Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy * Previous intravitreal drug delivery (intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular Exclusion Criteria: Both Eyes * GA in either eye due to causes other than AMD * Previous treatment with eculizumab, lampalizumab and/or fenretinide **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Birmingham **Country:** United States **Facility:** Uni of Alabama At Birmingham Clinical Research Unit **State:** Alabama **Zip:** 35233 **Location 2:** **City:** Phoenix **Country:** United States **Facility:** Retinal Research Institute, LLC **State:** Arizona **Zip:** 85014 **Location 3:** **City:** Tucson **Country:** United States **Facility:** Retina Centers P.C. **State:** Arizona **Zip:** 85704 **Location 4:** **City:** Bakersfield **Country:** United States **Facility:** California Retina Consultants **State:** California **Zip:** 93309 **Location 5:** **City:** Beverly Hills **Country:** United States **Facility:** Retina-Vitreous Associates Medical Group **State:** California **Zip:** 90211 **Location 6:** **City:** Irvine **Country:** United States **Facility:** The Gavin Herbert Eye Institute - UC, Irvine **State:** California **Zip:** 92697-4375 **Location 7:** **City:** Los Angeles **Country:** United States **Facility:** Jules Stein Eye Institute/ UCLA **State:** California **Zip:** 90095-7000 **Location 8:** **City:** Oakland **Country:** United States **Facility:** East Bay Retina Consultants **State:** California **Zip:** 94609 **Location 9:** **City:** Palm Desert **Country:** United States **Facility:** Southern CA Desert Retina Cons **State:** California **Zip:** 92211 **Location 10:** **City:** San Francisco **Country:** United States **Facility:** W Coast Retina Med Group Inc **State:** California **Zip:** 94107 **Location 11:** **City:** San Francisco **Country:** United States **Facility:** UCSF; Ophthalmology **State:** California **Zip:** 94143 **Location 12:** **City:** Santa Ana **Country:** United States **Facility:** Orange County Retina Med Group **State:** California **Zip:** 92705 **Location 13:** **City:** Santa Barbara **Country:** United States **Facility:** California Retina Consultants **State:** California **Zip:** 93103 **Location 14:** **City:** Boynton Beach **Country:** United States **Facility:** Florida Eye Microsurgical Inst **State:** Florida **Zip:** 33426 **Location 15:** **City:** Fort Myers **Country:** United States **Facility:** National Ophthalmic Research Institute **State:** Florida **Zip:** 33912 **Location 16:** **City:** Melbourne **Country:** United States **Facility:** Florida Eye Associates **State:** Florida **Zip:** 32901 **Location 17:** **City:** Palm Beach Gardens **Country:** United States **Facility:** Retina Care Specialists **State:** Florida **Zip:** 33410 **Location 18:** **City:** Palm Beach Gardens **Country:** United States **Facility:** Bascom Palmer Eye Institute **State:** Florida **Zip:** 33418 **Location 19:** **City:** Pensacola **Country:** United States **Facility:** Retina Specialty Institute **State:** Florida **Zip:** 32503 **Location 20:** **City:** Plantation **Country:** United States **Facility:** Fort Lauderdale Eye Institute **State:** Florida **Zip:** 33324 **Location 21:** **City:** Saint Petersburg **Country:** United States **Facility:** Retina Vitreous Assoc of FL **State:** Florida **Zip:** 33711 **Location 22:** **City:** Tallahassee **Country:** United States **Facility:** Southern Vitreoretinal Assoc **State:** Florida **Zip:** 32308 **Location 23:** **City:** Tampa **Country:** United States **Facility:** Retina Associates of Florida, LLC **State:** Florida **Zip:** 33609 **Location 24:** **City:** Augusta **Country:** United States **Facility:** Southeast Retina Center **State:** Georgia **Zip:** 30909 **Location 25:** **City:** Marietta **Country:** United States **Facility:** Georgia Retina PC **State:** Georgia **Zip:** 30060 **Location 26:** **City:** 'Aiea **Country:** United States **Facility:** Retina Consultants of Hawaii **State:** Hawaii **Zip:** 96701 **Location 27:** **City:** Chicago **Country:** United States **Facility:** Northwestern Medical Group/Northwestern University **State:** Illinois **Zip:** 60611 **Location 28:** **City:** Oak Forest **Country:** United States **Facility:** University Retina and Macula Associates, PC **State:** Illinois **Zip:** 60452 **Location 29:** **City:** Indianapolis **Country:** United States **Facility:** Midwest Eye Institute Northside **State:** Indiana **Zip:** 46290 **Location 30:** **City:** West Des Moines **Country:** United States **Facility:** Wolfe Eye Clinic **State:** Iowa **Zip:** 50266 **Location 31:** **City:** Shawnee Mission **Country:** United States **Facility:** Retina Associates **State:** Kansas **Zip:** 66204 **Location 32:** **City:** Lexington **Country:** United States **Facility:** Lahey Clinic Med Ctr **State:** Kentucky **Zip:** 02421 **Location 33:** **City:** Lexington **Country:** United States **Facility:** Retina Associates of Kentucky **State:** Kentucky **Zip:** 40509 **Location 34:** **City:** Portland **Country:** United States **Facility:** Maine Eye Center **State:** Maine **Zip:** 04101 **Location 35:** **City:** Towson **Country:** United States **Facility:** Retina Specialists **State:** Maryland **Zip:** 21204 **Location 36:** **City:** Boston **Country:** United States **Facility:** Tufts Medical Center Research **State:** Massachusetts **Zip:** 02111 **Location 37:** **City:** Boston **Country:** United States **Facility:** Ophthalmic Consultants of Boston **State:** Massachusetts **Zip:** 02114 **Location 38:** **City:** Worcester **Country:** United States **Facility:** Vitreo-Retinal Associates, PC **State:** Massachusetts **Zip:** 01605 **Location 39:** **City:** Grand Rapids **Country:** United States **Facility:** Vitreo-Retinal Associates **State:** Michigan **Zip:** 49546 **Location 40:** **City:** Jackson **Country:** United States **Facility:** Specialty Eye Institute **State:** Michigan **Zip:** 49202 **Location 41:** **City:** Royal Oak **Country:** United States **Facility:** Assoc Retinal Consultants PC **State:** Michigan **Zip:** 48073 **Location 42:** **City:** Southfield **Country:** United States **Facility:** Retina Consultants of Michigan **State:** Michigan **Zip:** 48034 **Location 43:** **City:** Lincoln **Country:** United States **Facility:** Eye Surgical Associates **State:** Nebraska **Zip:** 68506 **Location 44:** **City:** Las Vegas **Country:** United States **Facility:** Retina Consultants of Nevada **State:** Nevada **Zip:** 89123 **Location 45:** **City:** Bloomfield **Country:** United States **Facility:** Retina Center of New Jersey **State:** New Jersey **Zip:** 07003 **Location 46:** **City:** Edison **Country:** United States **Facility:** New Jersey Retina Research Foundation **State:** New Jersey **Zip:** 08820 **Location 47:** **City:** Lawrenceville **Country:** United States **Facility:** Delaware Valley Retina Assoc **State:** New Jersey **Zip:** 08648 **Location 48:** **City:** Hauppauge **Country:** United States **Facility:** Long Is. Vitreoretinal Consult **State:** New York **Zip:** 11788 **Location 49:** **City:** Lynbrook **Country:** United States **Facility:** Opthalmic Consultants of LI **State:** New York **Zip:** 11563 **Location 50:** **City:** New York **Country:** United States **Facility:** New York Eye & Ear Infirmary **State:** New York **Zip:** 10003 **Location 51:** **City:** Orchard Park **Country:** United States **Facility:** Retina Consultants of Western New York **State:** New York **Zip:** 14127 **Location 52:** **City:** Syracuse **Country:** United States **Facility:** Retina Vit Surgeons/Central NY **State:** New York **Zip:** 13224 **Location 53:** **City:** Asheville **Country:** United States **Facility:** Western Carolina Retinal Associate PA **State:** North Carolina **Zip:** 28803 **Location 54:** **City:** Winston-Salem **Country:** United States **Facility:** Wake Forest Baptist Health Eye Centre **State:** North Carolina **Zip:** 27157 **Location 55:** **City:** Beachwood **Country:** United States **Facility:** Retina Assoc of Cleveland Inc **State:** Ohio **Zip:** 44122 **Location 56:** **City:** Cleveland **Country:** United States **Facility:** Cleveland Clinic Foundation; Cole Eye Institute **State:** Ohio **Zip:** 44195 **Location 57:** **City:** Monroeville **Country:** United States **Facility:** Retina Vitreous Consultants **State:** Pennsylvania **Zip:** 15146 **Location 58:** **City:** West Mifflin **Country:** United States **Facility:** Associates in Ophthalmology **State:** Pennsylvania **Zip:** 15122 **Location 59:** **City:** Ladson **Country:** United States **Facility:** Charleston Neuroscience Inst **State:** South Carolina **Zip:** 29456 **Location 60:** **City:** Nashville **Country:** United States **Facility:** Tennessee Retina PC. **State:** Tennessee **Zip:** 37203 **Location 61:** **City:** Nashville **Country:** United States **Facility:** Vanderbilt **State:** Tennessee **Zip:** 37232 **Location 62:** **City:** Abilene **Country:** United States **Facility:** Retina Res Institute of Texas **State:** Texas **Zip:** 79606 **Location 63:** **City:** Arlington **Country:** United States **Facility:** Texas Retina Associates **State:** Texas **Zip:** 76012 **Location 64:** **City:** Austin **Country:** United States **Facility:** Austin Retina Associates **State:** Texas **Zip:** 78705 **Location 65:** **City:** Austin **Country:** United States **Facility:** Retina Research Center **State:** Texas **Zip:** 78705 **Location 66:** **City:** Dallas **Country:** United States **Facility:** UT Southwestern MC at Dallas **State:** Texas **Zip:** 75390 **Location 67:** **City:** McAllen **Country:** United States **Facility:** Valley Retina Institute P.A. **State:** Texas **Zip:** 78503 **Location 68:** **City:** Willow Park **Country:** United States **Facility:** Strategic Clinical Research Group, LLC **State:** Texas **Zip:** 76087 **Location 69:** **City:** Salt Lake City **Country:** United States **Facility:** Retina Associates of Utah **State:** Utah **Zip:** 84107 **Location 70:** **City:** Richmond **Country:** United States **Facility:** Eye Surgeons of Richmond Inc. dba Virginia Eye Institute **State:** Virginia **Zip:** 23226 **Location 71:** **City:** Richmond **Country:** United States **Facility:** Retina Institute of Virginia **State:** Virginia **Zip:** 23235 **Location 72:** **City:** Warrenton **Country:** United States **Facility:** Virginia Retina Center **State:** Virginia **Zip:** 20186 **Location 73:** **City:** Silverdale **Country:** United States **Facility:** Retina Center Northwest **State:** Washington **Zip:** 98383 **Location 74:** **City:** Spokane **Country:** United States **Facility:** Spokane Eye Clinical Research **State:** Washington **Zip:** 99204 **Location 75:** **City:** Morgantown **Country:** United States **Facility:** West Virginia University Eye Institute **State:** West Virginia **Zip:** 26506 **Location 76:** **City:** Madison **Country:** United States **Facility:** University of Wisconsin **State:** Wisconsin **Zip:** 53792 **Location 77:** **City:** Buenos Aires **Country:** Argentina **Facility:** Organizacion Medica de Investigacion **Zip:** C1015ABO **Location 78:** **City:** Caba **Country:** Argentina **Facility:** Fundacion Zambrano **Zip:** 1023 **Location 79:** **City:** Mendoza **Country:** Argentina **Facility:** Oftar **Zip:** M5500GGK **Location 80:** **City:** Rosario **Country:** Argentina **Facility:** Microcirugía Ocular S.A **Zip:** S2000CTC **Location 81:** **City:** Rosario **Country:** Argentina **Facility:** Grupo Laser Vision **Zip:** S2000DLA **Location 82:** **City:** Albury **Country:** Australia **Facility:** Eyeclinic Albury Wodonga **State:** New South Wales **Zip:** 2640 **Location 83:** **City:** Parramatta **Country:** Australia **Facility:** Marsden Eye Research Centre **State:** New South Wales **Zip:** 2150 **Location 84:** **City:** Sydney **Country:** Australia **Facility:** Save Sight Institute **State:** New South Wales **Zip:** 2000 **Location 85:** **City:** Westmead **Country:** Australia **Facility:** Sydney West Retina **State:** New South Wales **Zip:** 2145 **Location 86:** **City:** Linz **Country:** Austria **Facility:** Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde **Zip:** 4021 **Location 87:** **City:** Bruxelles **Country:** Belgium **Facility:** CHU Brugmann (Victor Horta) **Zip:** 1020 **Location 88:** **City:** Gent **Country:** Belgium **Facility:** UZ Gent **Zip:** 9000 **Location 89:** **City:** Leuven **Country:** Belgium **Facility:** UZ Leuven Sint Rafael **Zip:** 3000 **Location 90:** **City:** Liège **Country:** Belgium **Facility:** CHU Sart-Tilman **Zip:** 4000 **Location 91:** **City:** Calgary **Country:** Canada **Facility:** Calgary Retina Consultants **State:** Alberta **Zip:** T2J 0C8 **Location 92:** **City:** Vancouver **Country:** Canada **Facility:** University of British Columbia **State:** British Columbia **Zip:** V6T 1Z4 **Location 93:** **City:** Halifax **Country:** Canada **Facility:** QEII - HSC Department of Ophthalmology **State:** Nova Scotia **Zip:** B3H 2Y9 **Location 94:** **City:** Ottawa **Country:** Canada **Facility:** University of Ottawa Eye Institute **State:** Ontario **Zip:** K1H 8L6 **Location 95:** **City:** Toronto **Country:** Canada **Facility:** Sunnybrook Health Sciences Centre **State:** Ontario **Zip:** M4N 3M5 **Location 96:** **City:** Toronto **Country:** Canada **Facility:** St. Michael'S Hospital **State:** Ontario **Zip:** M5G 2C4 **Location 97:** **City:** Toronto **Country:** Canada **Facility:** University Health Network Toronto Western Hospital **State:** Ontario **Zip:** M5T 2S8 **Location 98:** **City:** Boisbriand **Country:** Canada **Facility:** Institut De L'Oeil Des Laurentides **State:** Quebec **Zip:** J7H 1S6 **Location 99:** **City:** Roskilde **Country:** Denmark **Facility:** Sjællands Universitetshospital, Roskilde; Øjenafdelingen **Zip:** 4000 **Location 100:** **City:** Creteil **Country:** France **Facility:** Chi De Creteil; Ophtalmologie **Zip:** 94010 **Location 101:** **City:** Paris **Country:** France **Facility:** Centre Odeon; Exploration Ophtalmologique **Zip:** 75006 **Location 102:** **City:** Paris **Country:** France **Facility:** Hopital Lariboisiere; Ophtalmologie **Zip:** 75010 **Location 103:** **City:** Paris **Country:** France **Facility:** Centre Ophtalmologique; Imagerie et laser **Zip:** 75015 **Location 104:** **City:** Paris **Country:** France **Facility:** Ch Pitie Salpetriere; Ophtalmologie **Zip:** 75651 **Location 105:** **City:** Poitiers **Country:** France **Facility:** CHU Poitiers - CHR La Miletrie; Ophtalmologie **Zip:** 86021 **Location 106:** **City:** Bonn **Country:** Germany **Facility:** Universitäts-Augenklinik Bonn **Zip:** 53127 **Location 107:** **City:** Göttingen **Country:** Germany **Facility:** Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde **Zip:** 37075 **Location 108:** **City:** Hannover **Country:** Germany **Facility:** Medizinische Hochschule Hannover, Klinik für Augenheilkunde **Zip:** 30625 **Location 109:** **City:** Köln **Country:** Germany **Facility:** Universitätsklinikum Köln; Augenklinik **Zip:** 50937 **Location 110:** **City:** Lübeck **Country:** Germany **Facility:** Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde **Zip:** 23538 **Location 111:** **City:** Münster **Country:** Germany **Facility:** Augenabteilung am St. Franziskus-Hospital **Zip:** 48145 **Location 112:** **City:** Münster **Country:** Germany **Facility:** Universitätsklinikum Münster; Augenheilkunde **Zip:** 48149 **Location 113:** **City:** Budapest **Country:** Hungary **Facility:** Budapest Retina Associates Kft. **Zip:** 1133 **Location 114:** **City:** Debrecem **Country:** Hungary **Facility:** Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika **Zip:** 4032 **Location 115:** **City:** Pecs **Country:** Hungary **Facility:** Ganglion Medial Center **Zip:** 7621 **Location 116:** **City:** Roma **Country:** Italy **Facility:** Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche **State:** Lazio **Zip:** 00133 **Location 117:** **City:** Roma **Country:** Italy **Facility:** Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico **State:** Lazio **Zip:** 00198 **Location 118:** **City:** Milano **Country:** Italy **Facility:** Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica **State:** Lombardia **Zip:** 20100 **Location 119:** **City:** Sassari **Country:** Italy **Facility:** Azienda Ospedaliero Universitaria Di Sassari;U.O. Oculistica **State:** Sardegna **Zip:** 07100 **Location 120:** **City:** Mexico, D.F. **Country:** Mexico **Facility:** Macula Retina Consultores **Zip:** 01120 **Location 121:** **City:** Mexico, D.F. **Country:** Mexico **Facility:** Hospital de la Ceguera APEC **Zip:** 04030 **Location 122:** **City:** Amsterdam **Country:** Netherlands **Facility:** Academisch Medisch Centrum Universiteit Amsterdam **Zip:** 1105 AZ **Location 123:** **City:** Leiden **Country:** Netherlands **Facility:** Leids Universitair Medisch Centrum **Zip:** 2333 ZA0 **Location 124:** **City:** Nijmegen **Country:** Netherlands **Facility:** Radboud University Nijmegen Medical Centre; Ophthalmology **Zip:** 6525 EX **Location 125:** **City:** Lima **Country:** Peru **Facility:** CLINICA RICARDO PALMA; Oftalmologos Contreras **Zip:** 27 **Location 126:** **City:** Lima **Country:** Peru **Facility:** Clinica Anglo Americana **Zip:** Lima 27 **Location 127:** **City:** Bydgoszcz **Country:** Poland **Facility:** OFTALMIKA Sp. z o.o **Zip:** 85-631 **Location 128:** **City:** Gdańsk **Country:** Poland **Facility:** Optimum Profesorskie Centrum Okulistyki **Zip:** 80-809 **Location 129:** **City:** Katowice **Country:** Poland **Facility:** Gabinet Okulistyczny Prof Edward Wylegala **Zip:** 40-594 **Location 130:** **City:** Krakow **Country:** Poland **Facility:** SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej **Zip:** 31-501 **Location 131:** **City:** Bratislava **Country:** Slovakia **Facility:** Nemocnica sv. Michala, a.s. **Zip:** 81108 **Location 132:** **City:** Trencin **Country:** Slovakia **Facility:** Fakultna nemocnica Trencin Ocna klinika **Zip:** 911 71 **Location 133:** **City:** Zilina **Country:** Slovakia **Facility:** Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie **Zip:** 012 07 **Location 134:** **City:** Hospitalet De Llobregat **Country:** Spain **Facility:** Hospital Universitari de Bellvitge; Servicio de Oftalmologia **State:** Barcelona **Zip:** 8907 **Location 135:** **City:** San Cugat Del Valles **Country:** Spain **Facility:** Hospital General de Catalunya **State:** Barcelona **Zip:** 08195 **Location 136:** **City:** Bilbao **Country:** Spain **Facility:** Instituto Clinico Quirurgico de Oftalmologia - ICQO **State:** Guipuzcoa **Zip:** 48006 **Location 137:** **City:** Alicante **Country:** Spain **Facility:** VISSUM Instituto Oftalmológico de Alicante **Zip:** 03016 **Location 138:** **City:** Barcelona **Country:** Spain **Facility:** Institut de la Macula i la retina **Zip:** 08022 **Location 139:** **City:** Valencia **Country:** Spain **Facility:** FISABIO. Fundación Oftalmologica del Mediterraneo **Zip:** 46015 **Location 140:** **City:** Valladolid **Country:** Spain **Facility:** Hospital Universitario Rio Hortega; Servicio de Oftalmologia **Zip:** 47012 **Location 141:** **City:** Zürich **Country:** Switzerland **Facility:** Stadtspital Triemli; Augenklinik **Zip:** 8063 **Location 142:** **City:** AYR **Country:** United Kingdom **Facility:** Ayr Hospital **Zip:** KA6 6DX **Location 143:** **City:** Edinburgh **Country:** United Kingdom **Facility:** The Princess Alexandra Eye Pavilion **Zip:** EH3 9HA **Location 144:** **City:** Frimley **Country:** United Kingdom **Facility:** Frimley Park Hospital **Zip:** GU16 7UJ **Location 145:** **City:** Sheffield **Country:** United Kingdom **Facility:** Royal Hallamshire Hospita **Zip:** S10 2JF #### Overall Officials **Official 1:** **Affiliation:** Hoffmann-La Roche **Name:** Clinical Trials **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Miere A, Capuano V, Kessler A, Zambrowski O, Jung C, Colantuono D, Pallone C, Semoun O, Petit E, Souied E. Deep learning-based classification of retinal atrophy using fundus autofluorescence imaging. Comput Biol Med. 2021 Mar;130:104198. doi: 10.1016/j.compbiomed.2020.104198. Epub 2020 Dec 28. **PMID:** 33383315 **Citation:** Heier JS, Pieramici D, Chakravarthy U, Patel SS, Gupta S, Lotery A, Lad EM, Silverman D, Henry EC, Anderesi M, Tschosik EA, Gray S, Ferrara D, Guymer R; Chroma and Spectri Study Investigators. Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials. Ophthalmol Retina. 2020 Jul;4(7):673-688. doi: 10.1016/j.oret.2020.01.019. Epub 2020 Jan 31. **PMID:** 32199866 **Citation:** Holz FG, Sadda SR, Busbee B, Chew EY, Mitchell P, Tufail A, Brittain C, Ferrara D, Gray S, Honigberg L, Martin J, Tong B, Ehrlich JS, Bressler NM; Chroma and Spectri Study Investigators. Efficacy and Safety of Lampalizumab for Geographic Atrophy Due to Age-Related Macular Degeneration: Chroma and Spectri Phase 3 Randomized Clinical Trials. JAMA Ophthalmol. 2018 Jun 1;136(6):666-677. doi: 10.1001/jamaophthalmol.2018.1544. **PMID:** 29801123 ## Document Section ### Large Document Module #### Large Docs - Date: 2017-10-02 - Filename: SAP_000.pdf - Has ICF: False - Has Protocol: False - Has SAP: True - Label: Statistical Analysis Plan - Size: 809247 - Type Abbrev: SAP - Upload Date: 2019-01-22T09:48 - Date: 2015-09-24 - Filename: Prot_001.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 3510852 - Type Abbrev: Prot - Upload Date: 2019-01-22T09:48 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012162 - Term: Retinal Degeneration - ID: D000012164 - Term: Retinal Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC11 - Name: Eye Diseases ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M4589 - Name: Atrophy - Relevance: HIGH - As Found: Atrophy - ID: M11260 - Name: Macular Degeneration - Relevance: HIGH - As Found: Age-related Macular Degeneration - ID: M28712 - Name: Geographic Atrophy - Relevance: HIGH - As Found: Geographic Atrophy - ID: M14997 - Name: Retinal Degeneration - Relevance: LOW - As Found: Unknown - ID: M14999 - Name: Retinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008268 - Term: Macular Degeneration - ID: D000057092 - Term: Geographic Atrophy - ID: D000001284 - Term: Atrophy ### Misc Info Module #### Removed Countries - Country: Brazil - Country: Portugal - Country: Russian Federation - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** Safety population included all participants who received at least one dose of study drug. #### Event Groups **Group ID:** EG000 **Title:** Sham Comparator **Deaths Num Affected:** 6 **Deaths Num At Risk:** 300 **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. **ID:** EG000 **Other Num Affected:** 221 **Other Num at Risk:** 300 **Serious Number Affected:** 97 **Serious Number At Risk:** 300 **Title:** Sham Comparator **Group ID:** EG001 **Title:** Lampalizumab Q4W **Deaths Num Affected:** 5 **Deaths Num At Risk:** 298 **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. **ID:** EG001 **Other Num Affected:** 239 **Other Num at Risk:** 298 **Serious Number Affected:** 118 **Serious Number At Risk:** 298 **Title:** Lampalizumab Q4W **Group ID:** EG002 **Title:** Lampalizumab Q6W **Deaths Num Affected:** 6 **Deaths Num At Risk:** 303 **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. **ID:** EG002 **Other Num Affected:** 232 **Other Num at Risk:** 303 **Serious Number Affected:** 108 **Serious Number At Risk:** 303 **Title:** Lampalizumab Q6W **Frequency Threshold:** 5 #### Other Events **Term:** Conjunctival haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 **Term:** Eye pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 **Term:** Vitreous floaters **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 **Term:** Vitreous detachment **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 **Term:** Dry eye **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 **Term:** Cataract **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 **Term:** Posterior capsule opacification **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 **Term:** Intraocular pressure increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA, version 20.1 **Term:** Nausea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 **Term:** Bronchitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 **Term:** Fall **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 **Term:** Back pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA, version 20.1 **Term:** Arthralgia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA, version 20.1 **Term:** Headache **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 **Term:** Cough **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA, version 20.1 **Term:** Hypertension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA, version 20.1 **Term:** Urinary tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 **Term:** Upper respiratory tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 **Term:** Influenza **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 **Term:** Retinal haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 **Term:** Punctate keratitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 **Term:** Nasopharyngitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 #### Serious Events **Term:** Anaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Acute myocardial infarction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 3 **Num At Risk:** 303 **Term:** Angina pectoris **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Angina unstable **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Arrhythmia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Arteriosclerosis coronary artery **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Atrial fibrillation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 3 **Num At Risk:** 303 **Term:** Atrial flutter **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Atrioventricular block first degree **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Bradycardia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Cardiac arrest **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Cardiac failure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Cardiac failure congestive **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 6 **Num At Risk:** 303 **Term:** Coronary artery disease **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Myocardial infarction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Myocardial ischaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Palpitations **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Tachycardia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Ventricular fibrillation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Colitis ischaemic **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Constipation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Diarrhoea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Diverticular hernia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Diverticulum intestinal **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Duodenal ulcer haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Dyspepsia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Enterocolitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Flatulence **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Gastric ulcer **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Gastric volvulus **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Gastritis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Gastroduodenitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Gastrointestinal haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Ileus **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Inguinal hernia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Oesophagitis ulcerative **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Pancreatitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Rectal ulcer **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Small intestinal obstruction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Upper gastrointestinal haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Chest pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Death **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** General physical health deterioration **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Impaired healing **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Bile duct stone **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Cholangitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Cholecystitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Cholelithiasis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Abdominal sepsis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Bronchitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Campylobacter infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Cellulitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Cystitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Device related infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Diverticulitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Endocarditis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Gastroenteritis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Infectious pleural effusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Influenza **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Perihepatic abscess **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Pneumonia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 9 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 11 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 5 **Num At Risk:** 303 **Term:** Pyelonephritis acute **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Sepsis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Septic shock **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Staphylococcal sepsis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Upper respiratory tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Urinary tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Viral upper respiratory tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Accidental overdose **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Acetabulum fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Ankle fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Comminuted fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Contusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Craniocerebral injury **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Dislocation of vertebra **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Fall **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 5 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 4 **Num At Risk:** 303 **Term:** Femur fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Fibula fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Forearm fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Hip fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 3 **Num At Risk:** 303 **Term:** Humerus fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Internal injury **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Lower limb fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Lumbar vertebral fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Muscle rupture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Pelvic fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Post procedural haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Radius fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Rib fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Road traffic accident **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Spinal compression fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Spinal fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Sternal fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Subdural haematoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Upper limb fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Blood pressure increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Heart rate irregular **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Myocardial necrosis marker increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Prostatic specific antigen increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Troponin increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Dehydration **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Gout **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Hypoglycaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Hypokalaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Hyponatraemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Iron deficiency **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Malnutrition **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Arthralgia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Arthritis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Haemarthrosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Intervertebral disc protrusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Neuropathic arthropathy **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Osteoarthritis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Rotator cuff syndrome **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Spinal column stenosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Benign neoplasm of ureter **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Bladder cancer **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Breast cancer **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Bronchial carcinoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Cholangiocarcinoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Endometrial cancer **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Lung adenocarcinoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Lung cancer metastatic **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Lung neoplasm malignant **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Malignant melanoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Malignant melanoma stage IV **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Malignant pleural effusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Meningioma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Myelodysplastic syndrome **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Myxofibrosarcoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Neoplasm skin **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Neuroendocrine carcinoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Non-small cell lung cancer metastatic **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Oesophageal carcinoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Ovarian cancer **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Ovarian cancer metastatic **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Pancreatic carcinoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Plasma cell myeloma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Prostate cancer **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Prostate cancer metastatic **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Skin cancer **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Squamous cell carcinoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Amyotrophic lateral sclerosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Carotid artery stenosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Cerebral haematoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Cerebral infarction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Cerebral microangiopathy **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Cerebrovascular accident **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Cervicogenic vertigo **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Dementia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Dementia Alzheimer's type **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Dizziness **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Dural arteriovenous fistula **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Epilepsy **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Generalised tonic-clonic seizure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Haemorrhagic stroke **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Headache **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Hemiparesis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Ischaemic stroke **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Lacunar infarction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Lumbar radiculopathy **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Paraesthesia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Presyncope **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Seizure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Senile dementia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Transient ischaemic attack **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Vertigo CNS origin **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Mental status changes **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Acute kidney injury **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Bladder cyst **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Chronic kidney disease **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Dysuria **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Haematuria **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Hydronephrosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Nephrolithiasis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Oliguria **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Renal failure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Renal impairment **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Tubulointerstitial nephritis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Urinary bladder polyp **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Urinary retention **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Acute pulmonary oedema **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Acute respiratory failure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Bronchial hyperreactivity **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Chronic obstructive pulmonary disease **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 5 **Num At Risk:** 303 **Term:** Dyspnoea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Epiglottic cyst **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Epistaxis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Haemoptysis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Hypoxia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Pleural effusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Pneumonitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Pneumothorax **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Pneumothorax spontaneous **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Pulmonary air leakage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Pulmonary embolism **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Skin ulcer **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Cardiac pacemaker battery replacement **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Surgical and medical procedures **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Aortic stenosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Blood pressure inadequately controlled **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Deep vein thrombosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Haematoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Hypertension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Hypotension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** May-Thurner syndrome **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Peripheral arterial occlusive disease **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Peripheral embolism **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Thrombophlebitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Syncope **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Spinal osteoarthritis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Spinal pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Blindness transient **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Vertigo **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Ear and labyrinth disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Borderline glaucoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Choroidal neovascularisation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Iritis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Neovascular age-related macular degeneration **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 3 **Num At Risk:** 303 **Term:** Open angle glaucoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Retinal artery occlusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Retinal detachment **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Retinal neovascularisation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Retinal tear **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Visual acuity reduced **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 10 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 12 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 8 **Num At Risk:** 303 **Term:** Visual acuity reduced transiently **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Vitreous haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Vitritis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Conjunctivitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Endophthalmitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Corneal abrasion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Facial bones fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Hyphaema **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Intraocular pressure increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 16 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 14 **Num At Risk:** 303 **Term:** Atrial septal defect **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Congenital, familial and genetic disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Postmenopausal haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Reproductive system and breast disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Uterovaginal prolapse **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Reproductive system and breast disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Haemorrhagic anaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Dry age-related macular degeneration **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 303 **Term:** Cataract **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Gastrointestinal angiectasia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Obstructive pancreatitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Colitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Pyrexia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Cervical vertebral fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Foreign body in eye **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Traumatic intracranial haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Back pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Bladder neoplasm **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Lipoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Urethral cancer **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Aphasia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 303 **Term:** Cognitive disorder **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Embolic stroke **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Term:** Orthostatic hypotension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA, version 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 300 **Group ID:** EG001 **Num At Risk:** 298 **Group ID:** EG002 **Num At Risk:** 303 **Time Frame:** Up to approximately 2 years ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 305 **Group ID:** BG001 **Value:** 298 **Group ID:** BG002 **Value:** 303 **Group ID:** BG003 **Value:** 906 **Units:** Participants ### Group **ID:** BG000 **Title:** Sham Comparator **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. ### Group **ID:** BG001 **Title:** Lampalizumab Q4W **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. ### Group **ID:** BG002 **Title:** Lampalizumab Q6W **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. ### Group **ID:** BG003 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 7.8 **Value:** 78.5 #### Measurement **Group ID:** BG001 **Spread:** 7.9 **Value:** 77.5 #### Measurement **Group ID:** BG002 **Spread:** 8.5 **Value:** 78.3 #### Measurement **Group ID:** BG003 **Spread:** 8.1 **Value:** 78.1 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 305 **Group ID:** BG001 **Value:** 298 **Group ID:** BG002 **Value:** 303 **Group ID:** BG003 **Value:** 906 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 186 #### Measurement **Group ID:** BG001 **Value:** 182 #### Measurement **Group ID:** BG002 **Value:** 185 #### Measurement **Group ID:** BG003 **Value:** 553 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 119 #### Measurement **Group ID:** BG001 **Value:** 116 #### Measurement **Group ID:** BG002 **Value:** 118 #### Measurement **Group ID:** BG003 **Value:** 353 **Category Title:** Male #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 305 **Group ID:** BG001 **Value:** 298 **Group ID:** BG002 **Value:** 303 **Group ID:** BG003 **Value:** 906 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 1 #### Measurement **Group ID:** BG003 **Value:** 2 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 0 #### Measurement **Group ID:** BG003 **Value:** 1 **Category Title:** Native Hawaiian or other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 302 #### Measurement **Group ID:** BG001 **Value:** 294 #### Measurement **Group ID:** BG002 **Value:** 295 #### Measurement **Group ID:** BG003 **Value:** 891 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 #### Measurement **Group ID:** BG003 **Value:** 1 **Category Title:** Multiple #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 6 #### Measurement **Group ID:** BG003 **Value:** 11 **Category Title:** Unknown #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 305 **Group ID:** BG001 **Value:** 298 **Group ID:** BG002 **Value:** 303 **Group ID:** BG003 **Value:** 906 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 20 #### Measurement **Group ID:** BG001 **Value:** 17 #### Measurement **Group ID:** BG002 **Value:** 18 #### Measurement **Group ID:** BG003 **Value:** 55 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 279 #### Measurement **Group ID:** BG001 **Value:** 278 #### Measurement **Group ID:** BG002 **Value:** 282 #### Measurement **Group ID:** BG003 **Value:** 839 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 3 #### Measurement **Group ID:** BG002 **Value:** 1 #### Measurement **Group ID:** BG003 **Value:** 6 **Category Title:** Not Stated #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 2 #### Measurement **Group ID:** BG003 **Value:** 6 **Category Title:** Unknown #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 305 **Group ID:** BG001 **Value:** 298 **Group ID:** BG002 **Value:** 303 **Group ID:** BG003 **Value:** 906 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 3.925 **Value:** 7.953 #### Measurement **Group ID:** BG001 **Spread:** 3.887 **Value:** 7.910 #### Measurement **Group ID:** BG002 **Spread:** 4.236 **Value:** 8.116 #### Measurement **Group ID:** BG003 **Spread:** 4.016 **Value:** 7.993 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 305 **Group ID:** BG001 **Value:** 298 **Group ID:** BG002 **Value:** 302 **Group ID:** BG003 **Value:** 905 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 16.8 **Value:** 29.1 #### Measurement **Group ID:** BG001 **Spread:** 13.4 **Value:** 25.2 #### Measurement **Group ID:** BG002 **Spread:** 13.4 **Value:** 20.5 #### Measurement **Group ID:** BG003 **Spread:** 15.1 **Value:** 25.1 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 44 **Group ID:** BG001 **Value:** 33 **Group ID:** BG002 **Value:** 39 **Group ID:** BG003 **Value:** 116 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 3.37 **Value:** 5.40 #### Measurement **Group ID:** BG001 **Spread:** 4.02 **Value:** 6.37 #### Measurement **Group ID:** BG002 **Spread:** 3.40 **Value:** 7.38 #### Measurement **Group ID:** BG003 **Spread:** 3.64 **Value:** 6.34 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 44 **Group ID:** BG001 **Value:** 33 **Group ID:** BG002 **Value:** 39 **Group ID:** BG003 **Value:** 116 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 9.9 **Value:** 65.9 #### Measurement **Group ID:** BG001 **Spread:** 10.0 **Value:** 66.1 #### Measurement **Group ID:** BG002 **Spread:** 10.1 **Value:** 66.4 #### Measurement **Group ID:** BG003 **Spread:** 10.0 **Value:** 66.2 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 301 **Group ID:** BG001 **Value:** 295 **Group ID:** BG002 **Value:** 301 **Group ID:** BG003 **Value:** 897 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 15.7 **Value:** 36.0 #### Measurement **Group ID:** BG001 **Spread:** 17.8 **Value:** 36.9 #### Measurement **Group ID:** BG002 **Spread:** 16.7 **Value:** 36.2 #### Measurement **Group ID:** BG003 **Spread:** 16.7 **Value:** 36.4 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 299 **Group ID:** BG001 **Value:** 287 **Group ID:** BG002 **Value:** 293 **Group ID:** BG003 **Value:** 879 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 57.98 **Value:** 106.89 #### Measurement **Group ID:** BG001 **Spread:** 60.14 **Value:** 109.18 #### Measurement **Group ID:** BG002 **Spread:** 62.37 **Value:** 104.22 #### Measurement **Group ID:** BG003 **Spread:** 60.12 **Value:** 106.74 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 278 **Group ID:** BG001 **Value:** 262 **Group ID:** BG002 **Value:** 269 **Group ID:** BG003 **Value:** 809 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 17.33 **Value:** 66.16 #### Measurement **Group ID:** BG001 **Spread:** 16.12 **Value:** 64.80 #### Measurement **Group ID:** BG002 **Spread:** 17.27 **Value:** 65.19 #### Measurement **Group ID:** BG003 **Spread:** 16.91 **Value:** 65.38 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 276 **Group ID:** BG001 **Value:** 275 **Group ID:** BG002 **Value:** 282 **Group ID:** BG003 **Value:** 833 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 0.83 **Value:** 2.69 #### Measurement **Group ID:** BG001 **Spread:** 0.79 **Value:** 2.71 #### Measurement **Group ID:** BG002 **Spread:** 0.82 **Value:** 2.70 #### Measurement **Group ID:** BG003 **Spread:** 0.81 **Value:** 2.70 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 276 **Group ID:** BG001 **Value:** 273 **Group ID:** BG002 **Value:** 280 **Group ID:** BG003 **Value:** 829 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 20.98 **Value:** 54.98 #### Measurement **Group ID:** BG001 **Spread:** 20.56 **Value:** 53.78 #### Measurement **Group ID:** BG002 **Spread:** 22.21 **Value:** 53.67 #### Measurement **Group ID:** BG003 **Spread:** 21.25 **Value:** 54.14 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 276 **Group ID:** BG001 **Value:** 275 **Group ID:** BG002 **Value:** 282 **Group ID:** BG003 **Value:** 833 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 21.46 **Value:** 62.86 #### Measurement **Group ID:** BG001 **Spread:** 20.48 **Value:** 60.97 #### Measurement **Group ID:** BG002 **Spread:** 22.16 **Value:** 62.10 #### Measurement **Group ID:** BG003 **Spread:** 21.37 **Value:** 61.98 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 276 **Group ID:** BG001 **Value:** 275 **Group ID:** BG002 **Value:** 282 **Group ID:** BG003 **Value:** 833 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 52.95 **Value:** 80.89 #### Measurement **Group ID:** BG001 **Spread:** 54.55 **Value:** 85.18 #### Measurement **Group ID:** BG002 **Spread:** 54.23 **Value:** 79.49 #### Measurement **Group ID:** BG003 **Spread:** 53.89 **Value:** 81.82 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 278 **Group ID:** BG001 **Value:** 265 **Group ID:** BG002 **Value:** 271 **Group ID:** BG003 **Value:** 814 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 3.915 **Value:** 8.015 #### Measurement **Group ID:** BG001 **Spread:** 4.118 **Value:** 8.152 #### Measurement **Group ID:** BG002 **Spread:** 4.399 **Value:** 8.406 #### Measurement **Group ID:** BG003 **Spread:** 4.142 **Value:** 8.190 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 181 **Group ID:** BG001 **Value:** 176 **Group ID:** BG002 **Value:** 177 **Group ID:** BG003 **Value:** 534 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 3.952 **Value:** 7.864 #### Measurement **Group ID:** BG001 **Spread:** 3.515 **Value:** 7.560 #### Measurement **Group ID:** BG002 **Spread:** 3.975 **Value:** 7.705 #### Measurement **Group ID:** BG003 **Spread:** 3.814 **Value:** 7.710 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 124 **Group ID:** BG001 **Value:** 122 **Group ID:** BG002 **Value:** 125 **Group ID:** BG003 **Value:** 371 **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race/Ethnicity, Customized **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race/Ethnicity, Customized **Unit of Measure:** Participants ### Measure 5 **Description:** At baseline the area of GA was assessed by FAF. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected. **Title:** Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) **Unit of Measure:** millimeter square (mm^2) ### Measure 6 **Description:** Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). **Title:** Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry **Unit of Measure:** absolute scotomatous points ### Measure 7 **Description:** Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). **Title:** Macular Sensitivity as Assessed by Mesopic Microperimetry **Unit of Measure:** decibel (dB) ### Measure 8 **Description:** BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters. BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected. **Title:** Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study **Unit of Measure:** letters ### Measure 9 **Description:** The LLVA was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. LLVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected. **Title:** Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions **Unit of Measure:** letters ### Measure 10 **Description:** Minnesota Low-Vision Reading (MNRead) acuity cards were continuous-text reading-acuity cards suitable for measuring reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected. **Title:** Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test or Radner Reading Charts **Unit of Measure:** words per minute (wpm) ### Measure 11 **Description:** NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health,general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, a higher score represents better functioning. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected. **Title:** National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score **Unit of Measure:** score on a scale ### Measure 12 **Description:** The FRI was an interviewer-administered questionnaire with 7-items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected. **Title:** Mean Functional Reading Independence (FRI) Index **Unit of Measure:** score on a scale ### Measure 13 **Description:** NEI-VFQ-25 questionnaire included 25 items based on near activities, which are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected. **Title:** NEI VFQ-25 Near Activity Subscale Score **Unit of Measure:** score on a scale ### Measure 14 **Description:** NEI-VFQ-25 questionnaire included 25 items based on which distance activities was measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected. **Title:** NEI VFQ-25 Distance Activity Subscale Score **Unit of Measure:** score on a scale ### Measure 15 **Description:** MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected. **Title:** Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts **Unit of Measure:** wpm ### Measure 16 **Description:** For CFI profile, positive biomarker status refers to the presence (carrier) of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB). **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected. **Title:** GA Area in Complement Factor I (CFI) Positive Participants **Unit of Measure:** mm^2 ### Measure 17 **Description:** For CFI profile, negative biomarker status refers to the absence of the risk allele at CFI and at least one risk allele at CFH or C2/CFB. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected. **Title:** GA Area in CFI Negative Participants **Unit of Measure:** mm^2 **Population Description:** Intent-to-treat (ITT) population included all the participants who were randomized to the study. ## Results Section - More Information Module ### Certain Agreement **Other Details:** The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but only after the first publication or presentation that involves the overall study. The Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Limitations and Caveats **Description:** This study was terminated early by the Sponsor because the compound had demonstrated to lack of efficacy. Thus, not all participants in this study completed the full duration of treatment. ### Point of Contact **Email:** [email protected] **Organization:** Hoffmann-La Roche **Phone:** 800 821 - 8590 **Title:** Medical Communications ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** -0.206 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.167 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.8381 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** -0.019 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -0.134 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.236 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.5901 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** 0.051 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** ### Outcome Measure 2 #### Analysis **CI Lower Limit:** -5.2 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 4.8 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.9350 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** -0.2 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -5.0 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 5.2 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.9789 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** 0.1 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** ### Outcome Measure 3 #### Analysis **CI Lower Limit:** -0.66 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.22 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.5538 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** 0.28 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -1.60 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.35 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.2032 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** -0.63 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** ### Outcome Measure 4 #### Analysis **CI Lower Limit:** -0.7 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 2.8 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.2547 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** 1.0 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -1.9 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.6 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.8423 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** -0.2 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** ### Outcome Measure 5 #### Analysis **CI Lower Limit:** 0.8 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 2.2 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.3248 **P-Value Comment:** **Parameter Type:** Odds Ratio (OR) **Parameter Value:** 1.3 **Statistical Comment:** **Statistical Method:** Regression, Logistic **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** 0.7 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.8 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.7209 **P-Value Comment:** **Parameter Type:** Odds Ratio (OR) **Parameter Value:** 1.1 **Statistical Comment:** **Statistical Method:** Regression, Logistic **Tested Non-Inferiority:** ### Outcome Measure 6 #### Analysis **CI Lower Limit:** -1.4 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 2.6 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.5695 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** 0.6 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -1.7 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 2.3 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.7865 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** 0.3 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** ### Outcome Measure 7 #### Analysis **CI Lower Limit:** 0.6 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.7 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.9448 **P-Value Comment:** **Parameter Type:** Odds Ratio (OR) **Parameter Value:** 1.0 **Statistical Comment:** **Statistical Method:** Regression, Logistic **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** 0.6 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.8 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.8764 **P-Value Comment:** **Parameter Type:** Odds Ratio (OR) **Parameter Value:** 1.0 **Statistical Comment:** **Statistical Method:** Regression, Logistic **Tested Non-Inferiority:** ### Outcome Measure 8 #### Analysis **CI Lower Limit:** -1.07 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 12.38 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.0991 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** 5.66 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -7.66 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 5.69 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.7713 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** -0.99 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** ### Outcome Measure 9 #### Analysis **CI Lower Limit:** -5.09 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 8.53 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.6204 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** 1.72 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -5.31 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 8.25 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.6705 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** 1.47 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** ### Outcome Measure 10 #### Analysis **CI Lower Limit:** -2.35 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.64 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.7246 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** -0.36 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -3.53 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.40 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.1193 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** -1.56 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** ### Outcome Measure 11 #### Analysis **CI Lower Limit:** -2.84 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 2.39 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.8659 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** -0.22 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -4.51 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.64 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.1399 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** -1.94 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** ### Outcome Measure 12 #### Analysis **CI Lower Limit:** -1.79 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 3.76 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.4855 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** 0.99 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -4.33 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.13 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.2515 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** -1.60 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** ### Outcome Measure 13 #### Analysis **CI Lower Limit:** -0.18 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.04 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.2075 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** -0.07 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -0.19 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.02 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.1222 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** -0.08 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** ### Outcome Measure 14 #### Analysis **CI Lower Limit:** -0.266 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.223 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.8612 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** -0.022 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -0.165 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.319 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.5317 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** 0.077 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -0.322 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.257 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.8240 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** -0.033 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -0.283 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.294 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.9676 **P-Value Comment:** **Parameter Type:** Difference in Adjusted Means **Parameter Value:** 0.006 **Statistical Comment:** **Statistical Method:** MMRM **Tested Non-Inferiority:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.066 - **Upper Limit:** - **Value:** 2.035 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.068 - **Upper Limit:** - **Value:** 2.016 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.067 - **Upper Limit:** - **Value:** 2.086 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.7 - **Upper Limit:** - **Value:** 8.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.8 - **Upper Limit:** - **Value:** 8.1 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 1.8 - **Upper Limit:** - **Value:** 8.3 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.33 - **Upper Limit:** - **Value:** -1.61 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.34 - **Upper Limit:** - **Value:** -1.33 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.35 - **Upper Limit:** - **Value:** -2.24 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.6 - **Upper Limit:** - **Value:** -4.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.6 - **Upper Limit:** - **Value:** -3.4 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.6 - **Upper Limit:** - **Value:** -4.6 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 81.6 - **Spread:** - **Upper Limit:** 90.0 - **Value:** 85.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 85.0 - **Spread:** - **Upper Limit:** 92.6 - **Value:** 88.8 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 83.0 - **Spread:** - **Upper Limit:** 91.1 - **Value:** 87.0 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.7 - **Upper Limit:** - **Value:** -3.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.7 - **Upper Limit:** - **Value:** -2.4 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.7 - **Upper Limit:** - **Value:** -2.7 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 82.7 - **Spread:** - **Upper Limit:** 90.9 - **Value:** 86.