Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2026-02-22 @ 2:46 PM
Study NCT ID:
NCT02538666
Status:
COMPLETED
Last Update Posted:
2023-01-05
First Post:
2015-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000074324', 'term': 'Ipilimumab'}], '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': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 34 months).', 'description': 'The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Global Placebo', 'description': '100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion', 'otherNumAtRisk': 273, 'deathsNumAtRisk': 275, 'otherNumAffected': 228, 'seriousNumAtRisk': 273, 'deathsNumAffected': 250, 'seriousNumAffected': 117}, {'id': 'EG001', 'title': 'Global Nivolumab 240 mg', 'description': 'Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion', 'otherNumAtRisk': 279, 'deathsNumAtRisk': 280, 'otherNumAffected': 244, 'seriousNumAtRisk': 279, 'deathsNumAffected': 231, 'seriousNumAffected': 131}, {'id': 'EG002', 'title': 'Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks', 'otherNumAtRisk': 278, 'deathsNumAtRisk': 279, 'otherNumAffected': 263, 'seriousNumAtRisk': 278, 'deathsNumAffected': 240, 'seriousNumAffected': 198}, {'id': 'EG003', 'title': 'China Placebo', 'description': '100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as an IV infusion', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 22, 'seriousNumAtRisk': 26, 'deathsNumAffected': 24, 'seriousNumAffected': 8}, {'id': 'EG004', 'title': 'China Nivolumab 240 mg', 'description': 'Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 23, 'seriousNumAtRisk': 25, 'deathsNumAffected': 23, 'seriousNumAffected': 10}, {'id': 'EG005', 'title': 'China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 23, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 88}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 78}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 45}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 86}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 43}, 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'EG002', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Dermatitis exfoliative generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Skin toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Superior vena cava stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Global Placebo', 'description': '100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion'}, {'id': 'OG001', 'title': 'Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '9.56', 'groupId': 'OG000', 'lowerLimit': '8.18', 'upperLimit': '11.01'}, {'value': '9.17', 'groupId': 'OG001', 'lowerLimit': '8.15', 'upperLimit': '10.25'}]}]}], 'analyses': [{'pValue': '0.3693', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.12', 'estimateComment': 'based on stratified 3-arms Cox proportional hazard model', 'groupDescription': 'nivolumab + ipilimumab over placebo', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by response to ECOG PS (0vs1), gender (MvF), irradiation following chemotherapy (YorN) as entered in IVRS'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 months)', 'description': 'OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the nivolumab + ipilimumab and placebo arms in the global population'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) of Nivolumab Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Global Placebo', 'description': '100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion'}, {'id': 'OG001', 'title': 'Global Nivolumab 240 mg', 'description': 'Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion'}, {'id': 'OG002', 'title': 'China Placebo', 'description': '100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as an IV infusion'}, {'id': 'OG003', 'title': 'China Nivolumab 240 mg', 'description': 'Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '9.56', 'groupId': 'OG000', 'lowerLimit': '8.18', 'upperLimit': '11.01'}, {'value': '10.18', 'groupId': 'OG001', 'lowerLimit': '9.43', 'upperLimit': '11.99'}, {'value': '9.28', 'groupId': 'OG002', 'lowerLimit': '5.59', 'upperLimit': '14.26'}, {'value': '8.18', 'groupId': 'OG003', 'lowerLimit': '7.20', 'upperLimit': '14.26'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.68', 'ciUpperLimit': '0.97', 'estimateComment': 'Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.', 'groupDescription': 'Global nivolumab over global placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.66', 'estimateComment': 'Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.', 'groupDescription': 'China nivolumab over China Placebo', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of death or last known alive date (up to approximately 73 months)', 'description': 'Overall Survival (OS) comparing nivolumab monotherapy versus placebo. