Viewing Study NCT01928394

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Ignite Creation Date: 2025-12-25 @ 1:28 AM
Ignite Modification Date: 2025-12-27 @ 11:45 PM
Study NCT ID: NCT01928394
Status: COMPLETED
Last Update Posted: 2024-12-27
First Post: 2013-08-21
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000074324', 'term': 'Ipilimumab'}, {'id': 'C574276', 'term': 'cobimetinib'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Includes events reported between first dose and 30 days (AEs) or 100 days (SAEs) after last dose of study therapy', 'eventGroups': [{'id': 'EG000', 'title': 'TNBC Arm N', 'description': 'Triple Negative Breast Cancer (TNBC) Nivolumab monotherapy (3 mg/kg) Q2W', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 18, 'seriousNumAtRisk': 18, 'deathsNumAffected': 17, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'TNBC Arm N-I Dose Level 1', 'description': 'Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'TNBC Arm N-I Dose Level 2', 'description': 'Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 17, 'seriousNumAtRisk': 18, 'deathsNumAffected': 18, 'seriousNumAffected': 11}, {'id': 'EG003', 'title': 'GC Arm N', 'description': 'Gastric Cancer (GC) Nivolumab 3 mg/kg Q2W', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 58, 'seriousNumAtRisk': 59, 'deathsNumAffected': 53, 'seriousNumAffected': 32}, {'id': 'EG004', 'title': 'GC Arm N-I Dose Level 1', 'description': 'Gastric Cancer(GC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'GC Arm N-I Dose Level 2', 'description': 'Gastric Cancer (GC) nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses; then nivolumab 3 mg/kg Q2W', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 47, 'seriousNumAtRisk': 49, 'deathsNumAffected': 42, 'seriousNumAffected': 37}, {'id': 'EG006', 'title': 'GC Arm N-I Dose Level 2b', 'description': 'Gastric Cancer (GC) Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 49, 'seriousNumAtRisk': 52, 'deathsNumAffected': 50, 'seriousNumAffected': 34}, {'id': 'EG007', 'title': 'PC Arm N', 'description': 'Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg Q2W', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 18, 'seriousNumAtRisk': 18, 'deathsNumAffected': 18, 'seriousNumAffected': 10}, {'id': 'EG008', 'title': 'PC Arm N-I Dose Level 1', 'description': 'Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG009', 'title': 'PC Arm N-I Dose Level 2', 'description': 'Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 17, 'seriousNumAtRisk': 18, 'deathsNumAffected': 18, 'seriousNumAffected': 11}, {'id': 'EG010', 'title': 'PC Arm N-I Dose Level 2d', 'description': 'Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q6W for 4 doses + cobimetinib 60 mg po qd 21 days on/7 days off', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 29, 'seriousNumAtRisk': 30, 'deathsNumAffected': 24, 'seriousNumAffected': 16}, {'id': 'EG011', 'title': 'SCLC Arm N', 'description': 'Small cell lung cancer (SCLC) pre-expansion and expansion cohort participants: Nivolumab monotherapy (3 mg/kg) Q2W', 'otherNumAtRisk': 245, 'deathsNumAtRisk': 245, 'otherNumAffected': 226, 'seriousNumAtRisk': 245, 'deathsNumAffected': 212, 'seriousNumAffected': 129}, {'id': 'EG012', 'title': 'SCLC Arm N-I Dose Level 2', 'description': 'Small cell lung cancer (SCLC) pre-expansion and expansion cohort participants: Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2Wi', 'otherNumAtRisk': 157, 'deathsNumAtRisk': 157, 'otherNumAffected': 147, 'seriousNumAtRisk': 157, 'deathsNumAffected': 136, 'seriousNumAffected': 111}, {'id': 'EG013', 'title': 'SCLC Arm N-I Dose Level 1', 'description': 'Small cell lung cancer (SCLC) participants treated with Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3mg/kg) Q2W', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG014', 'title': 