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96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Metastasis to ipsilateral internal mammary node (N3) NOTE: *Patients with primary tumors 5 cm (T3) or tumors involving the chest wall or skin who are not candidates for preoperative chemotherapy or who decline preoperative chemotherapy are eligible Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Measurable residual tumor at the primary site Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Measurable disease is defined as any mass that can be reproducibly measured by physical examination Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Planning to undergo surgical treatment with either segmental resection or total mastectomy Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Patients with a prior history of contralateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | No locally recurrent breast cancer Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | No evidence of distant metastatic disease (i.e., lung, liver, bone, or brain metastases) Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Hormone receptor status not specified Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | PATIENT CHARACTERISTICS: Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Menopausal status not specified Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | ANC 1,000/mm^3 Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Creatinine 1.5 times upper limit of normal (ULN) Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Total bilirubin 1.5 times ULN Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Serum glutamic oxaloacetic transminase (SGOT) and serum glutamic pyruvic transminase (SGPT) 1.5 times ULN Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Must be at least 18 years old Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Not pregnant or nursing Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Negative pregnancy test Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Fertile patients must use effective contraception Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | No serious medical illness that, in the judgement of the treating physician, places the patient at high risk of operative mortality Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | PRIOR CONCURRENT THERAPY: Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | See Disease Characteristics Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | No prior chemotherapy for this primary breast cancer Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | At least 7 days since prior tamoxifen or raloxifene as a preventive agent Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
c73faed2-371b-4238-bf7d-293fae380203 | primary trial: Adjuvant Radiotherapy secondary trial: Hypnotherapy the primary trial and the secondary trial have Hypnotherapy based interventions, the secondary trial also used pain medication in its intervention. | 0 |
c73faed2-371b-4238-bf7d-293fae380203 | primary trial: Adjuvant Radiotherapy secondary trial: Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home. the primary trial and the secondary trial have Hypnotherapy based interventions, the secondary trial also used pain medication in its intervention. | 0 |
c73faed2-371b-4238-bf7d-293fae380203 | primary trial: Adjuvant Radiotherapy secondary trial: Gabapentin the primary trial and the secondary trial have Hypnotherapy based interventions, the secondary trial also used pain medication in its intervention. | 0 |
c73faed2-371b-4238-bf7d-293fae380203 | primary trial: Adjuvant Radiotherapy secondary trial: Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily). the primary trial and the secondary trial have Hypnotherapy based interventions, the secondary trial also used pain medication in its intervention. | 0 |
c73faed2-371b-4238-bf7d-293fae380203 | primary trial: Adjuvant radiation was started within 12 weeks of local excision or breast re-excision. secondary trial: Hypnotherapy the primary trial and the secondary trial have Hypnotherapy based interventions, the secondary trial also used pain medication in its intervention. | 0 |
c73faed2-371b-4238-bf7d-293fae380203 | primary trial: Adjuvant radiation was started within 12 weeks of local excision or breast re-excision. secondary trial: Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home. the primary trial and the secondary trial have Hypnotherapy based interventions, the secondary trial also used pain medication in its intervention. | 0 |
c73faed2-371b-4238-bf7d-293fae380203 | primary trial: Adjuvant radiation was started within 12 weeks of local excision or breast re-excision. secondary trial: Gabapentin the primary trial and the secondary trial have Hypnotherapy based interventions, the secondary trial also used pain medication in its intervention. | 0 |
c73faed2-371b-4238-bf7d-293fae380203 | primary trial: Adjuvant radiation was started within 12 weeks of local excision or breast re-excision. secondary trial: Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily). the primary trial and the secondary trial have Hypnotherapy based interventions, the secondary trial also used pain medication in its intervention. | 0 |
c73faed2-371b-4238-bf7d-293fae380203 | primary trial: Adjuvant Radiotherapy: Adjuvant radiation therapy secondary trial: Hypnotherapy the primary trial and the secondary trial have Hypnotherapy based interventions, the secondary trial also used pain medication in its intervention. | 0 |
c73faed2-371b-4238-bf7d-293fae380203 | primary trial: Adjuvant Radiotherapy: Adjuvant radiation therapy secondary trial: Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home. the primary trial and the secondary trial have Hypnotherapy based interventions, the secondary trial also used pain medication in its intervention. | 0 |