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the nivolumab monotherapy and placebo arms'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Global Nivolumab 240 mg', 'description': 'Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion'}, {'id': 'OG001', 'title': 'Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks'}, {'id': 'OG002', 'title': 'China Nivolumab 240 mg', 'description': 'Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion'}, {'id': 'OG003', 'title': 'China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '10.18', 'groupId': 'OG000', 'lowerLimit': '9.43', 'upperLimit': '11.99'}, {'value': '9.17', 'groupId': 'OG001', 'lowerLimit': '8.15', 'upperLimit': '10.35'}, {'value': '8.18', 'groupId': 'OG002', 'lowerLimit': '7.20', 'upperLimit': '14.26'}, {'value': '10.48', 'groupId': 'OG003', 'lowerLimit': '7.13', 'upperLimit': '13.40'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.36', 'estimateComment': 'Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.', 'groupDescription': 'Global nivolumab + ipilimumab over global nivolumab', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.79', 'estimateComment': 'Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.', 'groupDescription': 'China nivolumab + ipilimumab over China nivolumab', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of death or last known alive date (up to approximately 73 months)', 'description': 'Overall Survival (OS) comparing Nivolumab + Ipilimumab Versus Nivolumab. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the Nivolumab + Ipilimumab and Nivolumab arms'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) Per BICR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}, {'value': '279', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Global Placebo', 'description': '100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion'}, {'id': 'OG001', 'title': 'Global Nivolumab 240 mg', 'description': 'Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion'}, {'id': 'OG002', 'title': 'Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks'}, {'id': 'OG003', 'title': 'China Placebo', 'description': '100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as an IV infusion'}, {'id': 'OG004', 'title': 'China Nivolumab 240 mg', 'description': 'Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion'}, {'id': 'OG005', 'title': 'China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.41', 'groupId': 'OG000', 'lowerLimit': '1.41', 'upperLimit': '1.48'}, {'value': '1.94', 'groupId': 'OG001', 'lowerLimit': '1.61', 'upperLimit': '2.63'}, {'value': '1.74', 'groupId': 'OG002', 'lowerLimit': '1.48', 'upperLimit': '2.63'}, {'value': '1.38', 'groupId': 'OG003', 'lowerLimit': '1.28', 'upperLimit': '2.56'}, {'value': '1.58', 'groupId': 'OG004', 'lowerLimit': '1.38', 'upperLimit': '4.11'}, {'value': '1.54', 'groupId': 'OG005', 'lowerLimit': '1.28', 'upperLimit': '2.73'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.88', 'estimateComment': 'Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.', 'groupDescription': 'Global nivolumab + ipilimumab over global placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.79', 'estimateComment': 'Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.', 'groupDescription': 'Global nivolumab over global placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.35', 'estimateComment': 'Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.', 'groupDescription': 'Global nivolumab+ ipilimumab over nivolumab', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.33', 'ciUpperLimit': '1.12', 'estimateComment': 'Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.', 'groupDescription': 'China Nivolumab + Ipilimumab over China placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '0.24', 'ciUpperLimit': '0.85', 'estimateComment': 'Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.', 'groupDescription': 'China Nivolumab over China placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '0.72', 'ciUpperLimit': '2.49', 'estimateComment': 'Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.', 'groupDescription': 'China Nivolumab + Ipilimumab over China Nivolumab', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)', 'description': 'PFS was defined as the time between the date of randomization and the first date of documented progression as determined by Blind Independent Central Review (BICR) or death due to any cause, whichever occurred first. Participants who died with no reported progression were considered to have progressed on the date of death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on study tumor assessments and did not die (or died after initiation of the subsequent anti- cancer therapy) were censored on their date of randomization. Participants who started any subsequent anti- cancer therapy without a prior reported Progressive Disease (PD) per BICR were censored at the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Global Placebo', 'description': '100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion'}, {'id': 'OG001', 'title': 'Global Nivolumab 240 mg', 'description': 'Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion'}, {'id': 'OG002', 'title': 'Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks'}], 'classes': [{'title': '≥10 mutations/mb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.96', 'groupId': 'OG000', 'lowerLimit': '7.49', 