'SCLC Arm N-I Dose Level 2b', 'description': 'Small cell lung cancer (SCLC) treated participants treated with Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 53, 'seriousNumAtRisk': 55, 'deathsNumAffected': 45, 'seriousNumAffected': 32}, {'id': 'EG015', 'title': 'BC Arm N', 'description': 'Bladder cancer (BC) participants: Nivolumab 3 mg/kg Q2W', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 77, 'seriousNumAtRisk': 78, 'deathsNumAffected': 60, 'seriousNumAffected': 41}, {'id': 'EG016', 'title': 'BC Arm N-I Dose Level 2', 'description': 'Bladder cancer (BC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 85, 'seriousNumAtRisk': 92, 'deathsNumAffected': 54, 'seriousNumAffected': 62}, {'id': 'EG017', 'title': 'BC Arm N-I Dose Level 2b', 'description': 'Bladder cancer (BC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 100, 'seriousNumAtRisk': 104, 'deathsNumAffected': 82, 'seriousNumAffected': 72}, {'id': 'EG018', 'title': 'OC Arm N-I Dose Level 2', 'description': 'Ovarian cancer (OC) participants:\n\nNivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 38, 'seriousNumAtRisk': 41, 'deathsNumAffected': 33, 'seriousNumAffected': 24}, {'id': 'EG019', 'title': 'OC Arm N-I Dose Level 2b', 'description': 'Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses,then nivolumab (3 mg/kg) Q2W', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 40, 'seriousNumAtRisk': 43, 'deathsNumAffected': 37, 'seriousNumAffected': 31}, {'id': 'EG020', 'title': 'OC Arm N-I Dose Level 2c', 'description': 'Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) Q2W + ipilimumab (1 mg/kg) Q6W', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 41, 'seriousNumAtRisk': 42, 'deathsNumAffected': 34, 'seriousNumAffected': 29}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 52, 'numAffected': 17}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 8}, {'groupId': 'EG010', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 245, 'numAffected': 37}, {'groupId': 'EG012', 'numAtRisk': 157, 'numAffected': 26}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 55, 'numAffected': 10}, {'groupId': 'EG015', 'numAtRisk': 78, 'numAffected': 27}, {'groupId': 'EG016', 'numAtRisk': 92, 'numAffected': 18}, {'groupId': 'EG017', 'numAtRisk': 104, 'numAffected': 30}, {'groupId': 'EG018', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG019', 'numAtRisk': 43, 'numAffected': 10}, {'groupId': 'EG020', 'numAtRisk': 42, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 92, 'numAffected': 3}, {'groupId': 'EG017', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG018', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG018', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG015', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 245, 'numAffected': 5}, {'groupId': 'EG012', 'numAtRisk': 157, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 55, 'numAffected': 6}, {'groupId': 'EG015', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG016', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG020', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 157, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 92, 'numAffected': 2}, {'groupId': 'EG017', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG020', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 245, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 157, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 42, 'numAffected': 2}], 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'description': 'Triple Negative Breast Cancer (TNBC) Nivolumab monotherapy (3 mg/kg) Q2W'}, {'id': 'OG001', 'title': 'TNBC Arm N-I Dose Level 1', 'description': 'Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W'}, {'id': 'OG002', 'title': 'TNBC Arm N-I Dose Level 2', 'description': 'Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W'}, {'id': 