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4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Documented results of oestrogen and progesterone receptors expression analysis; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Eastern Cooperative Oncology Group (ECOG) status 0, 1 or 2, not increasing within 2 weeks prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Life expectancy - 20 weeks or more from the moment of randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Presence of at least 1 tumour with a size not less than 1 cm (revealed with computed tomography (CT) slice thickness not more than 5 mm). Patients having bone metastasis as the only measurable tumour are not eligible for the trial; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Patients of childbearing potential must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior to inclusion into the trial and until 6 months after the last administration of the study drug. Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Previous anticancer therapy for metastatic BC, including cytotoxic chemotherapy, or previous anticancer therapy with signal transduction inhibitors (e.g. lapatinib), biological drugs (e.g. trastuzumab, bevacizumab), experimental (not approved for BC therapy) anticancer drugs. Any previous hormonal therapy is allowed; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Disease progression within 6 months after adjuvant and/or neoadjuvant anti BC therapy; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Surgery, radiation therapy, use of any experimental medications within 4 weeks (28 days) prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Hypersensitivity to paclitaxel and all medications containing polyoxyethylated castor oil, hypersensitivity to dexamethasone, diphenhydramine, ranitidine/cimetidine, recombinant murine proteins, contrast agents or excipients of study medications; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: BC metastases in central nervous system, progressing or clinically manifested (e.g. cerebral oedema, spinal cord injury), with exception of non-progressing metastases not requiring treatment with glucocorticosteroids and/or anticonvulsants within 4 weeks prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Cardiovascular system pathology (congestive heart failure (CHF) stage III-IV according to New York Heart Association (NYHA) classification, unstable angina pectoris, myocardial infarction) within 12 months prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Uncontrolled hypertension comprising all cases of arterial hypertension when no decrease in blood pressure could be achieved despite treatment with a combination of 3 antihypertensive drugs including one diuretic and non-medicamental correction methods (low salt diet, physical exercise); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Left ventricular ejection fraction <50% according to electrocardiography; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Neutrophils 1500/mm3; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Platelets 100 000/mm3; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Hemoglobin 90 g/L; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Creatinine level 1.5 × upper limit of normal (ULN); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Bilirubin level 1.5 × ULN; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Asparagine transferase (AST) and alanine transferase (ALT) levels 2.5 × ULN (5 × ULN for patients with liver metastases); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Alkaline phosphatase level 5 × ULN; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Pregnancy or lactation; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Any other concomitant cancer including contralateral breast cancer revealed within 5 years prior to screening, except curatively treated intraductal carcinoma in situ, curatively treated cervical carcinoma in situ or curatively treated basal cell or squamous cell carcinoma; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Conditions limiting patient's adherence to protocol requirements (dementia, neurologic or psychiatric disorders, drug addiction, alcoholism and others); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Stage II-IV neuropathy according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.0; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Concomitant participation in other clinical trials, previous participation in other clinical trials within 30 days before entering into the trial, previous participation in the same trial; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Acute or active chronic infections; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Hepatitis C virus, hepatitis B virus, HIV or syphilis infections; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug secondary trial: Obstacles in intravenous administration of study drugs Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Written informed consent and ability to follow the Protocol procedures; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Age from 18 years to 75 years inclusive; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Female gender; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Histologically confirmed breast cancer (BC); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Metastatic BC (stage IV according to TNM classification version 6); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Grade 3+ HER2 overexpression confirmed by immunohistochemical (IHC) staining or grade 2+ HER2 overexpression accompanied by HER2 gene amplification confirmed by fluorescent hybridization in situ (FISH) ; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Documented results of oestrogen and progesterone receptors expression analysis; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Eastern Cooperative Oncology Group (ECOG) status 0, 1 or 2, not increasing within 2 weeks prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Life expectancy - 20 weeks or more from the moment of randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Presence of at least 1 tumour with a size not less than 1 cm (revealed with computed tomography (CT) slice thickness not more than 5 mm). Patients having bone metastasis as the only measurable tumour are not eligible for the trial; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Patients of childbearing potential must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior to inclusion into the trial and until 6 months after the last administration of the study drug. Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Previous anticancer therapy for metastatic BC, including cytotoxic chemotherapy, or previous anticancer therapy with signal transduction inhibitors (e.g. lapatinib), biological drugs (e.g. trastuzumab, bevacizumab), experimental (not approved for BC therapy) anticancer drugs. Any previous hormonal therapy is allowed; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Disease progression within 6 months after adjuvant and/or neoadjuvant anti BC therapy; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Surgery, radiation therapy, use of any experimental medications within 4 weeks (28 days) prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Hypersensitivity to paclitaxel and all medications containing polyoxyethylated castor oil, hypersensitivity to dexamethasone, diphenhydramine, ranitidine/cimetidine, recombinant murine proteins, contrast agents or excipients of study medications; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: BC metastases in central nervous system, progressing or clinically manifested (e.g. cerebral oedema, spinal cord injury), with exception of non-progressing metastases not requiring treatment with glucocorticosteroids and/or anticonvulsants within 4 weeks prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Cardiovascular system pathology (congestive heart failure (CHF) stage III-IV according to New York Heart Association (NYHA) classification, unstable angina pectoris, myocardial infarction) within 12 months prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Uncontrolled hypertension comprising all cases of arterial hypertension when no decrease in blood pressure could be achieved despite treatment with a combination of 3 antihypertensive drugs including one diuretic and non-medicamental correction methods (low salt diet, physical exercise); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Left ventricular ejection fraction <50% according to electrocardiography; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Neutrophils 1500/mm3; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Platelets 100 000/mm3; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Hemoglobin 90 g/L; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Creatinine level 1.5 × upper limit of normal (ULN); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Bilirubin level 1.5 × ULN; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Asparagine transferase (AST) and alanine transferase (ALT) levels 2.5 × ULN (5 × ULN for patients with liver metastases); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Alkaline phosphatase level 5 × ULN; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Pregnancy or lactation; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Any other concomitant cancer including contralateral breast cancer revealed within 5 years prior to screening, except curatively treated intraductal carcinoma in situ, curatively treated cervical carcinoma in situ or curatively treated basal cell or squamous cell carcinoma; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Conditions limiting patient's adherence to protocol requirements (dementia, neurologic or psychiatric disorders, drug addiction, alcoholism and others); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Stage II-IV neuropathy according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.0; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Concomitant participation in other clinical trials, previous participation in other clinical trials within 30 days before entering into the trial, previous participation in the same trial; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Acute or active chronic infections; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Hepatitis C virus, hepatitis B virus, HIV or syphilis infections; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Concurrent endocrine therapy or bisphosphonates allowed secondary trial: Obstacles in intravenous administration of study drugs Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
cfb07772-e485-491c-8ae3-9009e3d04415 | Total: 6/40 (15.00%) One patient in the primary trial had a WBC count far below normal. | 0 |
cfb07772-e485-491c-8ae3-9009e3d04415 | Nausea 1/40 (2.50%) One patient in the primary trial had a WBC count far below normal. | 0 |
cfb07772-e485-491c-8ae3-9009e3d04415 | Vomiting 1/40 (2.50%) One patient in the primary trial had a WBC count far below normal. | 0 |
cfb07772-e485-491c-8ae3-9009e3d04415 | Chest pain 1/40 (2.50%) One patient in the primary trial had a WBC count far below normal. | 0 |
cfb07772-e485-491c-8ae3-9009e3d04415 | Hypercalcemia 1/40 (2.50%) One patient in the primary trial had a WBC count far below normal. | 0 |
cfb07772-e485-491c-8ae3-9009e3d04415 | Thromboembolism 2/40 (5.00%) One patient in the primary trial had a WBC count far below normal. | 0 |
a283b69c-0f36-4773-a711-9e6088a8ee63 | primary trial: No Prophylaxis secondary trial: Collective Placebo Cohort 2 patients in the primary trial receive naproxen at the same frequency as cohort 2 patients in the secondary trial receive Pilocarpine. | 1 |
a283b69c-0f36-4773-a711-9e6088a8ee63 | primary trial: No Prophylaxis secondary trial: Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks. Cohort 2 patients in the primary trial receive naproxen at the same frequency as cohort 2 patients in the secondary trial receive Pilocarpine. | 1 |
a283b69c-0f36-4773-a711-9e6088a8ee63 | primary trial: No Prophylaxis secondary trial: Pilocarpine 2 Times Per Day Cohort 2 patients in the primary trial receive naproxen at the same frequency as cohort 2 patients in the secondary trial receive Pilocarpine. | 1 |
a283b69c-0f36-4773-a711-9e6088a8ee63 | primary trial: No Prophylaxis secondary trial: Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks. Cohort 2 patients in the primary trial receive naproxen at the same frequency as cohort 2 patients in the secondary trial receive Pilocarpine. | 1 |