c73faed2-371b-4238-bf7d-293fae380203 | primary trial: Adjuvant Radiotherapy: Adjuvant radiation therapy secondary trial: Gabapentin the primary trial and the secondary trial have Hypnotherapy based interventions, the secondary trial also used pain medication in its intervention. | 0 |
c73faed2-371b-4238-bf7d-293fae380203 | primary trial: Adjuvant Radiotherapy: Adjuvant radiation therapy secondary trial: Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily). the primary trial and the secondary trial have Hypnotherapy based interventions, the secondary trial also used pain medication in its intervention. | 0 |
8765009d-ffc4-4395-ab7a-11ecdfd43a40 | Must be female with histologically confirmed breast cancer Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | 1 |
8765009d-ffc4-4395-ab7a-11ecdfd43a40 | Stage II-IV disease Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | 1 |
8765009d-ffc4-4395-ab7a-11ecdfd43a40 | ER and/or PR positive Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | 1 |
8765009d-ffc4-4395-ab7a-11ecdfd43a40 | ECOG Performance Status 0-1 Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | 1 |
8765009d-ffc4-4395-ab7a-11ecdfd43a40 | Tumor must be present following core needle biopsy as determined by physical exam or radiographic evaluation. Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | 1 |
8765009d-ffc4-4395-ab7a-11ecdfd43a40 | Postmenopausal Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | 1 |
8765009d-ffc4-4395-ab7a-11ecdfd43a40 | No prior treatment for current breast cancer. No other active malignancy is allowed.Adequately treated basal cell, squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years is permitted. Biphosphonates and palliative radiation for bone metastasis is permitted while on study. Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | 1 |
8765009d-ffc4-4395-ab7a-11ecdfd43a40 | Hormone replacement therapy must be discontinued. It is not permitted during the time on study. Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | 1 |
8765009d-ffc4-4395-ab7a-11ecdfd43a40 | Known history of aspirin or NSAID induced asthma, urticaria or allergic reactions; or allergy to sulfonamides severe enough in nature to require emergency room treatment or hospitalization. Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | 1 |
8765009d-ffc4-4395-ab7a-11ecdfd43a40 | History of myocardial infarction or other thrombotic events. Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | 1 |
8765009d-ffc4-4395-ab7a-11ecdfd43a40 | Inflammatory breast cancer (edema or ulceration of the skin of the breast). Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | 1 |
8765009d-ffc4-4395-ab7a-11ecdfd43a40 | Significant renal dysfunction (serum creatinine > 1.5 x upper limit of normal). Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | 1 |
8765009d-ffc4-4395-ab7a-11ecdfd43a40 | Significant hepatic dysfunction (serum bilirubin > 1.5 x upper limit of normal or AST, ALT > 3 x upper limit of normal) Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | 1 |
8765009d-ffc4-4395-ab7a-11ecdfd43a40 | ANC <1.5, platelets <100,000 K/uL, and hemoglobin < 9 g/dL. Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | 1 |
8765009d-ffc4-4395-ab7a-11ecdfd43a40 | Use of other COX-2 inhibitors such as rofecoxib (Vioxx®, aspirin, trisalicylate (Trilisate®), is not permitted during the time on study. No washout period is required. Baby aspirin, 81 mg po daily, is permitted. Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | 1 |
8765009d-ffc4-4395-ab7a-11ecdfd43a40 | Use of NSAID's such as ibuprofen (Advil® or Motrin®), naproxyn (Aleve® Naprosyn®, or Anaprox®), etodolac (Lodine®), oxaprozin (Daypro®), difusanil (Dolobid®), nabumetone (Relafin®), or tolmetin (Tolectin®) is not permitted during the time on study. Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | 1 |
0ad7293d-df35-42e8-881d-f2afc3f7d3fd | primary trial: Accelerated Intensity Modulated Radiation Therapy (AIMRT) secondary trial: AeroForm Tissue Expander Only patients in the primary trial receive 40.5 Gy of brachytherapy, patients in the secondary trial receive no radiotherapy whatsoever. | 0 |
0ad7293d-df35-42e8-881d-f2afc3f7d3fd | primary trial: Accelerated Intensity Modulated Radiation Therapy (AIMRT) secondary trial: AeroForm Tissue Expansion inflation with carbon dioxide by remote control Only patients in the primary trial receive 40.5 Gy of brachytherapy, patients in the secondary trial receive no radiotherapy whatsoever. | 0 |
0ad7293d-df35-42e8-881d-f2afc3f7d3fd | primary trial: Accelerated Intensity Modulated Radiation Therapy (AIMRT) secondary trial: AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander. Only patients in the primary trial receive 40.5 Gy of brachytherapy, patients in the secondary trial receive no radiotherapy whatsoever. | 0 |
0ad7293d-df35-42e8-881d-f2afc3f7d3fd | primary trial: All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered. secondary trial: AeroForm Tissue Expander Only patients in the primary trial receive 40.5 Gy of brachytherapy, patients in the secondary trial receive no radiotherapy whatsoever. | 0 |
0ad7293d-df35-42e8-881d-f2afc3f7d3fd | primary trial: All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered. secondary trial: AeroForm Tissue Expansion inflation with carbon dioxide by remote control Only patients in the primary trial receive 40.5 Gy of brachytherapy, patients in the secondary trial receive no radiotherapy whatsoever. | 0 |
0ad7293d-df35-42e8-881d-f2afc3f7d3fd | primary trial: All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered. secondary trial: AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander. Only patients in the primary trial receive 40.5 Gy of brachytherapy, patients in the secondary trial receive no radiotherapy whatsoever. | 0 |