'OG003', 'title': 'GC Arm N', 'description': 'Gastric Cancer (GC) Nivolumab 3 mg/kg Q2W'}, {'id': 'OG004', 'title': 'GC Arm N-I Dose Level 1', 'description': 'Gastric Cancer(GC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W'}, {'id': 'OG005', 'title': 'GC Arm N-I Dose Level 2', 'description': 'Gastric Cancer (GC) nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses; then nivolumab 3 mg/kg Q2W'}, {'id': 'OG006', 'title': 'GC Arm N-I Dose Level 2b', 'description': 'Gastric Cancer (GC) Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W'}, {'id': 'OG007', 'title': 'PC Arm N', 'description': 'Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg Q2W'}, {'id': 'OG008', 'title': 'PC Arm N-I Dose Level 1', 'description': 'Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W'}, {'id': 'OG009', 'title': 'PC Arm N-I Dose Level 2', 'description': 'Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W'}, {'id': 'OG010', 'title': 'PC Arm N-I Dose Level 2d', 'description': 'Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q6W for 4 doses + cobimetinib 60 mg po qd 21 days on/7 days off'}, {'id': 'OG011', 'title': 'SCLC Arm N - Pre-expansion', 'description': 'Small cell lung cancer (SCLC) participants treated in Pre-expansion Cohort with Nivolumab 3 mg/kg Q2W'}, {'id': 'OG012', 'title': 'SCLC Arm N-I Dose Level 2 - Pre-expansion', 'description': 'Small cell lung cancer (SCLC) treated participants in Pre-expansion cohort treated with Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W'}, {'id': 'OG013', 'title': 'SCLC Arm N Expansion', 'description': 'Small cell lung cancer (SCLC) expansion cohort participants:Nivolumab monotherapy (3 mg/kg) Q2W'}, {'id': 'OG014', 'title': 'SCLC Arm N-I Dose Level 2- Expansion', 'description': 'Small cell lung cancer (SCLC) expansion cohort participants Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2Wi'}, {'id': 'OG015', 'title': 'SCLC Arm N-I Dose Level 1 -', 'description': 'Small cell lung cancer (SCLC) participants treated with Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3mg/kg) Q2W'}, {'id': 'OG016', 'title': 'SCLC Arm N-I Dose Level 2b', 'description': 'Small cell lung cancer (SCLC) treated participants treated with Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W'}, {'id': 'OG017', 'title': 'SCLC Arm N- All Treated', 'description': 'Small cell lung cancer (SCLC) for all treated participants with Nivolumab 3 mg/kg Q2W'}, {'id': 'OG018', 'title': 'SCLC Arm N-I Dose Level 2 - All Treated', 'description': 'Small cell lung cancer (SCLC) all treated participants with Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses'}, {'id': 'OG019', 'title': 'BC Arm N', 'description': 'Bladder cancer (BC) participants: Nivolumab 3 mg/kg Q2W'}, {'id': 'OG020', 'title': 'BC Arm N-I Dose Level 2', 'description': 'Bladder cancer (BC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W'}, {'id': 'OG021', 'title': 'BC Arm N-I Dose Level 2b', 'description': 'Bladder cancer (BC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W'}, {'id': 'OG022', 'title': 'OC Arm N-I Dose Level 2', 'description': 'Ovarian cancer (OC) participants:\n\nNivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W'}, {'id': 'OG023', 'title': 'OC Arm N-I Dose Level 2b:', 'description': 'Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses,then nivolumab (3 mg/kg) Q2W'}, {'id': 'OG024', 'title': 'OC Arm N-I Dose Level 2c:', 'description': 'Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) Q2W + ipilimumab (1 mg/kg) Q6W'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '27.