'upperLimit': '13.67'}, {'value': '12.81', 'groupId': 'OG001', 'lowerLimit': '9.95', 'upperLimit': '18.60'}, {'value': '10.55', 'groupId': 'OG002', 'lowerLimit': '8.38', 'upperLimit': '14.16'}]}]}, {'title': '< 10 mutations/mb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.20', 'groupId': 'OG000', 'lowerLimit': '7.46', 'upperLimit': '11.04'}, {'value': '9.76', 'groupId': 'OG001', 'lowerLimit': '8.34', 'upperLimit': '11.30'}, {'value': '8.11', 'groupId': 'OG002', 'lowerLimit': '6.60', 'upperLimit': '10.05'}]}]}, {'title': '≥13 mutations/mb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.69', 'groupId': 'OG000', 'lowerLimit': '6.21', 'upperLimit': '13.63'}, {'value': '12.98', 'groupId': 'OG001', 'lowerLimit': '9.95', 'upperLimit': '18.60'}, {'value': '13.47', 'groupId': 'OG002', 'lowerLimit': '9.26', 'upperLimit': '21.75'}]}]}, {'title': '<13 mutations/mb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.02', 'groupId': 'OG000', 'lowerLimit': '7.66', 'upperLimit': '11.47'}, {'value': '9.89', 'groupId': 'OG001', 'lowerLimit': '8.64', 'upperLimit': '11.30'}, {'value': '7.85', 'groupId': 'OG002', 'lowerLimit': '6.67', 'upperLimit': '9.66'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.15', 'estimateComment': 'Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.', 'groupDescription': 'TMB cutoff ≥10 mutations/mb: Nivo+Ipi over placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.04', 'estimateComment': 'Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.', 'groupDescription': 'TMB cutoff ≥10 mutations/mb: Nivo over placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.92', 'estimateComment': 'Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.', 'groupDescription': 'TMB cutoff ≥13 mutations/mb: Nivo+Ipi over placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.44', 'ciUpperLimit': '0.93', 'estimateComment': 'Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.', 'groupDescription': 'TMB cutoff ≥13 mutations/mb: Nivo over placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.21', 'estimateComment': 'Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.', 'groupDescription': 'TMB cutoff \\<10 mutations/mb: Nivo+Ipi over placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.18', 'estimateComment': 'Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.', 'groupDescription': 'TMB cutoff \\<10 mutations/mb: Nivo over placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.35', 'estimateComment': 'Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.', 'groupDescription': 'TMB cutoff \\<13 mutations/mb: Nivo+Ipi over placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.20', 'estimateComment': 'Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.', 'groupDescription': 'TMB cutoff \\<13 mutations/mb: Nivo over placebo', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of death or last known alive date (up to approximately 73 months)', 'description': 'Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined.\n\nOS in TMB by the following cutoff points: ≥10 mutations/mb, \\< 10 mutations/mb, ≥13 mutations/mb, \\<13 mutations/mb', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All TMB evaluable participants in the global population'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Global Placebo', 'description': '100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion'}, {'id': 'OG001', 'title': 'Global Nivolumab 240 mg', 'description': 'Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion'}, {'id': 'OG002', 'title': 'Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks'}], 'classes': [{'title': '≥10 mutations/mb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.58', 'groupId': 'OG000', 'lowerLimit': '1.41', 'upperLimit': '2.63'}, {'value': '2.79', 'groupId': 'OG001', 'lowerLimit': '2.04', 'upperLimit': '4.17'}, {'value': '2.33', 'groupId': 'OG002', 'lowerLimit': '1.48', 'upperLimit': '2.92'}]}]}, {'title': '< 10 mutations/mb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.41', 'groupId': 'OG000', 'lowerLimit': '1.35', 'upperLimit': '1.45'}, {'value': '1.61', 'groupId': 'OG001', 'lowerLimit': '1.45', 'upperLimit': '2.53'}, {'value': '1.48', 'groupId': 'OG002', 'lowerLimit': '1.41', 'upperLimit': '2.00'}]}]}, {'title': '≥13 mutations/mb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.58', 'groupId': 'OG000', 'lowerLimit': '1.41', 'upperLimit': '2.63'}, {'value': '2.76', 'groupId': 'OG001', 'lowerLimit': '1.61', 'upperLimit': '4.11'}, {'value': '2.63', 'groupId': 'OG002', 'lowerLimit': '1.48', 'upperLimit': '3.81'}]}]}, {'title': '<13 mutations/mb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.41', 'groupId': 'OG000', 'lowerLimit': '1.38', 'upperLimit': '1.45'}, {'value': '1.84', 'groupId': 'OG001', 'lowerLimit': '1.48', 'upperLimit': '2.66'}, {'value': '1.48', 'groupId': 'OG002', 'lowerLimit': '1.41', 'upperLimit': '2.00'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.09', 'estimateComment': 'Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.', 'groupDescription': 'TMB cutoff ≥10 mutations/mb: Nivo+Ipi over placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.50', 