0ad7293d-df35-42e8-881d-f2afc3f7d3fd | primary trial: Accelerated intensity modulated radiation therapy (AIMRT) secondary trial: AeroForm Tissue Expander Only patients in the primary trial receive 40.5 Gy of brachytherapy, patients in the secondary trial receive no radiotherapy whatsoever. | 0 |
0ad7293d-df35-42e8-881d-f2afc3f7d3fd | primary trial: Accelerated intensity modulated radiation therapy (AIMRT) secondary trial: AeroForm Tissue Expansion inflation with carbon dioxide by remote control Only patients in the primary trial receive 40.5 Gy of brachytherapy, patients in the secondary trial receive no radiotherapy whatsoever. | 0 |
0ad7293d-df35-42e8-881d-f2afc3f7d3fd | primary trial: Accelerated intensity modulated radiation therapy (AIMRT) secondary trial: AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander. Only patients in the primary trial receive 40.5 Gy of brachytherapy, patients in the secondary trial receive no radiotherapy whatsoever. | 0 |
2bc1e094-41a1-46d9-9b0c-b5a47f23323d | Tissue diagnosis of a breast carcinoma Certain drinks are banned for patients undertaking the primary trial. | 1 |
2bc1e094-41a1-46d9-9b0c-b5a47f23323d | The oncologist must have prescribed doxorubicin as part of the planned chemotherapy regimen Certain drinks are banned for patients undertaking the primary trial. | 1 |
2bc1e094-41a1-46d9-9b0c-b5a47f23323d | Have acceptable organ function within 14 days of enrollment defined as: Certain drinks are banned for patients undertaking the primary trial. | 1 |
2bc1e094-41a1-46d9-9b0c-b5a47f23323d | liver function: total bilirubin, AST and ALT within normal institutional limits Certain drinks are banned for patients undertaking the primary trial. | 1 |
2bc1e094-41a1-46d9-9b0c-b5a47f23323d | kidney function: estimated Creatinine Clearance > 60 ml/min calculated creatinine clearance (for females) - formula: (140 - age) x weight x .85 divided by (sCr x 72) Certain drinks are banned for patients undertaking the primary trial. | 1 |
2bc1e094-41a1-46d9-9b0c-b5a47f23323d | At least 18 years old Certain drinks are banned for patients undertaking the primary trial. | 1 |
2bc1e094-41a1-46d9-9b0c-b5a47f23323d | Patient must have given written informed consent indicating an understanding of the investigational nature of the study Certain drinks are banned for patients undertaking the primary trial. | 1 |
2bc1e094-41a1-46d9-9b0c-b5a47f23323d | Agrees not to consume grapefruit juice while on the study Certain drinks are banned for patients undertaking the primary trial. | 1 |
2bc1e094-41a1-46d9-9b0c-b5a47f23323d | Known allergy to enalapril Certain drinks are banned for patients undertaking the primary trial. | 1 |
2bc1e094-41a1-46d9-9b0c-b5a47f23323d | Taking any known P450 cytochrome inducers or inhibitors Certain drinks are banned for patients undertaking the primary trial. | 1 |
2bc1e094-41a1-46d9-9b0c-b5a47f23323d | Taking any herbal supplements while on the study or the week prior to receiving doxorubicin Certain drinks are banned for patients undertaking the primary trial. | 1 |
2bc1e094-41a1-46d9-9b0c-b5a47f23323d | Taking an ace-inhibitor or angiotensin receptor blocker Certain drinks are banned for patients undertaking the primary trial. | 1 |
2bc1e094-41a1-46d9-9b0c-b5a47f23323d | Pregnant or lactating. Enalapril is Pregnancy Categories C (first trimester) and D (second and third trimesters) Certain drinks are banned for patients undertaking the primary trial. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Total: 12/32 (37.50%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Anaemia 0/32 (0.00%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Neutropenia 1/32 (3.13%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Thrombocytopenia 4/32 (12.50%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Atrial fibrillation 1/32 (3.13%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Cardiac failure congestive 1/32 (3.13%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Myocardial ischaemia 1/32 (3.13%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Abdominal discomfort 0/32 (0.00%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Ascites 1/32 (3.13%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Constipation 0/32 (0.00%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Rectal haemorrhage 1/32 (3.13%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Vomiting 1/32 (3.13%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Fatigue 1/32 (3.13%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Total: 8/20 (40.00%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Anaemia 1/20 (5.00%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Neutropenia 0/20 (0.00%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Thrombocytopenia 1/20 (5.00%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Atrial fibrillation 0/20 (0.00%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Cardiac failure congestive 0/20 (0.00%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Myocardial ischaemia 0/20 (0.00%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Abdominal discomfort 1/20 (5.00%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Ascites 0/20 (0.00%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Constipation 2/20 (10.00%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Rectal haemorrhage 0/20 (0.00%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Vomiting 0/20 (0.00%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |
83b83400-1439-462d-bba3-42817b5b1fa1 | Fatigue 0/20 (0.00%) Most of the cases of CHF in the primary trial, were in cohort 1. | 1 |