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '18.5'}, {'value': '11.9', 'groupId': 'OG003', 'lowerLimit': '4.9', 'upperLimit': '22.9'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': 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'OG017', 'lowerLimit': '8.1', 'upperLimit': '16.6'}, {'value': '22.3', 'groupId': 'OG018', 'lowerLimit': '16.0', 'upperLimit': '29.6'}, {'value': '25.6', 'groupId': 'OG019', 'lowerLimit': '16.4', 'upperLimit': '36.8'}, {'value': '38.0', 'groupId': 'OG020', 'lowerLimit': '28.1', 'upperLimit': '48.8'}, {'value': '26.9', 'groupId': 'OG021', 'lowerLimit': '18.7', 'upperLimit': '36.5'}, {'value': '12.2', 'groupId': 'OG022', 'lowerLimit': '4.1', 'upperLimit': '26.2'}, {'value': '7.0', 'groupId': 'OG023', 'lowerLimit': '1.5', 'upperLimit': '19.1'}, {'value': '9.5', 'groupId': 'OG024', 'lowerLimit': '2.7', 'upperLimit': '22.6'}]}]}], 'analyses': [{'pValue': '0.0309', 'groupIds': ['OG013', 'OG014'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.12', 'ciLowerLimit': '1.06', 'ciUpperLimit': '4.26', 'groupDescription': 'SCLC Arm N Expansion as compare to SCLC Arm N-I Dose Level 2- Expansion', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 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mg/kg) Q2W'}, {'id': 'FG003', 'title': 'GC Arm N', 'description': 'Gastric Cancer (GC) Nivolumab 3 mg/kg Q2W'}, {'id': 'FG004', 'title': 'GC Arm N-I Dose Level 1', 'description': 'Gastric Cancer(GC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W'}, {'id': 'FG005', 'title': 'GC Arm N-I Dose Level 2', 'description': 'Gastric Cancer (GC) nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses; then nivolumab 3 mg/kg Q2W'}, {'id': 'FG006', 'title': 'GC Arm N-I Dose Level 2b', 'description': 'Gastric Cancer (GC) Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W'}, {'id': 'FG007', 'title': 'PC Arm N', 'description': 'Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg Q2W'}, {'id': 'FG008', 'title': 'PC Arm N-I Dose Level 1', 'description': 'Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W'}, {'id': 'FG009', 'title': 'PC Arm N-I Dose Level 2', 'description': 'Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W'}, {'id': 'FG010', 'title': 'PC Arm N-I Dose Level 2d', 'description': 'Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q6W for 4 doses + cobimetinib 60 mg po qd 21 days on/7 days off'}, {'id': 'FG011', 'title': 'SCLC Arm N - Pre-expansion', 'description': 'Small cell lung cancer (SCLC) participants treated in Pre-expansion Cohort with Nivolumab 3 mg/kg Q2W'}, {'id': 'FG012', 'title': 'SCLC Arm N-I Dose Level 2 - Pre-expansion', 'description': 'Small cell lung cancer (SCLC) treated participants in Pre-expansion cohort treated with Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W'}, {'id': 'FG013', 'title': 'SCLC Arm N Expansion', 'description': 'Small cell lung cancer (SCLC) expansion cohort participants: Nivolumab monotherapy (3 mg/kg) Q2W'}, {'id': 'FG014', 'title': 'SCLC 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2b', 'description': 'Bladder cancer (BC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W'}, {'id': 'FG020', 'title': 'OC Arm N-I Dose Level 2', 'description': 'Ovarian cancer (OC) participants:\n\nNivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W'}, {'id': 'FG021', 'title': 'OC Arm N-I Dose Level 2b', 'description': 'Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses,then nivolumab (3 mg/kg) Q2W'}, {'id': 'FG022', 'title': 'OC Arm N-I Dose Level 2c:', 'description': 'Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) Q2W + ipilimumab (1 mg/kg) Q6W'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'comment': 'Started = Entering initial treatment or combination treatment after completion of monotherapy(MT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '59'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '49'}, {'groupId': 'FG006', 'numSubjects': '52'}, {'groupId': 'FG007', 'numSubjects': '18'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '18'}, {'groupId': 'FG010', 