'ciUpperLimit': '0.92', 'estimateComment': 'Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.', 'groupDescription': 'TMB cutoff ≥10 mutations/mb: Nivo over placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.07', 'estimateComment': 'Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.', 'groupDescription': 'TMB cutoff ≥13 mutations/mb: Nivo+Ipi over placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.46', 'ciUpperLimit': '0.95', 'estimateComment': 'Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.', 'groupDescription': 'TMB cutoff ≥13 mutations/mb: Nivo over placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.96', 'estimateComment': 'Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.', 'groupDescription': 'TMB cutoff \\<10 mutations/mb: Nivo+Ipi over placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.89', 'estimateComment': 'Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.', 'groupDescription': 'TMB cutoff \\<10 mutations/mb: Nivo over placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.01', 'estimateComment': 'Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.', 'groupDescription': 'TMB cutoff \\<13 mutations/mb: Nivo+Ipi over placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.89', 'estimateComment': 'Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.', 'groupDescription': 'TMB cutoff \\<13 mutations/mb: Nivo over placebo', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)', 'description': 'Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined.\n\nPFS in TMB by the following cutoff points: ≥10 mutations/mb, \\< 10 mutations/mb, ≥13 mutations/mb, \\<13 mutations/mb.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All TMB evaluable participants in the global population'}, {'type': 'POST_HOC', 'title': 'Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo - Extended Collection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Global Placebo', 'description': '100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion'}, {'id': 'OG001', 'title': 'Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks'}, {'id': 'OG002', 'title': 'China Placebo', 'description': '100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as an IV infusion'}, {'id': 'OG003', 'title': 'China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '9.56', 'groupId': 'OG000', 'lowerLimit': '8.18', 'upperLimit': '11.01'}, {'value': '9.17', 'groupId': 'OG001', 'lowerLimit': '8.15', 'upperLimit': '10.35'}, {'value': '9.28', 'groupId': 'OG002', 'lowerLimit': '5.59', 'upperLimit': '14.26'}, {'value': '10.48', 'groupId': 'OG003', 'lowerLimit': '7.13', 'upperLimit': '13.40'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.09', 'estimateComment': 'Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.', 'groupDescription': 'Global nivolumab + ipilimumab over Global placebo', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.67', 'estimateComment': 'Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.', 'groupDescription': 'China nivolumab + ipilimumab over China placebo', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of death or last known alive date (up to approximately 73 months)', 'description': 'Overall survival (OS) comparing nivolumab + ipilimumab versus placebo. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.\n\nNote: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 11-Nov-2021).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the nivolumab + ipilimumab and placebo arms'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion'}, {'id': 'FG001', 'title': 'Nivolumab 240 mg', 'description': 'Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion'}, {'id': 'FG002', 'title': 'Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks'}], 'periods': [{'title': 'Pre-Treatment', 'milestones': [{'type': 'STARTED', 'comment': 'Started = Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '304'}, {'groupId': 'FG002', 'numSubjects': '303'}]}, {'type': 'Global', 'achievements': [{'groupId': 'FG000', 'numSubjects': '275'}, {'groupId': 'FG001', 'numSubjects': '280'}, {'groupId': 'FG002', 'numSubjects': '279'}]}, {'type': 'China', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'comment': 'Completed = Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '298'}, {'groupId': 'FG001', 'numSubjects': '303'}, {'groupId': 'FG002', 'numSubjects': '302'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'comment': 'Started = Started Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '298'}, {'groupId': 'FG001', 'numSubjects': '303'}, {'groupId': 'FG002', 'numSubjects': '302'}]}, {'type': 'Global', 'achievements': [{'groupId': 'FG000', 'numSubjects': '273'}, {'groupId': 'FG001', 'numSubjects': '279'}, {'groupId': 'FG002', 'numSubjects': '278'}]}, {'type': 'China', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'comment': 'Completed = Continuing in treatment period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '298'}, {'groupId': 'FG001', 'numSubjects': '303'}, {'groupId': 'FG002', 'numSubjects': '302'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '227'}, {'groupId': 'FG002', 'numSubjects': '165'}]}, {'type': 'Study drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '92'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse event unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Participant request to discontinue study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Maximum clinical benefit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Poor/non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Administrative reason by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Not reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '907 participants were randomized and 903 were treated. 