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 80.9 - **Spread:** - **Upper Limit:** 89.6 - **Value:** 85.3 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 82.4 - **Spread:** - **Upper Limit:** 90.8 - **Value:** 86.6 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.37 - **Upper Limit:** - **Value:** -18.97 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.47 - **Upper Limit:** - **Value:** -13.32 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 2.44 - **Upper Limit:** - **Value:** -19.96 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.41 - **Upper Limit:** - **Value:** -19.63 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.49 - **Upper Limit:** - **Value:** -17.91 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 2.47 - **Upper Limit:** - **Value:** -18.16 **Title:** #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.71 - **Upper Limit:** - **Value:** -1.31 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.72 - **Upper Limit:** - **Value:** -1.66 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.70 - **Upper Limit:** - **Value:** -2.87 **Title:** #### Outcome Measure 11 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.93 - **Upper Limit:** - **Value:** -2.12 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.94 - **Upper Limit:** - **Value:** -2.35 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.92 - **Upper Limit:** - **Value:** -4.06 **Title:** #### Outcome Measure 12 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.99 - **Upper Limit:** - **Value:** -2.03 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.00 - **Upper Limit:** - **Value:** -1.04 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.97 - **Upper Limit:** - **Value:** -3.62 **Title:** #### Outcome Measure 13 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.04 - **Upper Limit:** - **Value:** -0.06 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.04 - **Upper Limit:** - **Value:** -0.13 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.04 - **Upper Limit:** - **Value:** -0.15 **Title:** #### Outcome Measure 14 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.086 - **Upper Limit:** - **Value:** 2.067 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.089 - **Upper Limit:** - **Value:** 2.045 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.087 - **Upper Limit:** - **Value:** 2.144 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 162 - **Group ID:** OG001 - **Value:** 152 - **Group ID:** OG002 - **Value:** 160 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.103 - **Upper Limit:** - **Value:** 2.006 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.105 - **Upper Limit:** - **Value:** 1.974 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.104 - **Upper Limit:** - **Value:** 2.012 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 112 - **Group ID:** OG001 - **Value:** 107 - **Group ID:** OG002 - **Value:** 110 **Units:** Participants ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression). **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in Mixed-effect model repeated measures (MMRM) analysis. **Reporting Status:** POSTED **Time Frame:** Baseline, Week 48 **Title:** Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48 **Type:** PRIMARY **Unit of Measure:** millimeter square (mm^2) ##### Group **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. **ID:** OG000 **Title:** Sham Comparator ##### Group **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. **ID:** OG001 **Title:** Lampalizumab Q4W ##### Group **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. **ID:** OG002 **Title:** Lampalizumab Q6W #### Outcome Measure 2 **Description:** Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening. **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). Participants analyzed in this outcome measure were those included in MMRM analysis. **Reporting Status:** POSTED **Time Frame:** Baseline, Week 48 **Title:** Change From Baseline in Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry at Week 48 **Type:** SECONDARY **Unit of Measure:** absolute scotomatous points ##### Group **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. **ID:** OG000 **Title:** Sham Comparator ##### Group **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. **ID:** OG001 **Title:** Lampalizumab Q4W ##### Group **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. **ID:** OG002 **Title:** Lampalizumab Q6W #### Outcome Measure 3 **Description:** Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). Participants analyzed in this outcome measure were those included in MMRM analysis. **Reporting Status:** POSTED **Time Frame:** Baseline, Week 48 **Title:** Change From Baseline in Mean Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48 **Type:** SECONDARY **Unit of Measure:** decibel (dB) ##### Group **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. **ID:** OG000 **Title:** Sham Comparator ##### Group **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. **ID:** OG001 **Title:** Lampalizumab Q4W ##### Group **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. **ID:** OG002 **Title:** Lampalizumab Q6W #### Outcome Measure 4 **Description:** BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis. **Reporting Status:** POSTED **Time Frame:** Baseline, Week 48 **Title:** Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48 **Type:** SECONDARY **Unit of Measure:** letters ##### Group **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. **ID:** OG000 **Title:** Sham Comparator ##### Group **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. **ID:** OG001 **Title:** Lampalizumab Q4W ##### Group **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. **ID:** OG002 **Title:** Lampalizumab Q6W #### Outcome Measure 5 **Description:** Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected. **Reporting Status:** POSTED **Time Frame:** Week 48 **Title:** Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48 **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. **ID:** OG000 **Title:** Sham Comparator ##### Group **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. **ID:** OG001 **Title:** Lampalizumab Q4W ##### Group **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. **ID:** OG002 **Title:** Lampalizumab Q6W #### Outcome Measure 6 **Description:** The LLVA was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. LLVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis. **Reporting Status:** POSTED **Time Frame:** Baseline, Week 48 **Title:** Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48 **Type:** SECONDARY **Unit of Measure:** letters ##### Group **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. **ID:** OG000 **Title:** Sham Comparator ##### Group **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. **ID:** OG001 **Title:** Lampalizumab Q4W ##### Group **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. **ID:** OG002 **Title:** Lampalizumab Q6W #### Outcome Measure 7 **Description:** Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected. **Reporting Status:** POSTED **Time Frame:** Week 48 **Title:** Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48 **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. **ID:** OG000 **Title:** Sham Comparator ##### Group **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. **ID:** OG001 **Title:** Lampalizumab Q4W ##### Group **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. **ID:** OG002 **Title:** Lampalizumab Q6W #### Outcome Measure 8 **Description:** MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis. **Reporting Status:** POSTED **Time Frame:** Baseline, Week 48 **Title:** Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48 **Type:** SECONDARY **Unit of Measure:** words per minute (wpm) ##### Group **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. **ID:** OG000 **Title:** Sham Comparator ##### Group **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. **ID:** OG001 **Title:** Lampalizumab Q4W ##### Group **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. **ID:** OG002 **Title:** Lampalizumab Q6W #### Outcome Measure 9 **Description:** MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis. **Reporting Status:** POSTED **Time Frame:** Baseline, Week 48 **Title:** Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48 **Type:** SECONDARY **Unit of Measure:** wpm ##### Group **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. **ID:** OG000 **Title:** Sham Comparator ##### Group **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. **ID:** OG001 **Title:** Lampalizumab Q4W ##### Group **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. **ID:** OG002 **Title:** Lampalizumab Q6W #### Outcome Measure 10 **Description:** NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health,general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis. **Reporting Status:** POSTED **Time Frame:** Baseline, Week 48 **Title:** Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48 **Type:** SECONDARY **Unit of Measure:** scores on a scale ##### Group **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. **ID:** OG000 **Title:** Sham Comparator ##### Group **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. **ID:** OG001 **Title:** Lampalizumab Q4W ##### Group **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. **ID:** OG002 **Title:** Lampalizumab Q6W #### Outcome Measure 11 **Description:** NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis. **Reporting Status:** POSTED **Time Frame:** Baseline, Week 48 **Title:** Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48 **Type:** SECONDARY **Unit of Measure:** score on a scale ##### Group **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. **ID:** OG000 **Title:** Sham Comparator ##### Group **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. **ID:** OG001 **Title:** Lampalizumab Q4W ##### Group **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. **ID:** OG002 **Title:** Lampalizumab Q6W #### Outcome Measure 12 **Description:** NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis. **Reporting Status:** POSTED **Time Frame:** Baseline, Week 48 **Title:** Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48 **Type:** SECONDARY **Unit of Measure:** score on a scale ##### Group **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. **ID:** OG000 **Title:** Sham Comparator ##### Group **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. **ID:** OG001 **Title:** Lampalizumab Q4W ##### Group **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. **ID:** OG002 **Title:** Lampalizumab Q6W #### Outcome Measure 13 **Description:** The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis. **Reporting Status:** POSTED **Time Frame:** Baseline, Week 48 **Title:** Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48 **Type:** SECONDARY **Unit of Measure:** score on a scale ##### Group **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. **ID:** OG000 **Title:** Sham Comparator ##### Group **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. **ID:** OG001 **Title:** Lampalizumab Q4W ##### Group **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. **ID:** OG002 **Title:** Lampalizumab Q6W #### Outcome Measure 14 **Description:** For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression). **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** ITT population included all the participants who were randomized to the study. The analysis was done specifically for CFI-positive and negative participants. Number analyzed for each row signifies the participants evaluated for specified categories for each reporting group. **Reporting Status:** POSTED **Time Frame:** Baseline, Week 48 **Title:** Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48 **Type:** PRIMARY **Unit of Measure:** mm^2 ##### Group **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. **ID:** OG000 **Title:** Sham Comparator ##### Group **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. **ID:** OG001 **Title:** Lampalizumab Q4W ##### Group **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. **ID:** OG002 **Title:** Lampalizumab Q6W ### Participant Flow Module #### Group **Description:** Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit. **ID:** FG000 **Title:** Sham Comparator #### Group **Description:** Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit. **ID:** FG001 **Title:** Lampalizumab Q4W #### Group **Description:** Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit. **ID:** FG002 **Title:** Lampalizumab Q6W #### Period **Title:** Overall Study ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 8 ###### Reason **Group ID:** FG001 **Number of Subjects:** 9 ###### Reason **Group ID:** FG002 **Number of Subjects:** 8 ##### Withdraw **Type:** Death ###### Reason **Group ID:** FG000 **Number of Subjects:** 5 ###### Reason **Group ID:** FG001 **Number of Subjects:** 4 ###### Reason **Group ID:** FG002 **Number of Subjects:** 6 ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 3 ###### Reason **Group ID:** FG001 **Number of Subjects:** 3 ###### Reason **Group ID:** FG002 **Number of Subjects:** 1 ##### Withdraw **Type:** Non-compliance ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ###### Reason **Group ID:** FG002 **Number of Subjects:** 1 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 25 ###### Reason **Group ID:** FG001 **Number of Subjects:** 29 ###### Reason **Group ID:** FG002 **Number of Subjects:** 24 ##### Withdraw **Type:** Study Terminated by Sponsor ###### Reason **Group ID:** FG000 **Number of Subjects:** 98 ###### Reason **Group ID:** FG001 **Number of Subjects:** 88 ###### Reason **Group ID:** FG002 **Number of Subjects:** 94 ##### Withdraw **Type:** Physician Decision ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ###### Reason **Group ID:** FG002 **Number of Subjects:** 2 ##### Withdraw **Type:** Unspecified Reason ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ###### Reason **Group ID:** FG001 **Number of Subjects:** 5 ###### Reason **Group ID:** FG002 **Number of Subjects:** 2 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 305 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 298 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 303 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 163 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 160 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 165 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 142 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 138 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 138 **Pre-Assignment Details:** This study enrolled participants with bilateral Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) and no signs of prior or active choroidal neovascularization (CNV), age \>= 50 years with a valid complement factor I (CFI)-profile biomarker result. **Recruitment Details:** A total of 906 participants were randomized to the study from 131 investigation sites across 19 countries. The study was terminated early by the Sponsor due to lack of efficacy. **Has Results:** True
## Protocol Section ### Identification Module **NCT ID:** NCT02077179 **Acronym:** HIP **Brief Title:** Health Improvement After Pregnancy (HIP) Program Randomized Control Trial **Official Title:** Health Improvement After Pregnancy (HIP) Program Randomized Control Trial #### Organization Study ID Info **ID:** OBGY-249-14 #### Organization **Class:** OTHER **Full Name:** Queen's University ### Status Module #### Completion Date **Date:** 2016-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-04-05 **Type:** ACTUAL **Last Update Submit Date:** 2017-04-04 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2016-04 **Type:** ACTUAL #### Start Date **Date:** 2014-09 **Status Verified Date:** 2017-04 #### Study First Post Date **Date:** 2014-03-04 **Type:** ESTIMATED **Study First Submit Date:** 2014-02-26 **Study First Submit QC Date:** 2014-03-03 **Why Stopped:** Poor retention and recruitment,changes need to be made to the program ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Queen's University #### Responsible Party **Investigator Affiliation:** Queen's University **Investigator Full Name:** Dr. Graeme Smith **Investigator Title:** Professor and Head of Obstetrics and Gynecology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Recent Canadian studies, public opinion polls and the Canadian Heart Health Strategy and Action Plan state that women's heart health is a key national priority; it should be addressed through improving heart health awareness and prevention, and reducing care inequities for women in general and younger women in particular. The investigators have developed an innovative and interactive mobile website based postpartum lifestyle modification program (regular physical activity and nutritional guidance), based on established national guidelines, to improve heart disease risk factors in women. The investigators will conduct a trial to determine if the mobile website based lifestyle modification program can be maintained and reduces a collection of risk factors, which occurring together, greatly increases the risk of developing heart disease. The investigators hypothesize that the interactive mobile website directing regular physical activity and personalized nutritional guidance, compared to standard postpartum care, will be motivational and result in a reduced modified metabolic syndrome z score at 8 months postpartum among the intervention group. ### Conditions Module **Conditions:** - Metabolic Cardiovascular Syndrome **Keywords:** - Postpartum - Preeclampsia - Gestational Hypertension - Gestational Diabetes - Exercise Intervention - Dietary Intervention - Behavioral Intervention - Mobile Website - Mobile Application ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 43 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in this arm will receive care as per the usual standards from Kingston General Hospital and their primary care provider. **Label:** Standard of Care **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Participants in this arm will follow the HIP Program in addition to their usual care from Kingston General Hospital and their primary care provider. **Intervention Names:** - Behavioral: HIP Program **Label:** HIP Program **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HIP Program **Description:** The entirety of the HIP Program is delivered through an interactive mobile website. The physical activity portion of the program consists of daily step counting, prescribed aerobic activity, structured strength and toning workouts, and daily stretching. The program was designed by a local trainer, specializing in postnatal exercise, to increase gradually in intensity, while encouraging a more active lifestyle. The program is designed to be completed at home with minimal equipment. The nutrition portion of the program consists of 16 video tutorials developed by a local Registered Dietitian and weekly diet logs. The video tutorials cover all aspects of healthy eating, from the basics of Canada's Food Guide, to smart snacking, to eating healthy over the holidays. **Name:** HIP Program **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome measure is the metabolic syndrome (MetS) z score, a continuous score of the five metabolic syndrome variables that make up the Adult Treatment Panel (ATP) III diagnostic criteria (waist circumference, blood pressure, high density lipoprotein, triglycerides and glucose). Differences between study arms will be compared. **Measure:** Metabolic Syndrome Z Score **Time Frame:** 32 weeks postpartum #### Secondary Outcomes **Description:** Adherence to the HIP Program will be assessed based on the number of times a participant indicates using the mobile website that a prescribed workout has been completed. This outcome will only be measured in the intervention arm. **Measure:** Adherence to the HIP Program; Percent of Workouts Completed **Time Frame:** 32 weeks postpartum **Description:** Differences between study arms for the following biochemical cardiovascular risk markers will be assessed at 32 weeks postpartum; lipid profile, fasting glucose, glycated hemoglobin, high sensitivity C-reactive protein, and urine microalbumin creatinine ratio. **Measure:** Differences in Biochemical Cardiovascular Risk Markers **Time Frame:** 32 weeks postpartum **Description:** Changes in systolic blood pressure, diastolic blood pressure and weight from baseline measures at 6-8 weeks postpartum will be assessed at the midpoint of the program at 20 weeks postpartum. Differences between study arms will be compared. **Measure:** Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Midpoint **Time Frame:** 20 weeks postpartum **Description:** Changes in systolic blood pressure, diastolic blood pressure and weight from baseline measures at 6-8 weeks postpartum will be assessed at the midpoint of the program at 32 weeks postpartum. Differences between study arms will be compared. **Measure:** Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Study Completion **Time Frame:** 32 weeks postpartum **Description:** Changes in systolic blood pressure, diastolic blood pressure, weight, body mass index, hip circumference, and waist circumference from midpoint measures at 20 weeks postpartum will be assessed at the end of the program at 32 weeks postpartum. Differences between study arms will be compared. **Measure:** Change in Anthropomorphic Measurements and Blood Pressure from Midpoint to Study Completion **Time Frame:** 32 weeks postpartum **Description:** Adherence to the HIP Program will be assessed based on the number of times a participant uses the mobile website to log their daily step count total. The number of times that the logged step count meets or exceeds the prescribed number of daily steps will also be assessed. This outcome will only be measured in the intervention arm. **Measure:** Adherence to the HIP Program; Percent of Step Counting Completed **Time Frame:** 32 weeks postpartum **Description:** Adherence to the HIP Program will be assessed based on the number of times a participant uses the mobile website to enter the weekly dietary log. The number of times that the dietary log meets the prescribed intake for each of the Canada's Food Guide food groups will also be assessed. This outcome will only be measured in the intervention arm. **Measure:** Adherence to the HIP Program; Percent of Dietary Logs Completed **Time Frame:** 32 weeks postpartum ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - must own or have daily access to one or more of the following; smart phone, tablet or laptop computer Exclusion Criteria: * Living greater than 100km from Kingston General Hospital * Having an existing and long term contraindication to exercise at the time of recruitment **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Kingston **Country:** Canada **Facility:** Queen's Unviersity **State:** Ontario **Zip:** K7L 2V7 #### Overall Officials **Official 1:** **Affiliation:** Queen's University **Name:** Graeme N Smith, MD,PhD,FRCSC **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Smith GN, Pudwell J, Roddy M. The Maternal Health Clinic: a new window of opportunity for early heart disease risk screening and intervention for women with pregnancy complications. J Obstet Gynaecol Can. 2013 Sep;35(9):831-839. doi: 10.1016/S1701-2163(15)30841-0. No abstract available. **PMID:** 24099450 **Citation:** Cusimano MC, Pudwell J, Roddy M, Cho CK, Smith GN. The maternal health clinic: an initiative for cardiovascular risk identification in women with pregnancy-related complications. Am J Obstet Gynecol. 2014 May;210(5):438.e1-9. doi: 10.1016/j.ajog.2013.12.001. Epub 2013 Dec 4. **PMID:** 24316270 **Citation:** Smith GN, Pudwell J, Walker M, Wen SW. Risk estimation of metabolic syndrome at one and three years after a pregnancy complicated by preeclampsia. J Obstet Gynaecol Can. 2012 Sep;34(9):836-841. doi: 10.1016/S1701-2163(16)35382-8. **PMID:** 22971452 **Citation:** Smith GN, Pudwell J, Walker M, Wen SW. Ten-year, thirty-year, and lifetime cardiovascular disease risk estimates following a pregnancy complicated by preeclampsia. J Obstet Gynaecol Can. 2012 Sep;34(9):830-835. doi: 10.1016/S1701-2163(16)35381-6. **PMID:** 22971451 **Citation:** Smith GN, Walker MC, Liu A, Wen SW, Swansburg M, Ramshaw H, White RR, Roddy M, Hladunewich M; Pre-Eclampsia New Emerging Team (PE-NET). A history of preeclampsia identifies women who have underlying cardiovascular risk factors. Am J Obstet Gynecol. 2009 Jan;200(1):58.e1-8. doi: 10.1016/j.ajog.2008.06.035. Epub 2008 Aug 8. **PMID:** 18691690 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007333 - Term: Insulin Resistance - ID: D000006946 - Term: Hyperinsulinism - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M23005 - Name: Metabolic Syndrome - Relevance: HIGH - As Found: Metabolic Cardiovascular Syndrome - ID: M14106 - Name: Pre-Eclampsia - Relevance: LOW - As Found: Unknown - ID: M19012 - Name: Diabetes, Gestational - Relevance: LOW - As Found: Unknown - ID: M25635 - Name: Hypertension, Pregnancy-Induced - Relevance: LOW - As Found: Unknown - ID: M10370 - Name: Insulin Resistance - Relevance: LOW - As Found: Unknown - ID: M9997 - Name: Hyperinsulinism - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000024821 - Term: Metabolic Syndrome ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT05394779 **Brief Title:** DEMETRA - ADVICE-002-2022 **Official Title:** Evaluation of Performance and Safety of DTXO App, an Innovative Digital Therapy, in Improving Weight Loss and Weight-Loss Maintenance of Patients With Obesity by Increasing Their Adherence to Dietary, Exercise Regimens and Psycho-Behavioral Program #### Organization Study ID Info **ID:** ADVICE-002-2022 #### Organization **Class:** INDUSTRY **Full Name:** Advice Pharma Group srl ### Status Module #### Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-02-08 **Type:** ACTUAL **Last Update Submit Date:** 2024-02-07 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Start Date **Date:** 2022-08-23 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2022-05-27 **Type:** ACTUAL **Study First Submit Date:** 2022-05-05 **Study First Submit QC Date:** 2022-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Advice Pharma Group srl #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate the safety and performance of DTXO App in improving weight loss and weight-loss maintenance in obese patients exposed to an experimental non-pharmacological treatment program. The App will include a dietary plan and customized advice program, a customized physical exercise program plan, a cognitive- behavioral assessment and support program, alerts and reminders on prescribed drugs intake and on dietary and exercise program, chat and online visits with clinical professionals, and trophies to improve patient engagement. **Detailed Description:** DTXO is a medical device designed to deliver digital therapy intervention (DTx) to patients. The DT, as part of Digital Health, utilizes high quality digital technologies to stimulate lifestyle changes in patients. DTXO has been set up to improve the commitment of patients in following therapeutic directives (i.e. nutritional programs, daily/weekly physical activities) to manage the disease of obesity. Moreover, DTXO can improve patient's awareness about patients disease (obesity) so is intended to improve weight loss, weight-loss maintenance, and overall health in patients with obesity by increasing their self-engagement, self-monitoring and adherence to dietary/exercise and behavioral programs. In this prospective, multicenter, pragmatic, randomized, double-arm placebo-controlled, parallel, single-blind study, the App integrates different non-pharmacological approaches, engaging the patient through monitoring of patients non-vital parameters, monitoring of patient diet and exercise, monitoring of patient psychological status, prescription of exercise and diet in a weight-loss program, and configurable data presentation charts for provision of additional information to professional users. The aim of this study is to monitor patients' non-vital parameters through data collection through patient-reported information, data collection through coupled devices, data processing by a proprietary algorithm based on clinical guidelines and data visualization by a proprietary interface; AND Prescribe diet, exercise and psycho-behavioral support intended for weight loss in obese patients. The dietary will be a personalized hypocaloric Mediterranean-based dietary program according to sex, ages must be between 18 and 65 years of age, physical activity level, dietary preferences and eating habits and prescribed by the nutritionist physician at baseline (V0), which aims at decreasing weight in obese patients and favoring patients' compliance and adherence to the diet. And regardless of the randomization arm, all patients enrolled in the study will be invited by the investigator to follow a dietary program with a daily caloric intake (kilocalories/day or kcal/day) assigned by a standardized method with a fixed caloric deficit equal to 800 kcal drawn on the suggested values range from 500 to 1000 kcal. Specifically, the caloric intake is classified starting from the measure of the daily Basal Metabolic Rate (BMR) based on genders (male, female), weight, height and age measured at baseline (V0). The study will enroll 246 subjects, both genders to obtain 172 overall valuable subjects (86 for each group). The recruitment period will last 4 months. Each patient will be followed for 12 months after baseline, during which lifestyle changes will be implemented with/without DTXO. Regular follow-up visits are foreseen at 3 months ±15 days (V1), 6 months ±15 days (V2), 9 months ±15 days (V3) and 12 months ±15 days (V4) after enrollment, in the end of the study is defined as the date of the last scheduled procedure shown in the Schedule of Activities for the last participant in the study globally. At the beginning of the study, patients will be evaluated for their body mass index (BMI=weight/height2 ) that according with the literature patients with BMI \>45 kg/m2 are in a severe condition that requires a combination of pharmacological and surgical treatment with lifestyle intervention and are therefore excluded from the study. The experimental arm will be compared with a control arm in which dietary and exercise programs will be delivered according to the current standard of care, which foresees, respectively, a standard paper-based approach and clinical recommendations. The control arm will also be equipped with a placebo App to ensure the patient's blindness to treatment allocation. Benefit/Risk Assessment: Benefits for patients resulting from study implementation is the possibility to provide simultaneous treatment strategies to improve the health status of obese patients. The expected result is that the simultaneous application of these strategies and the possibility of customizing patients' activities based on their habits and feedback will allow greater benefits than the application of separate, non-customized programs and a standard paper-based in-person approach. For this, the composite primary objective/endpoint consists of easily measurable objective markers. Both treatment arms will receive potential benefits by participating in this study. The control arm will receive the current standard of care (paper-based approach and face-to-face follow-up visits) for obese patients with the addition of a placebo app. However, greater benefits are hypothesized in the experimental arm due to the possibility of customization of physical activity in accordance with the perceptions and feedbacks of the patient, the availability of notifications and reminders for drug intake (dosage, frequency) to improve treatment adherence, the availability of contents to support and favor compliance with the prescribed diet, the possibility to schedule an online visit or communicate with the clinical specialist via chat through the App, and the availability of multimedia psycho-behavioral content (motivational exercises, self-acceptance exercises, mindfulness exercises, interactive emotional eating exercises, self-efficacy exercise). The main clinical benefit is improved weight loss and the overall health status of obese patients through the prescription of dietary and exercise programs delivered by a mobile App. Possible risks that can be anticipated in patients in the experimental arm are obsessive feeling about exercise and food intake and anxiety/guilt when not reaching assigned exercise or food intake goals, and interferences with subject's daily activities and/or social life to the higher "pressure" to adhere to the programs given by the DTXO App compared to the standard of care approach. Primary Objective - To evaluate the effect on weight loss in patients using DTXO compared to patients not-provided after 6 months of DTXO use. Secondary Objectives 1. To describe the primary objective in each randomized group. 2. To stratify the primary objective results by sex. 3. To stratify the primary objective results by ranges of BMI a baseline. 4. To evaluate the effect on weight-loss maintenance according to weight loss reached at 6 months in patients using DTXO compared to patients not-provided after 12 months of DTXO use. 5. To assess the percentage weight loss in each randomized group during the study. 6. To assess differences in physical function improvements between the two randomized groups during the study. 7. To assess the percentage weight loss between the two randomized groups during the study. 8. To assess the body fat distribution changes in each randomized group during the study. 9. To assess differences in body fat distribution changes between the two randomized groups during the study. 10. To stratify the percentage weight-loss changes by ranges of BMI at baseline. 11. To evaluate the effect on weight loss in patients using DTXO compared to patients not-provided after 12 months of DTXO use. 12. To assess the degree of physical inactivity reduction (IPAQ Questionnaire) in each randomized group during the study. 13. To assess the degree of stress reduction (DASS-21 scale) in each randomized group during the study. 14. To assess differences in the increase of quality of life (PGWBI questionnaire) between the two randomized groups during the study. Safety 15. To describe the safety profile in the two treatment groups. Primary Endpoints - To evaluate the change in absolute body weight (kg) at 6 months (V2) from baseline (V0) in obese DTXO users compared to obese Placebo App users Safety Endpoint To assess the rate of adverse events, adverse device effects, abnormality of laboratory parameters between the two randomized groups across the study (V1, V2, V3, V4). Statistical Hypotheses This study is designed to test the null hypothesis that the change in absolute body weight (kg) at 6 months (V2) from baseline (V0) in obese DTXO users compared to the obese placebo control group is equal to zero. The alternative hypothesis is that absolute body weight (kg) change between groups is less than zero. Sample Size Determination The sample size is estimated to provide statistical power for the primary endpoint. The sample size was computed according to the primary endpoint, namely the change in absolute body weight (kg) at 6 months (V2) from baseline (V0) in obese DTXO users compared to the obese placebo control group. Based on the primary endpoint, the statistical analysis determined that a total sample size of 172 patients (86 per group) would allow us 80% power and a two-sided type I error of 0.05 to detect a 1.5 kg difference in weight change at 6 months between the groups, assuming an SD of 3.5 kg. For this reasons, the goal is to enrolled 246 patients to account for a dropout rate of 30%. Data Quality Assurance All participant data relating to the study will be recorded on eCRF unless transmitted to the sponsor or designee electronically (e.g., laboratory data). The investigator is responsible for verifying that data entries are accurate and correct by electronically signing the eCRF. The investigator must permit study-related monitoring, audits, Institutional Review Board/Ethic Committee review, and regulatory agency inspections and provide direct access to source data documents. The sponsor or designee is responsible for the data management of this study including quality checking of the data. Study monitors will perform ongoing source data verification to confirm that data entered into the eCRF by authorized site personnel are accurate, complete, and verifiable from source documents; that the safety and rights of participants are being protected; and that the study is being conducted in accordance with the currently approved protocol and any other study agreements, ICH (International Conference on Harmonization) GCP (Good Clinical Practice), and all applicable regulatory requirements. ### Conditions Module **Conditions:** - Obesity - Health Behavior - Life Style - Dietary Habits - Weight Loss - Diet, Healthy - Diet Habit - Body Weight - Nutrition Disorders - Nutrition, Healthy - Overweight and Obesity - Behavioral Disorder **Keywords:** - Digital Therapeutics - Digital Medicine - Adherence - Software - Software Medical Device - Quality of life - Digital Therapy - Obesity - Exercise Program - Physical Activity - Diet - Nutritional Program - Psychological status ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Prospective, multicenter, pragmatic, randomized, double-arm, placebo-controlled, parallel, single-blind study. ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 246 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients randomized to Group A (experimental group) will be administered the Mediterranean based dietary program by means of App DTXO. The dietary program will be administered through the DTXO application. Each patient will select the assigned daily menu or the proposed alternatives; The dietary program is personalized according to the patients caloric intake needs and to their nutritional restrictions. Patients randomized to Group A (experimental group) will be administered the Physical activity program by means of App DTXO. The activity program will be administered through the DTXO application based on the individual's background fitness level. Patients randomized to Group A (experimental group) will be invited to follow a psycho-behavioral program to increase awareness of the behaviors and habits related to obesity, consisting of multimedia and educational content, self-assessment and dynamic exercises. **Intervention Names:** - Device: DTXO APP **Label:** DTXO APP **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients randomized in Group B (control group) will be delivered a dietary program, according to the current standard of care and will be printed on paper with the information on the Mediterranean diet and general educational content related to food. The control arm will also be equipped with a placebo App to ensure the patient's blindness to treatment allocation and there will be asked to the patient to complete weekly the Diet Adherence questionnaire. Patients randomized in Group B (control group) will be advised to perform regular physical activity and provided with educational material and some tips on physical activity; no formal plan will be provided, as currently done in standard clinical practice. Patients randomized in Group B (control group) will receive printed educational material with generic content and advice for self-help support and followed as per standard clinical practice. The placebo App will be used as a data entry tool for questionnaires. **Intervention Names:** - Device: PLACEBO APP - Control group **Label:** PLACEBO APP-Control group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - DTXO APP **Description:** DTXO is an investigational therapeutic intervention (Digital Therapeutics - DTx) for obese patients, under clinical validation with a randomized and placebo-controlled clinical trial for confirmatory purposes. It is intended to improve weight loss, weight-loss maintenance, and overall health in patients with obesity by increasing their self-engagement, self-monitoring and adherence to dietary/exercise and behavioral programs. The App integrates different non-pharmacological approaches, engaging the patient through monitoring of her/his non-vital parameters, monitoring of patient diet and exercise, monitoring of patient psychological status, prescription of exercise and diet in a weight-loss program. **Name:** DTXO APP **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - PLACEBO APP-Control group **Description:** The placebo App will include only the non-medical modules of the digital therapy and has been introduced to make the experience of subjects in the control arm more similar to that of subjects in the experimental arm; moreover, data collection through the placebo app (questionnaires) will streamline the data collection process, avoiding manual data entry and reducing the possibility of entry errors. **Name:** PLACEBO APP - Control group **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Change in absolute body weight (kg) at 6 months from baseline in obese DTXO users compared with obese Placebo App users **Measure:** Evaluation of change in body weight (kg) **Time Frame:** 6 months #### Secondary Outcomes **Description:** Evaluation of changes in health status with reference to the diet, at 12 months from baseline in both groups (treatment/placebo). The diet adherence assessment is performed through to the Diet Adherence NRS Scale where 0= low and 10= high. **Measure:** Evaluation of changes in patients' diet adherence with Numerical Rating Scale (NRS) scale **Time Frame:** 12 months **Description:** Evaluation of changes in health status with reference to the diet, at 12 months from baseline in both groups (treatment/placebo). The diet adherence assessment is performed through to the Diet Enjoyment using NRS Scale where 0= low and 10= high. **Measure:** Evaluation of changes in patients' diet enjoyment with Numerical Rating Scale (NRS) scale **Time Frame:** 12 months **Description:** Evaluation of changes in health status with reference to the diet, at 12 months from baseline in both groups (treatment/placebo). The diet adherence assessment is performed through to the Hunger/Satiety using NRS Scale where 0= low and 10= high. **Measure:** Evaluation of changes in patients' satiety with Numerical Rating Scale (NRS) scale **Time Frame:** 12 months **Description:** Evaluation of changes in health status with reference to the physical activity, at 12 months from baseline in both groups (treatment/placebo). The physical activity performance assessment is evaluated through the short physical performance battery (SPPB) that measures the results of the gait speed (3 or 4-meter walking speed test), chair stand (time to rise from a chair for five times) and balance tests (stand up for 10 seconds in 3 different positions). The scores range from 0 (worst performance) to 12 (best performance). **Measure:** Evaluation of changes in patients' physical activity with short physical performance battery assessment **Time Frame:** 12 months **Description:** Evaluation of changes in health status with reference to the psychological behavior, at 12 months from baseline in both groups (treatment/placebo). The psychological behavior is assessed through the Depression Anxiety Stress Scale (DASS-21), that is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Subjects are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week. Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items. Particular attention will be given to the following scores: score ≥18 or subscores Stress ≥26; Anxiety ≥15; Depression ≥21. Higher scores are indicative of more severe symptoms. **Measure:** Evaluation of changes in patients' psychological behavior Depression Anxiety Stress Scale (DASS-21) score ≥18 **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants must be between 18 and 65 years of age, at the time of signing the informed consent. * Male and Female. * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol. * BMI between 30.0 kg/m2 and 45 kg/m2 . * Participants must own a mobile phone, be willing to use mobile Apps and this type of technology (technology-savvy) and download the App described in the protocol. * Native speakers of Italian language or foreign subjects who have a full understanding of the Italian language, as the instructions and information for all health programs will only be given in Italian. Exclusion Criteria: * Heart failure (class \>II), ischemic attack or stroke within the previous 6 months to the planned date of randomization. * History or current evidence of drug or alcohol abuse. * Chronic kidney failure with GFR category \>G2 (ml/min/1.73 m2). * Type 1 diabetes. * Previous malignancy within the first 5 years. * Active eating disorder or previous history of bulimia and anorexia nervosa, active severe binge-eating disorder. * Psychiatric disorders not compensated or at risk of decompensation. * Visual or vision impairments * Secondary obesity related to endocrinopathies, genetic syndromes, hypothalamic lesions or neurological diseases and immobility. * Concomitant advanced obesity disease. * History of bariatric surgery in the previous 2 years or plans for bariatric surgery during the study period. * Referred pain to lower limb joints (hip, knee, ankle) on the NRS ≥ 5. * Weight loss ≥10% in the 6 months prior to the planned date of randomization. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Milan **Country:** Italy **Facility:** Istituto Auxologico Italiano **Zip:** 20145 #### Overall Officials **Official 1:** **Affiliation:** Advice Pharma Grou S.r.l **Name:** Alessandro Flavio Ferri **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Coons MJ, Demott A, Buscemi J, Duncan JM, Pellegrini CA, Steglitz J, Pictor A, Spring B. Technology Interventions to Curb Obesity: A Systematic Review of the Current Literature. Curr Cardiovasc Risk Rep. 2012 Apr;6(2):120-134. doi: 10.1007/s12170-012-0222-8. **PMID:** 23082235 **Citation:** Allen JK, Stephens J, Dennison Himmelfarb CR, Stewart KJ, Hauck S. Randomized controlled pilot study testing use of smartphone technology for obesity treatment. J Obes. 2013;2013:151597. doi: 10.1155/2013/151597. Epub 2013 Dec 10. **PMID:** 24392223 **Citation:** Appel LJ, Clark JM, Yeh HC, Wang NY, Coughlin JW, Daumit G, Miller ER 3rd, Dalcin A, Jerome GJ, Geller S, Noronha G, Pozefsky T, Charleston J, Reynolds JB, Durkin N, Rubin RR, Louis TA, Brancati FL. Comparative effectiveness of weight-loss interventions in clinical practice. N Engl J Med. 2011 Nov 24;365(21):1959-68. doi: 10.1056/NEJMoa1108660. Epub 2011 Nov 15. **PMID:** 22085317 **Citation:** Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. **PMID:** 2748771 **Citation:** Barton BB, Segger F, Fischer K, Obermeier M, Musil R. Update on weight-gain caused by antipsychotics: a systematic review and meta-analysis. Expert Opin Drug Saf. 2020 Mar;19(3):295-314. doi: 10.1080/14740338.2020.1713091. Epub 2020 Mar 12. **PMID:** 31952459 **Citation:** Canning KL, Brown RE, Wharton S, Sharma AM, Kuk JL. Edmonton Obesity Staging System Prevalence and Association with Weight Loss in a Publicly Funded Referral-Based Obesity Clinic. J Obes. 2015;2015:619734. doi: 10.1155/2015/619734. Epub 2015 Apr 28. **PMID:** 26060580 **Citation:** Curcio G, Tempesta D, Scarlata S, Marzano C, Moroni F, Rossini PM, Ferrara M, De Gennaro L. Validity of the Italian version of the Pittsburgh Sleep Quality Index (PSQI). Neurol Sci. 2013 Apr;34(4):511-9. doi: 10.1007/s10072-012-1085-y. Epub 2012 Apr 13. **PMID:** 22526760 **Citation:** da Vico L, Biffi B, Agostini S, Brazzo S, Masini ML, Fattirolli F, Mannucci E. [Validation of the Italian version of the questionnaire on nutrition knowledge by Moynihan]. Monaldi Arch Chest Dis. 2010 Sep;74(3):140-6. doi: 10.4081/monaldi.2010.263. Italian. **PMID:** 21114058 **Citation:** De Santi M, Contisciani D, Baldelli G, Brandi G, Schiavano GF, Amagliani G. Physical activity as a tool for health promotion: the evolution of international strategies and interventions. Ann Ist Super Sanita. 2020 Oct-Dec;56(4):419-429. doi: 10.4415/ANN_20_04_03. **PMID:** 33346167 **Citation:** d'Errico M, Pavlova M, Spandonaro F. The economic burden of obesity in Italy: a cost-of-illness study. Eur J Health Econ. 2022 Mar;23(2):177-192. doi: 10.1007/s10198-021-01358-1. Epub 2021 Aug 4. **PMID:** 34347176 **Citation:** DiClemente CC, Schlundt D, Gemmell L. Readiness and stages of change in addiction treatment. Am J Addict. 2004 Mar-Apr;13(2):103-19. doi: 10.1080/10550490490435777. **PMID:** 15204662 **Citation:** Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Fito M, Gea A, Hernan MA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts. N Engl J Med. 2018 Jun 21;378(25):e34. doi: 10.1056/NEJMoa1800389. Epub 2018 Jun 13. **PMID:** 29897866 **Citation:** Garcia-Conesa MT, Philippou E, Pafilas C, Massaro M, Quarta S, Andrade V, Jorge R, Chervenkov M, Ivanova T, Dimitrova D, Maksimova V, Smilkov K, Ackova DG, Miloseva L, Ruskovska T, Deligiannidou GE, Kontogiorgis CA, Pinto P. Exploring the Validity of the 14-Item Mediterranean Diet Adherence Screener (MEDAS): A Cross-National Study in Seven European Countries around the Mediterranean Region. Nutrients. 2020 Sep 27;12(10):2960. doi: 10.3390/nu12102960. **PMID:** 32992649 **Citation:** Gormally J, Black S, Daston S, Rardin D. The assessment of binge eating severity among obese persons. Addict Behav. 1982;7(1):47-55. doi: 10.1016/0306-4603(82)90024-7. **PMID:** 7080884 **Citation:** Monopoli WJ, Huet A, Allan NP, Judah MR, Bunford N. Distinct aspects of emotion dysregulation differentially correspond to magnitude and slope of the late positive potential to affective stimuli. Cogn Emot. 2022 Mar;36(2):372-383. doi: 10.1080/02699931.2021.2000370. Epub 2021 Nov 15. **PMID:** 34775912 **Citation:** Grossi E, Groth N, Mosconi P, Cerutti R, Pace F, Compare A, Apolone G. Development and validation of the short version of the Psychological General Well-Being Index (PGWB-S). Health Qual Life Outcomes. 2006 Nov 14;4:88. doi: 10.1186/1477-7525-4-88. **PMID:** 17105655 **Citation:** Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221. **PMID:** 10811152 **Citation:** Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. doi: 10.1079/phn2005898. **PMID:** 16925881 **Citation:** Izquierdo M, Merchant RA, Morley JE, Anker SD, Aprahamian I, Arai H, Aubertin-Leheudre M, Bernabei R, Cadore EL, Cesari M, Chen LK, de Souto Barreto P, Duque G, Ferrucci L, Fielding RA, Garcia-Hermoso A, Gutierrez-Robledo LM, Harridge SDR, Kirk B, Kritchevsky S, Landi F, Lazarus N, Martin FC, Marzetti E, Pahor M, Ramirez-Velez R, Rodriguez-Manas L, Rolland Y, Ruiz JG, Theou O, Villareal DT, Waters DL, Won Won C, Woo J, Vellas B, Fiatarone Singh M. International Exercise Recommendations in Older Adults (ICFSR): Expert Consensus Guidelines. J Nutr Health Aging. 2021;25(7):824-853. doi: 10.1007/s12603-021-1665-8. **PMID:** 34409961 **Citation:** Jacob JJ, Isaac R. Behavioral therapy for management of obesity. Indian J Endocrinol Metab. 2012 Jan;16(1):28-32. doi: 10.4103/2230-8210.91180. **PMID:** 22276250 **Citation:** James WP, Astrup A, Finer N, Hilsted J, Kopelman P, Rossner S, Saris WH, Van Gaal LF. Effect of sibutramine on weight maintenance after weight loss: a randomised trial. STORM Study Group. Sibutramine Trial of Obesity Reduction and Maintenance. Lancet. 2000 Dec 23-30;356(9248):2119-25. doi: 10.1016/s0140-6736(00)03491-7. **PMID:** 11191537 **Citation:** Jensen MP, Turner JA, Romano JM, Fisher LD. Comparative reliability and validity of chronic pain intensity measures. Pain. 1999 Nov;83(2):157-62. doi: 10.1016/s0304-3959(99)00101-3. **PMID:** 10534586 **Citation:** Kahn SE, Hull RL, Utzschneider KM. Mechanisms linking obesity to insulin resistance and type 2 diabetes. Nature. 2006 Dec 14;444(7121):840-6. doi: 10.1038/nature05482. **PMID:** 17167471 **Citation:** Kim M, Choi HJ. Digital Therapeutics for Obesity and Eating-Related Problems. Endocrinol Metab (Seoul). 2021 Apr;36(2):220-228. doi: 10.3803/EnM.2021.107. Epub 2021 Mar 24. **PMID:** 33761233 **Citation:** Kim M, Kim Y, Go Y, Lee S, Na M, Lee Y, Choi S, Choi HJ. Multidimensional Cognitive Behavioral Therapy for Obesity Applied by Psychologists Using a Digital Platform: Open-Label Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Apr 30;8(4):e14817. doi: 10.2196/14817. **PMID:** 32352391 **Citation:** Klasnja P, Pratt W. Healthcare in the pocket: mapping the space of mobile-phone health interventions. J Biomed Inform. 2012 Feb;45(1):184-98. doi: 10.1016/j.jbi.2011.08.017. Epub 2011 Sep 9. **PMID:** 21925288 **Citation:** Kozak AT, Buscemi J, Hawkins MA, Wang ML, Breland JY, Ross KM, Kommu A. Technology-based interventions for weight management: current randomized controlled trial evidence and future directions. J Behav Med. 2017 Feb;40(1):99-111. doi: 10.1007/s10865-016-9805-z. Epub 2016 Oct 25. **PMID:** 27783259 **Citation:** Kroeger CM, Hoddy KK, Varady KA. Impact of weight regain on metabolic disease risk: a review of human trials. J Obes. 2014;2014:614519. doi: 10.1155/2014/614519. Epub 2014 Aug 14. **PMID:** 25197563 **Citation:** Laing BY, Mangione CM, Tseng CH, Leng M, Vaisberg E, Mahida M, Bholat M, Glazier E, Morisky DE, Bell DS. Effectiveness of a smartphone application for weight loss compared with usual care in overweight primary care patients: a randomized, controlled trial. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S5-12. doi: 10.7326/M13-3005. **PMID:** 25402403 **Citation:** Langley GB, Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int. 1985;5(4):145-8. doi: 10.1007/BF00541514. **PMID:** 4048757 **Citation:** Leibel RL, Seeley RJ, Darsow T, Berg EG, Smith SR, Ratner R. Biologic Responses to Weight Loss and Weight Regain: Report From an American Diabetes Association Research Symposium. Diabetes. 2015 Jul;64(7):2299-309. doi: 10.2337/db15-0004. No abstract available. **PMID:** 26106187 **Citation:** Lemstra M, Bird Y, Nwankwo C, Rogers M, Moraros J. Weight loss intervention adherence and factors promoting adherence: a meta-analysis. Patient Prefer Adherence. 2016 Aug 12;10:1547-59. doi: 10.2147/PPA.S103649. eCollection 2016. **PMID:** 27574404 **Citation:** Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Ros E, Covas MI, Fiol M, Warnberg J, Aros F, Ruiz-Gutierrez V, Lamuela-Raventos RM, Lapetra J, Munoz MA, Martinez JA, Saez G, Serra-Majem L, Pinto X, Mitjavila MT, Tur JA, Portillo MP, Estruch R; PREDIMED Study Investigators. Cohort profile: design and methods of the PREDIMED study. Int J Epidemiol. 2012 Apr;41(2):377-85. doi: 10.1093/ije/dyq250. Epub 2010 Dec 20. No abstract available. **PMID:** 21172932 **Citation:** Mifflin MD, St Jeor ST, Hill LA, Scott BJ, Daugherty SA, Koh YO. A new predictive equation for resting energy expenditure in healthy individuals. Am J Clin Nutr. 1990 Feb;51(2):241-7. doi: 10.1093/ajcn/51.2.241. **PMID:** 2305711 **Citation:** Moynihan PJ, Mulvaney CE, Adamson AJ, Seal C, Steen N, Mathers JC, Zohouri FV. The nutrition knowledge of older adults living in sheltered housing accommodation. J Hum Nutr Diet. 2007 Oct;20(5):446-58. doi: 10.1111/j.1365-277X.2007.00808.x. **PMID:** 17845379 **Citation:** Neeland IJ, Poirier P, Despres JP. Cardiovascular and Metabolic Heterogeneity of Obesity: Clinical Challenges and Implications for Management. Circulation. 2018 Mar 27;137(13):1391-1406. doi: 10.1161/CIRCULATIONAHA.117.029617. **PMID:** 29581366 **Citation:** Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, Mullany EC, Biryukov S, Abbafati C, Abera SF, Abraham JP, Abu-Rmeileh NM, Achoki T, AlBuhairan FS, Alemu ZA, Alfonso R, Ali MK, Ali R, Guzman NA, Ammar W, Anwari P, Banerjee A, Barquera S, Basu S, Bennett DA, Bhutta Z, Blore J, Cabral N, Nonato IC, Chang JC, Chowdhury R, Courville KJ, Criqui MH, Cundiff DK, Dabhadkar KC, Dandona L, Davis A, Dayama A, Dharmaratne SD, Ding EL, Durrani AM, Esteghamati A, Farzadfar F, Fay DF, Feigin VL, Flaxman A, Forouzanfar MH, Goto A, Green MA, Gupta R, Hafezi-Nejad N, Hankey GJ, Harewood HC, Havmoeller R, Hay S, Hernandez L, Husseini A, Idrisov BT, Ikeda N, Islami F, Jahangir E, Jassal SK, Jee SH, Jeffreys M, Jonas JB, Kabagambe EK, Khalifa SE, Kengne AP, Khader YS, Khang YH, Kim D, Kimokoti RW, Kinge JM, Kokubo Y, Kosen S, Kwan G, Lai T, Leinsalu M, Li Y, Liang X, Liu S, Logroscino G, Lotufo PA, Lu Y, Ma J, Mainoo NK, Mensah GA, Merriman TR, Mokdad AH, Moschandreas J, Naghavi M, Naheed A, Nand D, Narayan KM, Nelson EL, Neuhouser ML, Nisar MI, Ohkubo T, Oti SO, Pedroza A, Prabhakaran D, Roy N, Sampson U, Seo H, Sepanlou SG, Shibuya K, Shiri R, Shiue I, Singh GM, Singh JA, Skirbekk V, Stapelberg NJ, Sturua L, Sykes BL, Tobias M, Tran BX, Trasande L, Toyoshima H, van de Vijver S, Vasankari TJ, Veerman JL, Velasquez-Melendez G, Vlassov VV, Vollset SE, Vos T, Wang C, Wang X, Weiderpass E, Werdecker A, Wright JL, Yang YC, Yatsuya H, Yoon J, Yoon SJ, Zhao Y, Zhou M, Zhu S, Lopez AD, Murray CJ, Gakidou E. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8. Epub 2014 May 29. Erratum In: Lancet. 2014 Aug 30;384(9945):746. **PMID:** 24880830 **Citation:** Nystoriak MA, Bhatnagar A. Cardiovascular Effects and Benefits of Exercise. Front Cardiovasc Med. 2018 Sep 28;5:135. doi: 10.3389/fcvm.2018.00135. eCollection 2018. **PMID:** 30324108 **Citation:** Pietrabissa G, Sorgente A, Rossi A, Simpson S, Riva G, Manzoni GM, Prochaska JO, Prochaska JM, Cattivelli R, Castelnuovo G. Stages of change in obesity and weight management: factorial structure of the Italian version of the University of Rhode Island Change Assessment Scale. Eat Weight Disord. 2017 Jun;22(2):361-367. doi: 10.1007/s40519-016-0289-1. Epub 2016 May 10. **PMID:** 27165047 **Citation:** Reik A, Holzapfel C. Randomized Controlled Lifestyle Intervention (LION) Study for Weight Loss and Maintenance in Adults With Obesity-Design and Methods. Front Nutr. 2020 Nov 10;7:586985. doi: 10.3389/fnut.2020.586985. eCollection 2020. **PMID:** 33240920 **Citation:** Ricca V, Mannucci E, Moretti S, Di Bernardo M, Zucchi T, Cabras PL, Rotella CM. Screening for binge eating disorder in obese outpatients. Compr Psychiatry. 2000 Mar-Apr;41(2):111-5. doi: 10.1016/s0010-440x(00)90143-3. **PMID:** 10741889 **Citation:** Rosato V, Temple NJ, La Vecchia C, Castellan G, Tavani A, Guercio V. Mediterranean diet and cardiovascular disease: a systematic review and meta-analysis of observational studies. Eur J Nutr. 2019 Feb;58(1):173-191. doi: 10.1007/s00394-017-1582-0. Epub 2017 Nov 25. **PMID:** 29177567 **Citation:** Sayon-Orea C, Razquin C, Bullo M, Corella D, Fito M, Romaguera D, Vioque J, Alonso-Gomez AM, Warnberg J, Martinez JA, Serra-Majem L, Estruch R, Tinahones FJ, Lapetra J, Pinto X, Tur JA, Lopez-Miranda J, Bueno-Cavanillas A, Delgado-Rodriguez M, Matia-Martin P, Daimiel L, Sanchez VM, Vidal J, Vazquez C, Ros E, Ruiz-Canela M, Sorli JV, Castaner O, Fiol M, Navarrete-Munoz EM, Aros F, Gomez-Gracia E, Zulet MA, Sanchez-Villegas A, Casas R, Bernal-Lopez R, Santos-Lozano JM, Corbella E, Bouzas C, Garcia-Arellano A, Basora J, Asensio EM, Schroder H, Monino M, Garcia de la Hera M, Tojal-Sierra L, Toledo E, Diaz-Lopez A, Goday A, Salas-Salvado J, Martinez-Gonzalez MA. Effect of a Nutritional and Behavioral Intervention on Energy-Reduced Mediterranean Diet Adherence Among Patients With Metabolic Syndrome: Interim Analysis of the PREDIMED-Plus Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1486-1499. doi: 10.1001/jama.2019.14630. **PMID:** 31613346 **Citation:** Schroder H, Fito M, Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Lamuela-Raventos R, Ros E, Salaverria I, Fiol M, Lapetra J, Vinyoles E, Gomez-Gracia E, Lahoz C, Serra-Majem L, Pinto X, Ruiz-Gutierrez V, Covas MI. A short screener is valid for assessing Mediterranean diet adherence among older Spanish men and women. J Nutr. 2011 Jun;141(6):1140-5. doi: 10.3945/jn.110.135566. Epub 2011 Apr 20. **PMID:** 21508208 **Citation:** Smith SC Jr. Multiple risk factors for cardiovascular disease and diabetes mellitus. Am J Med. 2007 Mar;120(3 Suppl 1):S3-S11. doi: 10.1016/j.amjmed.2007.01.002. **PMID:** 17320520 **Citation:** Spring B, Duncan JM, Janke EA, Kozak AT, McFadden HG, DeMott A, Pictor A, Epstein LH, Siddique J, Pellegrini CA, Buscemi J, Hedeker D. Integrating technology into standard weight loss treatment: a randomized controlled trial. JAMA Intern Med. 2013 Jan 28;173(2):105-11. doi: 10.1001/jamainternmed.2013.1221. **PMID:** 23229890 **Citation:** Spring B, Pellegrini C, McFadden HG, Pfammatter AF, Stump TK, Siddique J, King AC, Hedeker D. Multicomponent mHealth Intervention for Large, Sustained Change in Multiple Diet and Activity Risk Behaviors: The Make Better Choices 2 Randomized Controlled Trial. J Med Internet Res. 2018 Jun 19;20(6):e10528. doi: 10.2196/10528. **PMID:** 29921561 **Citation:** Spring B, Pellegrini CA, Pfammatter A, Duncan JM, Pictor A, McFadden HG, Siddique J, Hedeker D. Effects of an abbreviated obesity intervention supported by mobile technology: The ENGAGED randomized clinical trial. Obesity (Silver Spring). 2017 Jul;25(7):1191-1198. doi: 10.1002/oby.21842. Epub 2017 May 11. **PMID:** 28494136 **Citation:** Spring B, Schneider K, McFadden HG, Vaughn J, Kozak AT, Smith M, Moller AC, Epstein LH, Demott A, Hedeker D, Siddique J, Lloyd-Jones DM. Multiple behavior changes in diet and activity: a randomized controlled trial using mobile technology. Arch Intern Med. 2012 May 28;172(10):789-96. doi: 10.1001/archinternmed.2012.1044. **PMID:** 22636824 **Citation:** Steele RM, Mummery WK, Dwyer T. A comparison of face-to-face or internet-delivered physical activity intervention on targeted determinants. Health Educ Behav. 2009 Dec;36(6):1051-64. doi: 10.1177/1090198109335802. Epub 2009 Jun 5. **PMID:** 19502534 **Citation:** Swift DL, McGee JE, Earnest CP, Carlisle E, Nygard M, Johannsen NM. The Effects of Exercise and Physical Activity on Weight Loss and Maintenance. Prog Cardiovasc Dis. 2018 Jul-Aug;61(2):206-213. doi: 10.1016/j.pcad.2018.07.014. Epub 2018 Jul 9. **PMID:** 30003901 **Citation:** Taylor VH, Forhan M, Vigod SN, McIntyre RS, Morrison KM. The impact of obesity on quality of life. Best Pract Res Clin Endocrinol Metab. 2013 Apr;27(2):139-46. doi: 10.1016/j.beem.2013.04.004. Epub 2013 May 10. **PMID:** 23731876 **Citation:** Teixeira PJ, Carraca EV, Marques MM, Rutter H, Oppert JM, De Bourdeaudhuij I, Lakerveld J, Brug J. Successful behavior change in obesity interventions in adults: a systematic review of self-regulation mediators. BMC Med. 2015 Apr 16;13:84. doi: 10.1186/s12916-015-0323-6. **PMID:** 25907778 **Citation:** Turner-McGrievy GM, Beets MW, Moore JB, Kaczynski AT, Barr-Anderson DJ, Tate DF. Comparison of traditional versus mobile app self-monitoring of physical activity and dietary intake among overweight adults participating in an mHealth weight loss program. J Am Med Inform Assoc. 2013 May 1;20(3):513-8. doi: 10.1136/amiajnl-2012-001510. Epub 2013 Feb 21. **PMID:** 23429637 **Citation:** Verhaegen AA, Van Gaal LF. Drug-induced obesity and its metabolic consequences: a review with a focus on mechanisms and possible therapeutic options. J Endocrinol Invest. 2017 Nov;40(11):1165-1174. doi: 10.1007/s40618-017-0719-6. Epub 2017 Jun 28. **PMID:** 28660606 **Citation:** Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452. **PMID:** 8594834 **Citation:** Wyatt HR. Update on treatment strategies for obesity. J Clin Endocrinol Metab. 2013 Apr;98(4):1299-306. doi: 10.1210/jc.2012-3115. Epub 2013 Feb 26. **PMID:** 23443815 **Citation:** Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, Lau DC, le Roux CW, Violante Ortiz R, Jensen CB, Wilding JP; SCALE Obesity and Prediabetes NN8022-1839 Study Group. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015 Jul 2;373(1):11-22. doi: 10.1056/NEJMoa1411892. **PMID:** 26132939 **Citation:** Yumuk V, Tsigos C, Fried M, Schindler K, Busetto L, Micic D, Toplak H; Obesity Management Task Force of the European Association for the Study of Obesity. European Guidelines for Obesity Management in Adults. Obes Facts. 2015;8(6):402-24. doi: 10.1159/000442721. Epub 2015 Dec 5. Erratum In: Obes Facts. 2016;9(1):64. **PMID:** 26641646 #### See Also Links **Label:** Dupuy HJ. The Psychological general Well-Being (PGWB) Index. In: Assessment of Quality of Life in clinical trials of cardiovascular therapies. Edited by Wenger NK, Mattson ME, Furberg CD, Elinson J. Le Jacq Publishing 1984; Chap 9:170-183 **URL:** https://doi.org/10.1007/978-94-007-0753-5 **Label:** General Self-Efficacy Scale (GSE) **URL:** http://userpage.fu-berlin.de/~health/selfscal.htm **Label:** Cotter E.W., Kelly N.R. (2016) Binge Eating Scale (BES). In: Wade T. (eds) Encyclopedia of Feeding and Eating Disorders. Springer, Singapore. https://doi.org/10.1007/978-981-287-087-2_9-2 **URL:** https://doi.org/10.1007/978-981-287-087-2 **Label:** Hunt SM, McKenna S: A British adaptation of the general Wellbeing Index: a new tool for clinical research. British J Med Economics 1992, 2:49-60 **URL:** https://doi.org/10.1007/s11136-004-0793-z **Label:** Italian translations of the DASS. **URL:** http://www2.psy.unsw.edu.au/Groups/Dass/Italian/Italian.htm **Label:** Lovibond, S.H. \& Lovibond, P.F. (1995). Manual for the Depression Anxiety \& Stress Scales. (2nd Ed.)Sydney: Psychology Foundation **URL:** https://www.scirp.org/reference/ReferencesPapers.aspx?ReferenceID=1341416 **Label:** Mannocci A, Di Thiene D, Del Cimmuto A, Masala D, Boccia A, De Vito E, La Torre G. International Physical Activity Questionnaire: validation and assessment in an Italian sample. Ital J Public Health 2010; 7(4):369-76 **URL:** https://www.semanticscholar.org/paper/International-Physical-Activity-Questionnaire%3A-and-Mannocci-Thiene/8cf71eb6f21660c4b3907043ef68e798009700eb/figure/2 **Label:** S.I.O. - A.D.I. "Standard Italiani per la Cura dell'Obesità S.I.O. - A.D.I. 2016 - 2017" **URL:** https://www.centrodiriabilitazionenutrizionale.it/nutrizionisti/images/Documenti/Obesita/Ob1-Standard-SIO-ADI-2016-Final.pdf **Label:** SCL-90-R - Giunti Psychometrics **URL:** https://www.giuntipsy.it/catalogo/test/scl-90-r **Label:** SINU - società italiana di nutrizione umana. LARN: livelli di assunzione di rifereimento di nutrienti ed energia per la popolazione italiana, IV revisione, 2014 **URL:** https://sinu.it/tabelle-larn-2014/ **Label:** World Health Organization (WHO) - WHO Guidelines on Physical Activity and Sedentary Behaviour. 