'numSubjects': '30'}, {'groupId': 'FG011', 'numSubjects': '98'}, {'groupId': 'FG012', 'numSubjects': '61'}, {'groupId': 'FG013', 'numSubjects': '147'}, {'groupId': 'FG014', 'numSubjects': '96'}, {'groupId': 'FG015', 'numSubjects': '3'}, {'groupId': 'FG016', 'numSubjects': '55'}, {'groupId': 'FG017', 'numSubjects': '78'}, {'groupId': 'FG018', 'numSubjects': '92'}, {'groupId': 'FG019', 'numSubjects': '104'}, {'groupId': 'FG020', 'numSubjects': '41'}, {'groupId': 'FG021', 'numSubjects': '43'}, {'groupId': 'FG022', 'numSubjects': '42'}]}, {'type': 'Transition', 'comment': 'Participants who will transition after completing MT due to disease progression (DP)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '17'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '20'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'Transition- Continued', 'comment': 'Participants who were transitioned to another treatment after disease progression (DP).', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '17'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '19'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Completed = continuing treatment period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '5'}, {'groupId': 'FG012', 'numSubjects': '6'}, {'groupId': 'FG013', 'numSubjects': '8'}, {'groupId': 'FG014', 'numSubjects': '8'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '5'}, {'groupId': 'FG017', 'numSubjects': '7'}, {'groupId': 'FG018', 'numSubjects': '22'}, {'groupId': 'FG019', 'numSubjects': '8'}, {'groupId': 'FG020', 'numSubjects': '1'}, {'groupId': 'FG021', 'numSubjects': '1'}, {'groupId': 'FG022', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '56'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '43'}, {'groupId': 'FG006', 'numSubjects': '49'}, {'groupId': 'FG007', 'numSubjects': '18'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '18'}, {'groupId': 'FG010', 'numSubjects': '30'}, {'groupId': 'FG011', 'numSubjects': '93'}, {'groupId': 'FG012', 'numSubjects': '55'}, {'groupId': 'FG013', 'numSubjects': '139'}, {'groupId': 'FG014', 'numSubjects': '88'}, {'groupId': 'FG015', 'numSubjects': '2'}, {'groupId': 'FG016', 'numSubjects': '50'}, {'groupId': 'FG017', 'numSubjects': '71'}, {'groupId': 'FG018', 'numSubjects': '70'}, {'groupId': 'FG019', 'numSubjects': '96'}, {'groupId': 'FG020', 'numSubjects': '40'}, {'groupId': 'FG021', 'numSubjects': '42'}, {'groupId': 'FG022', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '48'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '25'}, {'groupId': 'FG006', 'numSubjects': '38'}, {'groupId': 'FG007', 'numSubjects': '16'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '11'}, {'groupId': 'FG010', 'numSubjects': '22'}, {'groupId': 'FG011', 'numSubjects': '73'}, {'groupId': 'FG012', 'numSubjects': '38'}, {'groupId': 'FG013', 'numSubjects': '118'}, {'groupId': 'FG014', 'numSubjects': '59'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '43'}, {'groupId': 'FG017', 'numSubjects': '56'}, {'groupId': 'FG018', 'numSubjects': '50'}, {'groupId': 'FG019', 'numSubjects': '71'}, {'groupId': 'FG020', 'numSubjects': '30'}, {'groupId': 'FG021', 'numSubjects': '31'}, {'groupId': 'FG022', 'numSubjects': '31'}]}, {'type': 'Study drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '7'}, {'groupId': 'FG013', 'numSubjects': '5'}, {'groupId': 'FG014', 'numSubjects': '12'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '3'}, {'groupId': 'FG017', 'numSubjects': '3'}, {'groupId': 'FG018', 'numSubjects': '12'}, {'groupId': 'FG019', 'numSubjects': '15'}, {'groupId': 'FG020', 'numSubjects': '4'}, {'groupId': 'FG021', 'numSubjects': '7'}, {'groupId': 'FG022', 'numSubjects': '4'}]}, {'type': 'AE unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '12'}, {'groupId': 'FG012', 'numSubjects': '6'}, {'groupId': 'FG013', 'numSubjects': '13'}, {'groupId': 