a283b69c-0f36-4773-a711-9e6088a8ee63 | primary trial: Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim. secondary trial: Collective Placebo Cohort 2 patients in the primary trial receive naproxen at the same frequency as cohort 2 patients in the secondary trial receive Pilocarpine. | 1 |
a283b69c-0f36-4773-a711-9e6088a8ee63 | primary trial: Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim. secondary trial: Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks. Cohort 2 patients in the primary trial receive naproxen at the same frequency as cohort 2 patients in the secondary trial receive Pilocarpine. | 1 |
a283b69c-0f36-4773-a711-9e6088a8ee63 | primary trial: Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim. secondary trial: Pilocarpine 2 Times Per Day Cohort 2 patients in the primary trial receive naproxen at the same frequency as cohort 2 patients in the secondary trial receive Pilocarpine. | 1 |
a283b69c-0f36-4773-a711-9e6088a8ee63 | primary trial: Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim. secondary trial: Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks. Cohort 2 patients in the primary trial receive naproxen at the same frequency as cohort 2 patients in the secondary trial receive Pilocarpine. | 1 |
a283b69c-0f36-4773-a711-9e6088a8ee63 | primary trial: Naproxen 500 mg BID secondary trial: Collective Placebo Cohort 2 patients in the primary trial receive naproxen at the same frequency as cohort 2 patients in the secondary trial receive Pilocarpine. | 1 |
a283b69c-0f36-4773-a711-9e6088a8ee63 | primary trial: Naproxen 500 mg BID secondary trial: Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks. Cohort 2 patients in the primary trial receive naproxen at the same frequency as cohort 2 patients in the secondary trial receive Pilocarpine. | 1 |
a283b69c-0f36-4773-a711-9e6088a8ee63 | primary trial: Naproxen 500 mg BID secondary trial: Pilocarpine 2 Times Per Day Cohort 2 patients in the primary trial receive naproxen at the same frequency as cohort 2 patients in the secondary trial receive Pilocarpine. | 1 |
a283b69c-0f36-4773-a711-9e6088a8ee63 | primary trial: Naproxen 500 mg BID secondary trial: Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks. Cohort 2 patients in the primary trial receive naproxen at the same frequency as cohort 2 patients in the secondary trial receive Pilocarpine. | 1 |
a283b69c-0f36-4773-a711-9e6088a8ee63 | primary trial: Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration. secondary trial: Collective Placebo Cohort 2 patients in the primary trial receive naproxen at the same frequency as cohort 2 patients in the secondary trial receive Pilocarpine. | 1 |
a283b69c-0f36-4773-a711-9e6088a8ee63 | primary trial: Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration. secondary trial: Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks. Cohort 2 patients in the primary trial receive naproxen at the same frequency as cohort 2 patients in the secondary trial receive Pilocarpine. | 1 |
a283b69c-0f36-4773-a711-9e6088a8ee63 | primary trial: Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration. secondary trial: Pilocarpine 2 Times Per Day Cohort 2 patients in the primary trial receive naproxen at the same frequency as cohort 2 patients in the secondary trial receive Pilocarpine. | 1 |
a283b69c-0f36-4773-a711-9e6088a8ee63 | primary trial: Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration. secondary trial: Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks. Cohort 2 patients in the primary trial receive naproxen at the same frequency as cohort 2 patients in the secondary trial receive Pilocarpine. | 1 |
8d90d538-3b56-48dd-bd58-007d266c923c | Total: 67/240 (27.92%) The only cases of cardiac problems in the primary trial occurred in cohort 1. | 0 |
8d90d538-3b56-48dd-bd58-007d266c923c | Anaemia 0/240 (0.00%) The only cases of cardiac problems in the primary trial occurred in cohort 1. | 0 |
8d90d538-3b56-48dd-bd58-007d266c923c | Febrile neutropenia 1/240 (0.42%) The only cases of cardiac problems in the primary trial occurred in cohort 1. | 0 |
8d90d538-3b56-48dd-bd58-007d266c923c | Leukopenia 2/240 (0.83%) The only cases of cardiac problems in the primary trial occurred in cohort 1. | 0 |
8d90d538-3b56-48dd-bd58-007d266c923c | Neutropenia 1/240 (0.42%) The only cases of cardiac problems in the primary trial occurred in cohort 1. | 0 |
8d90d538-3b56-48dd-bd58-007d266c923c | Thrombocytopenia 0/240 (0.00%) The only cases of cardiac problems in the primary trial occurred in cohort 1. | 0 |
8d90d538-3b56-48dd-bd58-007d266c923c | Atrial fibrillation 0/240 (0.00%) The only cases of cardiac problems in the primary trial occurred in cohort 1. | 0 |
8d90d538-3b56-48dd-bd58-007d266c923c | Cardiac failure congestive 2/240 (0.83%) The only cases of cardiac problems in the primary trial occurred in cohort 1. | 0 |
8d90d538-3b56-48dd-bd58-007d266c923c | Cardiac tamponade 1/240 (0.42%) The only cases of cardiac problems in the primary trial occurred in cohort 1. | 0 |
8d90d538-3b56-48dd-bd58-007d266c923c | Cardio-respiratory arrest 1/240 (0.42%) The only cases of cardiac problems in the primary trial occurred in cohort 1. | 0 |
8d90d538-3b56-48dd-bd58-007d266c923c | Left ventricular dysfunction 0/240 (0.00%) The only cases of cardiac problems in the primary trial occurred in cohort 1. | 0 |
8d90d538-3b56-48dd-bd58-007d266c923c | Total: 56/234 (23.93%) The only cases of cardiac problems in the primary trial occurred in cohort 1. | 0 |
8d90d538-3b56-48dd-bd58-007d266c923c | Anaemia 1/234 (0.43%) The only cases of cardiac problems in the primary trial occurred in cohort 1. | 0 |
8d90d538-3b56-48dd-bd58-007d266c923c | Febrile neutropenia 0/234 (0.00%) The only cases of cardiac problems in the primary trial occurred in cohort 1. | 0 |
8d90d538-3b56-48dd-bd58-007d266c923c | Leukopenia 0/234 (0.00%) The only cases of cardiac problems in the primary trial occurred in cohort 1. | 0 |
8d90d538-3b56-48dd-bd58-007d266c923c | Neutropenia 0/234 (0.00%) The only cases of cardiac problems in the primary trial occurred in cohort 1. | 0 |