2020 **URL:** https://apps.who.int/iris/bitstream/handle/10665/336656/9789240015128-eng.pdf ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044343 - Term: Overnutrition - ID: D000001836 - Term: Body Weight Changes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M5114 - Name: Body Weight - Relevance: HIGH - As Found: Body Weight - ID: M18102 - Name: Weight Loss - Relevance: HIGH - As Found: Weight Loss - ID: M12684 - Name: Nutrition Disorders - Relevance: HIGH - As Found: Nutrition Disorders - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M26186 - Name: Overweight - Relevance: HIGH - As Found: Overweight - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M5115 - Name: Body Weight Changes - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009765 - Term: Obesity - ID: D000050177 - Term: Overweight - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight - ID: D000015431 - Term: Weight Loss ### Intervention Browse Module - Browse Branches - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6263 - Name: Coal Tar - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT01366079 **Brief Title:** Dynamic Position Change in Colonic Adenoma Detection **Official Title:** Dynamic Position Change in Colonic Adenoma Detection: a Prospective, Randomized, Multicenter Study #### Organization Study ID Info **ID:** Dynamic study #### Organization **Class:** OTHER **Full Name:** The Catholic University of Korea ### Status Module #### Completion Date **Date:** 2015-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-03-31 **Type:** ESTIMATED **Last Update Submit Date:** 2015-03-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-03 **Type:** ACTUAL #### Start Date **Date:** 2011-07 **Status Verified Date:** 2015-03 #### Study First Post Date **Date:** 2011-06-03 **Type:** ESTIMATED **Study First Submit Date:** 2011-06-01 **Study First Submit QC Date:** 2011-06-02 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Catholic University of Korea #### Responsible Party **Investigator Affiliation:** The Catholic University of Korea **Investigator Full Name:** Jeong-Seon Ji **Investigator Title:** MD, PhD **Type:** PRINCIPAL_INVESTIGATOR ### Description Module **Brief Summary:** There was an only single operator study reporting dynamic position change during colonoscopy withdrawal significantly improved polyp and adenoma detection. So we designed a prospective, randomized multicenter study to verify the effect of dynamic position change in colonic adenoma detection. We think position change improve luminal distension and has the potential to improve adenoma detection rate. ### Conditions Module **Conditions:** - Position - Colonoscopy - Adenoma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 1072 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Position change group **Intervention Names:** - Procedure: Position change **Label:** Position change **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Left lateral position **Intervention Names:** - Procedure: Left lateral **Label:** Left lateral **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Position change **Description:** Patients change position (cecum to hepatic flexure, left lateral; transverse colon, supine; splenic flexure and descending colon , right lateral) during colonoscopy withdrawal. **Name:** Position change **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Left lateral **Description:** In left lateral position group patients are positioned left lateral decubitus during colonoscopy withdrawal. **Name:** Left lateral **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Adenoma detection **Time Frame:** 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patient aged over 45 years who will be performed colonoscopy for the first time Exclusion Criteria: * polyposis syndrome * musculoskeletal problem * Inflammatory bowel disease * previous bowel operation **Minimum Age:** 45 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Incheon, Daejeon, Bucheon, Seoul **Country:** Korea, Republic of **Facility:** Catholic University of Korea ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3591 - Name: Adenoma - Relevance: HIGH - As Found: Adenoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000236 - Term: Adenoma ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T120 - Name: Cola - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT01151579 **Brief Title:** Effect of Nebulized Bronchodilators on Heart Rate **Official Title:** Prospective Trial of Effect of Nebulized Bronchodilators on Heart Rate and Arrhythmias in Critically Ill Adult Patients #### Organization Study ID Info **ID:** ME 07-0011 #### Organization **Class:** INDUSTRY **Full Name:** Ascension Health ### Status Module #### Completion Date **Date:** 2009-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-10-23 **Type:** ESTIMATED **Last Update Submit Date:** 2015-09-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2009-11 **Type:** ACTUAL #### Results First Post Date **Date:** 2015-10-23 **Type:** ESTIMATED **Results First Submit Date:** 2015-03-12 **Results First Submit QC Date:** 2015-09-23 #### Start Date **Date:** 2008-12 **Status Verified Date:** 2015-09 #### Study First Post Date **Date:** 2010-06-28 **Type:** ESTIMATED **Study First Submit Date:** 2010-06-24 **Study First Submit QC Date:** 2010-06-25 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Ascension Health #### Lead Sponsor **Class:** INDUSTRY **Name:** Fahim Khorfan, MD #### Responsible Party **Investigator Affiliation:** Ascension Health **Investigator Full Name:** Fahim Khorfan, MD **Investigator Title:** ICU Pulmonologist **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of the study is to determine adverse events rates of nebulized albuterol versus levalbuterol among adult critically ill patients and determine if a differential exists in adverse events between the two drugs. **Detailed Description:** A randomized, single-blind, cross-over, prospective study was conducted in seventy critically ill adult patients with acute air flow obstruction. Patients were randomized to nebulized albuterol alternating with levalbuterol every 4 to 6 hours. Group A received albuterol 2.5 mg alternating with levalbuterol 0.63 mg. Group B received albuterol 2.5 mg alternating with levalbuterol 1.25 mg. All patients received nebulized ipratropium bromide 500 micrograms with each treatment. Heart rate and cardiac rhythm were continuously recorded before and 15 minutes after finishing each treatment. Any new rhythm abnormalities between treatments were also recorded. ### Conditions Module **Conditions:** - COPD - Sepsis - Shock **Keywords:** - Tachycardia - tachyarrhythmias - bronchodilator therapy - Critically ill patients ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 89 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients received an initial dose of levalbuterol 0.63 mg alternating with albuterol 2.5 mg. **Intervention Names:** - Drug: Levalbuterol - Drug: Albuterol **Label:** Levalbuterol 0.63 **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg. **Intervention Names:** - Drug: Levalbuterol - Drug: Albuterol **Label:** Levalbuterol 1.25 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Levalbuterol 0.63 - Levalbuterol 1.25 **Description:** inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg **Name:** Levalbuterol **Other Names:** - Xopenex - ipratropium **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Levalbuterol 0.63 - Levalbuterol 1.25 **Description:** Nebulized albuterol 2.5mg **Name:** Albuterol **Other Names:** - Salbutamol **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Average difference in Heart rate between pre and post breathing treatments **Measure:** Heart Rate in Beats Per Minute **Time Frame:** Five days #### Secondary Outcomes **Description:** Any new arrhythmia documented in the medical record that occurred between breathing treatments. **Measure:** Arrhythmias **Time Frame:** 15 minutes after each treatment for average of 3 to 5 days **Description:** Documented new arrhythmia occurring during study. **Measure:** Total Number of Participants With Arrhythmias **Time Frame:** Five days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults who required inhaled bronchodilator therapy in the form of short acting beta adrenergic receptor agonist and short acting anti-cholinergic treatment every 4-6 hours for respiratory functions Exclusion Criteria: * Known allergy or sensitivity to study medications * Baseline heart rate was greater than 110 beats per minute **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Grand Blanc **Country:** United States **Facility:** Genesys Regional Medical Center **State:** Michigan **Zip:** 48439 #### Overall Officials **Official 1:** **Affiliation:** Ascension Health **Name:** Fahim Khorfan, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Ascension Health **Name:** Kimberly R Barber, PhD **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Khorfan FM, Smith P, Watt S, Barber KR. Effects of nebulized bronchodilator therapy on heart rate and arrhythmias in critically ill adult patients. Chest. 2011 Dec;140(6):1466-1472. doi: 10.1378/chest.11-0525. Epub 2011 Sep 29. **PMID:** 21960699 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC01 - Name: Infections ### Condition Browse Module - Browse Leaves - ID: M15577 - Name: Shock - Relevance: LOW - As Found: Unknown - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M19010 - Name: Critical Illness - Relevance: LOW - As Found: Unknown - ID: M20864 - Name: Sepsis - Relevance: LOW - As Found: Unknown - ID: M16869 - Name: Toxemia - Relevance: LOW - As Found: Unknown - ID: M16384 - Name: Tachycardia - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000001993 - Term: Bronchodilator Agents - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018927 - Term: Anti-Asthmatic Agents - ID: D000019141 - Term: Respiratory System Agents - ID: D000015149 - Term: Tocolytic Agents - ID: D000012102 - Term: Reproductive Control Agents - ID: D000058666 - Term: Adrenergic beta-2 Receptor Agonists - ID: D000000318 - Term: Adrenergic beta-Agonists - ID: D000000322 - Term: Adrenergic Agonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018680 - Term: Cholinergic Antagonists - ID: D000018678 - Term: Cholinergic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3767 - Name: Albuterol - Relevance: HIGH - As Found: Diameter - ID: M12193 - Name: Ipratropium - Relevance: HIGH - As Found: Both eyes - ID: M5269 - Name: Bronchodilator Agents - Relevance: LOW - As Found: Unknown - ID: M20963 - Name: Anti-Asthmatic Agents - Relevance: LOW - As Found: Unknown - ID: M21137 - Name: Respiratory System Agents - Relevance: LOW - As Found: Unknown - ID: M17869 - Name: Tocolytic Agents - Relevance: LOW - As Found: Unknown - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M3670 - Name: Adrenergic beta-Agonists - Relevance: LOW - As Found: Unknown - ID: M3673 - Name: Adrenergic Agonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M20760 - Name: Cholinergic Antagonists - Relevance: LOW - As Found: Unknown - ID: M20758 - Name: Cholinergic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000420 - Term: Albuterol - ID: D000009241 - Term: Ipratropium ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** Cardiac arrhythmia #### Event Groups **Group ID:** EG000 **Title:** Nebulized Albuterol 2.5mg **Description:** Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg. **ID:** EG000 **Other Num at Risk:** 58 **Serious Number Affected:** 2 **Serious Number At Risk:** 58 **Title:** Nebulized Albuterol 2.5mg **Group ID:** EG001 **Title:** Levalbuterol 1.25 **Description:** Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg. **ID:** EG001 **Other Num at Risk:** 31 **Serious Number Affected:** 3 **Serious Number At Risk:** 31 **Title:** Levalbuterol 1.25 **Frequency Threshold:** 0 #### Serious Events **Term:** Ventricular tachycardia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Cardiac arrhythmia as documented by healthcare provider. **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 58 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 31 **Num Events:** 3 **Time Frame:** Within 5 days of treatment initiation and within 15 minutes of each individual treatment. ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 58 **Group ID:** BG001 **Value:** 31 **Group ID:** BG002 **Value:** 89 **Units:** Participants ### Group **ID:** BG000 **Title:** Nebulized Albuterol 2.5mg **Description:** Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg. ### Group **ID:** BG001 **Title:** Levalbuterol 1.25 **Description:** Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 18 #### Measurement **Group ID:** BG001 **Value:** 9 #### Measurement **Group ID:** BG002 **Value:** 27 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 40 #### Measurement **Group ID:** BG001 **Value:** 22 #### Measurement **Group ID:** BG002 **Value:** 62 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 13.1 **Value:** 67.3 #### Measurement **Group ID:** BG001 **Spread:** 13.7 **Value:** 67.5 #### Measurement **Group ID:** BG002 **Spread:** 13.4 **Value:** 67.3 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 31 #### Measurement **Group ID:** BG001 **Value:** 12 #### Measurement **Group ID:** BG002 **Value:** 43 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 27 #### Measurement **Group ID:** BG001 **Value:** 19 #### Measurement **Group ID:** BG002 **Value:** 46 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 58 #### Measurement **Group ID:** BG001 **Value:** 31 #### Measurement **Group ID:** BG002 **Value:** 89 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants **Population Description:** The number analyzed was determined by the power calculation and based on the number of participants randomized to treatment. ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Limitations and Caveats **Description:** Potential limitations are its single-center site and that the design may not have adequately eliminated all carryover effects from the levalbuterol. However, the number of side effects without carryover would be even lower than we observed. ### Point of Contact **Email:** [email protected] **Organization:** Genesys Regional Medical Center **Phone:** 810-606-7722 **Title:** Dr. Fahim Khorfan ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 0.5 **Estimate Comment:** **Group Description:** Null Hypothesis: No difference between groups in heart rate changes from baseline following treatment. Sample size calculation determined a need for at least 400 breathing treatments among 65 patients. **Non-Inferiority Comment:** A total of at least 400 treatemnts or 65 patients was required to achieve 94% power to determine a 1% change by treatment or a 5% change between groups to be significant at p-value of 0.01 and o.05, respectively. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.01 **P-Value Comment:** **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** 1 **Statistical Comment:** **Statistical Method:** Mixed Models Analysis **Tested Non-Inferiority:** True ### Outcome Measure 2 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Null hypothesis: no difference in incidence of arrhythmias between groups within the total number of breathing treatments. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.05 **P-Value Comment:** Analysis adjusted with Fischer exact chi-square for rare occurrences. **Parameter Type:** Risk Ratio (RR) **Parameter Value:** 1 **Statistical Comment:** **Statistical Method:** Chi-squared **Tested Non-Inferiority:** False ### Outcome Measure 3 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** To report on the number of events. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** Descriptive statistics (frequency) used to report the number of participants experiencing an event. **Statistical Method:** descriptive **Tested Non-Inferiority:** False ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 5.1 - **Upper Limit:** - **Value:** -0.16 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 5.4 - **Upper Limit:** - **Value:** 1.40 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.33 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.3 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Average difference in Heart rate between pre and post breathing treatments **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Average change in heart rate from baseline to final breathing treatment. **Reporting Status:** POSTED **Time Frame:** Five days **Title:** Heart Rate in Beats Per Minute **Type:** PRIMARY **Type Units Analyzed:** Breathing treatment episodes **Unit of Measure:** bpm ##### Group **Description:** Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg. **ID:** OG000 **Title:** Nebulized Albuterol 2.5mg ##### Group **Description:** Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg. **ID:** OG001 **Title:** Levalbuterol 1.25 #### Outcome Measure 2 **Description:** Any new arrhythmia documented in the medical record that occurred between breathing treatments. **Parameter Type:** NUMBER **Population Description:** The percentage of arrhythmias among the number of breathing treatments. **Reporting Status:** POSTED **Time Frame:** 15 minutes after each treatment for average of 3 to 5 days **Title:** Arrhythmias **Type:** SECONDARY **Unit of Measure:** percent ##### Group **Description:** Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg. **ID:** OG000 **Title:** Nebulized Albuterol 2.5mg ##### Group **Description:** Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg. **ID:** OG001 **Title:** Levalbuterol 1.25 #### Outcome Measure 3 **Description:** Documented new arrhythmia occurring during study. **Parameter Type:** NUMBER **Population Description:** Number of patients for whom arrhythmias occurred within 5 days after treatment initiation. **Reporting Status:** POSTED **Time Frame:** Five days **Title:** Total Number of Participants With Arrhythmias **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg. **ID:** OG000 **Title:** Nebulized Albuterol 2.5mg ##### Group **Description:** Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg. **ID:** OG001 **Title:** Levalbuterol 1.25 ### Participant Flow Module #### Group **Description:** Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg. **ID:** FG000 **Title:** Nebulized Albuterol 2.5mg #### Group **Description:** Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg. **ID:** FG001 **Title:** Levalbuterol 1.25 #### Period **Title:** Overall Study ##### Withdraw **Type:** Physician Decision ###### Reason **Group ID:** FG000 **Number of Subjects:** 3 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 3 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Withdraw **Type:** Not meet inclusion criteria ###### Reason **Group ID:** FG000 **Number of Subjects:** 6 ###### Reason **Group ID:** FG001 **Number of Subjects:** 4 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 58 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 31 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 46 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 24 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 12 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 7 **Pre-Assignment Details:** Patients were excluded if they had a known allergy or sensitivity to study medications or if baseline heart rate was greater than 110 bpm. Treating physicians detremined the need for and frequency of treatment with bronchodilator therapy. All other medications were allowed. **Recruitment Details:** Recruitment began initially August 21, 2007 at the medical center ICU. **Has Results:** True
## Protocol Section ### Identification Module **NCT ID:** NCT01016379 **Brief Title:** Studying DNA in Blood and Bone Marrow Samples From Young Patients With Acute Lymphoblastic Leukemia **Official Title:** Genome-Wide Interrogations in Childhood Acute Lymphoblastic Leukemia (ALL) #### Organization Study ID Info **ID:** AALL08B2 #### Organization **Class:** NETWORK **Full Name:** Children's Oncology Group #### Secondary ID Infos **ID:** COG-AALL08B2 **ID:** CDR0000659101 **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2011-02200 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2016-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-05-17 **Type:** ESTIMATED **Last Update Submit Date:** 2016-05-16 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-05 **Type:** ACTUAL #### Start Date **Date:** 2009-11 **Status Verified Date:** 2016-05 #### Study First Post Date **Date:** 2009-11-19 **Type:** ESTIMATED **Study First Submit Date:** 2009-11-18 **Study First Submit QC Date:** 2009-11-18 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** NETWORK **Name:** Children's Oncology Group #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment. PURPOSE: This research study is looking at DNA in blood and bone marrow samples from young patients with acute lymphoblastic leukemia. **Detailed Description:** OBJECTIVES: * To manage and oversee determination of genome-wide genotypes using common laboratory methodologies for young patients with newly diagnosed acute lymphoblastic leukemia (ALL). * To provide a mechanism for storing, distributing, and tracking usage of blast and germline genomic information for approved projects. * To facilitate research for childhood ALL using genome-wide germline and blast data to identify genetic variations associated with important phenotypes: treatment response (e.g., relapse risk, minimal residual disease status), adverse effects (e.g., osteonecrosis, infection risk, neurotoxicity), risk of ALL, and risk of ALL subtypes (e.g., TEL/AML1, BCR/ABL, T-cell). * To provide a data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood ALL. OUTLINE: This is a multicenter study. DNA from previously collected and banked blood and bone marrow samples is utilized for genome-wide genotyping. Genotype data is only used to examine specific questions related to the epidemiology and etiology of leukemia, response of leukemia to treatment, risk of recurrence, risk for development of side effects, and complications related to treatment. ### Conditions Module **Conditions:** - Leukemia **Keywords:** - untreated childhood acute lymphoblastic leukemia - recurrent childhood acute lymphoblastic leukemia ### Design Module #### Bio Spec **Description:** Blood and Bone Marrow **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** DNA analysis **Type:** GENETIC #### Intervention 2 **Name:** biologic sample preservation procedure **Type:** OTHER #### Intervention 3 **Name:** laboratory biomarker analysis **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Determination of genome-wide genotypes **Measure:** Mechanism for storing, distributing, and tracking usage of blast and germline genomic information **Measure:** Identification of genetic variations associated with important phenotypes (treatment response, adverse effects, risk of acute lymphoblastic leukemia [ALL], and risk of ALL subtypes) **Measure:** Data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood ALL ### Eligibility Module **Eligibility Criteria:** DISEASE CHARACTERISTICS: * Diagnosis of acute lymphoblastic leukemia (ALL) * Previously enrolled in COG-9900, COG-C1991, COG-AALL03B1, COG-AALL05B1, COG-AALL08P1, or other current COG or legacy trials for ALL AND consented to submit blood and marrow samples for biological research studies * Meets ≥ 1 of the following criteria: * Germline DNA that has been extracted from blood (preferentially) or bone marrow (if no appropriate blood available) that was collected on or after Day 28 of remission indication therapy, or is known to come from a sample that contained \< 10% leukemic blasts * ALL blast DNA that has been extracted from bone marrow (preferentially) or blood (if from a sample that contained \> 90% leukemic blasts and no diagnostic bone marrow is available) that was collected at the time of ALL diagnosis PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics **Maximum Age:** 30 Years **Minimum Age:** 1 Year **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** Young Patients With Acute Lymphoblastic Leukemia ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** University of California, San Francisco **Name:** Mignon Loh, MD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M10951 - Name: Leukemia, Lymphoid - Relevance: HIGH - As Found: Lymphoblastic Leukemia - ID: M27585 - Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma - Relevance: HIGH - As Found: Acute Lymphoblastic Leukemia - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M11220 - Name: Lymphoma - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T175 - Name: Acute Lymphoblastic Leukemia - Relevance: HIGH - As Found: Acute Lymphoblastic Leukemia - ID: T3533 - Name: Lymphoblastic Lymphoma - Relevance: HIGH - As Found: Acute Lymphoblastic Leukemia - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T1134 - Name: Childhood Acute Lymphoblastic Leukemia - Relevance: HIGH - As Found: Childhood acute lymphoblastic leukemia - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000054198 - Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma - ID: D000007945 - Term: Leukemia, Lymphoid ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT06069479 **Acronym:** Treat Trigono **Brief Title:** Comparing Conservative to Surgical Treatment of Trigonocephaly Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs **Official Title:** Comparing Effectiveness of a Conservative Policy to Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs #### Organization Study ID Info **ID:** PaNaMaID 9517 #### Organization **Class:** OTHER **Full Name:** Erasmus Medical Center ### Status Module #### Completion Date **Date:** 2031-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-10-05 **Type:** ACTUAL **Last Update Submit Date:** 2023-10-02 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2031-02-28 **Type:** ESTIMATED #### Start Date **Date:** 2022-09-01 **Type:** ACTUAL **Status Verified Date:** 2023-10 #### Study First Post Date **Date:** 2023-10-05 **Type:** ACTUAL **Study First Submit Date:** 2023-10-02 **Study First Submit QC Date:** 2023-10-02 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** LAPOSA **Class:** UNKNOWN **Name:** IJsselland ziekenhuis **Class:** OTHER **Name:** Sint Franciscus Gasthuis #### Lead Sponsor **Class:** OTHER **Name:** Erasmus Medical Center #### Responsible Party **Investigator Affiliation:** Erasmus Medical Center **Investigator Full Name:** Irene Mathijssen **Investigator Title:** prof.dr. MBA-H **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** RESEARCH QUESTION Is the effectiveness of conservative policy comparable to that of surgery in children with trigonocephaly, with regard to clinical outcomes and psychosocial functioning, stress for parents, and costs? DESIGN Observational cohort study in children, aged 0 to 8 years old, with trigonocephaly, excluding metopic ridging (physiologic early closure of metopic suture), treated conservatively or surgically. OUTCOME MEASURES Primary: Head growth decline, indicating raised intracranial pressure Secondary: fundoscopy, cognition, behavior, refraction and vision, forehead shape, quality of life, posttraumatic stress, decisional conflict, costs. **Detailed Description:** HYPOTHESIS Conservative treatment is non-inferior to surgery with regard to clinical outcomes, causes less burden of disease, and is cost-effective. STUDY DESIGN Observational cohort study STUDY POPULATION Children, aged 0 to 8 years old, with trigonocephaly, excluding metopic ridging (physiologic early closure of metopic suture) INTERVENTION Conservative policy USUAL CARE/COMPARISON Craniofacial surgery OUTCOME MEASURES Primary: Head growth decline (head circumference in SD), indicating raised intracranial pressure Secondary: fundoscopy, cognition, behavior, refraction and vision, forehead shape, quality of life, posttraumatic stress, decisional conflict, costs. Repeated measures at 0, 2, 4, 6, 8 years of age SAMPLE SIZE/DATA ANALYSIS Eligible patients \<= 3 years of age are included since Sept 2022 Sample size 440 patients \<1 year of age: 195 surgery and 245 conservative Non-inferiority with regard to head growth from 0-4 years (annual measurement) is determined using a linear mixed model adjusted for confounders: severity of phenotype, sex, syndrome and parental factors (e.g., education). COST-EFFECTIVINESS ANALYSIS/BIA An economic evaluation is performed with the incorporation of medical costs and costs due to loss of productivity for the parents. A detailed costs-study is done for medical specialist care, surgical costs, hospitalization and other costs directly associated with the interventions. Cost prizes of surgery will be determined by the bottom-up micro-costing method. Cost-utility will be measured with QALY (based on EQ-5D utility score) gained, with confidence ellipses and acceptability curves. The impact of conservative policy versus surgery will be investigated on assurance perspective and central level. From the viewpoint of the (health care) government, a societal perspective and perspective of the "budgettair kader zorg" will be highlighted. We will provide a valid framework with budget consequences by a range of predictions. Sensitivity analysis is done. TIME SCHEDULE Inclusion between Sept 2022 and Sept 2030. Analysis and reporting for each outcome parameter related to age is distributed from January 2025 to September 2031. New recommendation for treatment of trigonocephaly in guideline ready in 2031. ### Conditions Module **Conditions:** - Metopic Synostosis ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 440 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Children with trigonocephaly that are treated conservatively. **Label:** Conservative group #### Arm Group 2 **Description:** Children with trigonocephaly that are treated surgically. **Intervention Names:** - Procedure: craniofacial surgery **Label:** Surgical group ### Interventions #### Intervention 1 **Arm Group Labels:** - Surgical group **Description:** Surgical treatment, either stripcraniectomy or fronto-orbital advancement **Name:** craniofacial surgery **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Annual measurement of head circumference in SD for gender and age. Decline in head growth may indicate raised intracranial pressure **Measure:** Head growth **Time Frame:** from 0 to 8 years old #### Secondary Outcomes **Description:** Annual screening for presence of papilledema as sign of raised intracranial pressure **Measure:** fundoscopy **Time Frame:** from 1 to 4 years old **Description:** Validated tests for cognition and behavior of the child **Measure:** Cognition and behavior **Time Frame:** at 0, 2, 4 and 8 years old **Description:** tests taken by orthoptist **Measure:** refraction and vision **Time Frame:** at 1, 4 and 8 years old **Description:** 3D photos (objective) and VAS score by parents (subjective) to grade the forehead shape **Measure:** forehead shape **Time Frame:** at 0, 2, 4, 6 and 8 years old **Description:** Validated tests to measure quality of life of the child and parents and presence of PTS in parents **Measure:** Quality of life and post-traumatic stress **Time Frame:** at 0, 2, 4, 6 and 8 years old **Description:** questionnaire to determine whether or not parents are still content with their decision on type of treatment **Measure:** Decisional conflict **Time Frame:** at 8 years old ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * diagnosis of trigonocephaly Exclusion Criteria: * metopic ridge (physiologic early closure of metopic suture) **Maximum Age:** 8 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** Children with mild, moderate or severe trigonocephaly, between 0 and 8 years of age, excluding metopic ridge (i.e. physiologic early closure of metopic suture). ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Irene MJ Mathijssen, MD, PhD, MBA-H **Phone:** +31655758441 **Role:** CONTACT #### Locations **Location 1:** **City:** Rotterdam **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Irene MJ Mathijssen, MD, PhD, MBA-H - **Phone:** +31655758441 - **Role:** CONTACT **Country:** Netherlands **Facility:** Erasmus MC **Status:** RECRUITING **Zip:** 3012LE #### Overall Officials **Official 1:** **Affiliation:** Erasmus Medical Center **Name:** Irene MJ Mathijssen, MD, PhD, MBA-H **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Cornelissen MJ, Loudon SE, van Doorn FEC, Muller RPM, van Veelen MC, Mathijssen IMJ. Very Low Prevalence of Intracranial Hypertension in Trigonocephaly. Plast Reconstr Surg. 2017 Jan;139(1):97e-104e. doi: 10.1097/PRS.0000000000002866. **PMID:** 28027242 **Citation:** de Planque CA, Petr J, Gaillard L, Mutsaerts HJMM, van Veelen MC, Versnel SL, Dremmen MHG, Mathijssen IMJ. Cerebral Blood Flow of the Frontal Lobe in Untreated Children with Trigonocephaly versus Healthy Controls: An Arterial Spin Labeling Study. Plast Reconstr Surg. 2022 Apr 1;149(4):931-937. doi: 10.1097/PRS.0000000000008931. **PMID:** 35171857 **Citation:** Mathijssen IMJ; Working Group Guideline Craniosynostosis. Updated Guideline on Treatment and Management of Craniosynostosis. J Craniofac Surg. 2021 Jan-Feb 01;32(1):371-450. doi: 10.1097/SCS.0000000000007035. No abstract available. **PMID:** 33156164 **Citation:** Abdel-Alim T, Iping R, Wolvius EB, Mathijssen IMJ, Dirven CMF, Niessen WJ, van Veelen MC, Roshchupkin GV. Three-Dimensional Stereophotogrammetry in the Evaluation of Craniosynostosis: Current and Potential Use Cases. J Craniofac Surg. 2021 May 1;32(3):956-963. doi: 10.1097/SCS.0000000000007379. **PMID:** 33405445 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004413 - Term: Dysostoses - ID: D000001848 - Term: Bone Diseases, Developmental - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000009139 - Term: Musculoskeletal Abnormalities - ID: D000000013 - Term: Congenital Abnormalities - ID: D000019465 - Term: Craniofacial Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16357 - Name: Synostosis - Relevance: HIGH - As Found: Synostosis - ID: M6613 - Name: Craniosynostoses - Relevance: HIGH - As Found: Trigonocephaly - ID: M7587 - Name: Dysostoses - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M5127 - Name: Bone Diseases, Developmental - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M12096 - Name: Musculoskeletal Abnormalities - Relevance: LOW - As Found: Unknown - ID: M21420 - Name: Craniofacial Abnormalities - Relevance: LOW - As Found: Unknown - ID: T1638 - Name: Craniosynostosis - Relevance: LOW - As Found: Unknown - ID: T5091 - Name: Saethre-Chotzen Syndrome - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013580 - Term: Synostosis - ID: D000003398 - Term: Craniosynostoses ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT03369379 **Brief Title:** Valuation of Efficacy and Safety of Vitamin D3 Use in 80 Women Diagnosed With Fibromyalgia. Using FIQ Score and VAS. **Official Title:** Randomized, Double-blind, Placebo-controlled Trial to Measure the Efficacy and Safety of Vitamin D3 in Patients With Fibromyalgia. #### Organization Study ID Info **ID:** RE16-00019 #### Organization **Class:** OTHER **Full Name:** Universidad Autonoma de Nuevo Leon ### Status Module #### Completion Date **Date:** 2017-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-06-17 **Type:** ACTUAL **Last Update Submit Date:** 2020-06-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-12-31 **Type:** ACTUAL #### Start Date **Date:** 2017-05-31 **Type:** ACTUAL **Status Verified Date:** 2020-06 #### Study First Post Date **Date:** 2017-12-12 **Type:** ACTUAL **Study First Submit Date:** 2017-07-27 **Study First Submit QC Date:** 2017-12-05 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidad Autonoma de Nuevo Leon #### Responsible Party **Investigator Affiliation:** Universidad Autonoma de Nuevo Leon **Investigator Full Name:** Luis Ivan Lozano Plata **Investigator Title:** Dr. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** Fibromyalgia is a disease that significantly decreases the quality of life of people who suffer from it, has great repercussions at the socio-economic level due to the incapacity it produces. It is characterized by generalized pain, fatigue, sleep disorders, psychological stress and mental alterations, besides presenting painful points in different parts of the body to physical examination. Having few effective treatments is necessary to explore new options in their management to improve the general conditions of the patient. Previous studies have shown that patients with fibromyalgia have had low levels of vitamin D in the blood, a favorable response from post-vitamin D supplementation has been seen. This vitamin has been associated with pain pathways and with increased The perception of the same when it is in smaller amount. We will select patients with Fibromyalgia diagnosis from the external consultation of Rheumatology of the University Hospital "Dr. José Eleuterio González "of the UANL, over 18 years old who have not been previously supplemented with vitamin D, will initially be measured in blood of vitamin D, in addition to calcium as a safety measure, we will have a group that will only receive placebo and Another that will be supplemented with 50 thousand units weekly for 12 weeks, we will apply a questionnaire that measures pain scale and another one that measures the impact of the disease in the daily life of the patient, this will be done in a beginning and at the end of the 12 weeks . **Detailed Description:** Fibromyalgia is a disease characterized mainly by generalized pain, with great repercussion in the patient's quality of life as well as in his work and social performance. There are different therapies that have not been totally effective for the management of this pathology, for that reason it is necessary to look for cost-effective options and the reach of all the patients to obtain remission of the symptoms. Fibromyalgia affects 1-4% of the general population, patients manifest chronic pain and other comorbidities such as sleep disorders, fatigue, depression, psychological stress and cognitive disturbances. It is a significant cause of loss of employment and disconnection from the social environment. A longitudinal, prospective, randomized study with patients diagnosed with Fibromyalgia will be performed at the outpatient clinic of the Rheumatology Service at the University Hospital "Dr. José Eleuterio González "of the Autonomous University of Nuevo León. DEFINITION OF VARIABLES Dependent variable: Vitamin D levels Conceptual definition: it is considered as pro-hormone, its active metabolite 1-25-dihydroxyvitamin D functions as a hormone since it has its own receptors found in all human cells.4 Operational definition: Normal levels\> 30-100 ng / ml, 10-30 ng / ml insufficiency and a deficit \<10 ng / ml as defined by the laboratory.19 Measurement scale: qualitative. Independent variables: Fibromyalgia Impact Questionnaire (FIQ) Conceptual definition: a questionnaire that assesses the impact of FM in physical capacity, the possibility of doing the usual work and, in the case of performing a paid work, the degree to which FM has affected this activity as well As subjective items very related to the FM picture (pain, fatigue, tiredness and stiffness) and emotional state (anxiety and depression). Operational definition: consists of three domains functionality, global impact and symptomatology. It consists of 10 items. The first is the only one containing several sub-items (a-j), in number of 10, each with a rank of 4 points (from 0, always, to 3, never) according to a Likert scale. This item evaluates the functional capacity of the patient through questions about activities related to daily life: buy, drive, etc. The second and third items correspond to numerical scales that refer to days of the week: the second on a scale from 1 to 7, and the third from 1 to 5. The rest of the items are valued using analog visual scales (EVA) From 0 to 10. Type of variable: Quantitative dichotomous. Visual Analogue Scale (VAS) Conceptual definition: approach used to measure pain. In one line the patient scores a point that best describes the intensity of his pain. Operational definition: a scale that allows to measure the intensity of pain, draws a line that divides from 0 to 10, on the left corresponds to the use of pain with the number 0, on the right is the maximum degree of pain corresponds to 10 . Type of variable: quantitative Other variables: Age Conceptual definition: Time that has lived a person counting since birth. Operational definition: Age expressed in years according to the clinical file. Type of variable: quantitative. Gender Conceptual definition: set of people or things that has common general characteristics. Operational definition: male and female according to the clinical file. Type of variable: Qualitative. C-reactive protein (CRP) Conceptual definition: plasma protein or acute phase reactant that rises during inflammatory processes. Operational definition: it was considered elevated when its levels exceeded 1 mg / dl as it marks the laboratory. It was taken as positive or negative according to this commented level. Erythrocyte sedimentation rate (ESR) Conceptual definition: acute phase reactant, measures the time it takes erythrocytes to fall or decant in a period of time. It is elevated in inflammatory, infectious and neoplastic processes. Operational definition: elevated ESR levels were considered according to the formula adjusted for age in men = age / 2, for women = age + 10/2. MEASUREMENT TOOLS Fibromyalgia Impact Questionnaire (FIQ) Questionnaire that measures the impact that Fibromialgia has on the daily life of the patient. It is responsible for evaluating three items: functionality of the subject, overall impact of the disease and symptomatology. It was developed in 1980 by Drs. Carol Burckhardt, Sharon Clark and Robert Bennett Portland, Oregon USA. Published 1991, revisions 1997 - 2002 - 2009. It is one of the most used tools for evaluation of patients with FM. It consists of 10 items. The first is the only one containing several sub-items (a-j), in number of 10, each with a rank of 4 points (from 0, always, to 3, never) according to a Likert scale. This item evaluates the functional capacity of the patient through questions about activities related to daily life: buy, drive, etc. The second and third items correspond to numerical scales that refer to days of the week: the second on a scale from 1 to 7, and the third from 1 to 5. The rest of the items are valued using visual analogue scale (VAS) From 0 to 10. It was validated by Monterde in 2004. Visual Analog Scale (VAS) Scale that allows to measure the intensity of pain, draws a line that divides from 0 to 10, on the left corresponds to the use of pain with the number 0, on the right is the maximum degree of pain corresponds to 10. Mini Neuro-Psychiatric Interview It is a brief and highly structured interview of the major psychiatric disorders of ICD-10 and DSM-IV. It was elaborated by Y. Lecrubier et al. Of the "Salpétrére" of Paris and D. Scheehan et al. Of the University of Tampa Florida in 1992, 1994 and 1998. It serves to diagnose depressions, phobias, suicides, generalized anxiety disorders, agoraphobia, substance abuse or dependence. A tool of great utility in primary care. SAMPLE SIZE: According to Young's nomogram for sample size calculation for controlled clinical trials (with an alpha of 0.05 and statistical power of 0.8), the sample size (including a 20% to compensate for possible losses) by study group is : 80 patients. SAMPLING TECHNIQUE: Patients were selected using a non-probabilistic sampling technique for consecutive cases. STATISTIC ANALYSIS: The t-test for independent samples and logistic regression will be used to evaluate the effect of the independent variables on the dependent variable. A value of p ≤ 0.05 shall be considered significant. The statistical package SPSS version 17.0 for Windows 7 will be used. METHODS Allocation method: Consecutive incident patients will be included, those eligible for the study will be assigned to treatment groups using a pre-established allocation table, which was generated in the randomization module of the True Epistat statistical program. DESCRIPTION OF THE STUDY 1. Four visits are planned for the evaluation of subjects. 2. At the first visit, the subjects attend the consultation 12 of the Department of Rheumatology at the University Hospital "Dr. José Eleuterio González "where they are evaluated by a rheumatologist to confirm the diagnosis of Fibromyalgia according to the criteria of the American College of Rheumatology of 1990 and 2010. The Fibromyalgia Impact Questionnaire (FIQ) will be applied at baseline and the Visual Analog Scale (VAS). 3. Once the diagnosis of Fibromyalgia has been made, at the same first visit, a joint ultrasound will be performed by Rheumatologist expert in the field, in order to evaluate the presence of synovitis only in those patients with Primary Fibromyalgia. 4. All patients included in the Fibromyalgia Diagnostic Study will continue with their standard established treatment for the disease and may receive salvage treatment for pain management if they so require. 5. On the second visit, 15 ml of blood sample will be taken through venipuncture. 4ml of serum will be stored in aliquots of 0.5mL each in a freezer at -80 ° C located in the laboratory of the Rheumatology Service, in order to determine basal levels of vitamin D. Levels of c-reactive protein and Sedimentation to correlate them with the clinical data of inflammation obtained to the interrogation. We will determine levels of serum calcium to rule out the possibility of hypercalcemia at the start of the study and as a safety measure. In the case of clinical suspicion of Fibromyalgia secondary to rheumatoid arthritis, the study of rheumatoid factor and anti-cyclic citrullinated peptide antibodies will be carried out. The Mini-Neuro-psychiatric Interview will be applied by an expert Psychiatrist from the UANL, previously trained to perform this task. 6. At the second visit, subjects will be randomized to placebo or 50,000 international units of Vitamin D3 weekly for 12 weeks. It should be noted that neither the Rheumatologist who performed the Fibromyalgia diagnosis nor the person who will be responsible for providing the placebo or the vitamin will know the contents of the capsules. A double-blind study is planned. 7. At week 6 of the study a telephone call will be made to all patients to assess adverse effects. 8. The third visit will be performed at week 12 of the study, subjects from both groups are again assessed through the FibromyalgiaImpact Questionnaire (FIQ) and Visual Analogue Scale (VAS). A 15 ml blood sample will be taken to determine vitamin D levels as well as serum calcium levels for monitoring adverse effects. 9. After completing 12 weeks of vitamin D supplementation or placebo as appropriate. All subjects in the placebo group will have the option of receiving vitamin D3 supplementation 50,000 IU orally in capsules per week for 12 weeks and then on a fourth visit they will be given a 15ml blood sample to measure vitamin D levels. It means that the study will be opened to know the subjects who received placebo after having completed the first twelve weeks. The blood samples obtained will be stored in the Laboratory of the Department of Rheumatology only during the duration of the study. DATA COLLECTION SYSTEM A patient file will be included (Case report form). Finally, the data will be transferred to the database and analyzed with the SPSS program for Windows 7 version 17.0. ### Conditions Module **Conditions:** - Fibromyalgia - D Vitamin Deficiency **Keywords:** - Fibromyalgia - D Vitamin ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Longitudinal, prospective, interventional, randomized. ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Double blind, the subject of study and researcher. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In this group subjects will receive 1 vitamin D3 capsule of 50,000 units, each week, for 12 weeks. **Intervention Names:** - Drug: D3 Vitamin **Label:** D3 Vitamin **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** In this group the subjects will receive 1 placebo capsule each week for 12 weeks. **Intervention Names:** - Other: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - D3 Vitamin **Description:** Subjects will receive a capsule of 50,000 units of vitamin D3 echa week for 12 weeks, basal levels of vitamin D will be taken and again at week 12. **Name:** D3 Vitamin **Other Names:** - D3 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo pill **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Number of items in scale: The version from 19911 consisted of 10 items with 10 sub-items in the physical function scale (total items + sub-items = 19). The modified version from 1997 consists of 20 items with 11 physical function items (total items + sub-items = 30). The 2009 version consists of 21 items across the 3 domains of Function (n = 9), Overall Impact (n = 2), and Symptoms (n = 10). Subscales: Subscales from the 1991 version1 include physical function (10 sub-items), feel good (1 item), missed work (1 item), do job (1 item), pain (1 item), fatigue (1 item), rested (1 item), stiffness (1 item), anxiety (1 item), and depression (1 item). **Measure:** FIBROMYALGIA IMPACT QUESTIONNAIRE **Time Frame:** 12 weeks #### Secondary Outcomes **Description:** Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. **Measure:** VISUAL ANALOGUE SCALE **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Female patients older than 18 years. * Patients who agree to participate in the study. * Those that meet the ACR 1990 and 2010 criteria for Fibromyalgia. * No previous use of vitamin D. * Patients diagnosed with primary or secondary fibromyalgia. Exclusion Criteria: * Those subjects with previous use of vitamin D. * Known subjects with renal, liver, calcium metabolism disorders, malabsorption disorders, known neoplasms. * Subjects with serum calcium levels equal to or greater than 10.2 mg / dl. **Gender Based:** True **Gender Description:** Women diagnosed with Fibromyalgia from the outpatient clinic of the "Dr. José Eleuterio González" University Hospital of the Autonomous University of Nuevo Leon. **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Monterrey **Country:** Mexico **Facility:** Universidad Autónoma de Nuevo León **State:** Nuevo León **Zip:** 66460 #### Overall Officials **Official 1:** **Affiliation:** Hospital Universitario "Dr. José Eleuterio González" **Name:** Mario Alberto Garza Elizondo, Ph D **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** On request **Description:** It will be agreed with all participating researchers. **Info Types:** - SAP - CSR **IPD Sharing:** YES **Time Frame:** 5 years ### References Module #### References **Citation:** Yong WC, Sanguankeo A, Upala S. Effect of vitamin D supplementation in chronic widespread pain: a systematic review and meta-analysis. Clin Rheumatol. 2017 Dec;36(12):2825-2833. doi: 10.1007/s10067-017-3754-y. Epub 2017 Aug 15. **PMID:** 28812209 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000003677 - Term: Deficiency Diseases - ID: D000044342 - Term: Malnutrition - ID: D000009748 - Term: Nutrition Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M8486 - Name: Fibromyalgia - Relevance: HIGH - As Found: Fibromyalgia - ID: M12161 - Name: Myofascial Pain Syndromes - Relevance: HIGH - As Found: Fibromyalgia - ID: M17551 - Name: Vitamin D Deficiency - Relevance: HIGH - As Found: D Vitamin Deficiency - ID: M4660 - Name: Avitaminosis - Relevance: HIGH - As Found: Vitamin Deficiency - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M6879 - Name: Deficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M25306 - Name: Malnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005356 - Term: Fibromyalgia - ID: D000009209 - Term: Myofascial Pain Syndromes - ID: D000001361 - Term: Avitaminosis - ID: D000014808 - Term: Vitamin D Deficiency ### Intervention Browse Module - Ancestors - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000077264 - Term: Calcium-Regulating Hormones and Agents - ID: D000050071 - Term: Bone Density Conservation Agents ### Intervention Browse Module - Browse Branches - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M17550 - Name: Vitamin D - Relevance: LOW - As Found: Unknown - ID: M6003 - Name: Cholecalciferol - Relevance: HIGH - As Found: CYP2B - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: T442 - Name: Cholecalciferol - Relevance: HIGH - As Found: CYP2B - ID: T479 - Name: Vitamin D3 - Relevance: HIGH - As Found: CYP2B - ID: T440 - Name: Calciferol - Relevance: HIGH - As Found: CYP2B ### Intervention Browse Module - Meshes - ID: D000002762 - Term: Cholecalciferol ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT05750979 **Acronym:** LBSL **Brief Title:** Quantifying Disease Progression in LBSL **Official Title:** Quantifying Disease Progression in Leukoencephalopathy With Brainstem and Spinal Cord Involvement and Lactate Elevation (LBSL) #### Organization Study ID Info **ID:** LBSL #### Organization **Class:** OTHER **Full Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-03-02 **Type:** ACTUAL **Last Update Submit Date:** 2023-02-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2021-03-11 **Type:** ACTUAL **Status Verified Date:** 2023-02 #### Study First Post Date **Date:** 2023-03-02 **Type:** ACTUAL **Study First Submit Date:** 2023-02-18 **Study First Submit QC Date:** 2023-02-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** M. Engelen #### Responsible Party **Investigator Affiliation:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) **Investigator Full Name:** M. Engelen **Investigator Title:** Principal Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Leukoencephalopathy with brain stem involvement and lactate elevation (LBSL) is a genetic disorder caused by biallelic mutations in the DARS2 gene that encodes mitochondrial aspartyl tRNA synthase.(1, 2) It is characterized by typical abnormalities on MRI of the brain and spinal cord.(3) Clinically, the disorder is heterogeneous and can present in the neonatal period, later in childhood or even in adults.(3) In general it can be stated that the earlier presentations are characterized by rapid progression leading to severe disability and death. Presentation at a later age is typically characterized by a more benign disease course, although considerable disability is common. Clinically, the disease presents as a slowly progressive myelopathy with mainly involvement of the corticospinal tracts and the dorsal columns. Although the natural history has been studied in large cohorts, the rate of progression has not been systematically studied with clinimetric outcome scales or potential surrogate outcomes for spinal cord disease. ### Conditions Module **Conditions:** - LBSL - Leukoencephalopathies ### Design Module #### Bio Spec **Description:** Plasma Leukocytes PAXGene for RNA storage **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** disease progression **Measure:** The primary outcome is disease progression on all parameters **Time Frame:** 5 years ### Eligibility Module **Eligibility Criteria:** In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Age \> 16 years * Definite diagnosis of LBSL confirmed by DARS2 mutation analysis. * Able to understand Dutch or English and provide informed consent. * No contra-indications for MRI of brain and spinal cord. Subjects eligible to participate as healthy controls must meet all of the following criteria: * Willing to visit the hospital * 16 years or older * Provision of written informed consent to participate in the study obtained from the participant For the MRI controls: - No contra-indications for MRI of the brain and spinal cord A potential subject (patient or healthy control) who meets any of the following criteria will be excluded from participation in this study: * Unable to visit the hospital for the follow-up visits * Co-existing neurological disease that can cause pyramidal tract signs making interpretation of acquired data difficult (for instance, multiple sclerosis, stroke, etc) **Healthy Volunteers:** True **Minimum Age:** 16 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** LBSL patients and healthy age-matched controls. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marije Voermans **Phone:** +31205668227 **Role:** CONTACT #### Locations **Location 1:** **City:** Amsterdam-Zuidoost **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marije Voermans, RN - **Phone:** 0205668227 - **Role:** CONTACT **Country:** Netherlands **Facility:** Amsterdam UMC **State:** Noord-Holland **Status:** RECRUITING **Zip:** 1105AZ #### Overall Officials **Official 1:** **Affiliation:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) **Name:** M. Engelen, Dr **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M20559 - Name: Disease Progression - Relevance: HIGH - As Found: Disease Progression - ID: M28591 - Name: Leukoencephalopathies - Relevance: HIGH - As Found: Leukoencephalopathy - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000056784 - Term: Leukoencephalopathies - ID: D000018450 - Term: Disease Progression ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02823379 **Brief Title:** Smart Walk: A Physical Activity Program for African American Women **Official Title:** Smart Walk: A Physical Activity Program for African American Women #### Organization Study ID Info **ID:** STUDY00003131 #### Organization **Class:** OTHER **Full Name:** Arizona State University #### Secondary ID Infos **ID:** K99HL129012 **Link:** https://reporter.nih.gov/quickSearch/K99HL129012 **Type:** NIH **ID:** R00HL129012 **Link:** https://reporter.nih.gov/quickSearch/R00HL129012 **Type:** NIH ### Status Module #### Completion Date **Date:** 2020-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-07-08 **Type:** ACTUAL **Last Update Submit Date:** 2020-07-06 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-06 **Type:** ACTUAL #### Start Date **Date:** 2015-09 **Status Verified Date:** 2020-07 #### Study First Post Date **Date:** 2016-07-06 **Type:** ESTIMATED **Study First Submit Date:** 2016-07-01 **Study First Submit QC Date:** 2016-07-01 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Heart, Lung, and Blood Institute (NHLBI) #### Lead Sponsor **Class:** OTHER **Name:** Arizona State University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this project is to test an 8-month, culturally relevant, Smartphone-delivered PA program to improve and maintain high physical levels and reduce cardiometabolic disease risk among obese AA women. **Detailed Description:** A three-phase study will be used to refine and implement an established theory-based culturally relevant physical activity promotion intervention for obese African American women. Phase 1 (Aim 1a) will include formative research where 25 African American women provide feedback (via 9 focus groups) to further refine the physical activity intervention by specifying the deep structure cultural relevance of the theoretical mediators of self-regulation, self-efficacy, social support, behavioral capability, and outcome expectations.5 Phase 2 will focus on technical development of the refined culturally tailored intervention and 1-month demonstration trial of the Smartphone-delivered physical activity promotion program. Phase 3 (Aims 1b and 1c) will test the intervention and delivery strategy in a two-arm randomized trial where 60 sedentary, obese African American women will receive either the 8-month culturally relevant smartphone-delivered physical activity intervention or a 8-month wellness contact control condition ### Conditions Module **Conditions:** - Physical Activity **Keywords:** - physical activity - overweight - obese - exercise - women - African American - Smartphone - cardiovascular disease risk ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 62 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A culturally relevant physical activity promotion program delivered using a Smartphone application. **Intervention Names:** - Behavioral: Physical Activity **Label:** Physical Activity **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** A wellness contract control condition delivered using a Smartphone application. **Intervention Names:** - Behavioral: Wellness **Label:** Wellness Contact Control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Physical Activity **Description:** A Smartphone delivered physical activity program **Name:** Physical Activity **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Wellness Contact Control **Description:** A Smartphone delivered wellness intervention focused on topics other than physical activity (e.g., skin care, oral health, and breast exams). **Name:** Wellness **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** assessed by ActiGraph accelerometers **Measure:** Change in physical activity from baseline to 8-months **Time Frame:** three assessment periods: baseline, 4-months, and 8-months **Description:** Feasibility and acceptability will be assessed by examining recruitment, retention, adherence, self-reported treatment acceptance, and participant utilization of the Smartphone application provided by analytic tracking software. **Measure:** Feasibility and acceptability of the Smartphone delivered physical activity program **Time Frame:** 4-months #### Secondary Outcomes **Measure:** change in body mass index (BMI) from baseline to 8-months **Time Frame:** three assessment periods: baseline, 4-months, and 8-months **Description:** A modified Balke treadmill protocol will be used to estimate aerobic capacity (VO2peak). **Measure:** change in cardiorespiratory fitness from baseline to 8-months **Time Frame:** three assessment periods: baseline, 4-months, and 8-months **Description:** A measure of aortic stiffness, will be assessed with SphymocorTM using validated methodology **Measure:** change in Aortic Pulse Wave Velocity from baseline to 8-months **Time Frame:** three assessment periods: baseline, 4-months, and 8-months **Measure:** change in blood pressure from baseline to 8-months **Time Frame:** three assessment periods: baseline, 4-months, and 8-months **Measure:** change in total serum cholesterol from baseline to 8-months **Time Frame:** three assessment periods: baseline, 4-months, and 8-months **Measure:** change in serum high-density lipoprotein (HDL) from baseline to 8-months **Time Frame:** three assessment periods: baseline, 4-months, and 8-months **Measure:** change in serum low-density lipoprotein (LDL) from baseline to 8-months **Time Frame:** three assessment periods: baseline, 4-months, and 8-months **Measure:** change in serum triglycerides from baseline to 8-months **Time Frame:** three assessment periods: baseline, 4-months, and 8-months **Description:** measured using Immulite 1000 immunoassay analyzer (Siemens Healthcare Diagnostics) **Measure:** change in serum insulin from baseline to 8-months **Time Frame:** three assessment periods: baseline, 4-months, and 8-months **Description:** assessed by calculating homeostatic model assessment (HOMA) scores as: glucose (mg/dl) x insulin (μU/ml)/405. **Measure:** change in insulin sensitivity from baseline to 8-months **Time Frame:** three assessment periods: baseline, 4-months, and 8-months **Measure:** change in tumor necrosis factor alpha from baseline to 8-months **Time Frame:** three assessment periods: baseline, 4-months, and 8-months **Measure:** change in Interleukin 1 beta from baseline to 8-months **Time Frame:** three assessment periods: baseline, 4-months, and 8-months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Self-reported African American * Insufficiently Active ( 60 mins or less of PA per wk measured by Exercise Vital Sign Questionnaire) * BMI\>30 * English speaking and reading * Own non-Kindle Smartphone iOS 7 or above, or Android 2.3 or above Exclusion Criteria: * Concurrent participation in another physical activity, nutrition, or weight loss program * Endorsement of an item on the Physical Activity Readiness Questionnaire (PAR-Q) unless physical note is provided * Pregnant or plans to become pregnant in next 12 months * Plans to relocate out of Phoenix area in next 12 months **Healthy Volunteers:** True **Maximum Age:** 49 Years **Minimum Age:** 24 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Phoenix **Country:** United States **Facility:** Rodney P. Joseph **State:** Arizona **Zip:** 85004 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Joseph RP, Ainsworth BE, Vega-Lopez S, Adams MA, Todd M, Gaesser GA, Keller C. Cardiometabolic Risk Factors Among Insufficiently Active African American Women With Obesity: Baseline Findings From Smart Walk. J Cardiovasc Nurs. 2023 Mar-Apr 01;38(2):198-204. doi: 10.1097/JCN.0000000000000930. Epub 2022 Jul 5. **PMID:** 35794781 **Citation:** Joseph RP, Ainsworth BE, Mathis L, Hooker SP, Keller C. Incorporating religion and spirituality into the design of community-based physical activity programs for African American women: a qualitative inquiry. BMC Res Notes. 2017 Oct 23;10(1):506. doi: 10.1186/s13104-017-2830-3. **PMID:** 29058603 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT05346679 **Acronym:** DEPS-R **Brief Title:** DEPS-R Turkish Version in Adults With Type 1Diabetes **Official Title:** DIABETES EATING PROBLEM SURVEY- REVISED (DEPS-R) AMONG ADULTS WITH TYPE 1 DIABETES #### Organization Study ID Info **ID:** DEPS-R Adult #### Organization **Class:** OTHER **Full Name:** Ege University ### Status Module #### Completion Date **Date:** 2022-02-28 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-01-18 **Type:** ACTUAL **Last Update Submit Date:** 2024-01-16 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-10-30 **Type:** ACTUAL #### Start Date **Date:** 2021-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2022-04-26 **Type:** ACTUAL **Study First Submit Date:** 2022-04-16 **Study First Submit QC Date:** 2022-04-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Istanbul University #### Lead Sponsor **Class:** OTHER **Name:** Ege University #### Responsible Party **Investigator Affiliation:** Ege University **Investigator Full Name:** Yasemin Atik Altinok **Investigator Title:** Dietician, PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** A growing body of research has revealed the good psychometric properties and three-component factor structure of DEPS-R in children and adolescents with type 1 diabetes (T1D) but research with adults has limited and has differing results. The Diabetes Eating Problem Survey-Revised (DEPS-R) developed by Markowitz et al is a diabetes-specific self-report instrument to screen eating disorders for individuals with T1D. DEPS-R is a 16-item diabetes-specific self-report questionnaire to test for diabetes-specific eating disorders. Answers are scored on a six-point Likert scale, with higher scores indicating more DEB and a total score of ≥20 indicating a high risk for eating disorders (range 0-80). The original DEPS-R has been shown to have a good internal consistency (Cronbach's alpha=0.86) and construct validity in a sample of the pediatric population with T1D. This study aimed to evaluate the validity and reliability of the Turkish version of the DEPS-R questionnaire for adults with T1D, investigate its psychometric properties and factor structure, and examine its relationship with the EDE-Q questionnaire. **Detailed Description:** In this cross-sectional study, participants answered a DEPS-R and EDE-Q questionnaire during a regularly scheduled medical visit after obtaining written informed consent. All participants had established that patients with T1D were treated with multiple daily insulin or insulin pump therapy. Height was measured using a stadiometer to the nearest 0.1 cm in all participants. Weight was measured unclothed to the nearest 0.1 kg using a calibrated balance scale. Body Mass Index (BMI) was calculated by using the weight (kg)/height (m²) equation. Clinical data including HbA1c, T1D onset, birth date, and treatment model etc. was conducted as part of a standard clinical assessment. HbA1c was measured with ion-exchange high-performance liquid chromatography (Bio-rad Variant ll Turbo, Japan). ### Conditions Module **Conditions:** - Type 1 Diabetes **Keywords:** - type 1 diabetes - DEPS-R - confirmatory factor analysis - diabulimia - distributed eating disorder ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Diabetes Eating Problem Survey-Revised, min score 0, max score 80 DEPS-R score DEP-R score ≥20 indicating a high risk for eating disorders **Measure:** DEPS-R Score **Time Frame:** Day 1 **Description:** Eating Disorders Examination Questionnaire It consists of four subscales eating restraint, eating concern, shape concern, and weight concern. The global score represents an average of the four subscale scores, with higher scores indicating greater eating pathology. **Measure:** EDE-Q Score **Time Frame:** Day 1 **Description:** It will be calculated by subtracting the diabetes onset date from the date the patient was included in the study. **Measure:** Duration of diabetes (years) **Time Frame:** Day 1 **Description:** number **Measure:** HbA1c **Time Frame:** Day 1 **Description:** number **Measure:** BMI **Time Frame:** Day 1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Duration of T1D ≥1 year * A regular follow-up for at least 1 year (4 visits/year) * No major medical problems related to nutrition Exclusion Criteria: * Have major medical problems related to nutrition ( etc. celiac disorders, cystic fibrosis, dyslipidemia,.....) **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** The sample of this study consists of 100 participants with T1D who were being followed at the Istanbul University, Istanbul Faculty of Medicine, Endocrine and Diabetes Outpatient Clinic. ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Istanbul University **Zip:** 34000 #### Overall Officials **Official 1:** **Affiliation:** ege university department of pediatrics **Name:** yasemin A atik-altınok, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Atik Altinok Y, Ozgur S, Meseri R, Ozen S, Darcan S, Goksen D. Reliability and Validity of the Diabetes Eating Problem Survey in Turkish Children and Adolescents with Type 1 Diabetes Mellitus. J Clin Res Pediatr Endocrinol. 