'FG014', 'numSubjects': '6'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '1'}, {'groupId': 'FG017', 'numSubjects': '6'}, {'groupId': 'FG018', 'numSubjects': '3'}, {'groupId': 'FG019', 'numSubjects': '5'}, {'groupId': 'FG020', 'numSubjects': '1'}, {'groupId': 'FG021', 'numSubjects': '1'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'Participant request to stop therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '4'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '1'}, {'groupId': 'FG017', 'numSubjects': '3'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '1'}, {'groupId': 'FG020', 'numSubjects': '3'}, {'groupId': 'FG021', 'numSubjects': '1'}, {'groupId': 'FG022', 'numSubjects': '3'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '2'}, {'groupId': 'FG017', 'numSubjects': '1'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '1'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '2'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'Poor/non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '1'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '2'}, {'groupId': 'FG019', 'numSubjects': '2'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'Maximum clinical benefit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '2'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}]}, {'title': 'Follow-up Period', 'milestones': [{'type': 'STARTED', 'comment': 'started = number of Participants regardless of continuing treatment or not.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '50'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '49'}, {'groupId': 'FG006', 'numSubjects': '52'}, {'groupId': 'FG007', 'numSubjects': '16'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '18'}, {'groupId': 'FG010', 'numSubjects': '30'}, {'groupId': 'FG011', 'numSubjects': '81'}, {'groupId': 'FG012', 'numSubjects': '61'}, {'groupId': 'FG013', 'numSubjects': '145'}, {'groupId': 'FG014', 'numSubjects': '96'}, {'groupId': 'FG015', 'numSubjects': '3'}, {'groupId': 'FG016', 'numSubjects': '55'}, {'groupId': 'FG017', 'numSubjects': '58'}, {'groupId': 'FG018', 'numSubjects': '92'}, {'groupId': 'FG019', 'numSubjects': '104'}, {'groupId': 'FG020', 'numSubjects': '41'}, {'groupId': 'FG021', 'numSubjects': '43'}, {'groupId': 'FG022', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'comment': 'completed = continuing to be followed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '41'}, {'groupId': 'FG006', 'numSubjects': '40'}, {'groupId': 'FG007', 'numSubjects': '10'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '16'}, {'groupId': 'FG010', 'numSubjects': '19'}, {'groupId': 'FG011', 'numSubjects': '59'}, {'groupId': 'FG012', 'numSubjects': '47'}, {'groupId': 'FG013', 'numSubjects': '107'}, {'groupId': 'FG014', 'numSubjects': '66'}, {'groupId': 'FG015', 'numSubjects': '3'}, {'groupId': 'FG016', 'numSubjects': '41'}, {'groupId': 'FG017', 'numSubjects': '50'}, {'groupId': 'FG018', 'numSubjects': '76'}, {'groupId': 'FG019', 'numSubjects': '83'}, {'groupId': 'FG020', 'numSubjects': '32'}, {'groupId': 'FG021', 'numSubjects': '34'}, {'groupId': 'FG022', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '11'}, {'groupId': 'FG011', 'numSubjects': '22'}, {'groupId': 'FG012', 'numSubjects': '14'}, {'groupId': 'FG013', 'numSubjects': '38'}, {'groupId': 'FG014', 'numSubjects': '30'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '14'}, {'groupId': 'FG017', 'numSubjects': '8'}, {'groupId': 'FG018', 'numSubjects': '16'}, {'groupId': 'FG019', 'numSubjects': '21'}, {'groupId': 'FG020', 'numSubjects': '9'}, {'groupId': 'FG021', 'numSubjects': '9'}, {'groupId': 'FG022', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '8'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '12'}, {'groupId': 'FG014', 