2017 Dec 15;9(4):323-328. doi: 10.4274/jcrpe.4219. Epub 2017 Feb 23. **PMID:** 28270369 **Citation:** Karastogiannidou C, Giannoulaki P, Samaras I, Kotzakioulafi E, Didangelos T, Bocsan IC, Vassilopoulou E. The Diabetes Eating Problem Survey-Revised (DEPS-R) in a Greek Adult Population with Type 1 Diabetes Mellitus: Model Comparison Supporting a Single Factor Structure. Nutrients. 2021 Jul 12;13(7):2375. doi: 10.3390/nu13072375. **PMID:** 34371885 **Citation:** Wisting L, Wonderlich J, Skrivarhaug T, Dahl-Jorgensen K, Ro O. Psychometric properties and factor structure of the diabetes eating problem survey - revised (DEPS-R) among adult males and females with type 1 diabetes. J Eat Disord. 2019 Jan 17;7:2. doi: 10.1186/s40337-018-0232-0. eCollection 2019. **PMID:** 30675355 **Citation:** Wisting L, Froisland DH, Skrivarhaug T, Dahl-Jorgensen K, Ro O. Psychometric properties, norms, and factor structure of the diabetes eating problem survey-revised in a large sample of children and adolescents with type 1 diabetes. Diabetes Care. 2013 Aug;36(8):2198-202. doi: 10.2337/dc12-2282. Epub 2013 Mar 27. **PMID:** 23536586 **Citation:** Yilmaz Kafali H, Atik Altinok Y, Ozbaran B, Ozen S, Kose S, Tahillioglu A, Darcan S, Goksen D. Exploring emotional dysregulation characteristics and comorbid psychiatric disorders in type 1 diabetic children with disordered eating behavior risk. J Psychosom Res. 2020 Feb 11;131:109960. doi: 10.1016/j.jpsychores.2020.109960. Online ahead of print. **PMID:** 32070835 **Citation:** Watt A, Ng AH, Sandison A, Fourlanos S, Bramley A. Prevalence of disordered eating in adults with type 1 diabetes in an Australian metropolitan hospital. Health Soc Care Community. 2022 Jul;30(4):e974-e980. doi: 10.1111/hsc.13500. Epub 2021 Jul 12. **PMID:** 34250682 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Type 1 Diabetes - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003922 - Term: Diabetes Mellitus, Type 1 ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT01871779 **Brief Title:** Effect of Exercise Training on Protein Expression in Skeletal Muscle Tissue After Exercise in Peripheral Arterial Disease **Official Title:** The Effect of Different Forms of Exercise on Both the Clinical, Systemic and Local Biological Responses in Intermittent Claudication #### Organization Study ID Info **ID:** CALPAINCLAUD2011 #### Organization **Class:** OTHER **Full Name:** Flinders University ### Status Module #### Completion Date **Date:** 2013-02 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2013-06-07 **Type:** ESTIMATED **Last Update Submit Date:** 2013-06-04 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2012-12 **Type:** ACTUAL #### Start Date **Date:** 2010-10 **Status Verified Date:** 2013-06 #### Study First Post Date **Date:** 2013-06-07 **Type:** ESTIMATED **Study First Submit Date:** 2013-05-31 **Study First Submit QC Date:** 2013-06-04 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Flinders Medical Centre **Class:** OTHER **Name:** Royal Adelaide Hospital **Class:** OTHER **Name:** The Queen Elizabeth Hospital #### Lead Sponsor **Class:** OTHER **Name:** Flinders University #### Responsible Party **Investigator Affiliation:** Flinders University **Investigator Full Name:** Christopher L Delaney **Investigator Title:** Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Cardiovascular disease remain one of the leading causes of death in Australia, accounting for 47637 (36%) of deaths in 2004. Peripheral arterial disease (PAD) is a category of cardiovascular disease, characterised by intermittent claudication. This is defined as walking induced pain, cramping, aching, tiredness or heaviness in one or both legs that does not go away with continued walking and is relieved with rest. It is estimated that between 5-10% of individuals aged over 50 years suffer from claudication. The primary and most effective treatment for these patients is focused on improving walking ability and functional status. Current research has shown that approximately 30% of patients improve with exercise, while 30% continue to deteriorate and the rest show no change. The changes produced at a biochemical and cellular level due to exercise are unknown. To help better understand this, our study will assess the entire range of proteins expressed before and after exercise in the skeletal muscle tissue of patients with intermittent claudication. This will help to identifying key proteins that have a role in improving patient symptoms and outcome. **Detailed Description:** Why is this clinical problem important? Peripheral Arterial Disease (PAD) is a major health problem in Australia, with a prevalence of 15% in males aged over 65 years. The direct health care cost of PAD in Australia was $180m in 1994, of which 78% was associated with hospitalisations. PAD is also a marker for advanced cardiovascular disease (CVD) involving coronary, cerebral, renal and aortic vessels; with a 2-3 fold increased risk of CVD-related mortality. In 2006-2007, 25,813 hospitalizations and 2,163 deaths were a result of PAD (Australian Institute of Health and Welfare 2009). The ageing Australian population and the prevalence of PAD increases (Australian Institute of Health and Welfare 2009), the national annual health expenditure on cardiovascular disease is likely to increase, greatly exceeding the 5.4 billion dollars spent in 2000-01 (Australian Bureau of Statistics 2006). The most frequent symptom of mild to moderate PAD is intermittent claudication (IC), defined as walking-induced pain and cramping in one or both legs (most often calves) that is relieved with rest. The primary and most effective treatment for people with intermittent claudication is focused on improving walking ability and functional status. What is already known about the effect of exercise in intermittent claudication? The beneficial effects of exercise training as a treatment have been confirmed in several randomised controlled trials. The optimum form of exercise still hasn't been elucidated. The mechanisms of improvement of claudication with exercise are largely unknown. Although exercise stimulates an ischaemic-reperfusion (I-R) insult, repetitive exercise may produce an adaptive response to this I-R insult. Other potential themes include effect of exercise on stimulating or inhibiting angiogenesis and/or muscle protein synthesis. Although the principal cause of IC is reduced blood flow to the lower limbs relative to increased demand during exercise, the pathophysiology of IC is not completely understood. For example, limb haemodynamics does not closely correlate with clinical presentation or the limitations in peak exercise performance. Haemodynamic measures of the severity of PAD, such as the ankle-brachial systolic blood pressure index (ABI) and blood flow by strain gauge plethysmography, are poor predictors of exercise capacity in patients with IC. Cross-sectional studies indicate that inflammation is associated with the presence, progression and severity of PAD. This may explain the excess cardiovascular mortality, (at least 50% at 10 years), seen in these patients. The effect of exercise on claudication has been most studied with inflammatory markers in peripheral blood. What is the importance of measuring protein expression in muscle tissue? While peripheral blood bio-markers help in understanding the systemic manifestations of claudication, it does not reflect what is happening in the muscles and microcirculation. Most of the changes in protein expression are too subtle to be detected in peripheral blood. The ease of acquisition does not correspond to ease of interrogation. The dynamic range of proteins in serum makes analysis very challenging because high abundance proteins tend to mask those of lower abundance; whilst a small number of proteins including albumin, Beta 2-macroglobulin, transferrin, and immunoglobulins may represent over 90% of serum proteins11. The protein complement of a cell or tissue is dynamic and reflects the age, life-cycle, and conditions the cell is subjected to or a specific disease state. It is clear that in most diseases, proteins are subjected to numerous changes including post-translational modifications and/or proteolytic cleavage; equally in certain diseases, there is alteration of protein expression. Messenger ribonucleic acid (mRNA) is the molecule encoding the chemical blueprint for a protein. Yet the micro arrays examining differential expression of mRNA will not provide information on post-translational modification, therefore the only way to assess the impact of the proteins is at the protein level. Some studies have investigated the difference in histochemical and biochemical characteristics of skeletal muscle between patients with PAD and healthy age-matched subjects. Most of the studies into muscle biopsy from patients with PAD have demonstrated alterations in muscle fibre type distribution, denervation and alterations in muscle metabolism with no insight into protein expression12, 13, 14. There is considerable evidence that the metabolic status of skeletal muscle is perturbed in patients with PAD as compared with age-matched healthy controls. Amongst the earliest observations was the unexpected finding that the expression and activity of several mitochondrial enzymes are increased in skeletal muscle from limbs with PAD. The skeletal muscles in patients with IC, do change with exercise but the current evidence does not shed light on the mechanisms of change or if the change is the same in all patients. We do already know that some patients improve with exercise while others do not. A question thus arises as to whether there exists a bio-diversity in these patients' response to exercise. Armstrong et al studied disturbances in calcium homeostasis of skeletal muscle and suggested that they might play a key role in the development of exercise-induced muscle damage. Some of the immediate muscle changes after exercise have been attributed to protein degradation is initiated by non-lysosomal cysteine proteases, such as calpain. The elevation in intracellular calcium post-exercise can activate the calpains. Muscle tissue expresses three distinct calpains, including the well-characterized ubiquitous calpains - m- calpain, μ-calpain and n-calpain. Wang et al have concluded, in animal studies, that the increased levels of the protease m-calpain, promotes muscle injury whereas the calpastatin protein expression might execute a protective function for muscle injury. This has not yet been investigated in human studies. It can be hypothesised that the levels of calpastatin and m-calpain are important in explaining the variable response to exercise in IC and why some patients improve and others do not. There is some conflicting evidence on the benefit of exercise. Tsai et al have found that the normal training effect on the glucose transporter 4 (GLUT4) gene expression was completely eliminated by both acute and chronic ischemia at the pre-translational level. In addition, the chronic ischemia-induced muscle atrophy was seen to be more severe in the exercise-trained rats than in the untrained rats. This result suggests that for individuals with impaired microvascular conditions, exercise training might not be beneficial in maintaining muscle mass. Thus the effect of exercise training in human subjects with IC (ischaemia) is yet to be elucidated. We know that all subjects differ in their capacity for exercise and patients with intermittent claudication are no different. Patients undergoing exercise for intermittent claudication, would be different in terms of their expression of proteins due to exercise. For this reason, patients would act as their own controls by means of a biopsy from an unaffected muscle of each individual. An open ended mass spectroscopy examination of proteins in the exercising skeletal muscle would give an insight into the mechanistic pathway of the exercise effect in intermittent claudication. What is the relation between protein expression and inflammation in the exercise with intermittent claudication? The clinical model of exercise inducing an ischaemia-reperfusion type injury has been substantiated by evidence of markers of inflammation. Neutrophils are the first cells to begin accumulating in the tissue at the injury site, destroying necrotic tissue through phagocytosis while working in conjunction with resident macrophages from the muscle tissue itself. Neutrophil presence has been documented in muscle after various types of eccentric exercise. A study looking at neutrophil function in exercising claudicants showed increased neutrophil activation manifest by increased expression of the neutrophil adhesion receptor cluster of differentiation antigen IIb (CD11b) and degranulation manifest by an increase in plasma neutrophil elastase. This occurred immediately after exercise in these patients with intermittent claudication. Whether this equates to a trend to predict outcomes is still not clear. The protease m-Calpain is chemotactic factor for neutrophils and may play a role in the local and systemic inflammatory response. Such adaptations in cellular inflammatory responses have been reported earlier by Kunimatsu et al. Together with Calpastatin, these proteins may hold a key in the link between local muscle damage, repair and inducing a systemic inflammatory response. Chemical modification of proteins may play a role in the pathogenesis of disorders ranging from diabetes to atherosclerosis and ischemia-reperfusion injury and perhaps to the aging process itself. Advanced Glycosylation End products (AGEs) are the end products of glycosylation reactions in which a sugar molecule bonds to either a protein or lipid molecule without an enzyme to control the reaction. The formation and accumulation of AGEs has been implicated in the progression of age related disease, in particular cardiovascular disease. They have a range of pathological effects, including inhibition of vascular dilatation by interfering with nitric oxide (Endothelium Derived Relaxation factor), binding macrophage and endothelial cells to induce the secretion of inflammatory cytokines and enhancing oxidative stress. We hypothesise that exercise stimulates glucose uptake by the endothelial cells increasing the synthesis of AGE's. It remains to be determined whether exercise again enhances or reduces this process. The aim of this study is to examine inflammatory biomarkers, including Interleukin-6 (IL-6), Neutrophil elastase and Advanced Glycated End-products with proteins known to influence tissue damage or repair (Calpains and Calpastatin) to determine the effect of different forms of exercise on this process, in order to determine 1. Is exercise appropriate for all patients? i.e. 1. Do all patients respond with a pro inflammatory response? and 2. Does exercise produce an adaptive response to this in all patients? or 3. Does exercise stimulate an I-R insult in some patients that is not reduced by exercise training? 4. What is the local tissue response to exercise in terms of tissue damage or repair (as measured by protein analysis) 2. What is the best form of exercise for these suitable patients? 3. Is there a biodiversity in patients' response to exercise in terms of 1. Systemic inflammatory response (based on IL-6, Neutrophil Elastase \& AGE's)? 2. Local response (based on protein analysis)? 4. Does the physiological response to exercise in these patients reduce the risk of CVD related morbidity/mortality? a. As evidenced by changes in cardiopulmonary exercise testing (CPET) outcome parameters and endothelial function. 5. Is impaired endothelial function reversible? a. As measured by flow-mediated dilatation. The combined use of data from systemic blood and local muscle tissue would help to characterise the metabolic and functional consequences of age associated PAD changes in skeletal muscle. It would also help to identify a mechanistic pathway by which exercise exerts its effect on the patient with intermittent claudication. ### Conditions Module **Conditions:** - Peripheral Arterial Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 35 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The first group would undergo standard treadmill exercise to the point of pain and repeat these cycles for a total period of 35-45 minutes twice weekly for 12 weeks **Intervention Names:** - Other: Standard Treadmill Exercise **Label:** Standard Treadmill Exercise **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The second group would have a combination of intermittent treadmill and some resistance training with weights. They will undergo repeated cycles to a maximum of 35-45 minutes twice weekly for 12 weeks **Intervention Names:** - Other: Intermittent treadmill & resistance training **Label:** Intermittent Treadmill & Resistance Training **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Standard Treadmill Exercise **Description:** Standard treadmill exercise to the point of pain twice weekly for 35-45 minutes for 12 weeks **Name:** Standard Treadmill Exercise **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Intermittent Treadmill & Resistance Training **Description:** Combination of standard treadmill training and resistance training with weights twice weekly for 12 weeks **Name:** Intermittent treadmill & resistance training **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Patients will be exercised based on standard protocols and monitored for improvements in Maximal walking distance and Pain Free Walking distances. **Measure:** Improvement in Pain Free Walking Distance **Time Frame:** Change from baseline (pre intervention) to 12 weeks (post intervention) #### Secondary Outcomes **Description:** Skeletal muscle samples obtained from ultrasound guided biopsy of symptomatic medial gastrocnemius muscle will be assessed for protein activity of proteins from the calpain family, specifically, m-calpain and calpastatin. **Measure:** Skeletal muscle protein expression **Time Frame:** Change from baseline (pre intervention) to 12 weeks (post intervention) **Description:** Fasting C Reactive Protein, Interleukin 6 and Neutrophil Elastase will be analysed from serum via enzyme-linked immunosorbent assays. **Measure:** Inflammatory cytokines **Time Frame:** Change from baseline (pre intervention) to 12 weeks (post intervention) **Description:** Endothelium-mediated changes in vascular tone will be quantified by reactive hyperemia-peripheral artery tonometry index and flow-mediated dilatation using high resolution ultrasound. **Measure:** Endothelial function **Time Frame:** Change from baseline (pre intervention) to 12 weeks (post intervention) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. All claudicants with a walking distance of 50 metres or more with a resting ankle brachial index equal to or less than 0.9. 2. Claudicants meeting above criteria, who may have previously had a percutaneous arterial intervention for symptom control more than 12 months ago. Exclusion Criteria: 1. Patients with lower limb pain of other aetiologies - neurogenic claudication evidenced by normal ankle brachial indices and duplex ultrasound. 2. Patients with lower limb ischaemic rest pain 3. Patients with current or previous tissue loss, such as ulcers or necrotic lesions. 4. Patients with recent (\<12 months) history of peripheral vascular interventions for symptoms. 5. Patients with pre-existing cardiac or respiratory problems limiting exercise. 6. Patients with previous disabling strokes which would restrict exercise regimes 7. Patients with anticoagulation or blood dyscrasias. 8. Women who are pre-menopausal, 9. Women receiving hormone-replacement therapy. **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Daw Park **Country:** Australia **Facility:** Repatriation General Hospital **State:** South Australia **Zip:** 5041 #### Overall Officials **Official 1:** **Affiliation:** Flinders University and Flinders Medical Centre Department of Vascular Surgery **Name:** Christopher L Delaney, BMBS **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Flinders University and Flinders Medical Centre Department of Vascular Surgery **Name:** James I Spark, MBChB, MD, **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Delaney CL, Miller MD, Dickinson KM, Spark JI. Change in dietary intake of adults with intermittent claudication undergoing a supervised exercise program and compared to matched controls. Nutr J. 2014 Oct 15;13:100. doi: 10.1186/1475-2891-13-100. **PMID:** 25316347 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050197 - Term: Atherosclerosis - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10418 - Name: Intermittent Claudication - Relevance: LOW - As Found: Unknown - ID: M29213 - Name: Peripheral Arterial Disease - Relevance: HIGH - As Found: Peripheral Arterial Disease - ID: M18894 - Name: Peripheral Vascular Diseases - Relevance: HIGH - As Found: Peripheral Arterial Disease - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M26188 - Name: Atherosclerosis - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000058729 - Term: Peripheral Arterial Disease - ID: D000016491 - Term: Peripheral Vascular Diseases ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT03724279 **Brief Title:** Crossing Atheroma or Thrombus With ByCross Device for Revascularization of Peripheral Arteries of Diameter ≥ 3mm **Official Title:** Safety and Effectiveness of ByCross Rotational and Aspiration Device for Revascularization of Total or Sub-total Occluded Peripheral Arterial Vessels of Luminal Diameter Equal to or Larger Than 3mm: A Prospective, Multi-center Study #### Organization Study ID Info **ID:** QA 213.06 #### Organization **Class:** INDUSTRY **Full Name:** Taryag Medical Ltd. #### Secondary ID Infos **Domain:** World Health Organization (WHO-UTN) **ID:** U1111-1222-4481 **Type:** REGISTRY **Domain:** German Clinical Trials Registrar (DRKS) **ID:** DRKS00015758 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2019-10-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-04-14 **Type:** ACTUAL **Last Update Submit Date:** 2020-04-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-07-01 **Type:** ACTUAL #### Start Date **Date:** 2018-09-24 **Type:** ACTUAL **Status Verified Date:** 2020-04 #### Study First Post Date **Date:** 2018-10-30 **Type:** ACTUAL **Study First Submit Date:** 2018-10-17 **Study First Submit QC Date:** 2018-10-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Taryag Medical Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of the study is to demonstrate safety and effectiveness of ByCross Rotational and Aspiration device used for revascularization of total or sub-total occluded peripheral arterial vessels equal to or larger than 3mm in diameter. The ByCross is a single use, disposable, minimal invasive aspiration rotational atherectomy device. The ByCross is aimed to enable effective revascularization and restore blood flow in peripheral occluded vessels. In cases that the artery is completely blocked such that opening is not possible with currently available solutions and the procedure cannot be completed, the device is capable of crossing the blocked lesion without guiding wire and enables the completion of the procedure in a safe and effective manner, thus potentially eliminating the need for open bypass surgery. The ByCross can be used in several pathologies: calcified atheroma, old and fresh thrombus. Eligible adult patients with symptoms due to chronic sub-total and total occlusion will be enrolled and undergo percutaneous procedure including use of ByCross which will normally be followed by balloon inflation (Percutaneous Transluminal Angioplasty) in the artery at location where blockage has been opened by ByCross to further open the artery and restore full opening, and in some case followed by placement of a stent for long term stabilization. For demonstrating safety and effectiveness up to 42 patients will be enrolled. the procedure will take up to 2 hours followed by up to 48 hour hospitalization. Patients will then come for follow-up monitoring and examination 30 days and 6 months after procedure. Although this is unlikely, in some cases the physician can decide during procedure that following ByCross opening of the artery, ballooning or stent is not required. In this case the patient will come for another follow-up visit after 12 month. **Detailed Description:** Occlusive vascular disease (OVD) is the leading cause of mortality and morbidity in the Western world. Arterial obstructions generally start as a build-up of harder atherosclerotic material on which clotted blood (thrombus) forms, whereas veins obstruction contains mostly thrombus. Over 10 million patients in the US suffer from peripheral arterial disease (PAD) including 750,000 critical limb ischemia patients who are at risk of limb amputation. The existing pharmacological and bypass surgical methods to treat OVD are risky, expensive, and time-consuming. Overcoming these shortcomings presents a substantial opportunity for a mechanical catheter. Atherectomy with mechanical catheters has been used clinically for many years, and by now the clinical outcome of atherectomy is known as reflected by multiple clinical studies. The potential benefit of the technique compared with percutaneous transluminal angioplasty (PTA) and/or Stenting alone or as an adjunctive therapy has also been discussed, and more recently as an adjunctive prior to PTA with a drugeluting balloon and stenting. The existing catheters designed mainly for arteries are expensive, complicated to operate, demonstrate limited reduction in level of stenosis, might cause perforations, distal embolization and hemolysis, have no or poor aspiration, and cannot cross occlusions without passage of guidewire first. Despite the common use of these therapies and current benefits, there remain significant opportunities to extend catheter-based treatments with improved outcomes, to more patients and at lower cost. The ByCross is a minimal invasive, single use atherectomy and thrombectomy device, which is introduced over the wire into the peripheral vasculature for revascularization of chronic occluded peripheral vessels. The ByCross has a coaxial flexible rotating shaft with an expandable tip and integrates an independent aspiration system for suction of thrombotic material. The expandable tip is an elastic arc that can bow and enlarge the tip diameter from external tip diameter of 1.7mm at closed condition to 4.7mm at open condition. As the shaft rotates, the tip breaks the calcified atheroma or thrombus into small particles, which are simultaneously aspired into the shaft and removed into the attached collection bag. The ByCross allows injection of contrast medium and thrombolytic agents through the rotating tip during the procedure for continuance imaging and prevention of appositional thrombus formation. Due to its no-symmetrical helical design the tip rotation is eccentric, causing the tip to recenter is self within the lumen as it rotates. While ByCross is introduced over a guide wire, it does not require the passage of an occlusion with the wire first. To cross the occlusion the ByCross is advanced with running motor forth and back in a closed condition. Once the occluded segment is crossed the procedure is repeated with open tip at larger diameter vessels to further remove the remaining atheroma or thrombus. The ByCross is battery powered, and includes a remote-control unit which allows the user full ergonomic control of the device next to the puncture site. Based on compliance with standard requirements, design process and risk analysis process. The risk of occurrence of adverse events is not expected to be greater than the risk reported for other devices available in the market today. More over the past animal test supports the expected low risk. This study, aside to performance investigation, is intended to validate this. The potential significant advantage of the ByCross device in the treatment of chronic limb ischemia is the ability to cross Chronic Total Occlusion (calcified atheroma and/or thrombus, in oppose to other atherectomy devices which can only cross partial occluded vessel due to the necessity of progressing over the wire). Thus, instead of aborting the procedure, completion of revascularization procedure percutaneously is possible. In addition, the ByCross enables, due to its design, to achieve superior patency, injection of contrast medium and antiplatelet during operation of the radio-opaque tip, and enables simultaneous aspiration. These benefits potentially reduce prolonged percutaneous procedures if other means are required to enable chroni total occlusion (CTO) passage by guidewire, and, might, in the future, reduce the number of bypass surgeries in peripheral arteries, all with no risk compared to long term clinical use of equivalent devices. Information gathered in this study will further assure the ByCross device as superior solution enabling more beneficial minimal invasive procedure for the subjects with the same indication for treatment. The study is multi-center, single arm, open label, prospective study. 42 patients with total or subtotal occlusion at target vessel bearing length equal to or larger than 3cm at vessels diameter of 3mm or larger will be enrolled to the study. Eligible consented subjects will undergo a procedure and treated with the ByCross device. Additional adjunctive treatment (such as PTA, stenting etc.) may be performed per physician's discretion and according to standard of care. Assessment of device safety and performance will be performed intra and post procedural, at discharge, at 30 days post procedure and at 6 months. Subjects that will undergo procedure using ByCross only with NO adjunctive therapy will be followed-up at 12 months as well. The overall duration of participation for each subject is expected to be up to 7 months and 13 months for those that undergo procedure using ByCross only. Primary outcome measures are divided into two: performance and safety. The null hypotheses will be tested via the lower limit of the one-sided 95% exact confidence interval for the respective proportions. The expected Acute Procedural Success rate is 95% as is the rate of subjects free of device-related Major Adverse Events (MAEs) throughout a 30-day follow-up. The sample size required to achieve a lower one-sided 95% exact confidence limit that is greater than 85%, if the point estimate of the proportion is 95%, is calculated as 40 patients. To accommodate a potential 5% drop-out prior to completing 30 days follow-up, up to 42 patients may be required to be enrolled. ### Conditions Module **Conditions:** - Arterial Occlusive Diseases ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 42 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Percutaneous intervention including ByCross atherectomy and Thrombectomy potentially followed with PTA and/or stent placement **Intervention Names:** - Device: ByCross Atherectomy and Thrombectomy **Label:** ByCross Atherectomy and Thrombectomy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - ByCross Atherectomy and Thrombectomy **Description:** After assessment of the lesion by angiography the ByCross is advanced over a 0.035" guidewire through a sheath to the occlusion. Activation will rotate the shaft and start aspiration. Under fluoroscopy the ByCross is advanced continuously over the wire. in case passage is not possible the ByCross tip is advanced into the occlusion for 10mm, then wire is advanced to check is passage is possible, this is repeated until passage by the wire is achieved. At harder lesion the speed is set to high. Once the occlusion is crossed the ByCross tip is enlarged, device is advanced once more to increase opening. Additional adjunctive treatment may be performed per physician's discretion and according to standard of care. Performance criteria of the intervention is to achieved more than 70% opening. **Name:** ByCross Atherectomy and Thrombectomy **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Passage of the occlusion by the ByCross device and post atherectomy residual stenosis (assessed using angiograph) ≤ 50% to allow for angioplasty and/or stenting if required, and complete procedural success of residual stenosis ≤ 30%, with no Serious Adverse Events (SAE) during the procedure **Measure:** Rate of subjects with post atherectomy stenosis ≤ 50% and post procedure stenosis ≤ 30% **Time Frame:** Up to 8 hours post-procedure **Description:** Major Adverse Events (MAE), at 30 days follow-up. Each Major Adverse Event (MAE) will be assessed to determine whether its root cause is device-related complication, adjunctive therapy (e.g balloon and/or stent) related complication or other related complication. **Measure:** Rate of major adverse events **Time Frame:** 30-days follow-up #### Secondary Outcomes **Description:** No deterioration in target vessel stenosis level at 30 and 6 months compared to post procedure level. Stenosis evaluated using Duplex Ultrasound. **Measure:** Stenosis level **Time Frame:** up to 96 hours, 30-days and 6-months follow-up **Description:** Ankle Brachial Pressure Index (ABPI) at hospital discharge, 30 days and 6 months follow-up. ABPI is the ratio between the systolic blood pressure of the ankle divided by the systolic blood pressure of the arm. Scale can be larger than 0 and smaller than 1.2. 0.9-1.4 range indicates normal condition while values smaller than 0.8 indicates peripheral vascular disease. Lower value indicates higher severity. Scale higher than 1.4 indicates distortion of measurements due to abnormal vessel behavior (e.g. hardening). **Measure:** Ankle Brachial Pressure Index **Time Frame:** up to 96 hours, 30-days and 6 months follow-up **Description:** Major Adverse Events (MAE) during procedure, at hospital discharge at 6 months follow-up for all patients, and at 12 months follow-up for subjects that undergo procedure using ByCross with NO adjunctive therapy. Each Major Adverse Event (MAE) will be assessed to determine whether its root cause is device-related complication, adjunctive therapy (e.g balloon and/or stent) related complication or other related complication. **Measure:** Major adverse events **Time Frame:** Up to 8 hours post-procedure, up to 96 hours, 6-months follow-up, and 12-months if applicable ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subject has documented symptomatic (Rutherford 2-6), chronic peripheral vascular disease requiring percutaneous intervention and are indicated for atherectomy at superficial femoral (SFA) and/or popliteal artery and/or tibioperoneal trunk (TPT). * Target lesion is at least 10mm distal to the SFA origin and at least 10mm proximal to the distal end of the TPT. * Total or sub-total occlusion of target vessel (stenosis ≥80%) * Vessel lumen ≥3.0mm * Lesion length ≥3.0cm * Subject has been informed on the nature of the study and is willing and able to provide informed consent * Subject is capable of meeting study requirements including presences at follow-up visits Exclusion Criteria: * Subject is unable to take antiplatelet drugs * Vessel of the cardiopulmonary, coronary or cerebral circulation * Subject has anticipated life expectance \< 12 month * Subject is diagnosed with impaired renal function (creatinine \>2.5 mg/dL) * Subject has undergone or planned surgical or endovascular procedure 15 days before or after the study procedure * Vessel lumen \<3.0mm * Stent at access and target vessel or In-stent restenosis at target lesion * Target and/or access vessel include by-pass graft * Target vessel is dissected * Target is at vessel segment which includes tortuous course with radius of curvature \<= 40mm * Access pathway includes tortuous course with radius of curvature \<= 25mm * Target and/or access vessel includes aneurysm altered segments * Persistent vasospasm * Known or suspected allergy to any of the components of the sys-tem or to a medicinal product to be administered in connection with the planned procedure * Subject is pregnant or planning to become pregnant within the study period, or lactating mothers * Subject is enrolled to another clinical investigation that might interfere with this study **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Dusseldorf **Country:** Germany **Facility:** Augusta-Krankenhaus **Zip:** 40472 **Location 2:** **City:** Lingen **Country:** Germany **Facility:** Bonifatius Hospital Lingen **Zip:** 49808 #### Overall Officials **Official 1:** **Affiliation:** Bonifatius Hospital Lingen **Name:** Joerg Tessarek, M.D. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: HIGH - As Found: Arterial Occlusive Disease - ID: M16686 - Name: Thrombosis - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001157 - Term: Arterial Occlusive Diseases ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT03189979 **Brief Title:** Club Fit: Physical Activity and Healthy Eating at an After School Program **Official Title:** Club Fit: Pilot Testing of a Physical Activity and Healthy Eating Intervention at a Boys & Girls Club After School Program #### Organization Study ID Info **ID:** 14-003639 #### Organization **Class:** OTHER **Full Name:** Mayo Clinic #### Secondary ID Infos **ID:** UL1TR000135 **Link:** https://reporter.nih.gov/quickSearch/UL1TR000135 **Type:** NIH ### Status Module #### Completion Date **Date:** 2016-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-06-16 **Type:** ACTUAL **Last Update Submit Date:** 2017-06-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-05 **Type:** ACTUAL #### Start Date **Date:** 2015-10 **Type:** ACTUAL **Status Verified Date:** 2017-06 #### Study First Post Date **Date:** 2017-06-16 **Type:** ACTUAL **Study First Submit Date:** 2017-06-15 **Study First Submit QC Date:** 2017-06-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mayo Clinic #### Responsible Party **Investigator Affiliation:** Mayo Clinic **Investigator Full Name:** Mark L Wieland **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Background: Youth from low-income and minority families are disproportionately affected by obesity and its complications. This study presented pilot work to develop and implement a multi-component physical activity and healthy eating intervention at a Boys \& Girls Club (BGC) after school program. Methods: Using a community-based participatory approach, BGC staff and academic researchers developed intervention components informed by formative studies and based on a social ecological theory framework. Components included healthy eating and physical activity policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign. Preliminary intervention efficacy was assessed through a single group, pre-post study design with measured collected at baseline and 6 months. ### Conditions Module **Conditions:** - Childhood Obesity - Physical Activity - Dietary Habits **Keywords:** - community based participatory research - Childhood obesity ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 61 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intervention includes exposure to physical activity and healthy eating intervention policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign. **Intervention Names:** - Behavioral: Physical activity and healthy eating intervention **Label:** Club Fit **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Club Fit **Description:** Using a community-based participatory approach, BGC staff and academic researchers developed intervention components informed by formative studies and based on a social ecological theory framework. Components included healthy eating and physical activity policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign. **Name:** Physical activity and healthy eating intervention **Other Names:** - Club Fit **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Self-efficacy was assessed with a survey adapted from instruments developed for the Patient-centered Assessment and Counseling for Exercise plus Nutrition program for low-income, ethnically diverse adolescents. It was scored on a 10-point Likert scale from 1 (not at all confident) to 10 (extremely confident). **Measure:** Change in self-efficacy **Time Frame:** baseline, 6 months **Description:** Motivation for physical activity was scored on a 10-point Likert scale from 1 (not at all motivated) to 10 (extremely motivated). **Measure:** Change in motivation **Time Frame:** baseline, 6 months #### Secondary Outcomes **Description:** For body mass index (BMI), weight was measured to the nearest 0.1 kg using a single scale. Height was measured to the nearest 0.1 cm using a stadiometer. BMI was calculated as weight (kg)/height squared (m2). **Measure:** Change in body mass index **Time Frame:** baseline, 6 months **Description:** The Kinetic Activity Monitor accelerometer was used for objective physical activity assessment. Participants were asked to wear the accelerometer at their waist during waking hours for 10 consecutive days. The accelerometer was activated and data collected without providing feedback to participants. A valid assessment required 5 days of wear for at least 10 hours a day. Data output included sedentary time and time spent performing mild, moderate, and vigorous physical activities. **Measure:** Change in physical activity **Time Frame:** baseline, 6 months **Description:** Dietary assessment was performed with the Beverage and Snack Questionnaire 2. The instrument was adapted to include nine items (on a 7-point Likert scale) that addressed consumption of fruits, vegetables, and sugar sweetened beverages. The Likert scale ranged from "never or less than 1 per week" to "4+ per day." The greater number of fruits and vegetables, and fewer number of sugar sweetened beverages were considered a positive change in dietary quality. **Measure:** Change in dietary quality **Time Frame:** baseline, 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - Active Boys \& Girls Club participation, which was defined as expected Club attendance at least twice weekly. Exclusion Criteria: - None **Maximum Age:** 17 Years **Minimum Age:** 8 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Rochester **Country:** United States **Facility:** Boys & Girls Club of Rochester, MN **State:** Minnesota **Zip:** 55905 #### Overall Officials **Official 1:** **Affiliation:** Mayo Clinic **Name:** Mark L Wieland, MD, MPH **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Individual participant data will not be shared. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009765 - Term: Obesity - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M30155 - Name: Pediatric Obesity - Relevance: HIGH - As Found: Childhood Obesity - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000063766 - Term: Pediatric Obesity ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT05880979 **Acronym:** ETHR **Brief Title:** Engaging Together for Healthy Relationships **Official Title:** Engaging Together for Healthy Relationships: A Pilot Trial to Test a Brief Dating Violence Prevention Intervention for Pediatric Primary Care #### Organization Study ID Info **ID:** STUDY22060047 #### Organization **Class:** OTHER **Full Name:** University of Pittsburgh ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-08-23 **Type:** ACTUAL **Last Update Submit Date:** 2023-08-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-07-01 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2023-05-30 **Type:** ACTUAL **Study First Submit Date:** 2023-05-12 **Study First Submit QC Date:** 2023-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Pittsburgh #### Responsible Party **Investigator Affiliation:** University of Pittsburgh **Investigator Full Name:** Maya Ragavan **Investigator Title:** Assistant Professor of Pediatrics **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this pilot randomized clinical trial is to assess feasibility and acceptability of a brief parent-adolescent dating violence prevention intervention (Engaging Together for Healthy Relationships; ETHR) delivered in pediatric primary care settings. The main questions it aims to answer is if ETHR is acceptable and feasible. 4 healthcare providers will receive ETHR to share with their patients which includes clinician training, provider-delivered scripts, resource guides, and a comprehensive website. This will be compared to providers conducting routine well-child care with their patients. **Detailed Description:** The investigators are conducting a pilot randomized clinical trial to test a brief parent-adolescent dating violence prevention intervention (Engaging Together for Healthy Relationships; ETHR). ETHR has been developed for parents and adolescents, to be implemented within pediatric primary care settings. ETHR is a comprehensive intervention which includes a training for clinicians, brief educational scripts for providers, resource guides for the adolescent, parent, and dyad, a comprehensive website, and warm referral processes to connect families with local resources. The investigators will be comparing ETHR with routine care. The specific goal of the pilot trial is to test trial feasibility, as well as intervention acceptability and fidelity. The investigators also will be examining exploratory changes in secondary outcomes and early implementation barriers and facilitators. Four pediatric clinics will participate in this study. The investigator will recruit two providers from each clinic and randomize them into the intervention provider or control provider. The intervention provider will receive ETHR and the control provider will complete their regular well-child care. The investigators will enroll 15 families in the intervention arm and 5 in the control arm (3:1 enrollment). Families who are seeing the intervention provider for a well-child visit will be enrolled in the intervention arm; those seeing the control provider will be enrolled in the control arm. Families will be eligible if they are seeing the intervention or control providers for a well child visit, if the adolescent coming for the well-visit is between 11 to 15, if both the caregiver and adolescent are interested in participating, and if the family speaks and understands English. Families will be called 2 weeks ahead of their visit to enroll, consent, and complete a baseline survey (both the adolescent and parent will complete the survey). Participants will then attend their well -visit (where they will receive ETHR or routine care, depending on their provider). They will complete an acceptability and fidelity survey immediately post-visit, a resource utilization survey 1 month post visit, and a follow up survey (identical to the baseline survey) 3 months post visit. Providers will complete a brief fidelity and acceptability survey after each study visit (15 for intervention providers, 5 for control providers). All providers and a subset of families enrolled in the intervention arm (20 dyads, 40 participants) will also complete post-intervention interviews. ### Conditions Module **Conditions:** - Violence in Adolescence - Domestic Violence ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomization will occur at the provider-level ##### Masking Info **Masking:** SINGLE **Masking Description:** Participants will be told in the consent form that they may receive information about dating violence during their well-visit or they may not. They will not be specifically told if their provider is the intervention provider or control provider. **Who Masked:** - PARTICIPANT **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 168 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Providers and families in the intervention arm will receive the ETHR program which includes a clinician training, provider scripts, resource guides, a comprehensive website, and warm referral processes. **Intervention Names:** - Behavioral: Engaging Together for Healthy Relationships **Label:** Intervention (Engaging Together for Healthy Relationships) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Providers and families in the control arm will receive regular well-child care. All providers in the control arm will have access to ETHR after the pilot trial is over **Intervention Names:** - Behavioral: Regular well child care **Label:** Control (Receipt of regular well-child care) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention (Engaging Together for Healthy Relationships) **Description:** A comprehensive parent-adolescent dating violence prevention intervention designed to be provider delivered within the context of a pediatric well-child visit **Name:** Engaging Together for Healthy Relationships **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Control (Receipt of regular well-child care) **Description:** Participants will receive their regularly scheduled well-child care **Name:** Regular well child care **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Will assess through tracking data **Measure:** Percentage of participants who are eligible out of the total who are approached **Time Frame:** Through completion of study recruitment, an average of 6 months **Description:** Will assess through tracking data **Measure:** Percentage of participants who are consented out of the total who are eligible **Time Frame:** Through completion of study recruitment, an average of 6 months **Description:** Will assess through tracking data **Measure:** Percentage of participants who complete the baseline survey out of the total who consented **Time Frame:** Through completion of completing baseline surveys, an average of 6 months **Description:** Will assess through tracking data **Measure:** Percentage of participants who complete the well-visit out of the total who consented **Time Frame:** Through completion of completing well-visits, an average of 6 months **Description:** Will assess through tracking data **Measure:** Percentage of participants who complete the immediate post-intervention survey out of the total who consented **Time Frame:** Through completion of completing post-intervention survey, an average of 7 months **Description:** Through completion of completing 1- month post-intervention survey, an average of 8 months **Measure:** Percentage of participants who complete the 1-month post-intervention survey out of the total who consented **Time Frame:** 4 months **Description:** Will assess through tracking data **Measure:** Percentage of participants who complete the 3-month post-intervention survey out of the total who consented **Time Frame:** Through completion of completing 3 month post-intervention survey, an average of 12 months **Description:** Validated measure (Acceptability of Intervention Measure) **Measure:** Percentage of participants who strongly agree or agree that the intervention is acceptable using a 4-item validated measure (Acceptability of Intervention Measure) **Time Frame:** Through completion of completing immediate post-visit surveys, an average of 6 months #### Secondary Outcomes **Description:** Self-efficacy around ARA prevention, 1-5 scale (5=higher self-efficacy) **Measure:** Self-efficacy in preventing adolescent relationship abuse (ARA), change in outcome between baseline and 3 months **Time Frame:** Baseline, 3-month post intervention **Description:** Investigator developed measure (yes/no) **Measure:** Percentage of participants who utilize ARA resources at each measurement point, change in outcome over time **Time Frame:** Baseline, 1 month post intervention, 3 month post-intervention **Description:** Attitudes about Abusive Relationships, 1-5 scale (1=not abusive, 5=very abusive) **Measure:** Attitudes about ARA, change in outcome between baseline and 3 months **Time Frame:** Baseline, 3-month post intervention **Description:** Investigator developed measure, yes/no answer choices (yes=has communicated, no=has not communicated) **Measure:** Parent-adolescent communication around dating and ARA, change in outcome over time **Time Frame:** Baseline, 3-month post intervention **Description:** Parenting Practices Scale (never to always; 1=never, 5=always) **Measure:** Parental monitoring around dating and ARA, change in outcome over time **Time Frame:** Baseline, 3-month post intervention **Description:** CADRI Short Form 1-5 scale (never to everyday) **Measure:** Percentage of adolescents reporting ARA victimization and perpetration **Time Frame:** Baseline, 3-month post intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Providers: 1. Sees patient at an eligible primary care clinic 2. Speaks and understands English 3. Age 18 or older 4. Identifies as a pediatrician, nurse practitioner, physician assistant (pediatric primary care healthcare provider) Adolescents 1. Age 11 to 15 2. Attending an upcoming well-child visit from a provider enrolled in the study 3. Caregiver who is accompanying well-child visit with adolescent is also participating 4. Speaks and understands English Parents 1. Is parent or primary caregiver for an adolescent age 11 to 15 2. Adolescent has an upcoming well-child visit with a provider enrolled in the study 3. Accompanying child to the well-visit 4. Adolescent is interested and eligible to participate in study 5. Speaks and understand English Exclusion Criteria: Providers 1) Does not need inclusion criteria **Healthy Volunteers:** True **Minimum Age:** 11 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Monongahela **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Maya Ragavan - **Phone:** 412-692-6545 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Erin Mickievicz - **Role:** CONTACT **Country:** United States **Facility:** CCP South Hills **State:** Pennsylvania **Status:** RECRUITING **Zip:** 15063 **Location 2:** **City:** Pittsburgh **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Maya Ragavan - **Phone:** 412-692-6545 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Erin Mickievicz - **Role:** CONTACT **Country:** United States **Facility:** Primary Care Center Oakland **State:** Pennsylvania **Status:** RECRUITING **Zip:** 15213 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT01901679 **Brief Title:** Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women **Official Title:** A Pilot Study: Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women #### Organization Study ID Info **ID:** PHO-0807 #### Organization **Class:** OTHER **Full Name:** Rockefeller University ### Status Module #### Completion Date **Date:** 2014-08 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-02-01 **Type:** ACTUAL **Last Update Submit Date:** 2021-01-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-08 **Type:** ACTUAL #### Results First Post Date **Date:** 2021-02-01 **Type:** ACTUAL **Results First Submit Date:** 2020-11-13 **Results First Submit QC Date:** 2021-01-28 #### Start Date **Date:** 2013-07 **Status Verified Date:** 2021-01 #### Study First Post Date **Date:** 2013-07-17 **Type:** ESTIMATED **Study First Submit Date:** 2013-07-10 **Study First Submit QC Date:** 2013-07-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Rockefeller University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study plans to find out whether Celebrex may be potentially useful to decrease inflammation in fat tissues and thereby lower the production of substances such as estrogens that may increase the risk of developing breast cancer and lead to a poor outcome of the disease. **Detailed Description:** This study seeks to examine how effective the celebrex may be in reducing inflammation, crown-like structures in fat tissue, the enzyme aromatase, PGE-M in the urine and estrogen in blood and urine. Volunteer subjects will be expected to stay in the hospital for about 2 weeks taking Celebrex for approximately 10 days while eating a diet similar to what they consumed before coming into the hospital for the study. ### Conditions Module **Conditions:** - Obesity **Keywords:** - Obesity - Post-menopausal ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 10 **Type:** ACTUAL **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 10 days treatment with Celebrex to evaluate reduction of PGE-M in urine **Intervention Names:** - Drug: Celebrex **Label:** Celebrex **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Celebrex **Description:** 200 mg PO BID **Name:** Celebrex **Other Names:** - Celecoxib **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Study endpoint is a reduction in PGE-M in urine after treatment with celebrex **Measure:** To Determine Whether Oral Administration of Celebrex to Obese Women Will Reduce the PGE-M in Urine **Time Frame:** 10 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Postmenopausal woman defined as: 24 consecutive months without a menstrual period and currently not taking any medication known to induce amenorrhea. * Serum estradiol \< 20 pg/mL * Body Mass Index of 35-50 * Stable weight defined as (+/- 5 %) of body weight for at least three months * 40-70 years of age * Fluent in English Exclusion Criteria: * Known hypersensitivity to celecoxib or sulfonamides * Known peptic ulcer disease * Hypertension BP \> 150/90 (on 2 occasions after resting) * Fasting blood glucose \> 165 mg/dL * HIV positive * Screening creatinine \> 2X upper limit of normal * Screening LFT results \> 2x upper limit of normal * Smokers (or stopped \< 3 months ago) * Framingham risk score \> 15 * Evidence of active coronary disease by history and/or EKG * Subjects who consume 25 grams of soy protein/day or more than 45 mg of isoflavones/day, for subjects who consume this amount of soy, they may stop for 14 days prior to admission * Currently taking NSAIDS, aspirin, (if \> once a week, stopped \<30 days ago). * Consuming \> 3 servings of fish or seafood/week * Currently taking fish oil, omega-3 supplements or other herbal supplements that exceed GRAS (Generally Recognized as Safe) levels, (if currently taking fish oil/omega-3 supplements, there must be a 30 day washout period) * Current use of anti-coagulants * Currently taking any weight control medication * Currently taking thioridazine * Currently taking lithium * Currently taking any estrogen/progesterone hormones including vaginal cream, e-string, or vaginal tablets * Currently taking any medication that can alter fat stores as determined by the principal investigator * History of Inflammatory Bowel Disease or other chronic inflammatory disorders * History of any malignancy other than non-melanoma skin cancer in the past 5 years * History of any bleeding disorder * History of cardiovascular disease * Diagnosis of asthma * Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data. **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 40 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** New York **Country:** United States **Facility:** The Rockefeller University **State:** New York **Zip:** 10065 #### Overall Officials **Official 1:** **Affiliation:** Rockefeller University **Name:** Peter Holt, MD **Role:** PRINCIPAL_INVESTIGATOR ## Document Section ### Large Document Module #### Large Docs - Date: 2017-12-12 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 5033702 - Type Abbrev: Prot_SAP - Upload Date: 2020-09-29T15:17 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: T6036 - Name: Menopause - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007249 - Term: Inflammation ### Intervention Browse Module - Ancestors - ID: D000000894 - Term: Anti-Inflammatory Agents, Non-Steroidal - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000018501 - Term: Antirheumatic Agents - ID: D000052246 - Term: Cyclooxygenase 2 Inhibitors - ID: D000016861 - Term: Cyclooxygenase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M277 - Name: Celecoxib - Relevance: HIGH - As Found: Air - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4218 - Name: Anti-Inflammatory Agents, Non-Steroidal - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M27009 - Name: Cyclooxygenase 2 Inhibitors - Relevance: LOW - As Found: Unknown - ID: M19209 - Name: Cyclooxygenase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068579 - Term: Celecoxib ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol. #### Event Groups **Group ID:** EG000 **Title:** 1st Group: 3 Day run-in Period **Deaths Num At Risk:** 5 **Description:** After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge. **ID:** EG000 **Other Num Affected:** 2 **Other Num at Risk:** 5 **Serious Number Affected:** 1 **Serious Number At Risk:** 5 **Title:** 1st Group: 3 Day run-in Period **Group ID:** EG001 **Title:** 2nd Group: 14 Day run-in Period **Deaths Num At Risk:** 5 **Description:** After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge. **ID:** EG001 **Other Num Affected:** 4 **Other Num at Risk:** 5 **Serious Number At Risk:** 5 **Title:** 2nd Group: 14 Day run-in Period **Frequency Threshold:** 0 #### Other Events **Term:** bruise at biopsy site **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Due to the pinching of abdominal fat during the fat biopsy, a resultant bruise medial to the incision is common and expected. It resolved within 3-4 days and well tolerated. The risk is addressed in the informed consent. **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** CTCAE (4.0) **Term:** burn **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Participant spilled hot tea on her chest wall resulting in 1st degree scald burn of her upper chest. **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** CTCAE (4.0) **Term:** atypical chest pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Subject complained of chest pain after burning her skin with hot tea. **Organ System:** Cardiac disorders **Source Vocabulary:** CTCAE (4.0) **Term:** elevated serum cholesterol **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Subjet had history of hypercholesteremia. She stopped taking statin medication prescribed by PMD. Cholesterol level increased. PMD was informed and given test results. **Organ System:** Investigations **Source Vocabulary:** CTCAE (4.0) **Term:** elevated ALT **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** After 10 days on celecoxib, subject had mild elevation in ALT **Organ System:** Investigations **Source Vocabulary:** CTCAE (4.0) **Term:** GI Bloating and constipation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Subject complained of bloating and constipation. **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (4.0) **Term:** sore throat and dry cough **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Subject complained of sore throat and dry cough after a group gathering. Afebrile. **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** CTCAE (4.0) #### Serious Events **Term:** hemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** During abdominal fat biopsy procedure, there was moderate bleeding from the site. Procedure was stopped, and the bleeding ceased. Subject was stable and recovered promptly, but was monitored for an additional day for safety. **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** CTCAE (4.