'numSubjects': '7'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '5'}, {'groupId': 'FG017', 'numSubjects': '3'}, {'groupId': 'FG018', 'numSubjects': '2'}, {'groupId': 'FG019', 'numSubjects': '7'}, {'groupId': 'FG020', 'numSubjects': '4'}, {'groupId': 'FG021', 'numSubjects': '6'}, {'groupId': 'FG022', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '12'}, {'groupId': 'FG012', 'numSubjects': '11'}, {'groupId': 'FG013', 'numSubjects': '25'}, {'groupId': 'FG014', 'numSubjects': '18'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '6'}, {'groupId': 'FG017', 'numSubjects': '5'}, {'groupId': 'FG018', 'numSubjects': '13'}, {'groupId': 'FG019', 'numSubjects': '13'}, {'groupId': 'FG020', 'numSubjects': '5'}, {'groupId': 'FG021', 'numSubjects': '3'}, {'groupId': 'FG022', 'numSubjects': '2'}]}, {'type': 'other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '4'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '2'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '1'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '1'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '1131 participants were treated in total for TNBC, GC, PC, SCLC, BC and OC.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '49', 'groupId': 'BG005'}, {'value': '52', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '18', 'groupId': 'BG009'}, {'value': '30', 'groupId': 'BG010'}, {'value': '98', 'groupId': 'BG011'}, {'value': '61', 'groupId': 'BG012'}, {'value': '147', 'groupId': 'BG013'}, {'value': '96', 'groupId': 'BG014'}, {'value': '3', 'groupId': 'BG015'}, {'value': '55', 'groupId': 'BG016'}, {'value': '78', 'groupId': 'BG017'}, {'value': '92', 'groupId': 'BG018'}, {'value': '104', 'groupId': 'BG019'}, {'value': '41', 'groupId': 'BG020'}, {'value': '43', 'groupId': 'BG021'}, {'value': '42', 'groupId': 'BG022'}, {'value': '1131', 'groupId': 'BG023'}]}], 'groups': [{'id': 'BG000', 'title': 'TNBC Arm N', 'description': 'Triple Negative Breast Cancer (TNBC) Nivolumab monotherapy (3 mg/kg) Q2W'}, {'id': 'BG001', 'title': 'TNBC Arm N-I Dose Level 1', 'description': 'Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W'}, {'id': 'BG002', 'title': 'TNBC Arm N-I Dose Level 2', 'description': 'Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W'}, {'id': 'BG003', 'title': 'GC Arm N', 'description': 'Gastric Cancer (GC) Nivolumab 3 mg/kg Q2W'}, {'id': 'BG004', 'title': 'GC Arm N-I Dose Level 1', 'description': 'Gastric Cancer(GC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W'}, {'id': 'BG005', 'title': 'GC Arm N-I Dose Level 2', 'description': 'Gastric Cancer (GC) nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses; then nivolumab 3 mg/kg Q2W'}, {'id': 'BG006', 'title': 'GC Arm N-I Dose Level 2b', 'description': 'Gastric Cancer (GC) Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W'}, {'id': 'BG007', 'title': 'PC Arm N', 'description': 'Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg Q2W'}, {'id': 'BG008', 'title': 'PC Arm N-I Dose Level 1', 'description': 'Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W'}, {'id': 'BG009', 'title': 'PC Arm N-I Dose Level 2', 'description': 'Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W'}, {'id': 'BG010', 'title': 'PC Arm N-I Dose Level 2d', 'description': 'Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q6W for 4 doses + cobimetinib 60 mg po qd 21 days on/7 days off'}, {'id': 'BG011', 'title': 'SCLC Arm N - Pre-expansion', 'description': 'Small cell lung cancer (SCLC) participants treated in Pre-expansion Cohort with Nivolumab 3 mg/kg Q2W'}, {'id': 'BG012', 'title': 'SCLC Arm N-I Dose Level 2 - Pre-expansion', 'description': 'Small cell lung cancer (SCLC) treated participants in Pre-expansion cohort treated with Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W'}, {'id': 'BG013', 'title': 'SCLC Arm N Expansion', 'description': 'Small cell lung