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 5 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 5 **Time Frame:** Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 5 **Group ID:** BG001 **Value:** 5 **Group ID:** BG002 **Value:** 10 **Units:** Participants ### Group **ID:** BG000 **Title:** 3 Day run-in Period **Description:** After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge. ### Group **ID:** BG001 **Title:** 14 Day run-in Period **Description:** After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 56 **Upper Limit:** 68 **Value:** 62 #### Measurement **Group ID:** BG001 **Lower Limit:** 53 **Upper Limit:** 60 **Value:** 56 #### Measurement **Group ID:** BG002 **Lower Limit:** 53 **Upper Limit:** 68 **Value:** 59 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 5 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 10 **Class Title:** Female ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 7 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 3 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 5 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 10 **Class Title:** United States ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 38.2 **Upper Limit:** 43.1 **Value:** 40.2 #### Measurement **Group ID:** BG001 **Lower Limit:** 36.7 **Upper Limit:** 45.1 **Value:** 39.7 #### Measurement **Group ID:** BG002 **Lower Limit:** 36.7 **Upper Limit:** 45.1 **Value:** 40.0 **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** FULL_RANGE **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** NUMBER **Title:** Sex/Gender, Customized **Unit of Measure:** participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ### Measure 5 **Dispersion Type:** FULL_RANGE **Parameter Type:** MEAN **Title:** BMI **Unit of Measure:** kg/m^2 ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** The Rockefeller University **Phone:** 212-327-7706 **Title:** Dr. Peter R Holt ## Results Section - Outcome Measures Module ### Outcome Measure 1 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Study endpoint is a reduction in PGE-M in urine after treatment with celebrex **Population Description:** These samples were collected but not analyzed due to technical reasons. Investigator has retired and access to results was not available for this outcome. Best efforts were made to obtain the data; however, they were unsuccessful. **Reporting Status:** POSTED **Time Frame:** 10 days **Title:** To Determine Whether Oral Administration of Celebrex to Obese Women Will Reduce the PGE-M in Urine **Type:** PRIMARY ##### Group **Description:** After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge. **ID:** OG000 **Title:** 1st Group: 3 Day run-in Period ##### Group **Description:** After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge. **ID:** OG001 **Title:** 2nd Group: 14 Day run-in Period ### Participant Flow Module #### Group **Description:** After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge. **ID:** FG000 **Title:** 1st Group: 3 Day run-in Period #### Group **Description:** After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge. **ID:** FG001 **Title:** 2nd Group: 14 Day run-in Period #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 5 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 5 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 5 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 5 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 **Pre-Assignment Details:** All participants were screened for their usual dietary intake and instructed to continue to follow their usual diet during weeks prior to hospital admission and thoughout the entire study. . First group underwent 3 day run-in period inpatient, the second group underwent 14 day run-in period prior to starting Celecoxib 200mg po BID X 10 days. **Recruitment Details:** Recruitment was conducted during 2 outpatient visits at Rockefeller University Hospital outpatient clinic. Recruitment of subjects began on 6/10/13 and was completed on 6/30/14. **Has Results:** True
## Protocol Section ### Identification Module **NCT ID:** NCT02212379 **Brief Title:** Capacity of the Dual Combination Raltegravir/Etravirine to Maintain Virological Success in HIV-1 Infected Patients of at Least 45 Years of Age- ANRS 163 ETRAL **Official Title:** Dual Therapy Combining Raltegravir With Etravirine Maintains a High Level of Viral Suppression Over 96 Weeks in Long-term Experienced HIV-infected Individuals Over 45 Years on a PI-based Regimen: Results From the Phase II ANRS 163 ETRAL Study #### Organization Study ID Info **ID:** 2014-000828-24 #### Organization **Class:** OTHER_GOV **Full Name:** ANRS, Emerging Infectious Diseases #### Secondary ID Infos **Domain:** ANRS **ID:** ANRS 163 ETRAL **Type:** OTHER ### Status Module #### Completion Date **Date:** 2018-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-04-27 **Type:** ACTUAL **Last Update Submit Date:** 2021-03-31 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-10 **Type:** ACTUAL #### Results First Post Date **Date:** 2021-02-05 **Type:** ACTUAL **Results First Submit Date:** 2020-04-20 **Results First Submit QC Date:** 2021-01-11 #### Start Date **Date:** 2015-01 **Status Verified Date:** 2021-03 #### Study First Post Date **Date:** 2014-08-08 **Type:** ESTIMATED **Study First Submit Date:** 2014-07-30 **Study First Submit QC Date:** 2014-08-06 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Merck Sharp & Dohme LLC **Class:** INDUSTRY **Name:** Janssen-Cilag Ltd. #### Lead Sponsor **Class:** OTHER_GOV **Name:** ANRS, Emerging Infectious Diseases #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** This multicenter, international, non randomized (single arm), open, phase II trial aims to evaluate the capacity of the dual combination raltegravir/etravirine to maintain virological success in virologically suppressed HIV-1 infected patients, of at least 45 years of age, switching from a boosted PI-containing regimen. Patients will be followed for 96 weeks. The primary endpoint was the proportion of participants with virological success at 48 weeks. Virological success is defined as the absence of 2 consecutive plasma viral load \>50 copies/mL within 2 to 4 weeks apart. The study was designed to show an efficacy \>90%, assuming a success rate \>95%, with a power of 80% and a 5%type-1 error. A total of 160 individuals was required to achieve the objective. The principal secondary endpoint is the proportion of patients in therapeutic success up to week 48 and 96. ### Conditions Module **Conditions:** - HIV-1 Infection **Keywords:** - Raltegravir - Etravirine - aged, 45 and over - Viral load - Efficacy - Safety ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 170 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: raltegravir and etravirine **Label:** raltegravir and etravirine **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - raltegravir and etravirine **Description:** Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **Name:** raltegravir and etravirine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Virological success is defined as the absence of 2 consecutive plasma viral loads (VL) \> 50 copies/mL within 2 to 4 weeks of a dual raltegravir/etravirine regimen. The proportion of patients who maintained viral suppression under raltegravir plus etravirine was 99.4% (95% confidence interval (95% CI:95.6 -99.9) at week 48 and 98.7% (95% CI: 95.0 -99.7) at week 96 **Measure:** Percentage of Participants With Successful Virological Suppression at Weeks 48 and 96 **Time Frame:** at week48 and at week 96 #### Secondary Outcomes **Description:** Therapeutic success was defined as the absence of virological failure (i.e. 2 consecutive plasma viral loads (VL) \> 50 copies/mL within 2 to 4 weeks) and the absence of treatment interruption due to adverse event judged by DSMB as related to the study treatment or procedure **Measure:** Percentage of Patients With Therapeutic Success at Week 48 and Week 96 **Time Frame:** weeks 48 and 96 **Measure:** Percentage of Patients With Trial Treatment Interruption at Week 48 and Week 96 **Time Frame:** weeks 48 and 96 **Measure:** Percentage of Patients With With Grade Virological Failure (HIV-RNA Plasma VL Between 51 and 200 Copies/mL) **Time Frame:** weeks 48 and 96 **Description:** Time between the date of the study treatment initiation and the date of virological failure **Measure:** Median Time of Virological Failure **Time Frame:** week 96 **Measure:** Percentage of Patients With High Grade of Virological Failure Defined as HIV RNA > 200 Copies/mL **Time Frame:** weeks 48 and 96 **Measure:** Number of Patients With RAL and/or ETR Resistance Mutations Among Those With Virological Failure **Time Frame:** week 96 **Measure:** Factors Associated With the Occurrence of Plasma HIV-RNA Viral Load > 50 Copies/mL **Time Frame:** week 96 **Measure:** Evolution of Total Cell-associated HIV-DNA **Time Frame:** from day 0 to week 48 and week 96 **Measure:** Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio **Time Frame:** from day 0 to week 48 and week 96 **Description:** Number of all clinical and biological adverse events effects. Number of grade 3 or 4 clinical and biological adverse events and effects. **Measure:** Number of Participants Experiencing Adverse Events and Effects **Time Frame:** From day 0 to week 48 and week 96 **Measure:** Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia) **Time Frame:** from day 0 to week 96 **Description:** The Framingham risk score is expressed as a percentage. Higher scores mean a worse outcome and lower scores mean better outcome. Median percent change expressed as median (interquartile range (IQR)) **Measure:** Evolution of the Calibrated 5-year Framingham Risk Score **Time Frame:** from day 0 to week 48 and at week 96 **Description:** Percent change of the estimated Glomerular Filtration Rate (eGFR) calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Calculator) formula **Measure:** Percent Change of Renal Function **Time Frame:** from day 0 to week 96 **Description:** Evolution of total fat mass, limb fat and trunk fat from day 0 to week 96 **Measure:** Evolution of Body Fat Distribution From Day 0 to W96 (DXA Scan Sub-study, 80 Patients) **Time Frame:** from day 0 to week 96 **Description:** • Evolution of bone mineral density (BMD) measured by DXA scans (DXA scan sub-study, 81 patients) * Lumbar spine BMD, mg/cm2 * Total hip BMD, mg/cm2 **Measure:** Sub-study: Bone Mineral Density **Time Frame:** from day 0, to week 48 and week 96 **Description:** • Assessment of HIV-RNA viral load in human male genital compartment (20 patients) at week 48 **Measure:** Percentage of Participants With Detectable Seminal HIV-RNA Viral Load at Week 48 **Time Frame:** week 48 **Description:** • Evolution of the inflammation markers (IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, CRPus and insulin) on frozen plasma aliquots **Measure:** Inflammatory Parameters **Time Frame:** from day 0 to week 96 **Measure:** Percentage of Participants Reporting a Very Good or an Excellent Quality of Life at Day 0, Weeks 48 and 96 **Time Frame:** day 0 and weeks 48 and 96 **Description:** The compliance rate was estimated as the number of pills consumed (recorded using the self-reported 90 questionnaire) divided by the number of pills theoretically consumed, classified as low (80%), medium (80%-95%) or high (95%). **Measure:** Percentage of Participants Compliant With Treatment Program. **Time Frame:** at week 0, week 48, and week 96 **Description:** We measured the Anti-mullerian Hormone (AMH) level to evaluate the ovarian reserve (from D0 to W48) **Measure:** Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots **Time Frame:** from day 0, to week 48 **Measure:** Evolution of the Level of MCP1 From D0 to W48 on Frozen Samples **Time Frame:** from day 0, to week 48 **Description:** Metabolic markers measures are total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides. Inflammatory and innate immune activation markers measures are: IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, hsCRP and Insulin. Ovarian reserve measure is AMH **Measure:** Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96 **Time Frame:** from day 0, to week 96 **Description:** BMI, Hip circumference, Waist circumference, waist/hip ratio, Limb fat, Trunk fat, Total fat, Limb lean, Trunk lean, and Total lean **Measure:** Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status **Time Frame:** from day 0, to week 96 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Documented HIV-1 infection * Age ≥ 45 years * Naïve to integrase inhibitor and etravirine * At least 6 months of stable antiretroviral therapy (ART) including a boosted protease inhibitor, whatever the number of combined drugs * HIV-RNA plasma VL ≤ 50 copies/mL during the last 24 months prior to screening visit (Week-6/Week-4), documented by at least 4 time-points with no more than one blip in HIV-RNA plasma viral load between 51 and 200 copies/mL * HIV-RNA plasma VL ≤ 50 copies/mL at screening visit (Week-6/Week-4) * A genotype is available (on amplified DNA at Week-6/Week-4 Visit and/or on RNA in the medical history of the patient) and shows a virus sensitive to ETR OR no genotype is available (amplification failure on DNA at Week-6/Week-4 Visit and no genotype in the medical history of the patient), there are no virological failure on NNRTI in the medical history * CD4+ lymphocytes \> 200 cells/mm3 * Creatinine \< 2.5 x ULN * CPK (Creatine Phospho Kinase) \< 6 ULN (Upper Limit of Normal) * AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase) \< 5 ULN * Hemoglobin \> 10 g/dL * Platelets \> 100 000/mm3 * Negative urinary pregnancy test and use of efficient contraception for women of childbearing potential * For French participants only: subject enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme), article L1121-11 of the Public health code * Patients with a coverage from a social health * Signed informed consent Exclusion Criteria: * Previous exposure to raltegravir or etravirine * Presence of any documented integrase inhibitor mutation on DNA genotype at Week-6/Week-4 and/or on RNA in the medical history of the patient * Positive hepatitis B HBsAg or Positive HBc Ac and negative HBs Ac * HIV-2 infection * Active viral hepatitis C requiring a specific treatment during the 24 months of the trial * Patient with a history of non-compliance or irregular follow-up * Initiation of a concomitant anti-hypercholesterolemia (e.g. statins) or antidiabetic treatment within the last 3 months prior the screening visit (Week-6 /Week-4) * Patient using: Clopidogrel (Plavix®), Prasugrel (Effient®), Ticagrelor (Brilinta®), Ticlopidine (Ticlid®), Flurbiprofen (Antadys® - Cebutid®), Rifampin (Rifampicin® - Rifadin® - RofactMC - Rifater®), Rifapentine (Priftin®), St John's wort, Carbamazepine (Tegretol®), Phenobarbital, Phenytoin (Dilantin®),Avanafil (Stendra™), Triazolam (Halcion®) * Concomitant treatment using interferon, interleukins or any other immunotherapy or chemotherapy * Concomitant prophylactic or curative treatment for an opportunistic infection * All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance * Subjects under judicial protection due to temporarily and slightly diminished mental or physical faculties, or under legal guardianship * Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase * Pregnant women or breastfeeding women **Minimum Age:** 45 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bobigny **Country:** France **Facility:** Hôpital Avicenne **Zip:** 93000 **Location 2:** **City:** Bondy **Country:** France **Facility:** Hôpital Jean Verdier **Zip:** 93140 **Location 3:** **City:** Bordeaux **Country:** France **Facility:** Hôpital Saint André **Zip:** 33076 **Location 4:** **City:** Le Kremlin Bicêtre **Country:** France **Facility:** Hôpital Bicêtre **Zip:** 94275 **Location 5:** **City:** Lyon **Country:** France **Facility:** Hôpital Croix Rousse **Zip:** 69317 **Location 6:** **City:** Marseille **Country:** France **Facility:** Hôpital Sainte marguerite **Zip:** 13009 **Location 7:** **City:** Montpellier **Country:** France **Facility:** Hôpital Gui de Chauliac **Zip:** 34000 **Location 8:** **City:** Nantes **Country:** France **Facility:** CHU Hôtel Dieu **Zip:** 44093 **Location 9:** **City:** Nice **Country:** France **Facility:** Hôpital de l'Archet **Zip:** 06202 **Location 10:** **City:** Paris **Country:** France **Facility:** Hôpital Saint Louis **Zip:** 75010 **Location 11:** **City:** Paris **Country:** France **Facility:** Hôpital Pitié-Salpétrière **Zip:** 75013 **Location 12:** **City:** Paris **Country:** France **Facility:** Hôpital Cochin **Zip:** 75014 **Location 13:** **City:** Paris **Country:** France **Facility:** Hôpital Necker **Zip:** 75015 **Location 14:** **City:** Paris **Country:** France **Facility:** Hôpital Bichat Claude Bernard **Zip:** 75018 **Location 15:** **City:** Paris **Country:** France **Facility:** Hôpital Européen Georges Pompidou **Zip:** 75908 **Location 16:** **City:** Tours **Country:** France **Facility:** Hôpital Bretonneau **Zip:** 37044 **Location 17:** **City:** Barcelona **Country:** Spain **Facility:** Hospital de Bellvitge **Zip:** 08000 **Location 18:** **City:** Barcelona **Country:** Spain **Facility:** Hospital de la santa Creu i San Pau **Zip:** 08025 **Location 19:** **City:** Barcelona **Country:** Spain **Facility:** Hospital Clinic **Zip:** 08036 #### Overall Officials **Official 1:** **Affiliation:** Service des Maladies Infectieuses et Tropicales, Groupe Hospitalier Pitié-Salpêtrière, Paris, France **Name:** Christine Katlama, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Département des Maladies Infectieuses et Tropicales Hôpital Gui de Chauliac, CHU de Montpellier France **Name:** Jacques Reynes, MD **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** Inserm UMR S 1136 Université Pierre et Marie Curie Epidémiologie, stratégies thérapeutiques et virologie cliniques dans l'infection à VIH, Paris, France **Name:** Dominique Costagliola, PhD **Role:** STUDY_DIRECTOR ### References Module #### See Also Links **Label:** Related Info **URL:** http://www.anrs.fr/ ## Document Section ### Large Document Module #### Large Docs - Date: 2018-03-06 - Filename: Prot_SAP_ICF_000.pdf - Has ICF: True - Has Protocol: True - Has SAP: True - Label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study protocol, Statistical Analysis - Size: 3066298 - Type Abbrev: Prot_SAP_ICF - Upload Date: 2020-06-28T08:36 - Date: 2020-01-05 - Filename: ICF_001.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form: Informed Consent Form - Size: 381267 - Type Abbrev: ICF - Upload Date: 2021-01-05T10:35 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: LOW - As Found: Unknown - ID: M18250 - Name: HIV Infections - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000019380 - Term: Anti-HIV Agents - ID: D000044966 - Term: Anti-Retroviral Agents - ID: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000019428 - Term: HIV Integrase Inhibitors - ID: D000019429 - Term: Integrase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018894 - Term: Reverse Transcriptase Inhibitors - ID: D000019384 - Term: Nucleic Acid Synthesis Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: M333 - Name: Raltegravir Potassium - Relevance: HIGH - As Found: Adaptive - ID: M339955 - Name: Etravirine - Relevance: HIGH - As Found: CPET - ID: M21350 - Name: Anti-HIV Agents - Relevance: LOW - As Found: Unknown - ID: M25428 - Name: Anti-Retroviral Agents - Relevance: LOW - As Found: Unknown - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M21386 - Name: Integrase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M21385 - Name: HIV Integrase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20935 - Name: Reverse Transcriptase Inhibitors - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068898 - Term: Raltegravir Potassium - ID: C000451734 - Term: Etravirine ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Raltegravir and Etravirine **Deaths Num At Risk:** 165 **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** EG000 **Other Num Affected:** 23 **Other Num at Risk:** 165 **Serious Number Affected:** 26 **Serious Number At Risk:** 165 **Title:** Raltegravir and Etravirine **Frequency Threshold:** 1 #### Other Events **Term:** Headache **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Asthenia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Insomnia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Constipation **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Diarrhea **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Drowsiness **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** dysgeusia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** #### Serious Events **Term:** Prostatitis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Reproductive system and breast disorders ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 165 **Num Events:** 3 **Term:** Stroke **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 165 **Num Events:** 2 **Term:** Hospitalization further diagnosis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 165 **Num Events:** 2 **Term:** Arthritis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Delirious **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Hepatic cytolysis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Hyperglycemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Loss of teeth **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Open wound of back **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Osteoarthrosis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Parotidectomy **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Surgical and medical procedures ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Post herpetic neuralgia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Urinary tract infection **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Acute coronary syndrome **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Anal abcess **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** AST increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Fracture **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Lumbago **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Myocardial infarction **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Pulmonary carcinomia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Sciatica **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Term:** Surgery **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Surgical and medical procedures ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 165 **Num Events:** 1 **Time Frame:** Adverse events data were collected from baseline to week 48 and 96 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 165 **Units:** Participants ### Group **ID:** BG000 **Title:** Raltegravir and Etravirine **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 48 **Upper Limit:** 58 **Value:** 52 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 48 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 117 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 124 **Class Title:** Caucasian #### Measurement **Group ID:** BG000 **Value:** 24 **Class Title:** Sub-saharan Africa #### Measurement **Group ID:** BG000 **Value:** 17 **Class Title:** Others ### Measure #### Measurement **Group ID:** BG000 **Value:** 66 **Class Title:** Men who have Sex with Men #### Measurement **Group ID:** BG000 **Value:** 72 **Class Title:** Heterosexual #### Measurement **Group ID:** BG000 **Value:** 27 **Class Title:** Others/Unknown ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 12.8 **Upper Limit:** 24.2 **Value:** 19.8 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 36 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 93 **Upper Limit:** 286 **Value:** 209 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 16 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 11.1 **Upper Limit:** 19 **Value:** 16.9 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 3.4 **Upper Limit:** 9.3 **Value:** 6.9 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 32 **Upper Limit:** 89 **Value:** 58 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 120 **Class Title:** once daily #### Measurement **Group ID:** BG000 **Value:** 45 **Class Title:** twice daily ### Measure #### Measurement **Group ID:** BG000 **Value:** 107 **Class Title:** 2NRTIs + PI/r #### Measurement **Group ID:** BG000 **Value:** 11 **Class Title:** NNRTI + PI/r #### Measurement **Group ID:** BG000 **Value:** 35 **Class Title:** PI/r #### Measurement **Group ID:** BG000 **Value:** 12 **Class Title:** Others ### Measure #### Measurement **Group ID:** BG000 **Value:** 8 **Class Title:** Cardiovascular #### Measurement **Group ID:** BG000 **Value:** 53 **Class Title:** Dyslipidemia #### Measurement **Group ID:** BG000 **Value:** 45 **Class Title:** High blood pressure #### Measurement **Group ID:** BG000 **Value:** 10 **Class Title:** Diabetes ### Measure #### Measurement **Group ID:** BG000 **Value:** 60 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 31 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 14 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 525 **Upper Limit:** 904 **Value:** 700 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 525 **Upper Limit:** 966 **Value:** 678 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 0.67 **Upper Limit:** 1.33 **Value:** 0.94 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 4.6 **Upper Limit:** 6.1 **Value:** 5.4 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 3.4 **Upper Limit:** 4.6 **Value:** 3.9 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 2.7 **Upper Limit:** 3.8 **Value:** 3.2 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 1.1 **Upper Limit:** 1.6 **Value:** 1.3 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 1.0 **Upper Limit:** 2.1 **Value:** 1.3 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 0.6 **Upper Limit:** 1.8 **Value:** 1.0 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 4.7 **Upper Limit:** 5.7 **Value:** 5.2 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 79.2 **Upper Limit:** 103.2 **Value:** 93.9 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 22.5 **Upper Limit:** 26.6 **Value:** 24.3 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 84 **Upper Limit:** 99 **Value:** 92 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 90 **Upper Limit:** 99 **Value:** 95 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 0.9 **Upper Limit:** 1.03 **Value:** 0.97 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 18 **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race/Ethnicity, Customized **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Transmission group **Unit of Measure:** Participants ### Measure 5 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Time since HIV diagnosis **Unit of Measure:** years ### Measure 6 **Description:** number of patients with Prior AIDS event **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** CDC stage C **Unit of Measure:** Participants ### Measure 7 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** CD4 nadir cell count **Unit of Measure:** cells/mm^3 ### Measure 8 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Hepatitis C co-infection **Unit of Measure:** Participants ### Measure 9 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Antiretroviral treatment (ART) duration **Unit of Measure:** years ### Measure 10 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Duration of suppressed HIV viremia (<50 copies/ml), **Unit of Measure:** years ### Measure 11 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Duration of last combined antiretroviral therapy (cART) **Unit of Measure:** Months ### Measure 12 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Antiretroviral treatment daily dosing **Unit of Measure:** Participants ### Measure 13 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** cART at screening **Unit of Measure:** Participants ### Measure 14 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Comorbidities **Unit of Measure:** Participants ### Measure 15 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Active smoking **Unit of Measure:** Participants ### Measure 16 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Former smokers **Unit of Measure:** Participants ### Measure 17 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Alcohol use (>2 glasses/day) **Unit of Measure:** Participants ### Measure 18 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** CD4 cell count at screening **Unit of Measure:** cells/mm^3 ### Measure 19 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** CD8 cell count at screening **Unit of Measure:** cells/mm^3 ### Measure 20 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** CD4/CD8 ratio at screening **Unit of Measure:** ratio ### Measure 21 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Total cholesterol **Unit of Measure:** mmol/L ### Measure 22 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Non-HDL cholesterol **Unit of Measure:** mmol/L ### Measure 23 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** LDL cholesterol **Unit of Measure:** mmol/L ### Measure 24 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** HDL cholesterol **Unit of Measure:** mmol/L ### Measure 25 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Triglycerides **Unit of Measure:** mmol/L ### Measure 26 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Triglycerides/HDL ratio **Unit of Measure:** ratio ### Measure 27 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Glycaemia **Unit of Measure:** mmol/L ### Measure 28 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Estimated glomerular filtration rate (eGFR, CKD-EPI method) **Unit of Measure:** mL/min/1.73 m^2 ### Measure 29 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Body Mass Index (BMI) **Unit of Measure:** kg/m^2 ### Measure 30 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Waist circumference **Unit of Measure:** cm ### Measure 31 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Hip circumference **Unit of Measure:** cm ### Measure 32 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Waist/Hip ratio **Unit of Measure:** ratio ### Measure 33 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Viruses with mutations that could potentially impact etravirine **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement ### Limitations and Caveats **Description:** The absence of a comparator arm, which in terms of impact on fat, bone density and inflammation/activation markers may limit the interpretation of the observed changes over time. One limitation is the small number of women. ### Point of Contact **Email:** [email protected] **Organization:** Inserm, Sorbonne Universite, IPLESP **Phone:** 0142164280 **Title:** Dr Lambert Assoumou ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ### Outcome Measure 6 ### Outcome Measure 7 ### Outcome Measure 8 ### Outcome Measure 9 ### Outcome Measure 10 ### Outcome Measure 11 ### Outcome Measure 12 ### Outcome Measure 13 ### Outcome Measure 14 ### Outcome Measure 15 ### Outcome Measure 16 ### Outcome Measure 17 ### Outcome Measure 18 ### Outcome Measure 19 ### Outcome Measure 20 ### Outcome Measure 21 ### Outcome Measure 22 ### Outcome Measure 23 ### Outcome Measure 24 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 95.6 - **Spread:** - **Upper Limit:** 99.9 - **Value:** 99.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 95.0 - **Spread:** - **Upper Limit:** 99.7 - **Value:** 98.7 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 90.5 - **Spread:** - **Upper Limit:** 97.5 - **Value:** 95.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 87.5 - **Spread:** - **Upper Limit:** 95.8 - **Value:** 92.7 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.7 - **Spread:** - **Upper Limit:** 8.5 - **Value:** 4.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.9 - **Spread:** - **Upper Limit:** 10.9 - **Value:** 6.1 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 2.2 - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.01 - **Spread:** - **Upper Limit:** 3.3 - **Value:** 0.6 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1 - **Spread:** - **Upper Limit:** 96 - **Value:** 96 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.01 - **Spread:** - **Upper Limit:** 3.3 - **Value:** 0.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 2.2 - **Value:** 0 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.4 - **Spread:** - **Upper Limit:** 10.1 - **Value:** 3.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.5 - **Spread:** - **Upper Limit:** 85.1 - **Value:** 11.3 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -29 - **Spread:** - **Upper Limit:** 111 - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -37 - **Spread:** - **Upper Limit:** 45 - **Value:** 0 **Title:** #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -10.9 - **Spread:** - **Upper Limit:** 16.6 - **Value:** 1.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -18.7 - **Spread:** - **Upper Limit:** 16.6 - **Value:** -1.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -5.7 - **Spread:** - **Upper Limit:** 13.8 - **Value:** 5.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -9.4 - **Spread:** - **Upper Limit:** 18.9 - **Value:** 5.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -17.1 - **Spread:** - **Upper Limit:** 11.2 - **Value:** -5.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -2.6 - **Spread:** - **Upper Limit:** 21.9 - **Value:** 7.4 **Title:** #### Outcome Measure 11 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 154 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 165 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 15 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 165 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 108 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 156 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 11 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 156 **Units:** Participants #### Outcome Measure 12 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -40.2 - **Spread:** - **Upper Limit:** 10.4 - **Value:** -18.8 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 163 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -16.3 - **Spread:** - **Upper Limit:** 7.6 - **Value:** -0.5 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 163 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -7.1 - **Spread:** - **Upper Limit:** 21.6 - **Value:** 5.4 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 162 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -19.2 - **Spread:** - **Upper Limit:** 10.2 - **Value:** -4.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 155 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -7.0 - **Spread:** - **Upper Limit:** 10.0 - **Value:** 0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 163 **Units:** Participants #### Outcome Measure 13 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -22.9 - **Spread:** - **Upper Limit:** 37.7 - **Value:** 1.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -21.3 - **Spread:** - **Upper Limit:** 45.7 - **Value:** 9.7 **Title:** #### Outcome Measure 14 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -6.6 - **Spread:** - **Upper Limit:** 4.2 - **Value:** -0.6 **Title:** #### Outcome Measure 15 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.0 - **Spread:** - **Upper Limit:** 24.2 - **Value:** 12.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.7 - **Spread:** - **Upper Limit:** 27.8 - **Value:** 11.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.9 - **Spread:** - **Upper Limit:** 23.3 - **Value:** 12.2 **Title:** #### Outcome Measure 16 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.1 - **Spread:** - **Upper Limit:** 2.8 - **Value:** 0.7 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 81 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -2.9 - **Spread:** - **Upper Limit:** 1.8 - **Value:** -1.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 80 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0.9 - **Spread:** - **Upper Limit:** 1.9 - **Value:** 0.6 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 79 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -0.8 - **Spread:** - **Upper Limit:** 1.3 - **Value:** 0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 79 **Units:** Participants #### Outcome Measure 17 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** #### Outcome Measure 18 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -32.4 - **Spread:** - **Upper Limit:** 58.8 - **Value:** 0.8 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 144 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -23.9 - **Spread:** - **Upper Limit:** 16.5 - **Value:** -8.1 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 158 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -21.0 - **Spread:** - **Upper Limit:** 20.5 - **Value:** 0.7 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 158 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -38 - **Spread:** - **Upper Limit:** -8 - **Value:** -27 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 158 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -6.8 - **Spread:** - **Upper Limit:** 4.8 - **Value:** 0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 158 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -34.2 - **Spread:** - **Upper Limit:** 55.9 - **Value:** 0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 124 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -2.6 - **Spread:** - **Upper Limit:** 40.7 - **Value:** 16.5 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 135 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -16.0 - **Spread:** - **Upper Limit:** 42.5 - **Value:** 4.6 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 145 **Units:** Participants #### Outcome Measure 19 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 63 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 78 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 77 **Title:** #### Outcome Measure 20 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 13 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 155 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 155 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 139 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 155 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 146 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 16 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 146 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 123 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 146 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 12 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 136 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 9 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 136 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 115 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 136 **Units:** Participants #### Outcome Measure 21 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.075 - **Spread:** - **Upper Limit:** 0.290 - **Value:** 0.172 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 12 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.008 - **Spread:** - **Upper Limit:** 0.012 - **Value:** 0.009 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 6 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.008 - **Spread:** - **Upper Limit:** 0.0095 - **Value:** 0.009 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 22 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.034 - **Spread:** - **Upper Limit:** 0.400 - **Value:** 0.152 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 12 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.006 - **Spread:** - **Upper Limit:** 0.010 - **Value:** 0.008 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 6 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.004 - **Spread:** - **Upper Limit:** 0.007 - **Value:** 0.005 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 22 **Units:** Participants #### Outcome Measure 22 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -18.9 - **Spread:** - **Upper Limit:** 15.3 - **Value:** 3.1 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 12 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -2.1 - **Spread:** - **Upper Limit:** 10.9 - **Value:** 3.5 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 6 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -13.7 - **Spread:** - **Upper Limit:** 14.2 - **Value:** -2.4 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 22 **Units:** Participants #### Outcome Measure 23 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -7.99 - **Spread:** - **Upper Limit:** 15.88 - **Value:** 6.62 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.38 - **Spread:** - **Upper Limit:** 17.77 - **Value:** 6.91 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -15.81 - **Spread:** - **Upper Limit:** 2.38 - **Value:** -11.35 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 12 - **Group ID:** OG001 - **Value:** 6 - **Group ID:** OG002 - **Value:** 22 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -20.13 - **Spread:** - **Upper Limit:** 27.13 - **Value:** 5.52 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -13.10 - **Spread:** - **Upper Limit:** 22.08 - **Value:** 5.62 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -19.77 - **Spread:** - **Upper Limit:** -0.07 - **Value:** -6.58 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 12 - **Group ID:** OG001 - **Value:** 6 - **Group ID:** OG002 - **Value:** 22 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.90 - **Spread:** - **Upper Limit:** 27.79 - **Value:** 18.47 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 16.77 - **Spread:** - **Upper Limit:** 42.86 - **Value:** 27.74 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -11.35 - **Spread:** - **Upper Limit:** 9.92 - **Value:** -4.84 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 12 - **Group ID:** OG001 - **Value:** 6 - **Group ID:** OG002 - **Value:** 22 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -28.10 - **Spread:** - **Upper Limit:** 27.57 - **Value:** 5.59 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -45.18 - **Spread:** - **Upper Limit:** -13.70 - **Value:** -38.37 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -33.12 - **Spread:** - **Upper Limit:** 16.67 - **Value:** -0.99 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 12 - **Group ID:** OG001 - **Value:** 6 - **Group ID:** OG002 - **Value:** 22 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -39.2 - **Spread:** - **Upper Limit:** -5.4 - **Value:** -31.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -43.2 - **Spread:** - **Upper Limit:** -23.4 - **Value:** -32.8 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -36.5 - **Spread:** - **Upper Limit:** -3.6 - **Value:** -18.8 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 12 - **Group ID:** OG001 - **Value:** 6 - **Group ID:** OG002 - **Value:** 22 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -9.7 - **Spread:** - **Upper Limit:** 32.3 - **Value:** 10.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -9.2 - **Spread:** - **Upper Limit:** 34.2 - **Value:** 15.9 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -21.0 - **Spread:** - **Upper Limit:** 49.0 - **Value:** 4.8 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 12 - **Group ID:** OG001 - **Value:** 6 - **Group ID:** OG002 - **Value:** 22 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -36.0 - **Spread:** - **Upper Limit:** 31.5 - **Value:** 5.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -63.3 - **Spread:** - **Upper Limit:** 122.6 - **Value:** 31.8 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -44.7 - **Spread:** - **Upper Limit:** 19.0 - **Value:** -31.4 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 12 - **Group ID:** OG001 - **Value:** 6 - **Group ID:** OG002 - **Value:** 22 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -18.3 - **Spread:** - **Upper Limit:** 27.2 - **Value:** 6.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 14.6 - **Spread:** - **Upper Limit:** 90.2 - **Value:** 34.8 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -7.9 - **Spread:** - **Upper Limit:** 46.9 - **Value:** 23.1 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 10 - **Group ID:** OG001 - **Value:** 5 - **Group ID:** OG002 - **Value:** 19 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -5.3 - **Spread:** - **Upper Limit:** 3.7 - **Value:** 0.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -9.9 - **Spread:** - **Upper Limit:** 4.2 - **Value:** 1.8 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -7.8 - **Spread:** - **Upper Limit:** 3.4 - **Value:** -1.2 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 12 - **Group ID:** OG001 - **Value:** 6 - **Group ID:** OG002 - **Value:** 22 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -21.6 - **Spread:** - **Upper Limit:** 62.7 - **Value:** 5.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -50.5 - **Spread:** - **Upper Limit:** -20.8 - **Value:** -49.9 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -40.7 - **Spread:** - **Upper Limit:** 38.9 - **Value:** -0.9 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 12 - **Group ID:** OG001 - **Value:** 5 - **Group ID:** OG002 - **Value:** 20 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -37.3 - **Spread:** - **Upper Limit:** -2.9 - **Value:** -18.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -8.2 - **Spread:** - **Upper Limit:** 33.1 - **Value:** 8.2 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -34.9 - **Spread:** - **Upper Limit:** 31.1 - **Value:** -5.4 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 12 - **Group ID:** OG001 - **Value:** 6 - **Group ID:** OG002 - **Value:** 22 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -48.6 - **Spread:** - **Upper Limit:** -0.4 - **Value:** -29.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -7.9 - **Spread:** - **Upper Limit:** 50.0 - **Value:** 30.3 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -14.0 - **Spread:** - **Upper Limit:** 32.8 - **Value:** 11.4 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 12 - **Group ID:** OG001 - **Value:** 6 - **Group ID:** OG002 - **Value:** 21 **Units:** Participants #### Outcome Measure 24 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -5.49 - **Spread:** - **Upper Limit:** 2.59 - **Value:** -0.96 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.00 - **Spread:** - **Upper Limit:** 12.20 - **Value:** 5.69 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -1.10 - **Spread:** - **Upper Limit:** 5.17 - **Value:** 2.07 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 12 - **Group ID:** OG001 - **Value:** 6 - **Group ID:** OG002 - **Value:** 22 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -3.64 - **Spread:** - **Upper Limit:** 11.71 - **Value:** 7.06 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.16 - **Spread:** - **Upper Limit:** 8.85 - **Value:** 2.80 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -0.94 - **Spread:** - **Upper Limit:** 6.19 - **Value:** 3.09 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 6 - **Group ID:** OG002 - **Value:** 17 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -4.76 - **Spread:** - **Upper Limit:** 6.54 - **Value:** 2.74 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.80 - **Spread:** - **Upper Limit:** 15.85 - **Value:** 4.20 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 1.11 - **Spread:** - **Upper Limit:** 8.20 - **Value:** 6.52 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 6 - **Group ID:** OG002 - **Value:** 17 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -4.63 - **Spread:** - **Upper Limit:** -1.17 - **Value:** -3.43 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.42 - **Spread:** - **Upper Limit:** 10.54 - **Value:** 0.02 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -1.17 - **Spread:** - **Upper Limit:** 5.29 - **Value:** 1.85 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 6 - **Group ID:** OG002 - **Value:** 17 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -5.84 - **Spread:** - **Upper Limit:** 1.94 - **Value:** -2.94 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.62 - **Spread:** - **Upper Limit:** 16.91 - **Value:** 6.74 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -0.03 - **Spread:** - **Upper Limit:** 28.22 - **Value:** 10.89 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 5 - **Group ID:** OG001 - **Value:** 3 - **Group ID:** OG002 - **Value:** 9 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -12.91 - **Spread:** - **Upper Limit:** -2.27 - **Value:** -6.90 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 10.32 - **Spread:** - **Upper Limit:** 25.31 - **Value:** 18.80 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 5.96 - **Spread:** - **Upper Limit:** 39.40 - **Value:** 21.27 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 5 - **Group ID:** OG001 - **Value:** 3 - **Group ID:** OG002 - **Value:** 9 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -8.93 - **Spread:** - **Upper Limit:** -2.13 - **Value:** -2.59 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 7.35 - **Spread:** - **Upper Limit:** 17.91 - **Value:** 16.77 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 0.61 - **Spread:** - **Upper Limit:** 31.63 - **Value:** 24.39 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 5 - **Group ID:** OG001 - **Value:** 3 - **Group ID:** OG002 - **Value:** 9 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.89 - **Spread:** - **Upper Limit:** 0.96 - **Value:** -0.70 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -2.73 - **Spread:** - **Upper Limit:** 6.21 - **Value:** 2.13 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -2.91 - **Spread:** - **Upper Limit:** 1.93 - **Value:** -1.44 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 5 - **Group ID:** OG001 - **Value:** 3 - **Group ID:** OG002 - **Value:** 9 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -4.60 - **Spread:** - **Upper Limit:** 2.54 - **Value:** -0.79 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1.93 - **Spread:** - **Upper Limit:** 20.75 - **Value:** 5.53 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -6.20 - **Spread:** - **Upper Limit:** -0.34 - **Value:** -3.24 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 5 - **Group ID:** OG001 - **Value:** 3 - **Group ID:** OG002 - **Value:** 9 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.93 - **Spread:** - **Upper Limit:** 1.14 - **Value:** -1.35 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.02 - **Spread:** - **Upper Limit:** 8.12 - **Value:** 5.83 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** -4.14 - **Spread:** - **Upper Limit:** 2.94 - **Value:** -3.01 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 5 - **Group ID:** OG001 - **Value:** 3 - **Group ID:** OG002 - **Value:** 9 **Units:** Participants ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Virological success is defined as the absence of 2 consecutive plasma viral loads (VL) \> 50 copies/mL within 2 to 4 weeks of a dual raltegravir/etravirine regimen. The proportion of patients who maintained viral suppression under raltegravir plus etravirine was 99.4% (95% confidence interval (95% CI:95.6 -99.9) at week 48 and 98.7% (95% CI: 95.0 -99.7) at week 96 **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** at week48 and at week 96 **Title:** Percentage of Participants With Successful Virological Suppression at Weeks 48 and 96 **Type:** PRIMARY **Unit of Measure:** percentage of participant ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 2 **Description:** Therapeutic success was defined as the absence of virological failure (i.e. 2 consecutive plasma viral loads (VL) \> 50 copies/mL within 2 to 4 weeks) and the absence of treatment interruption due to adverse event judged by DSMB as related to the study treatment or procedure **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** weeks 48 and 96 **Title:** Percentage of Patients With Therapeutic Success at Week 48 and Week 96 **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 3 **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** weeks 48 and 96 **Title:** Percentage of Patients With Trial Treatment Interruption at Week 48 and Week 96 **Type:** SECONDARY **Unit of Measure:** percentage of participant ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 4 **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** weeks 48 and 96 **Title:** Percentage of Patients With With Grade Virological Failure (HIV-RNA Plasma VL Between 51 and 200 Copies/mL) **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 5 **Description:** Time between the date of the study treatment initiation and the date of virological failure **Dispersion Type:** Full Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** week 96 **Title:** Median Time of Virological Failure **Type:** SECONDARY **Unit of Measure:** weeks ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 6 **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** weeks 48 and 96 **Title:** Percentage of Patients With High Grade of Virological Failure Defined as HIV RNA > 200 Copies/mL **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 7 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** week 96 **Title:** Number of Patients With RAL and/or ETR Resistance Mutations Among Those With Virological Failure **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 8 **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** week 96 **Title:** Factors Associated With the Occurrence of Plasma HIV-RNA Viral Load > 50 Copies/mL **Type:** SECONDARY **Unit of Measure:** hazard ratio ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 9 **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** from day 0 to week 48 and week 96 **Title:** Evolution of Total Cell-associated HIV-DNA **Type:** SECONDARY **Unit of Measure:** percentage of change ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 10 **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** from day 0 to week 48 and week 96 **Title:** Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio **Type:** SECONDARY **Unit of Measure:** percentage of change ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 11 **Description:** Number of all clinical and biological adverse events effects. Number of grade 3 or 4 clinical and biological adverse events and effects. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** After week 48, only 156 participants remained on the study treatment **Reporting Status:** POSTED **Time Frame:** From day 0 to week 48 and week 96 **Title:** Number of Participants Experiencing Adverse Events and Effects **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 12 **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Population Description:** the number analyzed in one or more rows differs from overall number analyzed due to the Non determined data **Reporting Status:** POSTED **Time Frame:** from day 0 to week 96 **Title:** Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia) **Type:** SECONDARY **Unit of Measure:** percentage of change ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 13 **Description:** The Framingham risk score is expressed as a percentage. Higher scores mean a worse outcome and lower scores mean better outcome. Median percent change expressed as median (interquartile range (IQR)) **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Population Description:** the number of analyzed participants differs from overall participants due to the Non determined data. **Reporting Status:** POSTED **Time Frame:** from day 0 to week 48 and at week 96 **Title:** Evolution of the Calibrated 5-year Framingham Risk Score **Type:** SECONDARY **Unit of Measure:** Median percent change as median (IQR) ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 14 **Description:** Percent change of the estimated Glomerular Filtration Rate (eGFR) calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Calculator) formula **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** from day 0 to week 96 **Title:** Percent Change of Renal Function **Type:** SECONDARY **Unit of Measure:** Median percent change, as median (IQR) ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 15 **Description:** Evolution of total fat mass, limb fat and trunk fat from day 0 to week 96 **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Population Description:** Five participants were not evaluated at week 96 **Reporting Status:** POSTED **Time Frame:** from day 0 to week 96 **Title:** Evolution of Body Fat Distribution From Day 0 to W96 (DXA Scan Sub-study, 80 Patients) **Type:** SECONDARY **Unit of Measure:** percentage of change ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 16 **Description:** • Evolution of bone mineral density (BMD) measured by DXA scans (DXA scan sub-study, 81 patients) * Lumbar spine BMD, mg/cm2 * Total hip BMD, mg/cm2 **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Population Description:** The number analyzed in one or more rows differs from overall number analyzed due to the missing data **Reporting Status:** POSTED **Time Frame:** from day 0, to week 48 and week 96 **Title:** Sub-study: Bone Mineral Density **Type:** SECONDARY **Unit of Measure:** percentage of change ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 17 **Description:** • Assessment of HIV-RNA viral load in human male genital compartment (20 patients) at week 48 **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** week 48 **Title:** Percentage of Participants With Detectable Seminal HIV-RNA Viral Load at Week 48 **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 18 **Description:** • Evolution of the inflammation markers (IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, CRPus and insulin) on frozen plasma aliquots **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Population Description:** The number analyzed in one or more rows differs from overall number analyzed due to the missing data **Reporting Status:** POSTED **Time Frame:** from day 0 to week 96 **Title:** Inflammatory Parameters **Type:** SECONDARY **Unit of Measure:** percentage of change ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 19 **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** day 0 and weeks 48 and 96 **Title:** Percentage of Participants Reporting a Very Good or an Excellent Quality of Life at Day 0, Weeks 48 and 96 **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 20 **Description:** The compliance rate was estimated as the number of pills consumed (recorded using the self-reported 90 questionnaire) divided by the number of pills theoretically consumed, classified as low (80%), medium (80%-95%) or high (95%). **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Among 165 analyzed participated, 155 filled the baseline self-reported adherence questionnaire, 146 at week 48 and 136 at week 96 **Reporting Status:** POSTED **Time Frame:** at week 0, week 48, and week 96 **Title:** Percentage of Participants Compliant With Treatment Program. **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 21 **Description:** We measured the Anti-mullerian Hormone (AMH) level to evaluate the ovarian reserve (from D0 to W48) **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Population Description:** We evaluated the AMH level in 40 women with available samples. **Reporting Status:** POSTED **Time Frame:** from day 0, to week 48 **Title:** Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots **Type:** SECONDARY **Unit of Measure:** ng/mL ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 22 **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Population Description:** We evaluated the MCP1 level in 40 women with available samples. **Reporting Status:** POSTED **Time Frame:** from day 0, to week 48 **Title:** Evolution of the Level of MCP1 From D0 to W48 on Frozen Samples **Type:** SECONDARY **Unit of Measure:** Percentage change ##### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** OG000 **Title:** Raltegravir and Etravirine #### Outcome Measure 23 **Description:** Metabolic markers measures are total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides. Inflammatory and innate immune activation markers measures are: IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, hsCRP and Insulin. Ovarian reserve measure is AMH **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Population Description:** We evaluated the AMH level in 40 women with available samples **Reporting Status:** POSTED **Time Frame:** from day 0, to week 96 **Title:** Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96 **Type:** SECONDARY **Unit of Measure:** Percentage of change ##### Group **Description:** AMH was detectable (level \>0.06 ng/ml) indicating that they had an ovarian reserve and a status of reproductive activity **ID:** OG000 **Title:** Premenopausal With Mesurable AMH ##### Group **Description:** AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal **ID:** OG001 **Title:** Premenopausal With Reduced Ovarian Reserve ##### Group **Description:** The menopausal status was recorded by the questionnaire at inclusion **ID:** OG002 **Title:** Postmenopausal #### Outcome Measure 24 **Description:** BMI, Hip circumference, Waist circumference, waist/hip ratio, Limb fat, Trunk fat, Total fat, Limb lean, Trunk lean, and Total lean **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Population Description:** AMH level were evaluated in 40 women with available samples **Reporting Status:** POSTED **Time Frame:** from day 0, to week 96 **Title:** Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status **Type:** SECONDARY **Unit of Measure:** Percentage of change ##### Group **Description:** AMH was detectable (level \>0.06 ng/ml) indicating that they had an ovarian reserve and a status of reproductive activity **ID:** OG000 **Title:** Premenopausal With Mesurable AMH ##### Group **Description:** AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal **ID:** OG001 **Title:** Premenopausal With Reduced Ovarian Reserve ##### Group **Description:** The menopausal status was recorded by the questionnaire at inclusion **ID:** OG002 **Title:** Postmenopausal ### Participant Flow Module #### Group **Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal. Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal. **ID:** FG000 **Title:** Raltegravir and Etravirine #### Period **Title:** From Baseline to Week 48 ##### Withdraw **Type:** Lack of Efficacy ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 7 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 165 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 156 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 9 #### Period **Title:** From Week 48 to Week 96 ##### Withdraw **Type:** Lack of Efficacy ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 156 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 152 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 4 **Pre-Assignment Details:** Five patients did not initiate the trial treatment by their own decision, leaving 165 patients for the analysis. **Recruitment Details:** Between January and November 2015, 219 patients from 20 sites were screened and 170 patients were enrolled in the study. **Has Results:** True
## Protocol Section ### Identification Module **NCT ID:** NCT01056679 **Acronym:** AVD-Rev **Brief Title:** Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients **Official Title:** Phase I Trial of AVD Plus Lenalidomide (Revlimid) in Elderly Intermediate or Advanced Stage Hodgkin Lymphoma Patients #### Organization Study ID Info **ID:** AVD-Rev #### Organization **Class:** OTHER **Full Name:** University of Cologne ### Status Module #### Completion Date **Date:** 2016-02 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-03-22 **Type:** ACTUAL **Last Update Submit Date:** 2018-03-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-04 **Type:** ACTUAL #### Start Date **Date:** 2010-04 **Status Verified Date:** 2018-03 #### Study First Post Date **Date:** 2010-01-26 **Type:** ESTIMATED **Study First Submit Date:** 2009-09-08 **Study First Submit QC Date:** 2010-01-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Cologne #### Responsible Party **Investigator Affiliation:** University of Cologne **Investigator Full Name:** Prof. Dr. Andreas Engert **Investigator Title:** Prof. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to determine within the scope of the trial what the maximum tolerated dose (MTD) of lenalidomide in combination with AVD should be. ### Conditions Module **Conditions:** - Hodgkin Lymphoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with intermediate stage HL receive 4 cycles of AVD-Rev followed by 30 Gy IF-RT Patientes with advanced stage HL receive 6 to 8 cycles of AVD-Rev followed by 30 GY IF-RT depending on the FDG-PET results **Intervention Names:** - Drug: Doxorubicine - Drug: DTIC - Drug: Lenalidomide - Drug: Vinblastine **Label:** AVD-Rev **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - AVD-Rev **Description:** 50mg/m2 day 1 + 15 **Name:** Doxorubicine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - AVD-Rev **Description:** 375mg/m2 day 1 + 15 **Name:** DTIC **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - AVD-Rev **Description:** day 1 - 21 **Name:** Lenalidomide **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - AVD-Rev **Description:** 6mg/m2 day 1 + 15 **Name:** Vinblastine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Dose limiting toxicities (DLT) #### Secondary Outcomes **Measure:** Overall response rate (ORR) **Measure:** Progression free survival (PFS) **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Hodgkin Lymphoma, intermediate or advanced stage * Age \>60 and \<75 years * ECOG 2 or better * No major organ dysfunction * Ability to take aspirin or LMW Heparin Exclusion Criteria: * HL as composite lymphoma * Prior use of lenalidomide * Prior use of chemo- or radiotherapy **Maximum Age:** 75 Years **Minimum Age:** 60 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cologne **Country:** Germany **Facility:** 1st Dept. of Medicine, Cologne University Hospital **State:** NRW **Zip:** 50924 #### Overall Officials **Official 1:** **Affiliation:** University of Cologne **Name:** Andreas Engert, Prof. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** Related Info **URL:** http://www.ghsg.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M9751 - Name: Hodgkin Disease - Relevance: HIGH - As Found: Hodgkin Lymphoma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: HIGH - As Found: Lymphoma - ID: T2817 - Name: Hodgkin Lymphoma - Relevance: HIGH - As Found: Hodgkin Lymphoma ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000006689 - Term: Hodgkin Disease ### Intervention Browse Module - Ancestors - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000020533 - Term: Angiogenesis Inhibitors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000006131 - Term: Growth Inhibitors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M7492 - Name: Doxorubicin - Relevance: HIGH - As Found: Women - ID: M227339 - Name: Liposomal doxorubicin - Relevance: LOW - As Found: Unknown - ID: M1725 - Name: Lenalidomide - Relevance: HIGH - As Found: Respiratory - ID: M17492 - Name: Vinblastine - Relevance: HIGH - As Found: Issues - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000004317 - Term: Doxorubicin - ID: D000077269 - Term: Lenalidomide - ID: D000014747 - Term: Vinblastine ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT05073679 **Acronym:** ONPED **Brief Title:** Oral Naltrexone In Pediatric Eating Disorders **Official Title:** A Double-Blind Placebo-Controlled Evaluation of Effectiveness of Oral Naltrexone in Management of Adolescent Eating Disorders #### Organization Study ID Info **ID:** STUDY00014382 #### Organization **Class:** OTHER **Full Name:** Milton S. Hershey Medical Center #### Secondary ID Infos **Domain:** Food and Drug Administration **ID:** 150408 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2023-08-16 **Type:** ACTUAL **Last Update Submit Date:** 2023-08-15 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-04 **Type:** ESTIMATED #### Start Date **Date:** 2022-04-22 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2021-10-11 **Type:** ACTUAL **Study First Submit Date:** 2021-07-19 **Study First Submit QC Date:** 2021-10-04 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Children's Miracle Network #### Lead Sponsor **Class:** OTHER **Name:** Rosemary Claire Roden #### Responsible Party **Investigator Affiliation:** Milton S. Hershey Medical Center **Investigator Full Name:** Rosemary Claire Roden **Investigator Title:** Assistant Professor of Pediatrics **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The objective of this study is to evaluate the effectiveness of oral naltrexone tablets in pediatric and adolescent eating disorders, in particular anorexia nervosa and bulimia nervosa, as compared to placebo. Study participants will be patients in a partial hospitalization program or intensive outpatient program for eating disorder. **Detailed Description:** Subjects participating in this study will receive routine care for eating disorder at a partial hospitalization (PHP) level of care at MSHMC. In PHP, all patients have weekly medical screening visits for the duration of their time in care, as well as weekly individual therapy sessions, individual dietician sessions, and psychiatry appointments. They have supervised meals and numerous group therapy sessions. Every three weeks, patients in PHP complete a battery of mood and eating disorder indices including those evaluated in this study; participants in this study will complete an additional two surveys with this routine battery. Participants in this study will have no alterations in their routine eating disorder care outside of study article use and these additional surveys. Subjects will be enrolled at their first visit for eating disorder programming at child or adult partial hospitalization (PHP) programming at MSHMC adolescent medicine eating disorders clinic. Informed consent/assent will be obtained as described above. The subject will be provided with oral naltrexone or placebo weekly from the MSHMC research pharmacy. Subjects will be given one weeks' worth of medication at a time. Subjects will be randomized at enrollment to receive either study drug (naltrexone) or placebo. Participants or parents of minor participants will be provided study drug or placebo following completion of urine drug screen and consent/assent. Patients will take the medication daily for six weeks. For subjects who are enrolled in child PHP and who eat meals with parents, the families may choose to administer study drug during meals at programming. For adult patients enrolled in adult programming, subjects may choose to self-administer the medication. On their first contact with PHP, all patients in Child PHP complete various eating disorder indices as a part of routine care, including the ED-15, EDE-Q, RCMAS, CDI, GAD-7, and PHQ-9. This battery of indices is repeated every 3 weeks while a patient is in programming. For those who are enrolled in this study, they will complete their routine indices, in addition they will also complete the BIS/BAS and the ABUSI at enrollment and at weeks 3, 6, and 9 (after completion of medication) while in programming. Participants will receive routine eating disorder care while in PHP. Patients in Adult PHP typically complete a different inventory every three weeks. If a patient choses to participate in this study they will be asked to complete the same surveys as participants in Child PHP, and they will receive the same amount and type of compensation. Six months after enrollment, subjects will be sent copies of ED-15, EDE-Q, GAD-7, PHQ-9, BIS/BAS, and ABUSI indices either in an in-person medical appointment or via RedCap to complete. If the patient returns for medical follow-up between 5 and 7 months after enrollment, their height, weight, and body mass index will also be recorded to determine if weight restoration was maintained. At initial contact with the eating disorders clinic, all patients receive an initial battery of laboratory tests as a part of the standard of care for eating disorder. These tests include liver function assays and transaminase levels. ### Conditions Module **Conditions:** - Anorexia Nervosa/Bulimia - Anorexia in Adolescence - Anorexia Nervosa, Atypical - Anorexia Nervosa, Binge Eating/Purging Type - Purging (Eating Disorders) - Impulsive Behavior - Eating Disorders - Bulimia Nervosa - Eating Disorders in Adolescence ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** double-blind, placebo controlled randomized clinical trial ##### Masking Info **Masking:** TRIPLE **Masking Description:** The Penn State Health IDS pharmacy will purchase Naltrexone 50mg tablets from a pharmaceutical wholesaler. The IDS pharmacy will purchase gelatin capsules and USP grade methylcellulose from a pharmacy supplier to be used for compounding the active and placebo capsules. For the active Naltrexone 50mg capsules, a Naltrexone 50mg tablet will be placed in an empty gelatin capsule with methylcellulose filler. The placebo capsules will be empty gelatin capsules filled with Methylcellulose. Participants will be randomized using redcap at enrollment to either study article or placebo, and neither investigators nor care providers will be aware of which article the participants receive. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler **Intervention Names:** - Drug: Naltrexone Hydrochloride **Label:** Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks **Intervention Names:** - Other: Control **Label:** Control **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** 25mg x 3 days then 50mg a day thereafter **Name:** Naltrexone Hydrochloride **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Control **Description:** Methylcellulose and gelatin capsule only **Name:** Control **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Columbia Suicide Severity Rating Scale (CSSRS) **Time Frame:** enrollment for patients age 17 or older **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Columbia Suicide Severity Rating Scale (CSSRS) **Time Frame:** week 1 for patients age 17 or older **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Columbia Suicide Severity Rating Scale (CSSRS) **Time Frame:** week 2 for patients age 17 or older **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Columbia Suicide Severity Rating Scale (CSSRS) **Time Frame:** week 3 for patients age 17 or older **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Columbia Suicide Severity Rating Scale (CSSRS) **Time Frame:** week 4 for patients age 17 or older **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Columbia Suicide Severity Rating Scale (CSSRS) **Time Frame:** week 5 for patients age 17 or older **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Columbia Suicide Severity Rating Scale (CSSRS) **Time Frame:** week 6 for patients age 17 or older **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Columbia Suicide Severity Rating Scale (CSSRS) **Time Frame:** week 7 for patients age 17 or older **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Columbia Suicide Severity Rating Scale (CSSRS) **Time Frame:** week 8 for patients age 17 or older **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Columbia Suicide Severity Rating Scale (CSSRS) **Time Frame:** week 9 for patients age 17 or older **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Columbia Suicide Severity Rating Scale (CSSRS) **Time Frame:** 6 months after enrollment for patients age 17 or older **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Ask Suicide Screening Questions (ASQ) **Time Frame:** enrollment for patients age 16 or younger **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Ask Suicide Screening Questions (ASQ) **Time Frame:** week 1 for patients age 16 or younger **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Ask Suicide Screening Questions (ASQ) **Time Frame:** week 2 for patients age 16 or younger **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Ask Suicide Screening Questions (ASQ) **Time Frame:** week 3 for patients age 16 or younger **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Ask Suicide Screening Questions (ASQ) **Time Frame:** week 4 for patients age 16 or younger **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Ask Suicide Screening Questions (ASQ) **Time Frame:** week 5 for patients age 16 or younger **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Ask Suicide Screening Questions (ASQ) **Time Frame:** week 6 for patients age 16 or younger **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Ask Suicide Screening Questions (ASQ) **Time Frame:** week 7 for patients age 16 or younger **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Ask Suicide Screening Questions (ASQ) **Time Frame:** week 8 for patients age 16 or younger **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Ask Suicide Screening Questions (ASQ) **Time Frame:** week 9 for patients age 16 or younger **Description:** Evidence-based metric evaluating for presence of suicidal ideation and severity **Measure:** Ask Suicide Screening Questions (ASQ) **Time Frame:** 6 months after enrollment for patients age 16 or younger #### Primary Outcomes **Description:** ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. **Measure:** ED-15 score **Time Frame:** Time Frame: Measured at the following timepoints: enrollment **Description:** ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. **Measure:** ED-15 score **Time Frame:** Time Frame: Measured at the following timepoints: one week **Description:** ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. **Measure:** ED-15 score **Time Frame:** Time Frame: Measured at the following timepoints: three week **Description:** ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. **Measure:** ED-15 score **Time Frame:** Time Frame: Measured at the following timepoints: six weeks **Description:** ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. **Measure:** ED-15 score **Time Frame:** Time Frame: Measured at the following timepoints: nine weeks (last week of treatment) **Description:** ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. **Measure:** ED-15 score **Time Frame:** Time Frame: Measured at the following timepoints: 6 months after enrollment #### Secondary Outcomes **Description:** EDE-Q is an evidence-based metric of eating disorder severity **Measure:** Eating Disorder Examination Questionnaire score (EDE-Q) **Time Frame:** Measured at the following timepoints: enrollment **Description:** EDE-Q is an evidence-based metric of eating disorder severity **Measure:** Eating Disorder Examination Questionnaire score (EDE-Q) **Time Frame:** Measured at the following timepoints: one week **Description:** EDE-Q is an evidence-based metric of eating disorder severity **Measure:** Eating Disorder Examination Questionnaire score (EDE-Q) **Time Frame:** Measured at the following timepoints: three weeks **Description:** EDE-Q is an evidence-based metric of eating disorder severity **Measure:** Eating Disorder Examination Questionnaire score (EDE-Q) **Time Frame:** Measured at the following timepoints: six weeks **Description:** EDE-Q is an evidence-based metric of eating disorder severity **Measure:** Eating Disorder Examination Questionnaire score (EDE-Q) **Time Frame:** Measured at the following timepoints: nine weeks (last week of treatment) **Description:** EDE-Q is an evidence-based metric of eating disorder severity **Measure:** Eating Disorder Examination Questionnaire score (EDE-Q) **Time Frame:** Measured at the following timepoints: 6 months after enrollment **Description:** Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression **Measure:** Patient Health Questionnaire score (PHQ-9) **Time Frame:** Measured at the following timepoints: enrollment **Description:** Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression **Measure:** Patient Health Questionnaire score (PHQ-9) **Time Frame:** Measured at the following timepoints: one week **Description:** Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression **Measure:** Patient Health Questionnaire score (PHQ-9) **Time Frame:** Measured at the following timepoints: three weeks **Description:** Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression **Measure:** Patient Health Questionnaire score (PHQ-9) **Time Frame:** Measured at the following timepoints: six weeks **Description:** Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression **Measure:** Patient Health Questionnaire score (PHQ-9) **Time Frame:** Measured at the following timepoints: nine weeks (last week of treatment) **Description:** Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression **Measure:** Patient Health Questionnaire score (PHQ-9) **Time Frame:** Measured at the following timepoints: 6 months after enrollment **Description:** evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety **Measure:** Generalized Anxiety Disorder Screener score (GAD-7) **Time Frame:** Measured at the following timepoints: enrollment **Description:** evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety **Measure:** Generalized Anxiety Disorder Screener score (GAD-7) **Time Frame:** Measured at the following timepoints: one week **Description:** evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety **Measure:** Generalized Anxiety Disorder Screener score (GAD-7) **Time Frame:** Measured at the following timepoints: three weeks **Description:** evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety **Measure:** Generalized Anxiety Disorder Screener score (GAD-7) **Time Frame:** Measured at the following timepoints: six weeks **Description:** evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety **Measure:** Generalized Anxiety Disorder Screener score (GAD-7) **Time Frame:** Measured at the following timepoints: nine weeks (last week of treatment) **Description:** evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety **Measure:** Generalized Anxiety Disorder Screener score (GAD-7) **Time Frame:** Measured at the following timepoints: 6 months after enrollment **Description:** evidence-based metric of urge to self-harm **Measure:** Alexian Brothers Urge to Self-Injure Scale (ABUSI) **Time Frame:** Measured at the following timepoints: enrollment **Description:** evidence-based metric of urge to self-harm **Measure:** Alexian Brothers Urge to Self-Injure Scale (ABUSI) **Time Frame:** Measured at the following timepoints: one week **Description:** evidence-based metric of urge to self-harm **Measure:** Alexian Brothers Urge to Self-Injure Scale (ABUSI) **Time Frame:** Measured at the following timepoints: three weeks **Description:** evidence-based metric of urge to self-harm **Measure:** Alexian Brothers Urge to Self-Injure Scale (ABUSI) **Time Frame:** Measured at the following timepoints: six weeks **Description:** evidence-based metric of urge to self-harm **Measure:** Alexian Brothers Urge to Self-Injure Scale (ABUSI) **Time Frame:** Measured at the following timepoints: nine weeks (last week of treatment) **Description:** evidence-based metric of urge to self-harm **Measure:** Alexian Brothers Urge to Self-Injure Scale (ABUSI) **Time Frame:** Measured at the following timepoints: 6 months after enrollment **Description:** Evidence-based metric of impulsivity **Measure:** Behavioral Inhibition System/Behavioral Activation System score (BIS/BAS) **Time Frame:** Measured at the following timepoints: enrollment **Description:** Evidence-based metric of impulsivity **Measure:** Behavioral Inhibition System/Behavioral Activation System score (BIS/BAS) **Time Frame:** Measured at the following timepoints: one week **Description:** Evidence-based metric of impulsivity **Measure:** Behavioral Inhibition System/Behavioral Activation System score (BIS/BAS) **Time Frame:** Measured at the following timepoints: three weeks **Description:** Evidence-based metric of impulsivity **Measure:** Behavioral Inhibition System/Behavioral Activation System score (BIS/BAS) **Time Frame:** Measured at the following timepoints: six weeks **Description:** Evidence-based metric of impulsivity **Measure:** Behavioral Inhibition System/Behavioral Activation System score (BIS/BAS) **Time Frame:** Measured at the following timepoints: nine weeks (last week of treatment) **Description:** Evidence-based metric of impulsivity **Measure:** Behavioral Inhibition System/Behavioral Activation System score (BIS/BAS) **Time Frame:** Measured at the following timepoints: 6 months after enrollment **Description:** For participants who need to restore weight, will evaluate the rate of weight gain in care **Measure:** Rate of weight restoration **Time Frame:** Will evaluate total rate of weight restoration via chart review at the end of the study **Description:** For participants who need to restore weight, will evaluate the rate of weight gain in care **Measure:** Rate of weight restoration **Time Frame:** Will evaluate total rate of weight restoration via chart review 6 months after enrollment **Description:** Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility **Measure:** Need For Higher Level of Care **Time Frame:** Will evaluate total rate of weight restoration via chart review at the end of the study **Description:** Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility **Measure:** Need For Higher Level of Care **Time Frame:** Will evaluate total rate of weight restoration via chart review 6 months after enrollment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ages 13-25 (inclusive) * Any sex * Diagnoses of anorexia nervosa binge-purge subtype, bulimia nervosa, purging disorder, or atypical anorexia nervosa with bingeing or purging behaviors according to the Diagnostic and Statistical Manual version 5 diagnostic criteria * Electing to participate in child or adult partial hospitalization program for eating disorder treatment at MSHMC The diagnostic criteria for anorexia nervosa, binge-purge subtype, are: A. Restriction of energy intake relative to requirements, leading to a significantly low body weight in the context of age, sex, developmental trajectory, and physical health. Significantly low weight is defined as a weight that is less than minimally normal or, for children and adolescents, less than minimally expected. B. Intense fear of gaining weight or of becoming fat, or persistent behavior that interferes with weight gain, even though at a significantly low weight. C. Disturbance in the way in which one's body weight or shape is experienced, undue influence of body weight or shape on self-evaluation, or persistent lack of recognition of the seriousness of the current low body weight D. During the last three months the individual has engaged in recurrent episodes of binge eating or purging behaviour (i.e. self-induced vomiting, or the misuse of laxatives, diuretics, or enemas).19 E. A diagnosis of atypical anorexia nervosa can be made when the body weight is normal or high If these patients engage in bingeing or purging behaviors as defined in anorexia nervosa, binge-purge subtype, they are eligible for inclusion in this study The diagnostic criteria for bulimia nervosa are: A. Recurrent episodes of binge eating. An episode of binge eating is characterized by B. both: i. Eating in a discrete period of time (e.g. within any 2 hour period), an amount of food that is definitely larger than what most individuals would eat in a similar period of time under similar circumstances; ii. A sense of lack of control over eating during the episodes (e.g. a feeling that one cannot stop eating or control what or how much one is eating. C. Recurrent inappropriate compensatory behaviors to prevent weight gain, such as self-induced vomiting; misuse of laxatives, diuretics, or other medications; fasting; or excessive exercise. D. The binge eating and inappropriate compensatory behaviors both occur, on average, at least once a week for 3 months. E. Self-evaluation is unduly influenced by body shape and weight. F. The disturbance does not occur exclusively during episodes of anorexia nervosa. • The diagnostic criteria for purging disorder are: recurrent purging behavior to influence weight or shape (e.g. self-induced vomiting; misuse of laxatives, diuretics, or other medications) in the absence of binge eating. Exclusion Criteria: * Diagnosis of intellectual disability * History of known genetic or neurologic disease * Need for treatment with opioid painkillers * Weight \<25kg * Inability to swallow pills * Lack of proficiency in written or spoken English * Urine drug screen positive for opioids at enrollment * Positive serum pregnancy test at enrollment * Lactation * Elevation of three times the upper limit of normal for age in either alanine aminotransferase (ALT) or asparagine aminotransferase (AST).High risk of suicide at enrollment on Columbia Suicide Severity Rating Scale (C-SSRS, for participants age 18-25) or Ask Suicide Screening Questions (ASQ, participants age 13 to 17) **Maximum Age:** 25 Years **Minimum Age:** 13 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hershey **Country:** United States **Facility:** Penn State Milton S. Hershey Medical Center **State:** Pennsylvania **Zip:** 17033 #### Overall Officials **Official 1:** **Affiliation:** PennState Health Children's Hospital **Name:** Rosemary C Roden, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** No participant data is planned to be shared at the moment to protect patient privacy, as participants are all enrolled in a partial hospitalization program for mental health conditions. **IPD Sharing:** NO ### References Module #### References **Citation:** Tatham M, Turner H, Mountford VA, Tritt A, Dyas R, Waller G. Development, psychometric properties and preliminary clinical validation of a brief, session-by-session measure of eating disorder cognitions and behaviors: The ED-15. Int J Eat Disord. 2015 Nov;48(7):1005-15. doi: 10.1002/eat.22430. Epub 2015 May 26. **PMID:** 26011054 **Citation:** Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70. **PMID:** 7866415 **Citation:** Smucker MR, Craighead WE, Craighead LW, Green BJ. Normative and reliability data for the Children's Depression Inventory. J Abnorm Child Psychol. 1986 Mar;14(1):25-39. doi: 10.1007/BF00917219. **PMID:** 3950219 **Citation:** Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704. **PMID:** 22193671 **Citation:** Horowitz LM, Bridge JA, Teach SJ, Ballard E, Klima J, Rosenstein DL, Wharff EA, Ginnis K, Cannon E, Joshi P, Pao M. Ask Suicide-Screening Questions (ASQ): a brief instrument for the pediatric emergency department. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1170-6. doi: 10.1001/archpediatrics.2012.1276. **PMID:** 23027429 **Citation:** Campbell K, Peebles R. Eating disorders in children and adolescents: state of the art review. Pediatrics. 2014 Sep;134(3):582-92. doi: 10.1542/peds.2014-0194. **PMID:** 25157017 #### See Also Links **Label:** BIS/BAS **URL:** https://www.researchgate.net/publication/232481813_Behavioral_Inhibition_Behavioral_Activation_and_Affective_Responses_to_Impending_Reward_and_Punishment_The_BISBAS_Scales **Label:** Oral naltrexone package insert **URL:** https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018932s017lbl.pdf ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders - ID: D000012817 - Term: Signs and Symptoms, Digestive - ID: D000006963 - Term: Hyperphagia ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10220 - Name: Impulsive Behavior - Relevance: HIGH - As Found: Impulsive Behavior - ID: M5304 - Name: Bulimia - Relevance: HIGH - As Found: Bulimia - ID: M28641 - Name: Binge-Eating Disorder - Relevance: LOW - As Found: Unknown - ID: M4181 - Name: Anorexia - Relevance: HIGH - As Found: Anorexia - ID: M4182 - Name: Anorexia Nervosa - Relevance: HIGH - As Found: Anorexia Nervosa - ID: M26956 - Name: Bulimia Nervosa - Relevance: HIGH - As Found: Bulimia Nervosa - ID: M4380 - Name: Feeding and Eating Disorders - Relevance: HIGH - As Found: Eating Disorders - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: M10014 - Name: Hyperphagia - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000855 - Term: Anorexia - ID: D000002032 - Term: Bulimia - ID: D000001068 - Term: Feeding and Eating Disorders - ID: D000000856 - Term: Anorexia Nervosa - ID: D000052018 - Term: Bulimia Nervosa - ID: D000007175 - Term: Impulsive Behavior ### Intervention Browse Module - Ancestors - ID: D000000427 - Term: Alcohol Deterrents - ID: D000009292 - Term: Narcotic Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents ### Intervention Browse Module - Browse Branches - Abbrev: AlcDet - Name: Alcohol Deterrents - Abbrev: NarcAntag - Name: Narcotic Antagonists - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M12222 - Name: Naltrexone - Relevance: HIGH - As Found: Biliary stent - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown - ID: M12245 - Name: Narcotics - Relevance: LOW - As Found: Unknown - ID: M12243 - Name: Narcotic Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000009271 - Term: Naltrexone ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT05097079 **Brief Title:** Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Pediatric Subjects **Official Title:** A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® for the Treatment of Chronic Sialorrhea in Pediatric Subjects #### Organization Study ID Info **ID:** SN-SIAL-302 #### Organization **Class:** INDUSTRY **Full Name:** Supernus Pharmaceuticals, Inc. ### Status Module #### Completion Date **Date:** 2024-03-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2022-12-19 **Type:** ACTUAL **Last Update Submit Date:** 2022-12-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2023-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-30 **Type:** ESTIMATED **Status Verified Date:** 2022-12 #### Study First Post Date **Date:** 2021-10-27 **Type:** ACTUAL **Study First Submit Date:** 2021-10-18 **Study First Submit QC Date:** 2021-10-18 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Solstice Neurosciences #### Lead Sponsor **Class:** INDUSTRY **Name:** Supernus Pharmaceuticals, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study will evaluate the efficacy and safety of MYOBLOC for the Treatment of Chronic Sialorrhea in Pediatric Subjects. **Detailed Description:** This is a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of the Efficacy and Safety of MYOBLOC in Pediatric Subjects. ### Conditions Module **Conditions:** - Sialorrhea ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 108 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Weight-based dose (5.0 units/kg for submandibular gland and 25.0 units/kg for parotid gland) will be administered as single treatment and compared to placebo **Intervention Names:** - Drug: MYOBLOC Low Dose **Label:** MYOBLOC Low Dose **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Weight-based dose (10.0 units/kg for submandibular gland and 40.0 units/kg for parotid gland) will be administered as single treatment and compared to placebo **Intervention Names:** - Drug: MYOBLOC High Dose **Label:** MYOBLOC High Dose **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** A volume-matched placebo will be administered as single treatment **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - MYOBLOC Low Dose **Description:** Weight-based dose; 5.0 units/kg for submandibular gland and 25.0 units/kg for parotid gland **Name:** MYOBLOC Low Dose **Other Names:** - rimabotulinumtoxinB **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - MYOBLOC High Dose **Description:** Weight-based dose; 10.0 units/kg for submandibular gland and 40.0 units/kg for parotid gland **Name:** MYOBLOC High Dose **Other Names:** - rimabotulinumtoxinB **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Placebo **Description:** volume-matched placebo **Name:** Placebo **Other Names:** - PBO **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The first co-primary endpoint is the change from baseline in the Unstimulated Saliva Flow Rate (USFR; grams/minute) at Week 4 post-injection. At each study visit, the subject's saliva is collected for at least 3 minutes. The USFR (grams/minute) is calculated by dividing the 'total amount of saliva collected during the collection period (grams)' by the 'total duration of the collection period (minutes)'. The difference between the USFR at baseline visit (prior to injection) and the USFR at post-injection study visits is calculated. A change from baseline USFR that is \<0 grams/minutes represents a better outcome. **Measure:** Effect of MYOBLOC on Unstimulated Saliva Flow Rate (USFR) **Time Frame:** Baseline and Week 4 **Description:** The second co-primary endpoint is the Clinical Global Impression of Change (CGI-C) score at Week 4 post-injection. The CGI-C scale is a single item clinician assessment of how much the subject's condition (sialorrhea) has improved, worsened or has not changed relative to subject's state at baseline prior to treatment (injection). The CGI-C is rated on a 7-point Likert scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". A CGI-C score \<4 represents a better outcome. **Measure:** Effect of MYOBLOC on Clinical Global Impression of Change (CGI-C) scale **Time Frame:** Week 4 #### Secondary Outcomes **Description:** The key secondary endpoint is the Parent/Guardian Global Impression of Change (CGI-C) score at Week 4 post-injection. The PGI-C scale is a single item parent/guardian assessment of how much the subject's condition (sialorrhea) has improved, worsened or has not changed relative to subject's state at baseline prior to treatment (injection). The PGI-C is rated on a 7-point Likert scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". A PGI-C score \<4 represents a better outcome **Measure:** Effect of MYOBLOC on Parent/Guardian Global Impression of Change (PGI-C) scale **Time Frame:** Week 4 **Description:** The first additional secondary endpoint is the change from baseline in the Unstimulated Saliva Flow Rate (USFR) at Weeks 2, 8 and 13 post-injection. At each study visit, the subject's saliva is collected for at least 3 minutes. The USFR (grams/minute) is calculated by dividing the 'total amount of saliva collected during the collection period (grams)' by the 'total duration of the collection period (minutes)'. The difference between the USFR at baseline visit (prior to injection) and the USFR at post-injection study visits is calculated. A change from baseline USFR that is \<0 grams/minute represents a better outcome. **Measure:** Effect of MYOBLOC on Unstimulated Saliva Flow Rate (USFR) **Time Frame:** Baseline and Weeks 2, 8 and 13 **Description:** The second additional secondary endpoint is the Clinical Global Impression of Change (CGI-C) score at Weeks 2, 8, and 13 post-injection. The CGI-C scale is a single item clinician assessment of how much the subject's the subject's condition (sialorrhea) has improved, worsened or has not changed relative to subject's state at baseline prior to treatment (injection). The CGI-C is rated on a 7-point Likert scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". A CGI-C score \<4 represents a better outcome. **Measure:** Effect of MYOBLOC on Clinical Global Impression of Change (CGI-C) score **Time Frame:** Weeks 2, 8 and 13 **Description:** The third additional secondary endpoint is the Parent/Guardian Global Impression of Change (CGI-C) score at Week 2, 8, and 13 post-injection. The PGI-C scale is a single item parent/guardian assessment of how much the subject's condition (sialorrhea) has improved, worsened or has not changed relative to subject's state at baseline prior to treatment (injection). The PGI-C is rated on a 7-point Likert scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". Successful therapy is indicated by a lower score (\<4) in subsequent testing. A PGI-C score \<4 represents a better outcome. **Measure:** Effect of MYOBLOC on (PGI-C) **Time Frame:** Weeks 2, 8, and 13 **Description:** The fourth additional secondary endpoint is the change from baseline in the Modified Teacher's Drooling Scale (mTDS) score at Week4 post injection. The mTDS is a single-item scale used to assess subject's drooling severity and frequency. It is rated by the parent/guardian on a 9-point Likert scale (1-9) where 1=Dry: never drools; 2=Mild: only the lips are wet, occasionally; 3=Mild: only the lips are wet, frequently; 4=Moderate: wet on the lips and chin, occasionally; 5=Moderate: wet on the lips and chin, frequently; 6=Severe: drools to the extent that clothing becomes damp, occasionally; 7=Severe: drools to the extent that clothing becomes damp, frequently; 8=Profuse: clothing, hands, tray, and objects become wet, occasionally; 9=Profuse: clothing, hands, tray, and objects become wet, frequently. A change from baseline mTDS score \<0 represents a better outcome. **Measure:** Effect of MYOBLOC on Modified Teacher's Drooling Scale (mTDS) **Time Frame:** Baseline and Week 4 **Description:** The fifth additional secondary endpoint is the change from baseline in the Drooling Impact Scale (DIS) score at Week 4 post-injection. The DIS is a 10-item questionnaire used to assess the frequency, severity, and impact of subject's drooling. Each item is rated by the parent/guardian on a 10-point end-anchor semantic differential scale (1 to 10; where 1 = best outcome to 10 = worst outcome). The sum of all 10 items yields a total score (ranging from 10-100). A change from baseline DIS score \<0 represents a better outcome. **Measure:** Effect of MYOBLOC Drooling Impact Scale (DIS) **Time Frame:** Baseline and Week 4 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Written informed consent obtained from the subject's parent or legally authorized representative(s) (LAR)/guardian(s) in accordance with local laws and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements. 2. Written minor assent obtained from the subject, as applicable and in accordance with local laws and IRB/IEC requirements. 3. Male or female ages 3 to \< 17 years at the time of signing informed consent (and assent, if applicable) at Screening. 4. Minimum weight of 10 kg at Screening and Baseline (prior to randomization). 5. Chronic sialorrhea due to a neurological disorder (e.g., cerebral palsy (CP), or traumatic brain injury (TBI)) for at least 3 months prior to Screening. 6. A mTDS score ≥ 5 at Screening and Baseline (prior to randomization). 7. A minimum USFR of 0.2 g/min at Screening and Baseline (prior to randomization). 8. Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use/practice one of the following acceptable methods of contraception beginning during screening period prior to baseline (randomization, injection), for the duration of the study, and 2 months after study completion: 1. simultaneous use of male condom and intra-uterine contraceptive device placed during screening period prior to baseline (randomization, injection) 2. barrier method: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; 3. established use of oral, injected or implanted hormonal methods of contraception; 4. surgically sterile male partner (e.g., vasectomized partner is sole partner). With approval by the Investigator, subjects' parents or legal guardians may select abstinence as a form of birth control if deemed more appropriate. For the purposes of this study, all females are considered to be of childbearing potential unless they are confirmed by the Investigator to be premenarchal, biologically sterile, or surgically sterile (e.g., hysterectomy with bilateral oophorectomy, tubal ligation). 9. Subject and the subject's parent/LAR are willing and able to comply with scheduled visits, treatment plan, laboratory tests, home monitoring, and other study procedures. Exclusion Criteria: 1. FOCP subjects who are pregnant, lactating/breastfeeding and/or sexually active and not agreeing to use one of the acceptable birth control methods throughout the study. 2. History of drug or alcohol abuse within 6 months before Screening. 3. Treatment with an investigational drug, device, or biological agent within 30 days before Screening or while participating in this study. 4. Major surgery (requiring general anesthesia) within 3 months before screening, or any anticipated or scheduled surgery during the study period (with or without general anesthesia). 5. Aspiration pneumonia within 6 months before Screening. 6. History of moderate dysphagia or severe dysphagia (defined as an inability to swallow liquids, solids or both without choking or medical intervention) within 6 months before screening. Subjects who require gastrostomy tube feeding are not excluded provided tube placement was at least 30 days prior to Baseline (Day 1; injection). 7. Requires general anesthesia for study drug administration. 8. Prior botulinum toxin type A (BoNT/A) or BoNT/B treatment for sialorrhea or cervical dystonia within 20 weeks before screening. Prior BoNT/A or BoNT/B treatment in other anatomical locations is not exclusionary, but must have occurred at least 12 weeks prior to screening. Prior toxin exposure must have been well tolerated and without any significant long-term side effects in cases of repeated prior exposure. 9. Subjects must not receive nor have any plans to receive any other form of botulinum toxin treatment, other than the study drug (MYOBLOC), from the time that the informed consent is obtained until participation in the study is complete. 10. History of lack of response to MYOBLOC. 11. Any previous known or suspected hypersensitivity to botulinum toxins type A (BoNT/A) or B (BoNT/B) or to any of the MYOBLOC solution components. 12. Oxygen saturation \< 95% on room air at Screening and Baseline (prior to randomization). 13. Subjects taking medications with anticholinergic/antihistamine properties who have not been on a stable dose and regimen for at least 2 weeks before Day 1. The same dose and dosing regimen must be maintained through the Week 4 study visit. 14. Diagnosed with Obstructive Sleep Apnea which requires nightly Continuous Positive Airway Pressure (CPAP) or Bi-level Positive Airway Pressure (BiPAP) therapy, such that subject has been receiving nightly therapy for at least 30 days. 15. Current or recent treatment (exposure within 5 half-lives of screening) or treatment at any time during the study with aminoglycoside antibiotics, curare-like agents, other agents that interfere with neuromuscular function, or dopamine receptor blocking agents (e.g., clozapine). 16. Current treatment or treatment at any time during the study with Coumadin® (warfarin) or similar anti-coagulant medications. Anti-platelet medications are not specifically exclusionary. 17. Prior surgery or irradiation in the head and neck to control sialorrhea (including salivary gland surgery or salivary gland irradiation) within 1 year before screening or planned during the study. 18. Extremely poor dental and/or oral condition, including infection at injection site(s) that might preclude safe study participation according to the judgment of the Investigator. 19. Has one or more screening clinical laboratory test values outside the reference range that, in the opinion of the Investigator, are clinical significant, or any of the following: 1. Serum creatinine \>1.5 times the upper limit of normal (ULN); 2. Serum total bilirubin \>1.5 times ULN; 3. Serum alanine aminotransferase or aspartate aminotransferase \>2 times ULN. 20. Has any of the following cardiac findings at Screening: 1. Abnormal ECG that is, in the Investigator's opinion/evaluation, clinically significant; 2. PR interval \> 150 msec (2-5 years old); \> 170 msec (6-11 years old); or \> 180 msec (12-17 years old) 3. QRS interval \> 80 msec (2-5 years old); or \> 90 msec (6-17 years old) 4. QTcF interval \>450 msec (for males), or \>470 msec (for females) (QT corrected using Fridericia's method); 5. Second-or third-degree atrioventricular block; 6. Any rhythm, other than sinus rhythm, that is interpreted or assessed by the Investigator to be clinically significant. 21. Has received COVID-19 vaccine (single or 2nd dose) in the last 30 days prior to Screening. 22. Chronic or current use of inhaled corticosteroids, short acting beta-agonists or any other medication to manage asthma or other lung conditions such as emphysema. 23. Any other medical illness, condition, or clinical finding, including clinically significant abnormal laboratory values that in the opinion of the Investigator and/or the Sponsor, would put the subject at undue risk. **Maximum Age:** 17 Years **Minimum Age:** 3 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Joseph T Hull, PhD **Phone:** (240) 403-5324 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Lubna Jamal, MD, MBA **Phone:** 240-403-5727 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Supernus Pharmaceuticals **Name:** Jonathan Rubin, MD, MBA **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012466 - Term: Salivary Gland Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15604 - Name: Sialorrhea - Relevance: HIGH - As Found: Sialorrhea - ID: M15285 - Name: Salivary Gland Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012798 - Term: Sialorrhea ### Intervention Browse Module - Ancestors - ID: D000018726 - Term: Anti-Dyskinesia Agents - ID: D000065087 - Term: Acetylcholine Release Inhibitors - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018678 - Term: Cholinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000009465 - Term: Neuromuscular Agents - ID: D000018373 - Term: Peripheral Nervous System Agents ### Intervention Browse Module - Browse Branches - Abbrev: AnDyAg - Name: Anti-Dyskinesia Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaDiAg - Name: Vasodilator Agents ### Intervention Browse Module - Browse Leaves - ID: M254666 - Name: rimabotulinumtoxinB - Relevance: HIGH - As Found: Allegra - ID: M5183 - Name: Botulinum Toxins - Relevance: LOW - As Found: Unknown - ID: M21257 - Name: Botulinum Toxins, Type A - Relevance: HIGH - As Found: Allegra - ID: M3473 - Name: Acetylcholine - Relevance: LOW - As Found: Unknown - ID: M20758 - Name: Cholinergic Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000096323 - Term: rimabotulinumtoxinB - ID: D000019274 - Term: Botulinum Toxins, Type A ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02335879 **Brief Title:** Phase III Clinical Study of Domestic Recombinant Human Follitropin for Injection to Treat WHO Class II Anovulation #### Organization Study ID Info **ID:** GenSci 008 CT #### Organization **Class:** INDUSTRY **Full Name:** Changchun GeneScience Pharmaceutical Co., Ltd. ### Status Module #### Expanded Access Info #### Last Update Post Date **Date:** 2015-01-12 **Type:** ESTIMATED **Last Update Submit Date:** 2015-01-09 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2009-08 **Type:** ACTUAL #### Start Date **Date:** 2008-05 **Status Verified Date:** 2015-01 #### Study First Post Date **Date:** 2015-01-12 **Type:** ESTIMATED **Study First Submit Date:** 2015-01-05 **Study First Submit QC Date:** 2015-01-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Peking University People's Hospital **Class:** OTHER **Name:** Peking University First Hospital **Class:** OTHER **Name:** Reproductive & Genetic Hospital of CITIC-Xiangya **Class:** OTHER **Name:** Qilu Hospital of Shandong University **Class:** OTHER **Name:** Wuhan Union Hospital, China **Class:** OTHER **Name:** Second Hospital of Jilin University **Class:** OTHER **Name:** Shengjing Hospital **Class:** OTHER **Name:** The First Affiliated Hospital of Dalian Medical University **Class:** OTHER **Name:** Second Affiliated Hospital of Wenzhou Medical University #### Lead Sponsor **Class:** INDUSTRY **Name:** Changchun GeneScience Pharmaceutical Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** The purpose of this study is to evaluate the efficacy and safety of Domestic Recombinant Human Follitropin (Gonal-F) for Injection for treatment of WHO Ⅱ anovulation (including polycystic ovarian syndrome \[PCOS\] subjects). ### Conditions Module **Conditions:** - Anovulation ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 534 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Biological: Gonal-F **Label:** Recombinant Human Follitropin **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Recombinant Human Follitropin **Name:** Gonal-F **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Measure:** The efficiency reached mature follicle (the diameter of follicular ≥18mm by type-B ultrasonic) within the start period on the day of HCG day. **Time Frame:** participants will be followed within the HCG day, an expected average of 14±2 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Married infertile women at the age of 21-38. * BMI\<28kg/m2. * According to the detection level of serum estradiol (E2), prolactin (PRL), progesterone (P), testosterone (T), luteinizing hormone (LH), follicle stimulating hormone (FSH), subjects were diagnosed of WHO class II anovulation or oligo-ovulation, and the above hormone level of the subject is normal or normal after treatment at the beginning of study, and FSH\<10IU/L. * Bilateral fallopian tubes are unobstructed proved by hysterosalpingograph or laparoscopic examination within one year, no history of abortion or pelvic infection after the examination, the researcher decide whether the above examination need to repeat. If the subject had salpingoplasty under laparoscope, and the bilateral fallopian tubes are unobstructed after the surgery, there is no need to have the hysterosalpingograph. If it can not be confirmed, it must be done again to prove that the bilateral fallopian tubes are unobstructed. * Vaginal B-ultrasound examination shows that there is no ovarian pathological tumor, no hysteromyoma or hysteromyoma\<4cm, and does not affect the endometrial function. * Two examinations of spouse semen are normal within six months, or comply with the IUI standard. * No history of drug abuse. * Voluntarily sign the informed consent form and agree with medication and accepting evaluation according to the requirements of the research protocol. Exclusion Criteria: * The subject use gonadotropin therapy within the past three months (regardless the result of treatment). * The uterine factors affect pregnancy and other tumors. * Pregnancy contraindication, such as genetic diseases, mental diseases, drug abuse, sexually transmitted diseases, severe heart disease and hepatic and kidney function insufficiency. * Obscure vaginal bleeding. * Subjects are allergic to the application of FSH/HMG and HCG in the past. * Other conditions that the researchers think they are not suitable for the clinical trials. **Maximum Age:** 38 Years **Minimum Age:** 21 Years **Sex:** FEMALE **Standard Ages:** - ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010049 - Term: Ovarian Diseases - ID: D000000291 - Term: Adnexal Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases - ID: D000006058 - Term: Gonadal Disorders - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4184 - Name: Anovulation - Relevance: HIGH - As Found: Anovulation - ID: M12972 - Name: Ovarian Diseases - Relevance: LOW - As Found: Unknown - ID: M3643 - Name: Adnexal Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M9163 - Name: Gonadal Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000858 - Term: Anovulation ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M8759 - Name: Follicle Stimulating Hormone - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT04675879 **Brief Title:** Clinical and Radiological Results of Conservative Treatments in Proximal Humerus Fractures. **Official Title:** Clinical and Radiological Results of Conservative Treatments in Proximal Humerus Fractures.Prospective Randomized Trial #### Organization Study ID Info **ID:** 14052 #### Organization **Class:** OTHER **Full Name:** Bezmialem Vakif University ### Status Module #### Completion Date **Date:** 2023-02-23 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-02-24 **Type:** ACTUAL **Last Update Submit Date:** 2023-02-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-02-23 **Type:** ACTUAL #### Start Date **Date:** 2020-12-01 **Type:** ACTUAL **Status Verified Date:** 2023-02 #### Study First Post Date **Date:** 2020-12-19 **Type:** ACTUAL **Study First Submit Date:** 2020-12-15 **Study First Submit QC Date:** 2020-12-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Bezmialem Vakif University #### Responsible Party **Investigator Affiliation:** Bezmialem Vakif University **Investigator Full Name:** Murat Sarikas **Investigator Title:** Recident of orthopaedic surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In the investigators' prospective randomized study, the investigator will investigate the effect of different bandage types on functional and radiological results of proximal humerus fractures over 18 years of age, for whom conservative treatment is decided. In recent studies, it has been shown that surgical treatment in proximal humerus fractures has a high complication rate and is also not superior to conservative treatments in terms of functional results. Therefore, the importance of conservative treatment is increasing day by day in this group of fractures, especially in elderly patients with high risk for surgery. In these studies in the literature, the method in conservative treatment is not clearly specified, and the investigator will apply 3 different bandages to adjust the rotation of the shoulder in 3 different ways during the investigators' conservative treatment. The investigator will compare functional and radiological results between these groups. **Detailed Description:** Proximal humerus fractures, who are admitted to the investigators' emergency department and are decided to follow conservative follow-up criteria, will be given one of 3 different bandages (velpau bandage, classical shoulder arm sling, 30 degree padded shoulder arm sling) according to the previous randomization. Routinely, at the 2nd week, 6th week, 12th week, 6th month and 12th month outpatient clinic controls, the patients will be seen and their X-ray and clinical satisfaction status will be checked. X-rays will be taken as classical ap / lateral and true ap. At the end of the second week, which is absolute immobilization, elbow and wrist movements will begin. Afterwards, in the 6th week, according to the state of union with deltoid strengthening, passive and active shoulder joint range of motion exercises will be started. At the end of the 12th month, the follow-up will be terminated, and in this control, the existing joint movements will be recorded by measuring the degrees of anterior elevation, abduction, external rotation in neutral, external rotation at 90 degrees and internal rotation. In addition, in this control, the values will be noted by taking the Constant, ASES, DASH and VAS Scores. After all these values are noted for all 3 groups, statistical analysis between groups will be made for each variable and the result will be given. In addition, if complications(non-union,mal-union,stiffness etc.) occur during conservative follow-up in the investigators' patients, they will be recorded and whether there is a statistically significant difference in complications between the groups will be investigated. The investigators' aim in this study is to understand whether any of these 3 different bandage types, which are routinely used as an immobilization method in proximal humerus fractures, are superior to the other. A study comparing immobilization methods could not be found in the literature. These bandage types, which have not been compared with their effectiveness, are used effectively all over the world. With this study, the investigator set this on a scientific basis and set the correct direction of the investigators' treatments as the investigators' main goal. ### Conditions Module **Conditions:** - Proximal Humeral Fracture **Keywords:** - proximal humeral fractures - conservative treatments ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Previously randomized patients were divided into 3 groups to be treated with 3 different types of bandages. ##### Masking Info **Masking:** DOUBLE **Masking Description:** When the treatments are completed, those who will evaluate the clinical and radiological results will not know the treatment method. **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with velpau bandage. **Intervention Names:** - Device: Shoulder arm bandage **Label:** Velpau bandage (Group 1) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with shoulder arm sling. **Intervention Names:** - Device: Shoulder arm bandage **Label:** Shoulder arm sling (Group 2) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with padded shoulder arm sling with 30 degree abduction. **Intervention Names:** - Device: Shoulder arm bandage **Label:** Padded shoulder arm sling (Group 3) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Padded shoulder arm sling (Group 3) - Shoulder arm sling (Group 2) - Velpau bandage (Group 1) **Description:** Three different shoulder-arm bandage types **Name:** Shoulder arm bandage **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** degrees of external rotation achieved after conservative follow-up. **Measure:** External rotation degree **Time Frame:** 12 months #### Secondary Outcomes **Description:** degrees of anterior elevation achieved after conservative follow-up. **Measure:** Anterior elevation degree **Time Frame:** 12 months **Description:** degrees of abduction achieved after conservative follow-up. **Measure:** Abduction degree **Time Frame:** 12 months **Description:** degrees of internal rotation achieved after conservative follow-up. **Measure:** Internal rotation degree **Time Frame:** 12 months **Description:** DASH score obtained at the end of follow-up of patients who completed 12 months of conservative follow-up. Minimum and maximum values are respectively 0 and 100. Higher scores mean a worse outcome. **Measure:** DASH Score degree **Time Frame:** 12 months **Description:** Constant score obtained at the end of follow-up of patients who completed 12 months of conservative follow-up Minimum and maximum values are respectively 8 and 100. Higher scores mean a better outcome. **Measure:** Constant Score degree **Time Frame:** 12 months **Description:** ASES score obtained at the end of follow-up of patients who completed 12 months of conservative follow-up Minimum and maximum values are respectively 0 and 100. Higher scores mean a better outcome. **Measure:** ASES Score degree **Time Frame:** 12 months **Description:** VAS score obtained at the end of follow-up of patients who completed 12 months of conservative follow-up Minimum and maximum values are respectively 0 and 10. Higher scores mean a worse outcome. **Measure:** VAS Score degree **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Neer type 2, 3 and 4 proximal humerus fractures suitable for conservative follow-up * Patients older than 18 years Exclusion Criteria: * Previous surgery in the ipsilateral shoulder area * Fractured dislocation * Patients with open phys line * Patients with neurological problems affecting the upper extremity (MS, stroke, etc.) * Patients with fracture-induced neurovascular problems * Open fractures * Patients who require surgery for any reason while follw-up (malunion, nonunion, etc.) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Bezmialem Vakıf University **Zip:** 34500 #### Overall Officials **Official 1:** **Affiliation:** Bezmialem Vakif University **Name:** Mehmet Kapıcıoğlu **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** 6 months and 9 months after the start of the study. June 8 : The number of patients with follow-up reached 45. The 3rd month examinations were performed on half of our patients. **Description:** How many patients have been followed up so far? **Info Types:** - CSR **IPD Sharing:** YES **Time Frame:** 3 months ### References Module #### See Also Links **Label:** Manuel Soler-Peiro , Lorena García-Martínez , Luis Aguilella and Marcelino Perez-Bermejo . Conservative treatment of 3-part and 4-part proximal humeral fractures: a systematic review . Soler-Peiro et al. Journal of Orthopaedic Surgery and Research **URL:** https://doi.org/10.1186/s13018-020-01880-7 **Label:** Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial . PLOS Medicine **URL:** https://doi.org/10.1371/journal.pmed.1002855 **Label:** Lisa Howard , Randa Berdusco , Franco Momoli , J. Pollock , Allan Liew , Steve Papp , Karl-Andre Lalonde , Wade Gofton , Sara Ruggiero and Peter Lapner . Open reduction internal fixation vs non- operative management in proximal humerus fractures: a prosp **URL:** https://doi.org/10.1186/s12891-018-2223-3 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries - ID: D000001134 - Term: Arm Injuries - ID: D000070599 - Term: Shoulder Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M26370 - Name: Fractures, Bone - Relevance: HIGH - As Found: Fracture - ID: M9869 - Name: Humeral Fractures - Relevance: HIGH - As Found: Humeral Fractures - ID: M15592 - Name: Shoulder Fractures - Relevance: HIGH - As Found: Proximal Humeral Fracture - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M4444 - Name: Arm Injuries - Relevance: LOW - As Found: Unknown - ID: M602 - Name: Shoulder Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000050723 - Term: Fractures, Bone - ID: D000006810 - Term: Humeral Fractures - ID: D000012784 - Term: Shoulder Fractures ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02611479 **Brief Title:** Understanding Non-Response in Spine Fusion Surgery **Official Title:** Understanding Non-Response in Spine Fusion Surgery #### Organization Study ID Info **ID:** STUDY00001700 #### Organization **Class:** OTHER **Full Name:** University of Washington #### Secondary ID Infos **ID:** R21AR068009 **Link:** https://reporter.nih.gov/quickSearch/R21AR068009 **Type:** NIH ### Status Module #### Completion Date **Date:** 2018-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2019-05-08 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-08 **Type:** ACTUAL #### Results First Post Date **Date:** 2019-05-30 **Type:** ACTUAL **Results First Submit Date:** 2018-12-17 **Results First Submit QC Date:** 2019-05-08 #### Start Date **Date:** 2015-04 **Type:** ACTUAL **Status Verified Date:** 2019-05 #### Study First Post Date **Date:** 2015-11-20 **Type:** ESTIMATED **Study First Submit Date:** 2015-11-18 **Study First Submit QC Date:** 2015-11-19 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) #### Lead Sponsor **Class:** OTHER **Name:** University of Washington #### Responsible Party **Investigator Affiliation:** University of Washington **Investigator Full Name:** David Flum **Investigator Title:** Medical Director, Surgical Outcomes Research Center **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** To identify patient characteristics associated with non-response after spine fusion surgery for the treatment of degenerative disc disease (DDD). ### Conditions Module **Conditions:** - Spine Fusion **Keywords:** - patient reported outcomes ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 184 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Change in pain and function after spine fusion surgery was measured by the Oswestry Disability Index. Scores range from 0 to 100. The questionnaire has 10 questions about pain intensity, personal care, lifting ability, walking ability, sitting ability, standing ability, sleeping ability, sex ability, social life, and travelling. Each question is followed by 6 options which describe the amount of disability a patient may face in these situations and the patient marks the statement most applicable to them. Each question is scored on a scale (0-5) with the first option "0" indicating the least amount of disability and "5" indicating the most severe disability. Higher scores indicate worse outcomes, lower scores indicate better outcomes. **Measure:** Oswestry Disability Index **Time Frame:** Baseline, 60 day, 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subject has diagnosis of degenerative disc disease * Subject is undergoing lumbar spine fusion surgery Exclusion Criteria: * Subject is less than 18 years of age * Subject is not fluent in English * Subject requires a caretaker for medical decision making **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adults (18 and over) undergoing spine fusion surgery in Washington State. ### Contacts Locations Module #### Locations **Location 1:** **City:** Seattle **Country:** United States **Facility:** University of Washington **State:** Washington **Zip:** 98105 **Location 2:** **City:** Seattle **Country:** United States **Facility:** Proliance Surgeons **State:** Washington **Zip:** 98122 **Location 3:** **City:** Seattle **Country:** United States **Facility:** Swedish Medical Center **State:** Washington **Zip:** 98122 **Location 4:** **City:** Wenatchee **Country:** United States **Facility:** Confluence Health **State:** Washington **Zip:** 98801 #### Overall Officials **Official 1:** **Affiliation:** University of Washington **Name:** Amy M Cizik, MPH, PhC **Role:** STUDY_DIRECTOR ### References Module #### See Also Links **Label:** Related Info **URL:** http://www.becertain.org/ ## Document Section ### Large Document Module #### Large Docs - Date: 2019-02-06 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 599588 - Type Abbrev: Prot - Upload Date: 2019-05-08T18:48 - Date: 2019-02-06 - Filename: SAP_001.pdf - Has ICF: False - Has Protocol: False - Has SAP: True - Label: Statistical Analysis Plan - Size: 327210 - Type Abbrev: SAP - Upload Date: 2019-05-08T18:49 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** Adverse Events not tracked and are inapplicable to this study. #### Event Groups **Group ID:** EG000 **Title:** Spine Fusion Participants **Description:** Patients undergoing lumbar spine fusion surgery for any indication. **ID:** EG000 **Title:** Spine Fusion Participants **Frequency Threshold:** 0 **Time Frame:** Adverse Events not tracked and are inapplicable to this study. ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 149 **Units:** Participants ### Group **ID:** BG000 **Title:** Spine Fusion Participants **Description:** Patients undergoing lumbar spine fusion surgery for any indication. ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 71 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 78 **Category Title:** >=65 years #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 83 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 65 **Category Title:** Male #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 148 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 5 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 144 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Unknown or Not Reported #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 2 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 5 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 140 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 2 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Unknown or Not Reported #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 149 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** United States ### Measure #### Measurement **Group ID:** BG000 **Spread:** 15.4 **Value:** 41.3 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 9.2 **Value:** 55.0 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 9.6 **Value:** 52.5 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 7.4 **Value:** 55.4 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 1 **Category Title:** 1-3 months #### Measurement **Group ID:** BG000 **Value:** 4 **Category Title:** 3-6 months #### Measurement **Group ID:** BG000 **Value:** 19 **Category Title:** 6 months-1 year #### Measurement **Group ID:** BG000 **Value:** 39 **Category Title:** 1-5 years #### Measurement **Group ID:** BG000 **Value:** 51 **Category Title:** More than 5 years #### Measurement **Group ID:** BG000 **Value:** 35 **Category Title:** Missing #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 5.5 **Value:** 67.1 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 30 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** Not at all #### Measurement **Group ID:** BG000 **Value:** 38 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** To a slight degree #### Measurement **Group ID:** BG000 **Value:** 38 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** To a moderate degree #### Measurement **Group ID:** BG000 **Value:** 28 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** To a great degree #### Measurement **Group ID:** BG000 **Value:** 11 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** All the time ### Measure #### Measurement **Group ID:** BG000 **Value:** 42 **Category Title:** Alcohol #### Measurement **Group ID:** BG000 **Value:** 27 **Category Title:** Cannabis Use: Score Recoded #### Measurement **Group ID:** BG000 **Value:** 80 **Category Title:** Missing #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 106 **Category Title:** No #### Measurement **Group ID:** BG000 **Value:** 37 **Category Title:** Yes #### Measurement **Group ID:** BG000 **Value:** 6 **Category Title:** Missing #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 88 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 9 **Category Title:** Poor #### Measurement **Group ID:** BG000 **Value:** 43 **Category Title:** Fair #### Measurement **Group ID:** BG000 **Value:** 61 **Category Title:** Good #### Measurement **Group ID:** BG000 **Value:** 28 **Category Title:** Very good #### Measurement **Group ID:** BG000 **Value:** 8 **Category Title:** Excellent #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 8.1 **Value:** 54.8 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 8.8 **Value:** 55.2 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 112 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 149 **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** There is 1 missing. **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ### Measure 6 **Description:** Oswestry Low Back Pain Disability Index (ODI) Total Score Scale 0-100 Sub-Scale Measures (0-5) for each: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. Interpretation: Simply add up your points for each section and plug it in to the following formula in order to calculate your level of disability: point total / 50 X 100 = % disability (aka: 'point total' divided by '50' multiply by ' 100 = percent disability) Lower values represent better outcomes. Higher values represent worse outcomes. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Functional Limitations from back pain (ODI) **Unit of Measure:** units on a scale ### Measure 7 **Description:** PROMIS T Score: Total Anxiety Score 4 questions scaled 1-5 about anxiety, the raw score is the sum of these questions Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant. Lower values represent better outcomes. Higher values represent worse outcomes. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Anxiety **Unit of Measure:** T-scores ### Measure 8 **Description:** PROMIS T Score: Total Depression Score 4 questions scaled 1-5 about depression, the raw score is the sum of these questions Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant. Lower values represent better outcomes. Higher values represent worse outcomes. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Depression **Unit of Measure:** T-scores ### Measure 9 **Description:** PROMIS T Score: Total Sleep Disturbance Score 4 questions scaled 1-5 about sleep disturbance, the raw score is the sum of these questions Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant. Lower values represent worse outcomes. Higher values represent better outcomes. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Sleep **Unit of Measure:** T-scores ### Measure 10 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Pain chronicity **Unit of Measure:** Participants ### Measure 11 **Description:** PROMIS T Score: Total Pain Interference Score 4 questions scaled 1-5 about pain interference, the raw score is the sum of these questions Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant. Lower values represent better outcomes. Higher values represent worse outcomes. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Pain interference **Unit of Measure:** T-scores ### Measure 12 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Pain catastrophizing (fear avoidance) **Unit of Measure:** Participants ### Measure 13 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Alcohol, Marijuana Use **Unit of Measure:** Participants ### Measure 14 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Asthma **Unit of Measure:** Participants ### Measure 15 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Opioid/additional therapies use **Unit of Measure:** Participants ### Measure 16 **Description:** PROMIS G02: general quality of life **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Global health **Unit of Measure:** Participants ### Measure 17 **Description:** PROMIS T Score: Total Emotional Support Score 4 questions scaled 1-5 about emotional support, the raw score is the sum of these questions Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant. Lower values represent better outcomes. Higher values represent worse outcomes. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Emotional support **Unit of Measure:** T-scores ### Measure 18 **Description:** PROMIS T Score: Total Instrumental Support Score 4 questions scaled 1-5 about instrumental support, the raw score is the sum of these questions Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant. Lower values represent better outcomes. Higher values represent worse outcomes. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Instrumental support **Unit of Measure:** T-scores ### Measure 19 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Radiculopathy **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement ### Limitations and Caveats **Description:** Clinical variables were collected from SCOAP which is a quality improvement database and variables are not as reliable as research variables. It is unknown if participants that did not complete the surveys would have responded to surgery or not. ### Point of Contact **Email:** [email protected] **Organization:** Surgical Outcomes Research Center - SORCE **Phone:** 206-744-4631 **Title:** Dr. Amy Cizik - Research Assistant Professor, Ph.D., M.P.H., ## Results Section - Outcome Measures Module ### Outcome Measure 1 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 15.4 - **Upper Limit:** - **Value:** 41.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 17.1 - **Upper Limit:** - **Value:** 30.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 17.3 - **Upper Limit:** - **Value:** 19.4 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Change in pain and function after spine fusion surgery was measured by the Oswestry Disability Index. Scores range from 0 to 100. The questionnaire has 10 questions about pain intensity, personal care, lifting ability, walking ability, sitting ability, standing ability, sleeping ability, sex ability, social life, and travelling. Each question is followed by 6 options which describe the amount of disability a patient may face in these situations and the patient marks the statement most applicable to them. Each question is scored on a scale (0-5) with the first option "0" indicating the least amount of disability and "5" indicating the most severe disability. Higher scores indicate worse outcomes, lower scores indicate better outcomes. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** 140 participants out of the 149 baseline participant population were analyzed since 9 participants were excluded due to incomplete Oswestry Disability Index data. **Reporting Status:** POSTED **Time Frame:** Baseline, 60 day, 1 year **Title:** Oswestry Disability Index **Type:** PRIMARY **Unit of Measure:** score on a scale ##### Group **Description:** Patients undergoing lumbar spine fusion surgery for any indication. **ID:** OG000 **Title:** Spine Fusion Participants ### Participant Flow Module #### Group **Description:** Patients undergoing lumbar spine fusion surgery for any indication. **ID:** FG000 **Title:** Spine Fusion Participants #### Period **Title:** Baseline Enrollment ##### Withdraw **Type:** Exited study ###### Reason **Group ID:** FG000 **Number of Subjects:** 13 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 184 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 171 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 13 #### Period **Title:** Post-Surgery Follow-up at 30-90 Days ##### Withdraw **Type:** No surgery reported ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 171 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 169 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 2 #### Period **Title:** Post-Surgery Follow-up at 1-Year ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 18 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 169 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 151 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 18 #### Period **Title:** Data Cleaning ##### Withdraw **Type:** No baseline function or pain metrics ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 151 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 149 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 2 **Pre-Assignment Details:** If participants did not complete a baseline survey before their lumbar spine fusion surgery or were found to be ineligible they were excluded from the study before completing follow-up surveys. **Has Results:** True
## Protocol Section ### Identification Module **NCT ID:** NCT00565279 **Brief Title:** Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis **Official Title:** Efficacy and Safety of ASF 1057 Cream 0.5% in the Treatment of Seborrhoeic Dermatitis: A Phase III Randomised, Double-Blind, Vehicle and Placebo Controlled, Parallel Groups, Multi-Centre Trial. #### Organization Study ID Info **ID:** ASF1057-301 #### Organization **Class:** INDUSTRY **Full Name:** Astion Pharma A/S ### Status Module #### Completion Date **Date:** 2008-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2008-06-03 **Type:** ESTIMATED **Last Update Submit Date:** 2008-06-02 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2008-05 **Type:** ACTUAL #### Start Date **Date:** 2007-12 **Status Verified Date:** 2008-06 #### Study First Post Date **Date:** 2007-11-29 **Type:** ESTIMATED **Study First Submit Date:** 2007-11-28 **Study First Submit QC Date:** 2007-11-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Astion Pharma A/S #### Responsible Party **Old Name Title:** Dr Peder Andersen **Old Organization:** Astion Pharma A/S ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** A growing body of evidence supports the hypothesis that the pathophysiology of seborrhoeic dermatitis has a potentially causative neurogenic inflammatory aspect. ASF1057 is a new drug that acts through a modulation of neurogenic inflammation through important complementary mechanisms of action. This study will test the efficacy and safety of ASF1057 in the treatment of patients with seborrhoeic dermatitis. ### Conditions Module **Conditions:** - Seborrheic Dermatitis **Keywords:** - Seborrhoeic dermatitis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: ASF1057 **Label:** ASF1057 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: ASF1057 **Label:** ASF1057 placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Intervention Names:** - Drug: ASF1057 **Label:** ASF1057 Vehicle **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - ASF1057 - ASF1057 Vehicle - ASF1057 placebo **Description:** Twice daily, topical **Name:** ASF1057 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - ASF1057 - ASF1057 placebo **Description:** Twice daily, Topical **Name:** ASF1057 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Proportion of responders, defined as patients with OSS ≤ 1 score units. **Time Frame:** Baseline, day 7, day 14, and day 21 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Clinical diagnosis of moderate to severe seborrhoeic dermatitis Exclusion Criteria: * Other active skin diseases * Use of certain systemic and topical treatments * Extensive sun exposure **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Astion Pharma A/S **Name:** Peder M Andersen, MD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012871 - Term: Skin Diseases - ID: D000012625 - Term: Sebaceous Gland Diseases - ID: D000017443 - Term: Skin Diseases, Eczematous - ID: D000017444 - Term: Skin Diseases, Papulosquamous ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7067 - Name: Dermatitis - Relevance: HIGH - As Found: Dermatitis - ID: M15442 - Name: Dermatitis, Seborrheic - Relevance: HIGH - As Found: Seborrhoeic Dermatitis - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15439 - Name: Sebaceous Gland Diseases - Relevance: LOW - As Found: Unknown - ID: M19712 - Name: Skin Diseases, Eczematous - Relevance: LOW - As Found: Unknown - ID: M19713 - Name: Skin Diseases, Papulosquamous - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003872 - Term: Dermatitis - ID: D000012628 - Term: Dermatitis, Seborrheic ### Misc Info Module #### Removed Countries - Country: Denmark - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02806479 **Brief Title:** Hypertrophic Cardiomyopathy Pilot Study **Official Title:** Pilot Observational Case-control Study of the Electrical Heterogeneity in Patients With Hypertrophic Cardiomyopathy and High Arrhythmic Risk #### Organization Study ID Info **ID:** 15049 #### Organization **Class:** OTHER **Full Name:** Oregon Health and Science University ### Status Module #### Completion Date **Date:** 2020-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-09-16 **Type:** ACTUAL **Last Update Submit Date:** 2020-09-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-09 **Type:** ACTUAL #### Start Date **Date:** 2016-09 **Type:** ACTUAL **Status Verified Date:** 2020-09 #### Study First Post Date **Date:** 2016-06-20 **Type:** ESTIMATED **Study First Submit Date:** 2016-06-16 **Study First Submit QC Date:** 2016-06-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Oregon Health and Science University #### Responsible Party **Investigator Affiliation:** Oregon Health and Science University **Investigator Full Name:** Larisa Tereshchenko **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study evaluates mechanisms of arrhythmogenicity in hypertrophic cardiomyopathy, in comparison to patients with well-understood arrhythmogenic substrate (ischemic cardiomyopathy), as well as to individuals free from arrhythmogenic substrate ### Conditions Module **Conditions:** - Hypertrophic Cardiomyopathy - Coronary Artery Disease ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** HCM patients at high risk for ventricular arrhythmia **Intervention Names:** - Other: Observational: Arrhythmogenic Substrate **Label:** Case: Hypertrophic cardiomyopathy #### Arm Group 2 **Description:** Healthy Controls **Label:** Control I: Healthy #### Arm Group 3 **Description:** Ischemic cardiomyopathy patients with documented history of ventricular tachyarrhythmia and left ventricular hypertrophy **Intervention Names:** - Other: Observational: Arrhythmogenic Substrate **Label:** Control II: Post-MI with arrhythmogenic substrate #### Arm Group 4 **Description:** Ischemic cardiomyopathy patients without ventricular arrhythmia, as proven by non-inducibility and history of freedom from ventricular tachyarrhythmia during at least one ICD generator life **Label:** Control III: VT/VF-free ischemic cardiomyopathy ### Interventions #### Intervention 1 **Arm Group Labels:** - Case: Hypertrophic cardiomyopathy - Control II: Post-MI with arrhythmogenic substrate **Name:** Observational: Arrhythmogenic Substrate **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Non-invasively reconstructed epicardial activation map **Time Frame:** within one day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosed HCM * Documented history of sustained ventricular tachyarrhythmia or resuscitated sudden cardiac arrest * Maximal left ventricular wall thickness of \> 30mm * Extensive fibrosis on cardiac MRI (\>15% of total myocardial volume) * \>7.5%/5-year risk of sudden cardiac death as determined by HCM risk-SCD Exclusion Criteria: * age \< 18 years * Pregnancy * Atrial Fibrillation **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Case - Control study of hypertrophic cardiomyopathy patients at high risk for ventricular arrhythmias in comparison to three Controls groups ### Contacts Locations Module #### Locations **Location 1:** **City:** Portland **Country:** United States **Facility:** Oregon Health and Science University **State:** Oregon **Zip:** 97239 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Perez-Alday EA, Haq KT, German DM, Hamilton C, Johnson K, Phan F, Rogovoy NM, Yang K, Wirth A, Thomas JA, Dalouk K, Fuss C, Ferencik M, Heitner S, Tereshchenko LG. Mechanisms of Arrhythmogenicity in Hypertrophic Cardiomyopathy: Insight From Non-invasive Electrocardiographic Imaging. Front Physiol. 2020 Apr 24;11:344. doi: 10.3389/fphys.2020.00344. eCollection 2020. **PMID:** 32390862 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003327 - Term: Coronary Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000001020 - Term: Aortic Stenosis, Subvalvular - ID: D000001024 - Term: Aortic Valve Stenosis - ID: D000082862 - Term: Aortic Valve Disease - ID: D000006349 - Term: Heart Valve Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12154 - Name: Cardiomyopathies - Relevance: HIGH - As Found: Cardiomyopathy - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M10035 - Name: Hypertrophy - Relevance: HIGH - As Found: Hypertrophic - ID: M5568 - Name: Cardiomyopathy, Hypertrophic - Relevance: HIGH - As Found: Hypertrophic Cardiomyopathy - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M6475 - Name: Constriction, Pathologic - Relevance: LOW - As Found: Unknown - ID: M4340 - Name: Aortic Valve Stenosis - Relevance: LOW - As Found: Unknown - ID: M2379 - Name: Aortic Valve Disease - Relevance: LOW - As Found: Unknown - ID: M9437 - Name: Heart Valve Diseases - Relevance: LOW - As Found: Unknown - ID: T449 - Name: Aortic Valve Stenosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003324 - Term: Coronary Artery Disease - ID: D000009202 - Term: Cardiomyopathies - ID: D000002312 - Term: Cardiomyopathy, Hypertrophic - ID: D000006984 - Term: Hypertrophy ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT06247579 **Brief Title:** Effects of Dietary Polystyrene Microplastics on Anxiety- and Depression-like Behaviors **Official Title:** Effects of Dietary Polystyrene Microplastics From Disposable Plastic Tableware on Anxiety- and Depression-like Behaviors #### Organization Study ID Info **ID:** Dietary #### Organization **Class:** OTHER **Full Name:** Northern Jiangsu People's Hospital ### Status Module #### Completion Date **Date:** 2024-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-02-09 **Type:** ACTUAL **Last Update Submit Date:** 2024-02-07 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-04-25 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-02-08 **Type:** ACTUAL **Study First Submit Date:** 2024-01-07 **Study First Submit QC Date:** 2024-01-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Northern Jiangsu People's Hospital #### Responsible Party **Investigator Affiliation:** Northern Jiangsu People's Hospital **Investigator Full Name:** WenJing Zhao **Investigator Title:** M.D.; attending doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The objective of this clinical trial is to explore the potential impact of dietary polystyrene microplastics on anxiety- and depression-like behaviors in resident physicians. Specifically, the study aims to address two key questions: 1. Can dietary polystyrene microplastics induce alterations in the human gut microbiome? 2. Can dietary polystyrene microplastics exacerbate anxiety- and depression-like behaviors? Participants will be divided into two groups based on their habitual eating practices: The control group, consisting of resident physicians, will use non-disposable plastic tableware (NDPT) provided by hospital canteens for two months. In contrast, the exposure group, also comprising resident physicians, will use disposable plastic tableware (DPT) made of polystyrene, provided by the same hospital canteens, over the same period. **Detailed Description:** The mental health and well-being of resident physicians is a critical topic that has gained increasing attention recently. Recent studies have shown a growing prevalence of mental health illnesses worldwide. For medical trainees and resident physicians, high rates of depression, anxiety, suicidal ideation, and burnout have been consistently observed. Moreover, contemporary research suggests that dietary exposure plays a pivotal role in the development of mental illnesses. Disposable plastic tableware, commonly used during resident training programs, could be a contributing factor. However, the specific effects of dietary exposure from such tableware on mental health, particularly through the gut-brain axis, remain largely unexplored. Consequently, investigating the potential impact of dietary polystyrene microplastics on anxiety- and depression-like behaviors in resident physicians is essential. ### Conditions Module **Conditions:** - Depression, Anxiety **Keywords:** - Gut microbiome - Anxiety - Depression - Polystyrene microplastics ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The exposure group will use disposable plastic tableware (DPT) made of polystyrene, provided by the hospital canteens for two months ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The control group, consisting of resident physicians, will use non-disposable plastic tableware (NDPT) provided by hospital canteens for two months. **Label:** The control group **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** The exposure group, also comprising resident physicians, will use disposable plastic tableware (DPT) made of polystyrene, provided by the same hospital canteens for two months **Intervention Names:** - Other: Dietary polystyrene microplastics from disposable plastic tableware **Label:** The exposure group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - The exposure group **Description:** Microplastic release from the daily use of disposable plastic materials (e.g., plastic boxes) when holding hot food or drink. **Name:** Dietary polystyrene microplastics from disposable plastic tableware **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** In this study, the researchers utilized the Chinese version of the Depression Anxiety Stress Scales-21 (DASS-21), a widely recognized and reliable instrument for assessing depression, anxiety, and stress. This comprehensive tool is divided into three sections, each dedicated to evaluating the levels of depression, anxiety, and stress, respectively. The depression scale scores range from 0 to 21, with normal scores falling below 4. Anxiety scores also range from 0 to 21, with normal scores below 3. For stress, scores range from 0 to 18, with scores below 7 considered normal. Higher scores on any of these scales indicate elevated levels of depression, anxiety, or stress. In this research, the DASS-21 was employed to monitor the variations in anxiety and depression-like behaviors among the two groups, both at baseline and after the treatment period. **Measure:** Assessing mental status using the depression anxiety stress scales-21 (DASS-21) questionnaire **Time Frame:** At the baseline and end of this clinical trial an average of two months. the enrolled participants will be asked to complete the DASS-21 questionnaire. #### Secondary Outcomes **Description:** The gut microbiota encompasses the microorganisms residing in the human gastrointestinal tract. Microbial diversity refers to the variety of different species present in the gut microbiome. In this study, DNA extraction from fecal samples is carried out in two primary steps. Initially, the sample undergoes purification using multiple reagents and centrifugation. This process isolates the microbes by removing other fecal components. The next step involves lysing bacterial cells; this is achieved by incubating the samples in lysis buffer with agitation. Subsequently, the extracted DNA is amplified through techniques such as multiple displacement amplification. A 16S rRNA primer is then selected for gene sequencing. The sequences obtained from the 16S rRNA will be analyzed to ascertain the gut microbial diversity at the species level. **Measure:** Alterations in human gut microbial diversity investigated through 16S rRNA **Time Frame:** At the beginning and conclusion of this clinical trial, spanning an average duration of two months, the enrolled participants will be asked to provide fecal samples ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Volunteer resident physician at the base of Northern Jiangsu Hospital, Yangzhou, China Exclusion Criteria: * received chemotherapy, radiotherapy, or surgery in the 3 -6 months before sampling * diagnosed with mental illness * diagnosed with digestive system diseases **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ju Gao **Phone:** +8618118206088 **Role:** CONTACT #### Locations **Location 1:** **City:** Yangzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ju Gao - **Phone:** +8618118206088 - **Role:** CONTACT **Country:** China **Facility:** Ju Gao **State:** Jiangsu **Status:** RECRUITING **Zip:** 225001 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder - ID: D000001008 - Term: Anxiety Disorders ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT01445379 **Brief Title:** Phase I Study of Ipilimumab (Anti-CTLA-4) in Children and Adolescents With Treatment-Resistant Cancer **Official Title:** A Phase I Study of Ipilimumab (Anti-CTLA-4) in Children, Adolescents, and Young Adults With Treatment Refractory Cancer **NCT ID Aliases:** - NCT00556881 #### Organization Study ID Info **ID:** 080007 #### Organization **Class:** NIH **Full Name:** National Institutes of Health Clinical Center (CC) #### Secondary ID Infos **ID:** 08-C-0007 ### Status Module #### Completion Date **Date:** 2015-11-13 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-12-17 **Type:** ACTUAL **Last Update Submit Date:** 2019-12-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-04-18 **Type:** ACTUAL #### Start Date **Date:** 2007-10-01 **Status Verified Date:** 2015-11-13 #### Study First Post Date **Date:** 2011-10-03 **Type:** ESTIMATED **Study First Submit Date:** 2011-09-30 **Study First Submit QC Date:** 2011-09-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NIH **Name:** National Cancer Institute (NCI) ### Description Module **Brief Summary:** This study will examine the safety and efficacy of ipilimumab-an experimental cancer treatment drug used to boost immune response-in children, adolescents, and young adults. Ipilimumab may allow immune cells to react to and destroy abnormal cells in the body, and has been tested in adults for a variety of cancers and has shown responses in some research studies. Because ipilimumab has not been tested in children, adolescents, or young adults, it is considered an experimental drug. The purposes of this research study are to determine the highest safe dose of ipilimumab for children, adolescents, and young adults with solid tumor cancers; examine its effectiveness and possible side effects; and better understand how the body and the immune system process it over time. Candidates must be between 2 and 21 years of age and must have solid malignant tumors that have been resistant to standard therapy. Volunteers will be screened with a medical history, a clinical examination, and computerized scans such as magnetic resonance imaging (MRI). Participants must have completed their last dose of chemotherapy, radiation, chemotherapy, or antibody or investigational therapy at least four weeks prior to enrollment. During the study, participants will receive an intravenous dose of ipilimumab once every three weeks. The infusion of ipilimumab will last 90 minutes, and the participant s vital signs will be monitored while the medicine is infusing and several times in the first 24 hours after the first dose (requiring a hospital stay during that time). If the participant is able to tolerate the first dose of ipilimumab, further doses (called cycles ) may be received on an outpatient basis. Blood and urine tests will be given on a regular basis during these cycles. After four cycles, participants whose tumors do not grow and who do not have unacceptable side effects will continue to receive ipilimumab every three months to maintain the current condition, until researchers conclude the study. **Detailed Description:** Background: Solid tumors represent approximately one fourth of cancer diagnoses in children. Despite intensive regimens, patients with metastatic or recurrent solid tumors have unsatisfactory survival rates. Therefore new therapies are needed to improve outcomes. Accumulating preclinical and clinical evidence supports the use of biologic approaches to heighten antitumor immunity in order to improve the effectiveness of immune based therapy. Both directly activating immune based therapies such as cytokines and tumor vaccines as well as therapies which disrupt negative counterregulatory signals such as those mediated by CTLA-4:B7 may enhance existent antitumor immune responses. Antibodies directed against CTLA-4 potently augment immune responses in animal models and anti-CTLA-4 antibodies have demonstrated antitumor effects in a variety of preclinical tumor models. Phase I and phase II studies using ipilimumab have been performed in adults with a variety of tumor types. Clinical responses have been observed in renal cell carcinoma, melanoma, and prostate cancer. No trials have yet been performed to evaluate ipilimumab in children with malignancy. Objectives: To determine the tolerance and toxicity profile of ipilimumab at a range of doses up to, but not exceeding, the highest dose tolerated in adults, in patients less than or equal to 21 years of age with refractory solid tumors. To assess the pharmacokinetics of ipilimumab administered intravenously in patients less than or equal to 21 years of age with advanced and/or refractory solid tumors. Eligibility: Patients must be 1-21 years of age at the time of enrollment with solid malignant tumors refractory to standard therapy. Design: A Phase I dose finding study with 4 planned dose levels. Three patients will be enrolled at each dose level with an expanded cohort of 12 at the highest or maximum torlerated dose with intent to include 6 patients \< 12 years. Re-induction with 4 infusions of ipilimumab at the assigned dose followed by another maintenance phase is possible for subjects who have progressed during maintenance therapy. ### Conditions Module **Conditions:** - Sarcoma - Wilm's Tumor - Lymphoma - Neuroblastoma **Keywords:** - Solid Tumor - Monoclonal Antibody - Pediatrics - Pharmacokinetics - Immunotherapy - Sarcoma - Lymphoma - Neuroblastoma ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 33 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Ipilumumab (DSE) given on day 1 of 21 day cycle for 4 cycles, from cycle 5+ ipilumumab will be given \~every 12wks **Intervention Names:** - Drug: Ipilimumab **Label:** 1 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 **Description:** Dose Level Escalation: 1mg/kg, 3mg/kg, 5mg/kg, 10mg/kg **Name:** Ipilimumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** To determine the tolerance and toxicity profile **Time Frame:** 1 year **Measure:** Pharmacokinetics **Time Frame:** 1 year #### Secondary Outcomes **Measure:** Evaluate immunomodulatory activity. **Time Frame:** 2 years **Measure:** Quantify antitumor effects **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** * INCLUSION CRITERIA: AGE: Patients must be greater than or equal to 1 years and less than or equal to 21 years of age. DIAGNOSIS: Histologically confirmed solid tumors, which may include but are not limited to rhabdomyosarcoma and other soft tissue sarcomas, Ewing s sarcoma family of tumors, osteosarcoma, neuroblastoma, Wilm s tumor, Hodgkin's or non-Hodgkin's lymphoma. Patients with melanoma are eligible. Patients with a previous history of CNS metastases are eligible if the metastases have been treated with surgery and/or radiotherapy, are clinically stable as evidenced by no requirements for corticosteroids, the patient has no evolving neurologic deficits and no progression in residual brain abnormalities without specific therapy over 4 weeks. MEASURABLE/EVALUABLE DISEASE: Patients must have measurable or evaluable tumors. PRIOR THERAPY: * The patient s cancer must have relapsed following or failed to respond to standard therapy and/or the patient s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival. * Patients must have completed their last dose of irradiation, chemotherapy, monoclonal antibody, or investigational therapy at least 4 weeks prior to enrollment. For patients who have undergone autologous stem cell transplantation, at least 3 months must have elapsed since transplant. * Patients must have recovered from the toxic effects (to a grade 1 or less) of all prior therapy prior to enrollment, with the exception of the following: * Hematological toxicity: recovery to levels required below * Low electrolyte levels (Such individuals should receive appropriate supplementation) * For patients on anticoagulant therapy or with pre-existing coagulation abnormalities, PT, PTT must return to baseline. * Liver function tests must resolve to values required below * Grade 3 hypoalbuminemia * Alopecia * Sterility PERFORMANCE STATUS: Patients greater than 10 years old must have a Karnofsky Score of greater than or equal to 50 and children less than 10 years old must have a Lansky score of greater than 50. Patients who are unable to walk because of paralysis or weakness, but who are up in a wheelchair will be considered ambulatory for the purpose of calculating the performance score. HEMATOLOGIC FUNCTION: Patients must have adequate bone marrow function, defined as a peripheral absolute granulocyte count of greater than or equal to 1000/microL, hemoglobin greater than or equal to 8 gm/dl, and a platelet count greater than or equal to 50,000/microL (may be corrected with transfusions). HEPATIC FUNCTION: Aspartate transaminase (AST) and alanine transaminase (ALT), less than or equal to 2.5-fold the upper limit of normal (ULN). Normal total bilirubin. RENAL FUNCTION: Patients must have normal age-adjusted serum creatinine (see table below) OR a creatinine clearance greater than or equal to 70 mL/min/1.73 m(2). MAXIMUM SERUM CREATININE LEVEL FOR AGE: * For children whose age is less than or equal to 5 years, 0.8 mg/dL * For children whose age is greater than 5 but less than or equal to 10, 1.0 mg/dL * For children whose age is greater than 10 but less than or equal to 15, 1.2 mg/dL * For children whose age is greater than 15, 1.5 mg/dL INFECTIOUS DISEASE: -A patient with viral hepatitis (HBV, HCV) or human immunodeficiency virus (HIV) will be excluded from trial to limit confounding variables in the assessment of the potential hepatic toxicity of ipilimumab and uncertain impact of ipilimumab administration on viral replication. Serology will not be required unless infection is clinically suspected. A positive hepatitis B titer does not exclude a patient if immunization has been performed and if there is no history of disease. INFORMED CONSENT: All patients or their legal guardians (if the patient is less than 18 years old) must sign a document of informed consent (Pediatric Oncology Branch, NCI screening protocol for NIH patients) prior to performing studies to determine patient eligibility. After confirmation of eligibility, all patients or their legal guardians must voluntarily sign the IRB approved protocol specific informed consent to document their understanding of the investigational nature, the risks of this study and their willingness to receive the therapy and undergo the research studies involved including pharmacokinetic studies. The consent must be signed before any protocol related studies are performed (This does not include routine laboratory tests or imaging studies required to establish eligibility). When appropriate, pediatric patients will be included in all discussions in order to obtain verbal assent. DURABLE POWER OF ATTORNEY (DPA): Patients who are greater than or equal to 18 years of age will be offered the opportunity to assign a DPA so that another person can make decisions about their medical care if they become incapacitated or cognitively impaired. BIRTH CONTROL: Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control which includes abstinence, while they are being treated on this study and for 60 days following the last dose. Females of childbearing potential must have a negative pregnancy test within 14 days prior to initiation of study therapy and prior to each additional dose of ipilimumab. EXCLUSION CRITERIA: * Primary brain tumors * Clinically significant unrelated systemic illness, such as serious infections or organ dysfunction, which in the judgment of the Principal or Associate Investigators would compromise the patient s ability to tolerate the agents in this trial or are likely to interfere with the study procedures or results. This includes but is not limited to: * Critically-ill or medically unstable patients * Patients with active infection or other significant systemic illness * Patients with active diarrhea * Patients with active eye inflammation, uveitis * Presence of a symptomatic pleural effusion * Patients with symptoms of congestive heart failure or uncontrolled cardiac rhythm disturbance * History of malignant hyperthermia * Concurrent or history of autoimmune disease excluding stable asthma * Positive direct Coombs testing or history of hemolytic anemia * Patients with a history of ongoing or intermittent bowel obstruction * Concurrent radiation * Patients with a history of allogeneic bone marrow transplantation. * Untreated CNS metastases will render the patient ineligible however patients with a previous history of CNS metastases are eligible if: the metastases have been treated with surgery and/or radiotherapy, are clinically stable as evidenced by no requirements for corticosteroids, the patient has no evolving neurologic deficits and no progression in residual brain abnormalities without specific therapy are eligible one week post radiation or radiosurgery. Patients with asymptomatic subcentemeric CNS lesions will be eligible for trial if no immediate radiation or surgery. * Patients with a history of previous therapy with ipilimumab will be excluded from study participation. * Treatment with any of the following immunomodulatory agents within 14 days prior to study entry: --Systemic corticosteroid therapy ---Erythropoeitin * Retinoic acid * Fenretinide * Interferons or interleukins * Cytokine-fusion proteins * Growth hormone * IVIG * Treatment with myeloid growth factors (GM-CSF or G-CSF) within 72 hours prior to study entry. * Patients with autoimmune disease, including autoimmune hemolytic anemia, ulcerative and hemorrhagic colitis, endocrine disorders (e.g., thyroiditis, hyperthyroidism, hypothyroidism, autoimmune hypophysitis/hypopituitarism, and adrenal insufficiency), sarcoid granuloma, myasthenia gravis, polymyositis, and Guillain-Barre syndrome. * Pregnant or breastfeeding females are excluded because ipilimumab may be harmful to the developing fetus or nursing child. * Concurrent administration of any other investigational agent. **Maximum Age:** 21 Years **Minimum Age:** 3 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bethesda **Country:** United States **Facility:** National Institutes of Health Clinical Center, 9000 Rockville Pike **State:** Maryland **Zip:** 20892 **Location 2:** **City:** Boston **Country:** United States **Facility:** Dana Farber Cancer Institute **State:** Massachusetts **Zip:** 02115 **Location 3:** **City:** New York **Country:** United States **Facility:** Memorial Sloan Kettering Cancer Center **State:** New York **Zip:** 10021 #### Overall Officials **Official 1:** **Affiliation:** National Cancer Institute (NCI) **Name:** Melinda S Merchant, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Linet MS, Ries LA, Smith MA, Tarone RE, Devesa SS. Cancer surveillance series: recent trends in childhood cancer incidence and mortality in the United States. J Natl Cancer Inst. 1999 Jun 16;91(12):1051-8. doi: 10.1093/jnci/91.12.1051. **PMID:** 10379968 **Citation:** Dunn GP, Old LJ, Schreiber RD. The three Es of cancer immunoediting. Annu Rev Immunol. 2004;22:329-60. doi: 10.1146/annurev.immunol.22.012703.104803. **PMID:** 15032581 **Citation:** Zou W. Immunosuppressive networks in the tumour environment and their therapeutic relevance. Nat Rev Cancer. 2005 Apr;5(4):263-74. doi: 10.1038/nrc1586. **PMID:** 15776005 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000018241 - Term: Neuroectodermal Tumors, Primitive, Peripheral - ID: D000018242 - Term: Neuroectodermal Tumors, Primitive - ID: D000018302 - Term: Neoplasms, Neuroepithelial - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000018193 - Term: Neoplasms, Complex and Mixed - ID: D000007680 - Term: Kidney Neoplasms - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009386 - Term: Neoplastic Syndromes, Hereditary - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11220 - Name: Lymphoma - Relevance: LOW - As Found: Unknown - ID: M15327 - Name: Sarcoma - Relevance: HIGH - As Found: Sarcoma - ID: M12341 - Name: Wilms Tumor - Relevance: HIGH - As Found: Wilms Tumor - ID: M12391 - Name: Neuroblastoma - Relevance: HIGH - As Found: Neuroblastoma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: M20387 - Name: Neuroectodermal Tumors, Primitive, Peripheral - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M20446 - Name: Neoplasms, Neuroepithelial - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: M10703 - Name: Kidney Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M12331 - Name: Neoplastic Syndromes, Hereditary - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown - ID: T5284 - Name: Soft Tissue Sarcoma - Relevance: LOW - As Found: Unknown - ID: T5932 - Name: Wilms' Tumor - Relevance: HIGH - As Found: Wilms Tumor - ID: T4085 - Name: Neuroblastoma - Relevance: HIGH - As Found: Neuroblastoma - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012509 - Term: Sarcoma - ID: D000009447 - Term: Neuroblastoma - ID: D000009396 - Term: Wilms Tumor ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M1348 - Name: Ipilimumab - Relevance: HIGH - As Found: While - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000074324 - Term: Ipilimumab ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT00644579 **Brief Title:** bLAC - Treatment of Cutaneous Warts in Immune Suppressed, Kidney Transplanted Patients **Official Title:** bLAC - A Phase II Double-Blind, Placebo Controlled, Clinical Proof of Concept Trial of the Efficacy of 8 Weeks Treatment of Cutaneous Warts With bLAC in Immune Suppressed, Kidney Transplanted Patients #### Organization Study ID Info **ID:** CL-1205 #### Organization **Class:** INDUSTRY **Full Name:** NatImmune A/S #### Secondary ID Infos **ID:** EudraCT number: 2007-006738-33 ### Status Module #### Completion Date **Date:** 2009-02 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2008-03-27 **Type:** ESTIMATED **Last Update Submit Date:** 2008-03-26 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2008-12 **Type:** ESTIMATED #### Start Date **Date:** 2008-03 **Status Verified Date:** 2008-03 #### Study First Post Date **Date:** 2008-03-27 **Type:** ESTIMATED **Study First Submit Date:** 2008-03-25 **Study First Submit QC Date:** 2008-03-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** NatImmune A/S #### Responsible Party **Old Name Title:** NatImmune A/S **Old Organization:** NatImmune ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** As many as 85 % of renal transplant patients may suffer from viral warts with a high degree of treatment resistance. Promising results of hLAC (human lactalbumin complex with lipid) point to a beneficial effect without noticeable side effects of bLAC (bovine lactalbumin complex with lipid). The aim of first clinical trial with bLAC is to show proof of concept in treatment of cutaneous wart lesions on hands and/or feet after local administration of bLAC in two dose groups to immune suppressed, kidney transplanted patients. ### Conditions Module **Conditions:** - Cutaneous Warts **Keywords:** - wart - cutaneous - transplant - Cutaneous warts in immune suppressed, kidney transplant patients ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** bLAC high dose **Intervention Names:** - Drug: bLAC **Label:** 1 **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** bLAC low dose **Intervention Names:** - Drug: bLAC **Label:** 2 **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Intervention Names:** - Drug: Placebo **Label:** 3 **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 - 2 **Description:** bLAC high and low dose and placebo **Name:** bLAC **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 3 **Description:** Placebo **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Reduction in the area of wart lesions located on fingers and/or palms and/or toes and/or soles of the feet, measured by an objective method by drawing of individual lesions **Time Frame:** Prospective #### Secondary Outcomes **Measure:** Clearance of index wart lesions. Time to clearance of warts. Recurrence rate of previously cleared wart lesions. Occurrence of new warts.overall changes of index warts lesions. Safety and tolerability. **Time Frame:** Prospective ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Cutaneous warts on ingers and/or palms and/or toes and/or soles of feet * Common warts and mosaic warts, diagnosed by an experienced dermatologist * Solitary wart lesions or 2 or more lesions per patient * Lesions present for more than 6 months * Men or women, aged 18 or above * History of kidney transplantation and immune suppressive therapy after transplant * Concomitant immune suppressive therapy stable for 6 months prior to randomization * Agreement from patient to allow photographs to be taken and used as part of trial data documentation (2 centres) * Women of childbearing potential must have negative pregnancy test at screening and must use adequate contraception * Ability to comply with requirements of trial * Written informed consent Exclusion Criteria: * Verruca plana lesions * Suspected allergy to milk verified by serum analysis of IgE towards cow milk * Breastfeeding * Any local medication for any purpose other than wart treatment in target area during 4 weeks prior to randomization and during treatment period * Concomitant treatment with other wart therapies two weeks prior to randomization and during trial period * Intolerance towards bovine alpha-lactalbumin, oleic acid or any excipient in the formulation * Known HIV infection or any current uncontrolled infection * Any chronic or acute skin condition susceptible of interfering with evaluation of drug effect in this trial * Participation in any investigational trial or use of any investigational drug within 30 days prior to inclusion in this trial * Any health problems which according to Investigator's clinical judgment will make the patient unsuitable for inclusion in the trial **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Claus Zachariae, MD, Chief Physician **Phone:** +4539773203 **Role:** CONTACT #### Locations **Location 1:** **City:** Aalborg **Contacts:** ***Contact 1:*** - **Name:** Henrik Sølvsten, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Denmark **Facility:** Dermatology Clinic, Vesterbro **Status:** RECRUITING **Zip:** DK-9000 **Location 2:** **City:** Aarhus C **Contacts:** ***Contact 1:*** - **Name:** Mette S Deleuran, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Denmark **Facility:** Marselisborg University Hospital **Status:** RECRUITING **Zip:** DK-8000 **Location 3:** **City:** Copenhagen NV **Contacts:** ***Contact 1:*** - **Name:** Merete Hædersdal, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Denmark **Facility:** Bispebjerg University Hospital **Status:** RECRUITING **Zip:** DK-2400 **Location 4:** **City:** Hellerup **Contacts:** ***Contact 1:*** - **Name:** Claus Zachariae, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Denmark **Facility:** Gentoftte Amtssygehus **Status:** RECRUITING **Zip:** DK-2900 **Location 5:** **City:** Odense **Contacts:** ***Contact 1:*** - **Name:** Henrik Lorentzen, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Denmark **Facility:** Odense University Hospital **Status:** RECRUITING **Zip:** DK-5000 #### Overall Officials **Official 1:** **Affiliation:** Gentofte Amtssygehus **Name:** Claus Zachariae, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000030361 - Term: Papillomavirus Infections - ID: D000004266 - Term: DNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000007239 - Term: Infections - ID: D000017193 - Term: Skin Diseases, Viral - ID: D000014412 - Term: Tumor Virus Infections - ID: D000012874 - Term: Skin Diseases, Infectious - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M17603 - Name: Warts - Relevance: HIGH - As Found: Warts - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M23687 - Name: Papillomavirus Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M7442 - Name: DNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M19501 - Name: Skin Diseases, Viral - Relevance: LOW - As Found: Unknown - ID: M17162 - Name: Tumor Virus Infections - Relevance: LOW - As Found: Unknown - ID: M15677 - Name: Skin Diseases, Infectious - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014860 - Term: Warts ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT00686179 **Acronym:** TQT **Brief Title:** Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days **Official Title:** A Double-Blind, Randomised, Multicentre, Placebo-Controlled, 4-Ways Crossover Study to Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days, Using Moxifloxacin as a Positive Control, in Healthy Male Volunteers, CYP2D6 Extensive and Poor Metabolisers. #### Organization Study ID Info **ID:** D3690C00004 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca #### Secondary ID Infos **ID:** EUdract NO 2007-004859-11 ### Status Module #### Completion Date **Date:** 2008-08 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2008-09-25 **Type:** ESTIMATED **Last Update Submit Date:** 2008-09-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2008-08 **Type:** ACTUAL #### Start Date **Date:** 2008-01 **Status Verified Date:** 2008-09 #### Study First Post Date **Date:** 2008-05-29 **Type:** ESTIMATED **Study First Submit Date:** 2008-05-27 **Study First Submit QC Date:** 2008-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Old Name Title:** Hans-Göran Hårdemark, MD, PhD, Medical Science Director, AZD3480 **Old Organization:** AstraZeneca R&D, Södertälje, Sweden ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate the effects on cardiac repolarisation of supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using moxifloxacin as positive control. ### Conditions Module **Conditions:** - Healthy **Keywords:** - TQT - ECG - QT - QTc - AZD3480 - ECG(QTc effects) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 75 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Escalating doses of AZD3480 during 6 days **Intervention Names:** - Drug: AZD3480 **Label:** 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Repeated doses of AZD3480 during 6 days **Intervention Names:** - Drug: AZD3480 **Label:** 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Placebo during 6 days **Intervention Names:** - Drug: PLACEBO **Label:** 3 **Type:** PLACEBO_COMPARATOR #### Arm Group 4 **Description:** Placebo during 5 days, active day 6 **Intervention Names:** - Drug: Moxifloxacin **Label:** 4 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 - 2 **Description:** Capsule, oral, single dose, 6 days **Name:** AZD3480 **Other Names:** - TC-1734-226 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 4 **Description:** Capsule(encapsulated), oral, single dose **Name:** Moxifloxacin **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - 3 **Description:** Capsule, oral, single dose **Name:** PLACEBO **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** QTcX interval (supratherapeutic doses in comparison to placebo).Subject-specific correction of QT, QTcF and QTcB (supportive outcome variables).Bazett QTcB=QT*RR-1/2Fridericia QTcF=QT'RR-1/3 **Time Frame:** 11 dECG measurements x 4 (4-way crossover) #### Secondary Outcomes **Measure:** QTcX (therapeutic doses in comparison to placebo).PR-, QRS-, RR-intervals **Time Frame:** 11 dECG measurements x 4 (4-way crossover) **Measure:** Plasma concentration (AUC, Cmax, tmax etc) **Time Frame:** 11 PK-measurements x 4 (4-way crossover) **Measure:** Registration of AEs, blood pressure, ECG, clinical laboratory tests **Time Frame:** From enrolment to follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participation in a previous study for genotyping for identification to be extensive or poor metaboliser (CYP2D6 enzyme) * Physically and mentally healthy male volunteers Exclusion Criteria: * History of clinically significant diseases or illness. * Participation in another study the last 3 months * Prescribed or non-prescribed medications from 3 weeks prior to first treatment day until follow-up except for paracetamol (max 1.5 g per day.) **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 20 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden **Name:** Hans-Göran Hårdemark **Role:** STUDY_DIRECTOR ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CaAg - Name: Cardiotonic Agents - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: Repr - Name: Reproductive Control Agents ### Intervention Browse Module - Browse Leaves - ID: M1722 - Name: Moxifloxacin - Relevance: HIGH - As Found: Range - ID: M13561 - Name: Phenylephrine - Relevance: LOW - As Found: Unknown - ID: M13031 - Name: Oxymetazoline - Relevance: LOW - As Found: Unknown - ID: M266292 - Name: Norgestimate, ethinyl estradiol drug combination - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077266 - Term: Moxifloxacin ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT06196879 **Brief Title:** A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT) **Official Title:** A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study to Evaluate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT) #### Organization Study ID Info **ID:** UPB-CP-04 #### Organization **Class:** INDUSTRY **Full Name:** Upstream Bio Inc. #### Secondary ID Infos **Domain:** EUCT **ID:** 2023-507410-27-00 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-06-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-02-19 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-27 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-01-09 **Type:** ACTUAL **Study First Submit Date:** 2023-12-24 **Study First Submit QC Date:** 2023-12-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Upstream Bio Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to evaluate the efficacy and safety of verekitug (UPB-101) in participants with severe asthma. The study will evaluate the incidence of asthma exacerbations, other pharmacodynamic (PD) parameters such as lung function and asthma control, and the safety and tolerability of verekitug (UPB-101) compared to placebo. **Detailed Description:** This is a multicenter, randomized, placebo-controlled, parallel group study to assess the efficacy and safety of verekitug (UPB-101) administered subcutaneously (SC). A total of approximately 436 adult participants with severe asthma are planned for enrolment and will be randomized in a 1:1:1:1 ratio to receive verekitug (UPB-101) at doses of 100 mg every 12 weeks (Q12W), 400 mg every 24 weeks (Q24W), and 100 mg every 24 weeks (Q24W), or placebo administered SC. In order to maintain the blinding of different doses, all participants will receive 2 SC injections at each dosing visit. This study consists of a Screening/Run-In Period (approximately 4 weeks), Treatment Period (up to 60 weeks with a minimum of 24 weeks) and Follow-up Period (ending approximately 16 weeks after the last administration of study intervention). ### Conditions Module **Conditions:** - Severe Asthma **Keywords:** - VALIANT - Respiratory Tract Diseases - Bronchial Diseases - Asthma - Lung Diseases - Uncontrolled Asthma - Severe Asthma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 436 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive 0.5 milliliter (mL) of verekitug (UPB-101) formulated solution (containing 100 milligrams \[mg\] of verekitug \[UPB-101\]) and 2.0 mL of placebo subcutaneously in two separate injections every 12 weeks up to Week 48. **Intervention Names:** - Drug: Verekitug (UPB-101) - Drug: Placebo **Label:** Verekitug (UPB-101): 100 mg Q12W / Placebo **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive 2.0 mL of verekitug (UPB-101) formulated solution (containing 400 mg of verekitug \[UPB-101\]) and 0.5 mL of placebo subcutaneously in two separate injections every 24 weeks up to Week 48. Participants will also receive 2 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits. **Intervention Names:** - Drug: Verekitug (UPB-101) - Drug: Placebo **Label:** Verekitug (UPB-101): 400 mg Q24W / Placebo **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants will receive 0.5 mL of verekitug (UPB-101) formulated solution (containing 100 mg of verekitug \[UPB-101\]) and 2.0 mL of placebo subcutaneously in two separate injections every 24 weeks up to Week 48. Participants will also receive 2 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits. **Intervention Names:** - Drug: Verekitug (UPB-101) - Drug: Placebo **Label:** Verekitug (UPB-101): 100 mg Q24W / Placebo **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Participants will receive 0.5 mL of matching placebo and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 48. **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Verekitug (UPB-101): 100 mg Q12W / Placebo - Verekitug (UPB-101): 100 mg Q24W / Placebo - Verekitug (UPB-101): 400 mg Q24W / Placebo **Description:** Verekitug (UPB-101) formulated solution **Name:** Verekitug (UPB-101) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo - Verekitug (UPB-101): 100 mg Q12W / Placebo - Verekitug (UPB-101): 100 mg Q24W / Placebo - Verekitug (UPB-101): 400 mg Q24W / Placebo **Description:** Verekitug (UPB-101) matching placebo **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** An asthma exacerbation is defined as a worsening of asthma that required treatment with systemic (oral or intravenous) corticosteroids for at least three consecutive days or a single depo-injectable dose of corticosteroids or an emergency room (ER) or urgent care visit that required systemic corticosteroids or an admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for greater than or equal to 24 hours. **Measure:** Annual Asthma Exacerbation Rate (AAER) **Time Frame:** Baseline up to Week 60 #### Secondary Outcomes **Description:** Spirometry will be performed pre-bronchodilator (BD) to measure lung function. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. **Measure:** Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) of Pre-bronchodilator (Pre-BD) to Week 60 **Time Frame:** Baseline to Week 60 **Description:** Standardized single breath FeNO test is performed to evaluate airway inflammation. **Measure:** Change from Baseline in Fractional exhaled nitric oxide (FeNO) to Week 60 **Time Frame:** Baseline to Week 60 **Description:** ACQ-6 is a participant-reported questionnaire to assess asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses. **Measure:** Change from Baseline in Asthma Control Questionnaire-6 (ACQ-6) to Week 60 **Time Frame:** Baseline to Week 60 **Description:** An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. **Measure:** Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs **Time Frame:** Up to Week 64 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF). * Age 18 to 75 years of age (inclusive) at the time of consent. * Physician-diagnosed asthma for at least 12 months prior to Visit 1. * Participant has evidence of bronchodilator (BD) reversibility as documented by either historical reversibility (within 12 months prior to study entry) or reversibility during screening. * Documented treatment with a total daily dose of either medium or high dose inhaled corticosteroids (ICS) for at least 3 months. Participants on medium dose ICS must also have been taking at least one additional maintenance asthma controller medication for at least 3 months. * Documented history of asthma exacerbation(s) within 12 months of Visit 1. * Asthma Control Questionnaire-6 (ACQ-6) score greater than or equal to (\>=) 1.5 at screening and randomization. * Participant must have a pre-BD FEV1 value of \>=30 percent (%) and \<=80% predicted at Screening. * Minimum compliance with daily diary and background asthma medication(s) as captured in the daily diary during the Run-in Period. * Agrees to follow the required contraceptive techniques/methods. * Female or male participant agrees not to donate eggs or sperm, respectively, for a period of 120 days after the last dose of the study drug intervention or at the Final Visit, whichever occurs last. Exclusion Criteria: * Inpatient hospitalization due to asthma at any time within 4 weeks prior to Visit 1 or during the Screening/Run-in Period. * Previous exposure to verekitug (UPB-101) or known allergy/sensitivity to any of its excipients. * Previous biologics for asthma treatment for which the appropriate washout period is not fulfilled prior to Visit 1. If the half-life is not known, a 24-week washout period prior to Visit 1 should be applied. * Allergen immunotherapy (unless maintenance dose) within 12 weeks prior to Visit 1 or plans to begin therapy or change dosing during the study. * For participants taking oral corticosteroids (OCS), the dose has not been stable for at least 2 weeks prior to Visit 1 and/or is \>10 milligram (mg) daily, or \>20 mg every other day. * Evidence of active or suspected bacterial, viral, fungal, or parasitic infections within 2 weeks prior to Visit 1. * History compatible with or diagnosis of a parasitic infection and has not been treated or has not responded to standard of care therapy. * Current tobacco smokers, nicotine vapers (including electronic cigarettes), snuff users or participants with a smoking history \>=10 pack years. (Former nicotine smokers with a smoking history of \<10 pack years, former nicotine vapers and former snuff users must have stopped for at least 6 months prior to Visit 1 to be eligible). * Positive coronavirus disease 2019 (COVID-19) test with lower respiratory tract symptoms within 28 days before Visit 1. * Pregnant or breastfeeding or planning to become pregnant or breastfeed during the study or unwilling to use adequate birth control, if of reproductive potential and sexually active. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Upstream Bio Clinical Trials Information (Privacy Notice: https://www.upstreambio.com/privacy) **Phone:** 888-446-3130 **Role:** CONTACT #### Locations **Location 1:** **City:** Birmingham **Country:** United States **Facility:** AllerVie Clinical Research **State:** Alabama **Status:** RECRUITING **Zip:** 35209 **Location 2:** **City:** Bakersfield **Country:** United States **Facility:** Kern Research, Inc. **State:** California **Status:** RECRUITING **Zip:** 93301 **Location 3:** **City:** Los Angeles **Country:** United States **Facility:** Velocity Clinical Research - Lafayette LA **State:** California **Status:** RECRUITING **Zip:** 70508 **Location 4:** **City:** Newport Beach **Country:** United States **Facility:** Newport Native MD Inc **State:** California **Status:** RECRUITING **Zip:** 92663 **Location 5:** **City:** Northridge **Country:** United States **Facility:** California Medical Research Associates Inc. **State:** California **Status:** RECRUITING **Zip:** 91324 **Location 6:** **City:** Upland **Country:** United States **Facility:** Integrated Research of Inland Inc **State:** California **Status:** RECRUITING **Zip:** 91786 **Location 7:** **City:** Walnut Creek **Country:** United States **Facility:** Allergy & Asthma Clinical Research **State:** California **Status:** RECRUITING **Zip:** 94598 **Location 8:** **City:** Westminster **Country:** United States **Facility:** Allianz Research Institute **State:** California **Status:** RECRUITING **Zip:** 92683 **Location 9:** **City:** Miami **Country:** United States **Facility:** Health and Life Research Institute, LLC **State:** Florida **Status:** RECRUITING **Zip:** 33155 **Location 10:** **City:** Miami **Country:** United States **Facility:** Phoenix Medical Research **State:** Florida **Status:** RECRUITING **Zip:** 33165 **Location 11:** **City:** Miami **Country:** United States **Facility:** Research Institute of South Florida **State:** Florida **Status:** RECRUITING **Zip:** 33173 **Location 12:** **City:** Miami **Country:** United States **Facility:** Clinical Site Partners, LLC dba Flourish Research **State:** Florida **Status:** RECRUITING **Zip:** 33176 **Location 13:** **City:** Miami **Country:** United States **Facility:** Clinical Site Partners **State:** Florida **Status:** RECRUITING **Zip:** 33176 **Location 14:** **City:** Miami **Country:** United States **Facility:** Nouvelle Clinical Research **State:** Florida **Status:** RECRUITING **Zip:** 33189 **Location 15:** **City:** Orlando **Country:** United States **Facility:** Anderson Allergy And Asthma, PA **State:** Florida **Status:** RECRUITING **Zip:** 32806 **Location 16:** **City:** Plantation **Country:** United States **Facility:** Edward Jenner Research Group, LLC **State:** Florida **Status:** RECRUITING **Zip:** 33317 **Location 17:** **City:** Winter Park **Country:** United States **Facility:** Clinical Site Partners dba Flourish research **State:** Florida **Status:** RECRUITING **Zip:** 32789 **Location 18:** **City:** Boise **Country:** United States **Facility:** Treasure Valley Medical Research **State:** Idaho **Status:** RECRUITING **Zip:** 83706 **Location 19:** **City:** Meridian **Country:** United States **Facility:** Velocity Clinical Research - Meridian **State:** Idaho **Status:** RECRUITING **Zip:** 83642 **Location 20:** **City:** White Marsh **Country:** United States **Facility:** Chesapeake Clinical Research Inc **State:** Maryland **Status:** RECRUITING **Zip:** 21162 **Location 21:** **City:** Farmington Hills **Country:** United States **Facility:** Pulmonary Research Institute of Southeast Michigan **State:** Michigan **Status:** RECRUITING **Zip:** 48336 **Location 22:** **City:** Flint **Country:** United States **Facility:** AA Medical Research Center **State:** Michigan **Status:** NOT_YET_RECRUITING **Zip:** 48504 **Location 23:** **City:** Flint **Country:** United States **Facility:** AA MRC **State:** Michigan **Status:** RECRUITING **Zip:** 48504 **Location 24:** **City:** Las Vegas **Country:** United States **Facility:** M3 Wake Research **State:** Nevada **Status:** RECRUITING **Zip:** 89106 **Location 25:** **City:** Bronx **Country:** United States **Facility:** Urban Health Plan INC **State:** New York **Status:** RECRUITING **Zip:** 10459 **Location 26:** **City:** Huntersville **Country:** United States **Facility:** Advanced Respiratory and Sleep Medicine LLC **State:** North Carolina **Status:** RECRUITING **Zip:** 28078 **Location 27:** **City:** Toledo **Country:** United States **Facility:** Toledo Institute of Clinical Research Inc **State:** Ohio **Status:** RECRUITING **Zip:** 43617 **Location 28:** **City:** Edmond **Country:** United States **Facility:** OK Clinical Research, LLC **State:** Oklahoma **Status:** RECRUITING **Zip:** 73034 **Location 29:** **City:** Medford **Country:** United States **Facility:** Velocity Clinical Research - Medford **State:** Oregon **Status:** RECRUITING **Zip:** 97504 **Location 30:** **City:** Anderson **Country:** United States **Facility:** Velocity Clinical Research - Anderson **State:** South Carolina **Status:** RECRUITING **Zip:** 29621 **Location 31:** **City:** Charleston **Country:** United States **Facility:** WR-Notus Clinical Research, LLC **State:** South Carolina **Status:** RECRUITING **Zip:** 29414 **Location 32:** **City:** Spartanburg **Country:** United States **Facility:** Velocity Clinical Research - Spartanburg **State:** South Carolina **Status:** RECRUITING **Zip:** 29303 **Location 33:** **City:** Chattanooga **Country:** United States **Facility:** WR-ClinSearch, LLC **State:** Tennessee **Status:** RECRUITING **Zip:** 37421 **Location 34:** **City:** Dallas **Country:** United States **Facility:** Alina Clinical Trials, LLC **State:** Texas **Status:** RECRUITING **Zip:** 75225 **Location 35:** **City:** Dallas **Country:** United States **Facility:** AARA Research Center **State:** Texas **Status:** RECRUITING **Zip:** 75231 **Location 36:** **City:** El Paso **Country:** United States **Facility:** El Paso Pulmonary Association **State:** Texas **Status:** RECRUITING **Zip:** 79902 **Location 37:** **City:** Houston **Country:** United States **Facility:** Greater Houston Memorial Pulmonary and Sleep **State:** Texas **Status:** RECRUITING **Zip:** 77008 **Location 38:** **City:** McKinney **Country:** United States **Facility:** Metroplex Pulmonary and Sleep Center Drive **State:** Texas **Status:** RECRUITING **Zip:** 75069 **Location 39:** **City:** Tomball **Country:** United States **Facility:** DM Clinical Tomball **State:** Texas **Status:** RECRUITING **Zip:** 77375 **Location 40:** **City:** West Jordan **Country:** United States **Facility:** Velocity Clinical Research **State:** Utah **Status:** RECRUITING **Zip:** 84088 **Location 41:** **City:** Ajax **Country:** Canada **Facility:** Dynamic Drug Advancement **State:** Ontario **Status:** RECRUITING **Zip:** L1S 2J5 **Location 42:** **City:** Ottawa **Country:** Canada **Facility:** Ottawa Allergy Research Corp **State:** Ontario **Status:** RECRUITING **Zip:** K1H 1E4 **Location 43:** **City:** Toronto **Country:** Canada **Facility:** Toronto Allergists **State:** Ontario **Status:** RECRUITING **Zip:** M5G1E2 **Location 44:** **City:** Winchester **Country:** Canada **Facility:** Winchester Hospital **State:** Ontario **Status:** RECRUITING **Zip:** K0C 2K0 #### Overall Officials **Official 1:** **Affiliation:** Upstream Bio **Name:** James C Lee, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT02081079 **Brief Title:** Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection **Official Title:** A Phase 2, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection #### Organization Study ID Info **ID:** GS-US-337-1119 #### Organization **Class:** INDUSTRY **Full Name:** Gilead Sciences #### Secondary ID Infos **ID:** 2013-003978-27 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2015-02 **Type:** ACTUAL #### Disp First Post Date **Date:** 2015-10-27 **Type:** ESTIMATED **Disp First Submit Date:** 2015-10-21 **Disp First Submit QC Date:** 2015-10-21 #### Expanded Access Info #### Last Update Post Date **Date:** 2018-11-19 **Type:** ACTUAL **Last Update Submit Date:** 2018-10-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-11 **Type:** ACTUAL #### Results First Post Date **Date:** 2016-01-14 **Type:** ESTIMATED **Results First Submit Date:** 2015-12-10 **Results First Submit QC Date:** 2015-12-10 #### Start Date **Date:** 2014-03 **Status Verified Date:** 2016-04 #### Study First Post Date **Date:** 2014-03-07 **Type:** ESTIMATED **Study First Submit Date:** 2014-03-05 **Study First Submit QC Date:** 2014-03-06 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Gilead Sciences #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy. ### Conditions Module **Conditions:** - Chronic Genotype 4 HCV - Chronic Genotype 5 HCV **Keywords:** - HCV GT 4 - HCV GT 5 ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 85 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 4 hepatitis C virus (HCV) infection **Intervention Names:** - Drug: LDV/SOF **Label:** Genotype 4 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 5 hepatitis C virus (HCV) infection **Intervention Names:** - Drug: LDV/SOF **Label:** Genotype 5 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Genotype 4 - Genotype 5 **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily **Name:** LDV/SOF **Other Names:** - Harvoni® - GS-5885/GS-7977 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. **Measure:** Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) **Time Frame:** Posttreatment Week 12 **Measure:** Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event **Time Frame:** Up to 12 weeks #### Secondary Outcomes **Description:** SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively. **Measure:** Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) **Time Frame:** Posttreatment Weeks 4 and 24 **Description:** Virologic failure was defined as either: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); or * Relapse: * HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment **Measure:** Percentage of Patients With Virologic Failure **Time Frame:** Up to posttreatment Week 24 **Measure:** Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12 **Time Frame:** Baseline; Weeks 2, 4, 8, and 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * HCV RNA ≥ 10\^4 IU/mL at screening * Chronic genotype 4 or 5 HCV Infection * Individuals may be treatment naive or treatment experienced * Presence or absence of cirrhosis, a liver biopsy may be required * Healthy according to medical history and physical examination with the exception of HCV diagnosis * Agree to use two forms of highly effective contraception for the duration of the study Exclusion Criteria: * History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator * Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors * History of any other clinically significant chronic liver disease * Evidence of or history of decompensated liver disease * HIV or chronic hepatitis B (HBV) infection * Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers) * Chronic use of immunosuppressive agents or immunomodulatory agents **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Clermont Ferrand **Country:** France **Zip:** 63003 **Location 2:** **City:** Clichy **Country:** France **Zip:** 92110 **Location 3:** **City:** Limoges **Country:** France **Zip:** 87042 **Location 4:** **City:** Toulouse **Country:** France **Zip:** 31059 **Location 5:** **City:** Villejuif **Country:** France **Zip:** 94800 #### Overall Officials **Official 1:** **Affiliation:** Gilead Sciences **Name:** Kathryn Kersey, MSc **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** A secured external environment with username, password, and RSA code. **Description:** Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency. **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** 18 months after study completion **URL:** http://www.gilead.com/research/disclosure-and-transparency ### References Module #### References **Citation:** Abergel A, Metivier S, Samuel D, Jiang D, Kersey K, Pang PS, Svarovskaia E, Knox SJ, Loustaud-Ratti V, Asselah T. Ledipasvir plus sofosbuvir for 12 weeks in patients with hepatitis C genotype 4 infection. Hepatology. 2016 Oct;64(4):1049-56. doi: 10.1002/hep.28706. Epub 2016 Jul 29. **PMID:** 27351341 **Citation:** Abergel A, Asselah T, Metivier S, Kersey K, Jiang D, Mo H, Pang PS, Samuel D, Loustaud-Ratti V. Ledipasvir-sofosbuvir in patients with hepatitis C virus genotype 5 infection: an open-label, multicentre, single-arm, phase 2 study. Lancet Infect Dis. 2016 Apr;16(4):459-64. doi: 10.1016/S1473-3099(15)00529-0. Epub 2016 Jan 21. **PMID:** 26803446 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M9611 - Name: Hepatitis C - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: HIGH - As Found: Chronic ### Intervention Browse Module - Ancestors - ID: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M443 - Name: Sofosbuvir - Relevance: HIGH - As Found: Pertuzumab - ID: M349895 - Name: Ledipasvir - Relevance: HIGH - As Found: Lung Transplantation - ID: M184719 - Name: Ledipasvir, sofosbuvir drug combination - Relevance: HIGH - As Found: Polycystic Ovary Syndrome - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069474 - Term: Sofosbuvir - ID: C000595958 - Term: Ledipasvir, sofosbuvir drug combination - ID: C000586541 - Term: Ledipasvir ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** Safety Analysis Set: participants were randomized and received at least 1 dose of study drug #### Event Groups **Group ID:** EG000 **Title:** Genotype 4 **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 4 HCV infection **ID:** EG000 **Other Num Affected:** 31 **Other Num at Risk:** 44 **Serious Number At Risk:** 44 **Title:** Genotype 4 **Group ID:** EG001 **Title:** Genotype 5 **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection **ID:** EG001 **Other Num Affected:** 31 **Other Num at Risk:** 41 **Serious Number Affected:** 1 **Serious Number At Risk:** 41 **Title:** Genotype 5 **Frequency Threshold:** 5 #### Other Events **Term:** Vertigo **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Ear and labyrinth disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Abdominal pain upper **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Diarrhoea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Nausea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Asthenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Fatigue **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Nasopharyngitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) **Term:** Urinary tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (17.1) **Term:** Wound **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA (17.1) **Term:** Arthralgia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Back pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Musculoskeletal pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Myalgia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Dizziness **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Headache **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (17.1) **Term:** Cough **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA (17.1) #### Serious Events **Term:** Depression **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA (17.