cancer (SCLC) expansion cohort participants:Nivolumab monotherapy (3 mg/kg) Q2W'}, {'id': 'BG014', 'title': 'SCLC Arm N-I Dose Level 2- Expansion', 'description': 'Small cell lung cancer (SCLC) expansion cohort participants Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2Wi'}, {'id': 'BG015', 'title': 'SCLC Arm N-I Dose Level 1 -', 'description': 'Small cell lung cancer (SCLC) participants treated with Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3mg/kg) Q2W'}, {'id': 'BG016', 'title': 'SCLC Arm N-I Dose Level 2b', 'description': 'Small cell lung cancer (SCLC) treated participants treated with Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W'}, {'id': 'BG017', 'title': 'BC Arm N', 'description': 'Bladder cancer (BC) participants: Nivolumab 3 mg/kg Q2W'}, {'id': 'BG018', 'title': 'BC Arm N-I Dose Level 2', 'description': 'Bladder cancer (BC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W'}, {'id': 'BG019', 'title': 'BC Arm N-I Dose Level 2b', 'description': 'Bladder cancer (BC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W'}, {'id': 'BG020', 'title': 'OC Arm N-I Dose Level 2', 'description': 'Ovarian cancer (OC) participants:\n\nNivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W'}, {'id': 'BG021', 'title': 'OC Arm N-I Dose Level 2b:', 'description': 'Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses,then nivolumab (3 mg/kg) Q2W'}, {'id': 'BG022', 'title': 'OC Arm N-I 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Nivolumab Alone and With Ipilimumab in Previously Treated Metastatic Urothelial Carcinoma: CheckMate 032 Nivolumab 1 mg/kg Plus Ipilimumab 3 mg/kg Expansion Cohort Results. J Clin Oncol. 2019 Jul 1;37(19):1608-1616. doi: 10.1200/JCO.19.00538. Epub 2019 May 17.'}, {'pmid': '30110194', 'type': 'DERIVED', 'citation': 'Janjigian YY, Bendell J, Calvo E, Kim JW, Ascierto PA, Sharma P, Ott PA, Peltola K, Jaeger D, Evans J, de Braud F, Chau I, Harbison CT, Dorange C, Tschaika M, Le DT. CheckMate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients With Metastatic Esophagogastric Cancer. J Clin Oncol. 2018 Oct 1;36(28):2836-2844. doi: 10.1200/JCO.2017.76.6212. Epub 2018 Aug 15.'}, {'pmid': '29489427', 'type': 'DERIVED', 'citation': 'Teo MY, Seier K, Ostrovnaya I, Regazzi AM, Kania BE, Moran MM, Cipolla CK, Bluth MJ, Chaim J, Al-Ahmadie H, Snyder A, Carlo MI, Solit DB, Berger MF, Funt S, Wolchok JD, Iyer G, Bajorin DF, Callahan MK, Rosenberg JE. Alterations in DNA Damage Response and Repair Genes as Potential Marker of Clinical Benefit From PD-1/PD-L1 Blockade in Advanced Urothelial Cancers. J Clin Oncol. 2018 Jun 10;36(17):1685-1694. doi: 10.1200/JCO.2017.75.7740. Epub 2018 Feb 28.'}, {'pmid': '27733243', 'type': 'DERIVED', 'citation': 'Sharma P, Callahan MK, Bono P, Kim J, Spiliopoulou P, Calvo E, Pillai RN, Ott PA, de Braud F, Morse M, Le DT, Jaeger D, Chan E, Harbison C, Lin CS, Tschaika M, Azrilevich A, Rosenberg JE. Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial. Lancet Oncol. 2016 Nov;17(11):1590-1598. doi: 10.1016/S1470-2045(16)30496-X. Epub 2016 Oct 9.'}, {'pmid': '27269741', 'type': 'DERIVED', 'citation': 'Antonia SJ, Lopez-Martin JA, Bendell J, Ott PA, Taylor M, Eder JP, Jager D, Pietanza MC, Le DT, de Braud F, Morse MA, Ascierto PA, Horn L, Amin A, Pillai RN, Evans J, Chau I, Bono P, Atmaca A, Sharma P, Harbison CT, Lin CS, Christensen O, Calvo E. Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial. Lancet Oncol. 2016 Jul;17(7):883-895. doi: 10.1016/S1470-2045(16)30098-5. Epub 2016 Jun 4.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'To investigate the safety and efficacy of nivolumab as a single agent or in combination with ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer (SCLC), bladder cancer (BC), and ovarian cancer (OC). 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