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 44 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 41 **Time Frame:** Up to 12 weeks plus 30 days ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 22 **Group ID:** BG001 **Value:** 22 **Group ID:** BG002 **Value:** 21 **Group ID:** BG003 **Value:** 20 **Group ID:** BG004 **Value:** 85 **Units:** Participants ### Group **ID:** BG000 **Title:** Genotype 4: Treatment-naive **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection ### Group **ID:** BG001 **Title:** Genotype 4: Treatment-experienced **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection ### Group **ID:** BG002 **Title:** Genotype 5: Treatment-naive **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection ### Group **ID:** BG003 **Title:** Genotype 5: Treatment-experienced **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection ### Group **ID:** BG004 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 9.2 **Value:** 52 #### Measurement **Group ID:** BG001 **Spread:** 8.8 **Value:** 50 #### Measurement **Group ID:** BG002 **Spread:** 10.4 **Value:** 61 #### Measurement **Group ID:** BG003 **Spread:** 8.6 **Value:** 64 #### Measurement **Group ID:** BG004 **Spread:** 10.8 **Value:** 57 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 11 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 10 #### Measurement **Group ID:** BG003 **Value:** 10 #### Measurement **Group ID:** BG004 **Value:** 36 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 11 #### Measurement **Group ID:** BG001 **Value:** 17 #### Measurement **Group ID:** BG002 **Value:** 11 #### Measurement **Group ID:** BG003 **Value:** 10 #### Measurement **Group ID:** BG004 **Value:** 49 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 0 #### Measurement **Group ID:** BG003 **Value:** 0 #### Measurement **Group ID:** BG004 **Value:** 8 **Class Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 19 #### Measurement **Group ID:** BG001 **Value:** 17 #### Measurement **Group ID:** BG002 **Value:** 21 #### Measurement **Group ID:** BG003 **Value:** 20 #### Measurement **Group ID:** BG004 **Value:** 77 **Class Title:** White ### Measure #### Measurement **Group ID:** BG000 **Value:** 22 #### Measurement **Group ID:** BG001 **Value:** 22 #### Measurement **Group ID:** BG002 **Value:** 21 #### Measurement **Group ID:** BG003 **Value:** 20 #### Measurement **Group ID:** BG004 **Value:** 85 **Class Title:** France ### Measure #### Measurement **Group ID:** BG000 **Spread:** 0.40 **Value:** 6.0 #### Measurement **Group ID:** BG001 **Spread:** 0.48 **Value:** 6.3 #### Measurement **Group ID:** BG002 **Spread:** 0.48 **Value:** 6.2 #### Measurement **Group ID:** BG003 **Spread:** 0.39 **Value:** 6.6 #### Measurement **Group ID:** BG004 **Spread:** 0.48 **Value:** 6.3 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 22 #### Measurement **Group ID:** BG001 **Value:** 22 #### Measurement **Group ID:** BG002 **Value:** 0 #### Measurement **Group ID:** BG003 **Value:** 0 #### Measurement **Group ID:** BG004 **Value:** 44 **Class Title:** Genotype 4 #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 21 #### Measurement **Group ID:** BG003 **Value:** 20 #### Measurement **Group ID:** BG004 **Value:** 41 **Class Title:** Genotype 5 ### Measure #### Measurement **Group ID:** BG000 **Value:** 21 #### Measurement **Group ID:** BG001 **Value:** 13 #### Measurement **Group ID:** BG002 **Value:** 18 #### Measurement **Group ID:** BG003 **Value:** 14 #### Measurement **Group ID:** BG004 **Value:** 66 **Class Title:** Absence #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 9 #### Measurement **Group ID:** BG002 **Value:** 3 #### Measurement **Group ID:** BG003 **Value:** 6 #### Measurement **Group ID:** BG004 **Value:** 19 **Class Title:** Presence ### Measure #### Measurement **Group ID:** BG000 **Value:** 7 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 13 #### Measurement **Group ID:** BG003 **Value:** 6 #### Measurement **Group ID:** BG004 **Value:** 27 **Class Title:** CC #### Measurement **Group ID:** BG000 **Value:** 11 #### Measurement **Group ID:** BG001 **Value:** 16 #### Measurement **Group ID:** BG002 **Value:** 7 #### Measurement **Group ID:** BG003 **Value:** 11 #### Measurement **Group ID:** BG004 **Value:** 45 **Class Title:** CT #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 1 #### Measurement **Group ID:** BG003 **Value:** 3 #### Measurement **Group ID:** BG004 **Value:** 13 **Class Title:** TT **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** NUMBER **Title:** Race/Ethnicity, Customized **Unit of Measure:** participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ### Measure 5 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** HCV RNA **Unit of Measure:** log10 copies/mL ### Measure 6 **Parameter Type:** NUMBER **Title:** HCV Genotype **Unit of Measure:** participants ### Measure 7 **Parameter Type:** NUMBER **Title:** Cirrhosis Status **Unit of Measure:** participants ### Measure 8 **Description:** The CC, CT, and TT alleles are different forms of the IL28b gene. **Parameter Type:** NUMBER **Title:** IL28b Status **Unit of Measure:** participants **Population Description:** Safety Analysis Set: participants were enrolled and received at least 1 dose of study drug ## Results Section - More Information Module ### Certain Agreement **Other Details:** After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years **Restriction Type:** OTHER **Restrictive Agreement:** True ### Limitations and Caveats **Description:** There were no limitations affecting the analysis or results. ### Point of Contact **Email:** [email protected] **Organization:** Gilead Sciences **Title:** Clinical Trial Disclosures ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 95.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 90.9 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 95.2 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 95.0 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 95.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 90.9 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 95.2 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 95.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 95.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 90.9 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 95.2 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 95.0 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 9.1 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4.8 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5.0 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.397 - **Upper Limit:** - **Value:** -4.65 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.495 - **Upper Limit:** - **Value:** -4.77 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.479 - **Upper Limit:** - **Value:** -4.97 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 0.477 - **Upper Limit:** - **Value:** -4.94 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.396 - **Upper Limit:** - **Value:** -4.86 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.490 - **Upper Limit:** - **Value:** -5.17 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.474 - **Upper Limit:** - **Value:** -5.07 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 0.381 - **Upper Limit:** - **Value:** -5.39 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.401 - **Upper Limit:** - **Value:** -4.88 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.484 - **Upper Limit:** - **Value:** -5.18 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.474 - **Upper Limit:** - **Value:** -5.07 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 0.387 - **Upper Limit:** - **Value:** -5.45 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.401 - **Upper Limit:** - **Value:** -4.88 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.484 - **Upper Limit:** - **Value:** -5.18 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.474 - **Upper Limit:** - **Value:** -5.07 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 0.387 - **Upper Limit:** - **Value:** -5.45 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. **Parameter Type:** NUMBER **Population Description:** Full Analysis Set: participants with genotype 4 or 5 HCV infection who were enrolled and received at least on dose of study drug. **Reporting Status:** POSTED **Time Frame:** Posttreatment Week 12 **Title:** Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection **ID:** OG000 **Title:** Genotype 4: Treatment-naive ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection **ID:** OG001 **Title:** Genotype 4: Treatment-experienced ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection **ID:** OG002 **Title:** Genotype 5: Treatment-naive ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection **ID:** OG003 **Title:** Genotype 5: Treatment-experienced #### Outcome Measure 2 **Parameter Type:** NUMBER **Population Description:** Safety Analysis Set: participants were enrolled and received at least 1 dose of study drug **Reporting Status:** POSTED **Time Frame:** Up to 12 weeks **Title:** Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 4 HCV infection **ID:** OG000 **Title:** Genotype 4 ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection **ID:** OG001 **Title:** Genotype 5 #### Outcome Measure 3 **Description:** SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively. **Parameter Type:** NUMBER **Population Description:** Full Analysis Set **Reporting Status:** POSTED **Time Frame:** Posttreatment Weeks 4 and 24 **Title:** Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection **ID:** OG000 **Title:** Genotype 4: Treatment-naive ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection **ID:** OG001 **Title:** Genotype 4: Treatment-experienced ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection **ID:** OG002 **Title:** Genotype 5: Treatment-naive ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection **ID:** OG003 **Title:** Genotype 5: Treatment-experienced #### Outcome Measure 4 **Description:** Virologic failure was defined as either: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); or * Relapse: * HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment **Parameter Type:** NUMBER **Population Description:** Full Analysis Set **Reporting Status:** POSTED **Time Frame:** Up to posttreatment Week 24 **Title:** Percentage of Patients With Virologic Failure **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection **ID:** OG000 **Title:** Genotype 4: Treatment-naive ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection **ID:** OG001 **Title:** Genotype 4: Treatment-experienced ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection **ID:** OG002 **Title:** Genotype 5: Treatment-naive ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection **ID:** OG003 **Title:** Genotype 5: Treatment-experienced #### Outcome Measure 5 **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Full Analysis Set **Reporting Status:** POSTED **Time Frame:** Baseline; Weeks 2, 4, 8, and 12 **Title:** Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12 **Type:** SECONDARY **Unit of Measure:** log10 IU/mL ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection **ID:** OG000 **Title:** Genotype 4: Treatment-naive ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection **ID:** OG001 **Title:** Genotype 4: Treatment-experienced ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection **ID:** OG002 **Title:** Genotype 5: Treatment-naive ##### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection **ID:** OG003 **Title:** Genotype 5: Treatment-experienced ### Participant Flow Module #### Group **Description:** Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily for up to 12 weeks in participants with genotype 4 hepatitis C virus (HCV) infection **ID:** FG000 **Title:** Genotype 4 #### Group **Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection **ID:** FG001 **Title:** Genotype 5 #### Period **Title:** Overall Study ##### Withdraw **Type:** Lack of Efficacy ###### Reason **Group ID:** FG000 **Number of Subjects:** 3 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 44 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 41 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 40 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 39 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 4 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 2 **Pre-Assignment Details:** 91 participants were screened. **Recruitment Details:** Participants were enrolled at study sites in France. The first participant was screened on 07 March 2014. The last study visit occurred on 17 February 2015. **Has Results:** True
## Protocol Section ### Identification Module **NCT ID:** NCT00276679 **Brief Title:** Temozolomide in Treating Young Patients With High-Risk Relapsed or Refractory Neuroblastoma **Official Title:** Phase II Study of Temozolomide (Temodal) in Children Over 1 Year of Age With Relapsed or Refractory High Risk Neuroblastoma #### Organization Study ID Info **ID:** CDR0000454577 #### Organization **Class:** NIH **Full Name:** National Cancer Institute (NCI) #### Secondary ID Infos **ID:** CCLG-NAG-2003-02 **ID:** EU-20591 **ID:** CCLG-SFOP-NAG-2003-02 ### Status Module #### Completion Date **Date:** 2006-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2013-09-17 **Type:** ESTIMATED **Last Update Submit Date:** 2013-09-16 **Overall Status:** COMPLETED #### Start Date **Date:** 2003-04 **Status Verified Date:** 2006-01 #### Study First Post Date **Date:** 2006-01-13 **Type:** ESTIMATED **Study First Submit Date:** 2006-01-12 **Study First Submit QC Date:** 2006-01-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Children's Cancer and Leukaemia Group ### Description Module **Brief Summary:** RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with high-risk relapsed or refractory neuroblastoma. **Detailed Description:** OBJECTIVES: Primary * Determine the anti-tumor activity of temozolomide in young patients with high-risk relapsed or refractory neuroblastoma. Secondary * Determine the duration of response in patients treated with this drug. * Determine tolerability of this drug in these patients * Determine the tumor expression of the cellular repair mechanisms which repair DNA damage (O6-methylguanine-DNA methyltransferase \[MGMT\] and mismatch repair \[MMR\] systems) in patients treated with this drug. * Correlate MGMT and MMR expression with outcomes in patients treated with this drug. * Determine if MGMT and MMR expression/activity changes in the tumor during initial presentation, treatment, and relapse/progression in patients treated with this drug. * Determine the activity of MGMT in bone marrow taken at relapse, in terms of hematological toxicity, in patients treated with this drug. OUTLINE: This is a multicenter, open label, nonrandomized study. Patients receive oral temozolomide once daily for 5 days. Treatment repeats every 28 days for 2 courses. Patients achieving stable or responding disease after completion of the 2 courses may receive up to 10 additional courses of treatment in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study. ### Conditions Module **Conditions:** - Neuroblastoma **Keywords:** - recurrent neuroblastoma - disseminated neuroblastoma - localized unresectable neuroblastoma ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** temozolomide **Type:** DRUG ### Eligibility Module **Eligibility Criteria:** DISEASE CHARACTERISTICS: * Histologically proven neuroblastoma * High-risk relapsed or refractory disease, defined as 1 of the following: * Metastatic disease * Localized MYC-N amplified disease * Localized non MYC-N amplified disease at second relapse * Measurable primary or metastatic disease by cross-sectional imaging or MIBG scan PATIENT CHARACTERISTICS: * Lansky performance status 40-100% * Life expectancy \> 2 months * Not pregnant or nursing * Fertile patients must use effective contraception during the course of this study and for 6 months after study completion * Organ toxicity \< grade 2 * Platelets ≥ 100,000/mm\^3 (50,000/mm\^3 after stem cell transplant or in case of marrow involvement) * Neutrophil count ≥ 500/mm\^3 * Bilirubin \< 1.5 times normal * AST and ALT ≤ 2.5 times normal * No known HIV positivity PRIOR CONCURRENT THERAPY: * More than 21 days since prior chemotherapy treatment (isotretinoin is counted as chemotherapy for this purpose) * More than 30 days since prior radiotherapy except local palliative treatment for pain control * No more than 2 prior treatments for neuroblastoma * No other concurrent investigative treatment for neuroblastoma **Maximum Age:** 16 Years **Minimum Age:** 1 Year **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Toulouse **Country:** France **Facility:** Centre Hospitalier Regional de Purpan **Zip:** 31026 **Location 2:** **City:** Dublin **Country:** Ireland **Facility:** Our Lady's Hospital for Sick Children **Zip:** 12 **Location 3:** **City:** Birmingham **Country:** United Kingdom **Facility:** Birmingham Children's Hospital **State:** England **Zip:** B4 6NH **Location 4:** **City:** Bristol **Country:** United Kingdom **Facility:** Institute of Child Health at University of Bristol **State:** England **Zip:** BS2 8AE **Location 5:** **City:** Cambridge **Country:** United Kingdom **Facility:** Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust **State:** England **Zip:** CB2 2QQ **Location 6:** **City:** Leeds **Country:** United Kingdom **Facility:** Leeds Cancer Centre at St. James's University Hospital **State:** England **Zip:** LS9 7TF **Location 7:** **City:** Leicester **Country:** United Kingdom **Facility:** Leicester Royal Infirmary **State:** England **Zip:** LE1 5WW **Location 8:** **City:** Liverpool **Country:** United Kingdom **Facility:** Royal Liverpool Children's Hospital, Alder Hey **State:** England **Zip:** L12 2AP **Location 9:** **City:** London **Country:** United Kingdom **Facility:** Royal London Hospital **State:** England **Zip:** E1 1BB **Location 10:** **City:** London **Country:** United Kingdom **Facility:** Great Ormond Street Hospital for Children NHS Trust **State:** England **Zip:** WC1N 3JH **Location 11:** **City:** Manchester **Country:** United Kingdom **Facility:** Central Manchester and Manchester Children's University Hospitals NHS Trust **State:** England **Zip:** M27 4HA **Location 12:** **City:** Newcastle-Upon-Tyne **Country:** United Kingdom **Facility:** Sir James Spence Institute of Child Health **State:** England **Zip:** NE1 4LP **Location 13:** **City:** Nottingham **Country:** United Kingdom **Facility:** Queen's Medical Centre **State:** England **Zip:** NG7 2UH **Location 14:** **City:** Oxford **Country:** United Kingdom **Facility:** Oxford Radcliffe Hospital **State:** England **Zip:** 0X3 9DU **Location 15:** **City:** Sheffield **Country:** United Kingdom **Facility:** Children's Hospital - Sheffield **State:** England **Zip:** S10 2TH **Location 16:** **City:** Southampton **Country:** United Kingdom **Facility:** Southampton General Hospital **State:** England **Zip:** SO16 6YD **Location 17:** **City:** Sutton **Country:** United Kingdom **Facility:** Royal Marsden NHS Foundation Trust - Surrey **State:** England **Zip:** SM2 5PT **Location 18:** **City:** Belfast **Country:** United Kingdom **Facility:** Royal Belfast Hospital for Sick Children **State:** Northern Ireland **Zip:** BT12 6BE **Location 19:** **City:** Aberdeen **Country:** United Kingdom **Facility:** Royal Aberdeen Children's Hospital **State:** Scotland **Zip:** AB25 2ZG **Location 20:** **City:** Edinburgh **Country:** United Kingdom **Facility:** Royal Hospital for Sick Children **State:** Scotland **Zip:** EH9 1LF **Location 21:** **City:** Glasgow **Country:** United Kingdom **Facility:** Royal Hospital for Sick Children **State:** Scotland **Zip:** G3 8SJ **Location 22:** **City:** Cardiff **Country:** United Kingdom **Facility:** Childrens Hospital for Wales **State:** Wales **Zip:** CF14 4XW #### Overall Officials **Official 1:** **Affiliation:** Centre Hospitalier Regional de Purpan **Name:** Herve Rubie, MD **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** University of Newcastle Upon-Tyne **Name:** Andrew David J. Pearson, MD, FRCP, DCh **Official 3:** **Affiliation:** Great Ormond Street Hospital for Children NHS Foundation Trust **Name:** Julia Chisholm, MD ### References Module #### References **Citation:** Rubie H, Chisholm J, Defachelles AS, Morland B, Munzer C, Valteau-Couanet D, Mosseri V, Bergeron C, Weston C, Coze C, Auvrignon A, Djafari L, Hobson R, Baunin C, Dickinson F, Brisse H, McHugh K, Biassoni L, Giammarile F, Vassal G; Societe Francaisedes Cancers de l'Enfant; United Kingdom Children Cancer Study Group-New Agents Group Study. Phase II study of temozolomide in relapsed or refractory high-risk neuroblastoma: a joint Societe Francaise des Cancers de l'Enfant and United Kingdom Children Cancer Study Group-New Agents Group Study. J Clin Oncol. 2006 Nov 20;24(33):5259-64. doi: 10.1200/JCO.2006.06.1572. **PMID:** 17114659 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018241 - Term: Neuroectodermal Tumors, Primitive, Peripheral - ID: D000018242 - Term: Neuroectodermal Tumors, Primitive - ID: D000018302 - Term: Neoplasms, Neuroepithelial - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009380 - Term: Neoplasms, Nerve Tissue ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M12391 - Name: Neuroblastoma - Relevance: HIGH - As Found: Neuroblastoma - ID: M20387 - Name: Neuroectodermal Tumors, Primitive, Peripheral - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M20446 - Name: Neoplasms, Neuroepithelial - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: T4085 - Name: Neuroblastoma - Relevance: HIGH - As Found: Neuroblastoma - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009447 - Term: Neuroblastoma ### Intervention Browse Module - Ancestors - ID: D000018906 - Term: Antineoplastic Agents, Alkylating - ID: D000000477 - Term: Alkylating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1692 - Name: Temozolomide - Relevance: HIGH - As Found: Skills - ID: M20942 - Name: Antineoplastic Agents, Alkylating - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077204 - Term: Temozolomide ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT01607879 **Brief Title:** Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation **Official Title:** Use of β-hydroxy-β-methylbutyrate to Counteract Loss of Muscle Mass and Strength in Older Men With Prostate Cancer Started on Androgen Deprivation Therapy #### Organization Study ID Info **ID:** 00016781 #### Organization **Class:** OTHER **Full Name:** Medical College of Wisconsin ### Status Module #### Completion Date **Date:** 2021-02-16 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-09-22 **Type:** ACTUAL **Last Update Submit Date:** 2023-09-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-07 **Type:** ACTUAL #### Results First Post Date **Date:** 2023-09-22 **Type:** ACTUAL **Results First Submit Date:** 2023-07-18 **Results First Submit QC Date:** 2023-09-20 #### Start Date **Date:** 2014-03 **Status Verified Date:** 2023-09 #### Study First Post Date **Date:** 2012-05-30 **Type:** ESTIMATED **Study First Submit Date:** 2012-04-20 **Study First Submit QC Date:** 2012-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Medical College of Wisconsin #### Responsible Party **Investigator Affiliation:** Medical College of Wisconsin **Investigator Full Name:** Kathryn A Bylow, MD **Investigator Title:** Associate Professor of Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a study of HMB plus amino acids in older men with prostate cancer starting androgen deprivation therapy (ADT). The investigators hypothesize that the use of this nutritional supplementation will decrease the loss of muscle mass and strength that occurs when men start ADT. **Detailed Description:** It is well established that older patients experience age-related loss of muscle mass and function (sarcopenia), presumably due to an imbalance of protein synthesis versus protein breakdown. In addition, studies have shown that men who start on ADT experience increased muscle protein breakdown and decreased synthesis. β-hydroxy-β-methylbutyrate (HMB), a leucine metabolite, has been shown to slow protein breakdown. When HMB is given with arginine and lysine (which support protein synthesis) in randomized trials, researchers have shown that elderly men and women who receive this nutritional supplementation experience improvement in fat-free mass, strength, functionality and protein synthesis when compared with controls. In addition, patients with advanced cancer who experienced weight loss of at least 5% have also been shown to benefit from HMB, with supplementation resulting in a significant increase of fat-free mass when compared to controls. Thus, it seems reasonable that older men with prostate cancer starting on ADT who experience lean muscle loss as a result of aging and ADT, may achieve some benefit from supplementation with HMB as well. Use of HMB in men with prostate cancer has not been reported. ### Conditions Module **Conditions:** - Prostate Cancer **Keywords:** - Prostate Cancer - Men - Androgen Deprivation Therapy - Elderly - Geriatric - Nutritional supplementation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 48 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) **Intervention Names:** - Drug: Standard of care ADT + (HMB + arginine + glutamine) **Label:** Standard of care ADT + (HMB + AG) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Standard of care androgen deprivation therapy **Intervention Names:** - Other: Standard of care ADT **Label:** Standard of care ADT **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Standard of care ADT + (HMB + AG) **Description:** 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine. Take one packet twice daily for 3 months **Name:** Standard of care ADT + (HMB + arginine + glutamine) **Other Names:** - Juven **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Standard of care ADT **Description:** Patient will receive standard of care androgen deprivation therapy (ADT) alone **Name:** Standard of care ADT **Other Names:** - Standard of care androgen deprivation therapy (ADT) **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** This measure will be the change of lean body mass from baseline reported in kilograms. **Measure:** Change From Baseline in Body Composition (Lean Body Mass) **Time Frame:** Baseline, 3 months #### Secondary Outcomes **Description:** Cross-sectional area of the dorsiflexor muscle will be measured in mm\^2 using magnetic resonance imaging. The dorsiflexor muscles at the front of the leg are responsible for lifting the ball of the foot with the heel in contact with the ground. One dorsiflexor muscle in one leg was analyzed per participant. **Measure:** Change From Baseline of Dorsiflexor Muscle Size in mm^2. **Time Frame:** Baseline and 3 months **Description:** Dorsiflexor muscle strength in kilograms will be measured with a custom lower leg ergometer. The dorsiflexor muscles at the front of the leg are responsible for lifting the ball of the foot with the heel in contact with the ground. **Measure:** Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms. **Time Frame:** Baseline and 3 months **Description:** The SPPB uses Likert-style ratings for balance, walking speed, and standing test (Guralnik, 2000). Balance metric is the ability to hold three standing positions (feet side-by-side; side of the heel of one foot touching the big toe of the other foot; heel of one foot in front of and touching the toes of the other) up to 10 seconds. Inability to hold a position scores '0'. The sum of scores is the Balance Score. Scoring range is 0-4. Higher scores indicate better balance. Walking metric is time to walk 8 feet. Faster times score more points. Inability to complete the walk scores '0'. The score range is 0-4. Higher scores indicate better mobility. The Standing Test. The subject is asked to stand and sit five times as quickly as possible. Inability to complete five repetitions scores '0'. Shorter times score more points. Scoring range is 0-4. Higher scores indicate better mobility. Overall score is the sum of the scores ranging 0 to 12. Higher scores indicate better performance. **Measure:** Physical Performance Measured Using the Short Physical Performance Battery (SPPB) **Time Frame:** Baseline and 3 months **Description:** This measure will be the change in the number of reported falls from baseline (defined as the 3 months preceding the baseline visit), and the 3 month period beginning after the baseline visit and continuing through 3 months of therapy. **Measure:** Change From Baseline in the Number of Fall Events **Time Frame:** Baseline, 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate 2. Age 60 years or older 3. Patients with asymptomatic or minimally symptomatic prostate cancer for which they are about to start androgen deprivation therapy (ADT) per provider recommendation * Asymptomatic or minimally symptomatic (as judged by treating physician) metastases allowed * Men receiving ADT for localized prostate cancer are allowed 4. Patient able to give informed consent. Exclusion Criteria: 1. Patient already on ADT 2. Patients who are visiting clinic for a second opinion only 3. Patients with a diagnosis of dementia 4. Patients with a diagnosis of a neuromuscular disorder (i.e. multiple sclerosis) **Minimum Age:** 60 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Milwaukee **Country:** United States **Facility:** Froedtert Hospital and the Medical College of Wisconsin **State:** Wisconsin **Zip:** 53226 #### Overall Officials **Official 1:** **Affiliation:** Medical College of Wisconsin **Name:** Kathryn Bylow, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221. **PMID:** 10811152 ## Document Section ### Large Document Module #### Large Docs - Date: 2015-08-14 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 241191 - Type Abbrev: Prot_SAP - Upload Date: 2022-12-01T15:06 - Date: 2018-10-01 - Filename: ICF_001.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 198518 - Type Abbrev: ICF - Upload Date: 2022-12-01T15:07 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Prostate Cancer - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011471 - Term: Prostatic Neoplasms ### Intervention Browse Module - Ancestors - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M4059 - Name: Androgens - Relevance: HIGH - As Found: Prognostic - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: T1 - Name: Arginine - Relevance: HIGH - As Found: Radical - ID: T6 - Name: Glutamine - Relevance: HIGH - As Found: Bladder Cancer ### Intervention Browse Module - Meshes - ID: D000000728 - Term: Androgens ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Standard of Care ADT + (HMB + AG) **Deaths Num Affected:** 1 **Deaths Num At Risk:** 24 **Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine. Take one packet twice daily for 3 months **ID:** EG000 **Other Num Affected:** 8 **Other Num at Risk:** 24 **Serious Number Affected:** 1 **Serious Number At Risk:** 24 **Title:** Standard of Care ADT + (HMB + AG) **Group ID:** EG001 **Title:** Standard of Care ADT **Deaths Num At Risk:** 24 **Description:** Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone **ID:** EG001 **Other Num Affected:** 7 **Other Num at Risk:** 24 **Serious Number Affected:** 2 **Serious Number At Risk:** 24 **Title:** Standard of Care ADT **Frequency Threshold:** 0 #### Other Events **Term:** Anorexia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE 4.0 **Term:** Face pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Hand pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Joint pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Neck pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Melanoma **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Neoplasm - other **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** CTCAE (4.0) **Term:** Dizziness **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Headache **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Transient ischemic event **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Incontinence, Urinary **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Urinary frequency/urgency **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Urinary retention **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** CTCAE (4.0) #### Serious Events **Term:** Leukocytes decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE 4.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 24 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Multi-organ failure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** CTCAE 4.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Transient ischemic attack **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** CTCAE 4.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 24 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Time Frame:** 8 months ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 24 **Group ID:** BG001 **Value:** 24 **Group ID:** BG002 **Value:** 48 **Units:** Participants ### Group **ID:** BG000 **Title:** Standard of Care ADT + (HMB + AG) **Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine. Take one packet twice daily for 3 months ### Group **ID:** BG001 **Title:** Standard of Care ADT **Description:** Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 10 #### Measurement **Group ID:** BG002 **Value:** 13 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 21 #### Measurement **Group ID:** BG001 **Value:** 14 #### Measurement **Group ID:** BG002 **Value:** 35 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 5.6 **Value:** 70.6 #### Measurement **Group ID:** BG001 **Spread:** 5.1 **Value:** 67.4 #### Measurement **Group ID:** BG002 **Spread:** 5.6 **Value:** 69.0 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 24 #### Measurement **Group ID:** BG001 **Value:** 24 #### Measurement **Group ID:** BG002 **Value:** 48 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 23 #### Measurement **Group ID:** BG001 **Value:** 24 #### Measurement **Group ID:** BG002 **Value:** 47 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 2 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 24 #### Measurement **Group ID:** BG001 **Value:** 22 #### Measurement **Group ID:** BG002 **Value:** 46 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 24 #### Measurement **Group ID:** BG001 **Value:** 24 #### Measurement **Group ID:** BG002 **Value:** 48 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 6 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** Froedtert and the Medical college of Wisconsin **Phone:** 414-805-4600 **Title:** Kathryn Bylow, MD ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.1497 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 1 sided **Tested Non-Inferiority:** ### Outcome Measure 2 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.17 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** ### Outcome Measure 3 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.75 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** ### Outcome Measure 4 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.925 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 5 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 1.0 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 8.66 - **Upper Limit:** - **Value:** 54.93 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.39 - **Upper Limit:** - **Value:** 57.58 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.42 - **Upper Limit:** - **Value:** -1.27 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.22 - **Upper Limit:** - **Value:** -0.60 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 322 - **Upper Limit:** - **Value:** 1378 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 177 - **Upper Limit:** - **Value:** 1348 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 37 - **Upper Limit:** - **Value:** -36 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 164 - **Upper Limit:** - **Value:** 30 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 3.1 - **Upper Limit:** - **Value:** 17.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 3.0 - **Upper Limit:** - **Value:** 18.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 5.3 - **Upper Limit:** - **Value:** -1.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.0 - **Upper Limit:** - **Value:** 1.0 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.6 - **Upper Limit:** - **Value:** 10.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.7 - **Upper Limit:** - **Value:** 10.7 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 24 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.1 - **Upper Limit:** - **Value:** 11.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.2 - **Upper Limit:** - **Value:** 11.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 20 - **Group ID:** OG001 - **Value:** 23 **Units:** Participants #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 24 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** -1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 21 - **Group ID:** OG001 - **Value:** 24 **Units:** Participants ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** This measure will be the change of lean body mass from baseline reported in kilograms. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline, 3 months **Title:** Change From Baseline in Body Composition (Lean Body Mass) **Type:** PRIMARY **Unit of Measure:** Kilogram ##### Group **Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine. Take one packet twice daily for 3 months **ID:** OG000 **Title:** Standard of Care ADT + (HMB + AG) ##### Group **Description:** Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone **ID:** OG001 **Title:** Standard of Care ADT #### Outcome Measure 2 **Description:** Cross-sectional area of the dorsiflexor muscle will be measured in mm\^2 using magnetic resonance imaging. The dorsiflexor muscles at the front of the leg are responsible for lifting the ball of the foot with the heel in contact with the ground. One dorsiflexor muscle in one leg was analyzed per participant. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Due to unavailability of equipment, only 5 subjects in the HMB+AG group and 8 subjects in the standard ADT therapy group completed both baseline and 3 months follow-up measurements. **Reporting Status:** POSTED **Time Frame:** Baseline and 3 months **Title:** Change From Baseline of Dorsiflexor Muscle Size in mm^2. **Type:** SECONDARY **Unit of Measure:** mm^2 ##### Group **Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine. Take one packet twice daily for 3 months **ID:** OG000 **Title:** Standard of Care ADT + (HMB + AG) ##### Group **Description:** Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone **ID:** OG001 **Title:** Standard of Care ADT #### Outcome Measure 3 **Description:** Dorsiflexor muscle strength in kilograms will be measured with a custom lower leg ergometer. The dorsiflexor muscles at the front of the leg are responsible for lifting the ball of the foot with the heel in contact with the ground. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Due to unavailability of equipment, only 5 subjects in the HMB+AG group and 10 subjects in the standard ADT group completed both baseline and 3 month follo-up visits. **Reporting Status:** POSTED **Time Frame:** Baseline and 3 months **Title:** Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms. **Type:** SECONDARY **Unit of Measure:** kilogram ##### Group **Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine. Take one packet twice daily for 3 months **ID:** OG000 **Title:** Standard of Care ADT + (HMB + AG) ##### Group **Description:** Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone **ID:** OG001 **Title:** Standard of Care ADT #### Outcome Measure 4 **Description:** The SPPB uses Likert-style ratings for balance, walking speed, and standing test (Guralnik, 2000). Balance metric is the ability to hold three standing positions (feet side-by-side; side of the heel of one foot touching the big toe of the other foot; heel of one foot in front of and touching the toes of the other) up to 10 seconds. Inability to hold a position scores '0'. The sum of scores is the Balance Score. Scoring range is 0-4. Higher scores indicate better balance. Walking metric is time to walk 8 feet. Faster times score more points. Inability to complete the walk scores '0'. The score range is 0-4. Higher scores indicate better mobility. The Standing Test. The subject is asked to stand and sit five times as quickly as possible. Inability to complete five repetitions scores '0'. Shorter times score more points. Scoring range is 0-4. Higher scores indicate better mobility. Overall score is the sum of the scores ranging 0 to 12. Higher scores indicate better performance. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Four subjects in the HMB+AG group and one subject in the standard ADT group did not complete the SPPB test at the 3-month follow-up. **Reporting Status:** POSTED **Time Frame:** Baseline and 3 months **Title:** Physical Performance Measured Using the Short Physical Performance Battery (SPPB) **Type:** SECONDARY **Unit of Measure:** score on a scale ##### Group **Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine. Take one packet twice daily for 3 months **ID:** OG000 **Title:** Standard of Care ADT + (HMB + AG) ##### Group **Description:** Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone **ID:** OG001 **Title:** Standard of Care ADT #### Outcome Measure 5 **Description:** This measure will be the change in the number of reported falls from baseline (defined as the 3 months preceding the baseline visit), and the 3 month period beginning after the baseline visit and continuing through 3 months of therapy. **Parameter Type:** NUMBER **Population Description:** Three subjects in the HMB+AG group did not report the number of falls at the 3-month follow-up. **Reporting Status:** POSTED **Time Frame:** Baseline, 3 months **Title:** Change From Baseline in the Number of Fall Events **Type:** SECONDARY **Unit of Measure:** Falls ##### Group **Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine. Take one packet twice daily for 3 months **ID:** OG000 **Title:** Standard of Care ADT + (HMB + AG) ##### Group **Description:** Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone **ID:** OG001 **Title:** Standard of Care ADT ### Participant Flow Module #### Group **Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine. Take one packet twice daily for 3 months **ID:** FG000 **Title:** Standard of Care ADT + (HMB + AG) #### Group **Description:** Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone **ID:** FG001 **Title:** Standard of Care ADT #### Period **Title:** Overall Study ##### Withdraw **Type:** Death ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 24 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 24 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 23 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 24 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 **Has Results:** True
## Protocol Section ### Identification Module **NCT ID:** NCT04666779 **Brief Title:** Access to Chiropractic Care During the COVID-19 Pandemic **Official Title:** Access to Chiropractic Care During the COVID-19 Pandemic: a Prospective Comparative Cohort Trial #### Organization Study ID Info **ID:** CohortChiroCOVID19 #### Organization **Class:** OTHER **Full Name:** Real Centro Universitario Maria Cristina ### Status Module #### Completion Date **Date:** 2021-09-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-09-16 **Type:** ACTUAL **Last Update Submit Date:** 2021-09-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-02-21 **Type:** ACTUAL #### Start Date **Date:** 2020-12-18 **Type:** ACTUAL **Status Verified Date:** 2021-09 #### Study First Post Date **Date:** 2020-12-14 **Type:** ACTUAL **Study First Submit Date:** 2020-12-11 **Study First Submit QC Date:** 2020-12-11 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Birmingham **Class:** OTHER **Name:** Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz **Class:** OTHER **Name:** Université du Québec à Trois-Rivières #### Lead Sponsor **Class:** OTHER **Name:** Real Centro Universitario Maria Cristina #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a prospective comparative cohort trial taking place during the first year of the Coronavirus-19 (COVID-19) pandemic in Spain. Chiropractic patients throughout Spain were invited to participate independently of the care received, including patients who had stopped visiting their chiropractors since the pandemic hit. The main exposure variable is the access to chiropractic care services, and the degree of this exposure during the months following initial lockdown phase in Spain. Participants will fill an online questionnaire with self-reported outcome-measures. ### Conditions Module **Conditions:** - Access to Chiropractic Care Services ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 399 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 6 Months ### Arms Interventions Module #### Arm Group 1 **Description:** Group not accessing chiropractic care **Label:** No access #### Arm Group 2 **Description:** Group with access to care in a 6 months period. Differences in the degree of access, measured in ranges of numbers of visits, will be used as independent variable within this group. **Intervention Names:** - Other: Chiropractic care **Label:** Access to care ### Interventions #### Intervention 1 **Arm Group Labels:** - Access to care **Description:** Care provided by chiropractors, based on manual therapy, exercise prescription and patient advice/education/reassurance **Name:** Chiropractic care **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Numerical Rating Scale (0-10, 0=no pain, 10=maximum pain) **Measure:** Pain intensity **Time Frame:** 6 months **Description:** Duration of pain symptoms, PREVIOUS to the study, measured in months (up to 3 months, more than 3 months) **Measure:** Pain duration **Time Frame:** 6 months **Description:** Ranges: Constant, every day, every week, occasionally **Measure:** Pain frequency **Time Frame:** 6 months **Description:** Categories: New pain, worsened, no change, improv, gone **Measure:** Pain perceived improvement **Time Frame:** 6 months **Description:** From the Brief Pain Inventory (7 items, 0-10: 0= minimal score, 70=maximal score) **Measure:** Pain interference **Time Frame:** 6 months **Description:** Validated questionnaire (short version 4 items, 1-4: 4= minimal score, 16=maximal score) **Measure:** Pain Catastrophizing Scale **Time Frame:** 6 months **Description:** Validated questionnaire (short version 11 items, 0-3: 0=minimal score, 33=maximal score) **Measure:** Tampa Scale Kinesiophobia **Time Frame:** 6 months #### Secondary Outcomes **Description:** Validated questionnaire (7 items , 1-3: 1= minimal score, 21=maximal score) **Measure:** General Anxiety Disorder scale **Time Frame:** 6 months **Description:** Questionnaire (12 items, 1-4: 1=minimal score, 48=maximal score) **Measure:** Fear of Illness and Virus Evaluation **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * chiropractic patients with pain, active when lockdown was declared, over the age of 16 Exclusion Criteria: * new patients in the clinic after the pandemic hit **Minimum Age:** 16 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Chiropractic patients when the pandemic hit in Spain (March 2020), who consulted a chiropractor for pain as one of the chief complaints (not necessarily the main or the only one) ### Contacts Locations Module #### Locations **Location 1:** **City:** San Lorenzo De El Escorial **Country:** Spain **Facility:** Real Centro Universitario María Cristina **State:** Madrid **Zip:** 28200 #### Overall Officials **Official 1:** **Affiliation:** Real Centro Universitario María Cristina **Name:** Arantxa Ortega de Mues, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** All collected IPD will be shared, the format is yet to be decided. **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 Pandemic - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT01841879 **Brief Title:** Mumbai Worksite Tobacco Control Study **Official Title:** Mumbai Worksite Tobacco Control Study #### Organization Study ID Info **ID:** R01CA140304 **Link:** https://reporter.nih.gov/quickSearch/R01CA140304 **Type:** NIH #### Organization **Class:** OTHER **Full Name:** Harvard School of Public Health (HSPH) #### Secondary ID Infos **ID:** R01CA140304 **Link:** https://reporter.nih.gov/quickSearch/R01CA140304 **Type:** NIH ### Status Module #### Completion Date **Date:** 2016-06-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-04-17 **Type:** ACTUAL **Last Update Submit Date:** 2017-04-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-06-30 **Type:** ACTUAL #### Start Date **Date:** 2010-06 **Status Verified Date:** 2017-04 #### Study First Post Date **Date:** 2013-04-29 **Type:** ESTIMATED **Study First Submit Date:** 2013-03-19 **Study First Submit QC Date:** 2013-04-24 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) **Class:** OTHER **Name:** Healis-Sekhsaria Institute for Public Health **Class:** OTHER **Name:** Carelon Research **Class:** OTHER **Name:** Dana-Farber Cancer Institute #### Lead Sponsor **Class:** OTHER **Name:** Harvard School of Public Health (HSPH) #### Responsible Party **Investigator Affiliation:** Harvard School of Public Health (HSPH) **Investigator Full Name:** Glorian Sorensen **Investigator Title:** Professor of Society, Human Development, and Health **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The investigators are designing and testing the effectiveness of an integrated tobacco control and occupational health (OH) intervention aimed at promoting tobacco cessation among workers and supporting the adoption, implementation, and enforcement of tobacco control policies in 20 manufacturing worksites in the greater Mumbai region of India. **Detailed Description:** Through 6 health education events at the worksites, blue-collar workers (who face dual health risks through their exposures to occupational hazards and their high rates of tobacco use) will gain the knowledge, skills, and social support needed to quit tobacco use. Simultaneously, management will receive OH and tobacco policy consultations to help build a healthy and safe work environment, where workers' hazardous exposures are reduced. ### Conditions Module **Conditions:** - Tobacco Use Cessation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 6880 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Receives the full Healthy, Safe, and Tobacco-Free Worksites intervention **Intervention Names:** - Behavioral: Intervention Program **Label:** Intervention Program **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Receives abbreviated 2-month delayed intervention designed to provide employees with knowledge and skills to quit tobacco after final data collection time point, as well as one non-tobacco event in between data collection points. **Intervention Names:** - Behavioral: Delayed Intervention **Label:** Delayed Intervention Control **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention Program **Description:** Receives an integrated tobacco control and occupational health (OH) intervention (The Healthy, Safe, and Tobacco-Free Worksites program) aimed at promoting tobacco cessation among workers and supporting the adoption, implementation, and enforcement of tobacco control policies. Through six health education events at the worksites, blue-collar workers (who face dual health risks through their exposures to occupational hazards and their high rates of tobacco use) will gain the knowledge, skills, and social support needed to quit tobacco use. Simultaneously, management will receive OH and tobacco policy consultations to help build a healthy and safe work environment, where workers' hazardous exposures are reduced. **Name:** Intervention Program **Other Names:** - Healthy, Safe, and Tobacco-Free Worksites Program **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Delayed Intervention Control **Description:** Receives abbreviated 2-month delayed intervention designed to provide employees with knowledge and skills to quit tobacco after final data collection time point, as well as one non-tobacco event in between data collection points. **Name:** Delayed Intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Measure:** Tobacco use cessation **Time Frame:** 6-month post intervention #### Secondary Outcomes **Measure:** Changes in company tobacco policy **Time Frame:** 6-month post intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Manufacturing worksites located in the Mumbai, Thane, or Raigad districts of India * Employ at least 60% production workers/40% administrative staff OR at employ at least 200 production workers on staff. NOTE: We are defining "workers" as anyone who is on the company roster, regardless of whether they're permanent or contractual * Companies must be autonomous decision-makers and allow us to function at their worksite * Companies must be willing to provide us with a current employee roster Exclusion Criteria: * Employees do not speak English, Hindi, or Marathi **Healthy Volunteers:** True **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Navi Mumbai **Country:** India **Facility:** Healis-Sekhsaria Institute for Public Health **State:** Maharshtra #### Overall Officials **Official 1:** **Affiliation:** Harvard School of Public Health, Dana-Farber Cancer Institute **Name:** Glorian Sorensen, PhD, MPH **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Sorensen G, Pednekar M, Cordeira LS, Pawar P, Nagler EM, Stoddard AM, Kim HY, Gupta PC. Effects of a worksite tobacco control intervention in India: the Mumbai worksite tobacco control study, a cluster-randomised trial. Tob Control. 2017 Mar;26(2):210-216. doi: 10.1136/tobaccocontrol-2015-052671. Epub 2016 Feb 16. **PMID:** 26883793 #### See Also Links **Label:** Healis-Sekhsaria Institute for Public Health's website **URL:** http://www.healis.org **Label:** The Center for Community-Based Research's website **URL:** http://www.community-based-research.org/ ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24
## Protocol Section ### Identification Module **NCT ID:** NCT01953679 **Acronym:** CCN013 **Brief Title:** Efficacy Study of Two Continuous Regimens of Oral Daily 5 mg or 10 mg of Ulipristal Acetate (UPA), Versus a Dose of 5.0mg UPA for 24/4 Days **Official Title:** A Phase IIb Randomized, Double Blind, Comparative Study to Assess the Efficacy, Safety, Tolerability and Inhibition of Ovulation of Two Continuous Regimens of Oral Daily 5 mg or 10 mg of Ulipristal Acetate (UPA), Versus a Dose of 5.0mg UPA for 24/4 Days #### Organization Study ID Info **ID:** CCN013 #### Organization **Class:** OTHER **Full Name:** Health Decisions ### Status Module #### Completion Date **Date:** 2015-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-02-22 **Type:** ESTIMATED **Last Update Submit Date:** 2016-02-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2015-08 **Type:** ACTUAL #### Start Date **Date:** 2014-03 **Status Verified Date:** 2016-02 #### Study First Post Date **Date:** 2013-10-01 **Type:** ESTIMATED **Study First Submit Date:** 2013-08-23 **Study First Submit QC Date:** 2013-09-26 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) #### Lead Sponsor **Class:** OTHER **Name:** Health Decisions #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** To compare the pharmacodynamic effects of 2 continuous dose regimens of ulipristal acetate 5.0 and 10.0 mg-only oral contraception, versus a 24/4 day regimen of UPA 5.0 mg. ### Conditions Module **Conditions:** - Focus: Estrogen-free Oral Contraception ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 180 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Continuous regimen of oral daily 5 mg of ulipristal acetate (UPA) versus a cyclic regimen of 5 mg UPA for 24 days followed by a 4 day hormone free interval. **Intervention Names:** - Drug: Ulipristal Acetate **Label:** 5mg UPA **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Continuous regimen of oral daily 10 mg of ulipristal acetate (UPA) versus a cyclic regimen of 5 mg UPA for 24 days followed by a 4 day hormone free interval. **Intervention Names:** - Drug: Ulipristal Acetate **Label:** 10mg UPA **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 10mg UPA - 5mg UPA **Name:** Ulipristal Acetate **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** * Two consecutive serum progesterone values ≥10nMol/L (3ng/mL) within a four day window; * A follicle ≥13 mm followed by a single serum progesterone value ≥10nMol/L (3ng/mL) without a second high progesterone level but with follicle disappearance, suggestive of follicular rupture. **Measure:** Ovulation inhibition **Time Frame:** Approximately 6.5 months #### Secondary Outcomes **Description:** Total number of bleeding and spotting days per 28 day and 84 day interval, menses duration and intensity, bleeding-related AEs, hematocrit levels, subject's acceptability of treatment. **Measure:** Bleeding profile **Time Frame:** Approximately 6.5 months **Description:** Follicle growth (≥13 mm and ≥15 mm) and rupture assessed using transvaginal ultrasound (TVUS) twice weekly during the 84 day treatment. **Measure:** Follicle growth and rupture **Time Frame:** Approximately 6.5 months **Description:** 1. Endometrial thickness by TVUS 2. Endometrial biopsies during the Baseline cycle at Visit BL2 (Proliferative phase), on Treatment at Visit 22 ± 1 visit (between days 70 -80) OR 7-10 days following any suspected ovulation that occurs after the first 28 days of treatment, and at the end of the recovery period after two full washout cycles during day 7 following start of second menses (Proliferative phase). **Measure:** Endometrial safety **Time Frame:** Approximately 6.5 months **Measure:** Overall subject satisfaction and safety **Time Frame:** Approximately 6.5 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Women between 18 and 35 years old. 2. In good health, with regular menstrual cycles that occur every 21-35 days. 1. If subject is postpartum or post-abortal (with abortion in second trimester), she will be required to have two normal menstrual cycles (3 menses) prior to screening. 2. If subject had an abortion in the first trimester, she will be required to have at least one menstrual cycle (two menses) prior to screening. 3. No current use of hormonal contraception or an intrauterine device and having had at least one complete menstrual cycle since having stopped hormonal contraception before starting the treatment. a. No use of injectable contraceptives (e.g. cyclofem or depo-medroxyprogesterone acetate) during the 6 months prior to screening unless the subject has returned to normal menses since last injection. 4. Have a negative urine pregnancy test at the admission visit. 5. Will not be at risk for pregnancy. They will be consistently using a non-hormonal method, barrier method with every act of intercourse until the time of study exit OR have a surgically sterile male partner with a vasectomy, must have undergone previous tubal ligation, be abstinent, or be in a same-sex relationship from the control period through study exit (including recovery period). 6. In the opinion of the investigator, willing and able to follow all study requirements, including use of the study product and willing to record requested information on a daily diary. 7. Understand and sign an IRB approved inform consent form prior to screening activities (including fasting blood draws). 8. Will have diastolic blood pressure (BP) ≤95 mm Hg and systolic BP ≤145 mm Hg after 5 minutes in sitting position. 9. BMI \< 40 kg/m2 and not having previously undergone bariatric surgery. 10. Agree not to participate in any other clinical trials during the course of this study. Exclusion Criteria: 1. Women less than 18 and older than 35 years old. 2. Women with menstrual cycle length of less than 21 or more than 35 days; or with spontaneous irregular menstrual cycle length with intra-individual variations of more than 5 days. a. If subject is postpartum or post-abortal (with abortion in second trimester) and not had two normal menstrual cycles (3 menses) prior to screening. b. If subject had an abortion in the first trimester and not had at least one menstrual cycle (two menses) prior to screening. 3. Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test. 4. Unwilling to use a barrier method with every act of intercourse until study exit OR not have a surgically sterile male partner with a vasectomy, not have undergone previous tubal ligation, not abstinent, or not in a same-sex relationship from the control period through study exit (including recovery period). 5. Women planning pregnancy within their months of study participation. 6. Currently breast-feeding or within 30 days of discontinuing breast feeding, unless the woman has already had a menses following discontinuation of breast feeding. 7. Current use of an IUD, or other hormonal contraception within last complete menstrual cycle prior to screening. a. Use of injectable contraceptives (e.g. cyclofem or depo-medroxyprogesterone acetate) during the 6 months prior to screening without the subject returning to normal menses since last injection. 8. Undiagnosed abnormal genital bleeding. 9. Known hypersensitivity to the active substance UPA or any of the excipients of the study treatment. 10. Anomalies in endometrial appearance, TVUS or safety labs done at screening visit recognized as clinically significant by the investigator. 11. Subject with a previous history of endometrial ablation. 12. A clinically significant Pap test abnormality, as managed by current local or national guidelines. Women with a current abnormal Pap (within the last eighteen months): 1. In accordance with the Bethesda system of classification: smear suggestive of high-grade pre-cancerous lesion(s), including high grade squamous intraepithelial lesions (HGSILs), are excluded; • Women with low grade squamous intraepithelial lesion (LGSIL) or atypical squamous cells of undetermined significance (ASCUS)/high-risk human papillomavirus (HPV) positive, or Atypical squamous cells, cannot rule out a high grade lesion (ASC-H) may participate if further evaluated with colposcopy and biopsy determines no evidence of a lesion with a severity greater than cervical intraepithelial neoplasia (CIN) I. • Women with a biopsy finding of CIN I should have follow-up for this finding per standard of care; women are excluded if treatment is indicated. 2. In accordance with other Pap class systems: • Women with high grade dysplasia are excluded. • Women with atypical glandular cells of undetermined significance (AGUS) are excluded. • Women with low grade dysplasia or CIN I interpretation on Pap test may participate following exclusion of a high grade lesion by colposcopic evaluation based on Investigator discretion and provided there is appropriate follow up in accordance with local standards. 13. Has any of the following known contraindication to progestin-only oral contraceptive (OC): 1. History or existing breast cancer, or other hormone sensitive neoplasia; 2. Current and history of ischemic heart disease or stroke while pregnant or taking birth control pills; 3. Acute deep venous thrombosis or pulmonary embolism; 4. Systemic Lupus Erythematosus with positive or unknown antiphospholipid antibodies; 5. Benign and malignant liver tumors; 6. Severe (decompensated) cirrhosis. 14. Hereditary galactose intolerance, Lapp lactase deficiency , or glucose-galactose malabsorption. 15. Known or suspected alcoholism or drug abuse. 16. Known HIV infection. 17. Smoking 15 cigarettes or more per day must be evaluated by the investigator or medically qualified designee for inclusion based on risk factors that would increase their risk for cardiovascular disease (CVD) and thromboembolism. 18. Current or past deep vein thrombophlebitis or thromboembolic disorders. 19. Current or past medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive, unless she is stable on antidepressant medication. 20. Concomitant use of medication thought to interact with UPA (per SPCs): 1. CYP3A4 inducers (rifampin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, phenytoin, St John's Wort, topiramate), 2. Other hormonal contraceptives including emergency contraception. 21. Use of any medications that can interfere with the metabolism of hormone contraceptives, antibiotics that can interfere with metabolism of hormone contraceptives, and any drugs designated by the FDA as Pregnancy Category D or X. 22. Current participation in any other trial of an investigational medicine or device or participation in the past three months before start of first treatment phase. 23. Headaches with focal neurological symptoms only. 24. Have diastolic blood pressure (BP) \>95 mm Hg and systolic BP \>145 mm Hg after 5 minutes in sitting position. 1. Hypertensive subjects who are treatment controlled and in the judgment of the investigator are a good candidate require a waiver for participation. 25. BMI ≥40 kg/m² or having previously undergone bariatric surgery. 26. Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study. - **Healthy Volunteers:** True **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Los Angeles **Country:** United States **Facility:** California Family Health Council **State:** California **Zip:** 90010 **Location 2:** **City:** San Francisco **Country:** United States **Facility:** University of California, San Francisco **State:** California **Zip:** 94110 **Location 3:** **City:** Aurora **Country:** United States **Facility:** University of Colorado - Denver Anschutz Medical Campus **State:** Colorado **Zip:** 80045 **Location 4:** **City:** Chicago **Country:** United States **Facility:** University of Chicago **State:** Illinois **Zip:** 60637 **Location 5:** **City:** New York **Country:** United States **Facility:** NYU School of Medicine **State:** New York **Zip:** 10016 **Location 6:** **City:** New York **Country:** United States **Facility:** Columbia University Medical Center **State:** New York **Zip:** 10032 **Location 7:** **City:** Cincinnati **Country:** United States **Facility:** University of Cincinnati-Holmes Hospital **State:** Ohio **Zip:** 45267 **Location 8:** **City:** Portland **Country:** United States **Facility:** Oregon Health and Sciences University **State:** Oregon **Zip:** 97239 **Location 9:** **City:** Philadelphia **Country:** United States **Facility:** University of Pennsylvania Medical Center **State:** Pennsylvania **Zip:** 19104 **Location 10:** **City:** Norfolk **Country:** United States **Facility:** Eastern Virgina Medical School **State:** Virginia **Zip:** 23507 ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000080066 - Term: Contraceptive Agents, Hormonal - ID: D000003270 - Term: Contraceptive Agents - ID: D000012102 - Term: Reproductive Control Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000003271 - Term: Contraceptive Agents, Female ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Repr - Name: Reproductive Control Agents ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M266299 - Name: Ulipristal acetate - Relevance: HIGH - As Found: Verum - ID: M6494 - Name: Contraceptive Agents - Relevance: LOW - As Found: Unknown - ID: M2116 - Name: Contraceptive Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M6495 - Name: Contraceptive Agents, Female - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000555622 - Term: Ulipristal acetate ### Misc Info Module - Version Holder: 2024-05-24