2 participants were in both the Global and China population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}, {'value': '907', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '100 mL of 0.9% Sodium Chloride Solution or 5% Dextrose administered as placebo for nivolumab and ipilimumab as an IV infusion'}, {'id': 'BG001', 'title': 'Nivolumab 240 mg', 'description': 'Nivolumab 240 mg administered every 2 weeks as a 30-minute IV infusion'}, {'id': 'BG002', 'title': 'Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Nivolumab 1 mg/kg (30-minute IV infusion) + Ipilimumab 3 mg/kg (90-minute IV infusion) administered every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 65', 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '152', 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'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Randomized Participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-20', 'size': 17593392, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-01T10:44', 'hasProtocol': True}, {'date': '2018-10-04', 'size': 6877442, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-01T10:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 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OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.'}, {'measure': 'Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab', 'timeFrame': 'From randomization to the date of death or last known alive date (up to approximately 73 months)', 'description': 'Overall Survival (OS) comparing Nivolumab + Ipilimumab Versus Nivolumab. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. 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Participants who did not have any on study tumor assessments and did not die (or died after initiation of the subsequent anti- cancer therapy) were censored on their date of randomization. Participants who started any subsequent anti- cancer therapy without a prior reported Progressive Disease (PD) per BICR were censored at the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.'}, {'measure': 'Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population', 'timeFrame': 'From randomization to the date of death or last known alive date (up to approximately 73 months)', 'description': 'Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined.\n\nOS in TMB by the following cutoff points: ≥10 mutations/mb, \\< 10 mutations/mb, ≥13 mutations/mb, \\<13 mutations/mb'}, {'measure': 'Progression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population', 'timeFrame': 'From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)', 'description': 'Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined.\n\nPFS in TMB by the following cutoff points: ≥10 mutations/mb, \\< 10 mutations/mb, ≥13 mutations/mb, \\<13 mutations/mb.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '35383114', 'type': 'DERIVED', 'citation': 'Kang YK, Reck M, Nghiem P, Feng Y, Plautz G, Kim HR, Owonikoko TK, Boku N, Chen LT, Lei M, Chang H, Lin WH, Roy A, Bello A, Sheng J. Assessment of hyperprogression versus the natural course of disease development with nivolumab with or without ipilimumab versus placebo in phase III, randomized, controlled trials. J Immunother Cancer. 2022 Apr;10(4):e004273. doi: 10.1136/jitc-2021-004273.'}, {'pmid': '33683919', 'type': 'DERIVED', 'citation': 'Owonikoko TK, Park K, Govindan R, Ready N, Reck M, Peters S, Dakhil SR, Navarro A, Rodriguez-Cid J, Schenker M, Lee JS, Gutierrez V, Percent I, Morgensztern D, Barrios CH, Greillier L, Baka S, Patel M, Lin WH, Selvaggi G, Baudelet C, Baden J, Pandya D, Doshi P, Kim HR. Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451. J Clin Oncol. 2021 Apr 20;39(12):1349-1359. doi: 10.1200/JCO.20.02212. Epub 2021 Mar 8.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSStudyConnect.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with histologically or cytologically confirmed extensive stage disease SCLC\n* Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion Criteria:\n\n* Subjects with symptomatic Central Nervous System (CNS) metastases\n* Subjects receiving consolidative chest radiation\n* Subjects with active, known, or suspected autoimmune disease are excluded\n* All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT02538666', 'acronym': 'CheckMate 451', 'briefTitle': 'An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)', 'orgStudyIdInfo': {'id': 'CA209-451'}, 'secondaryIdInfos': [{'id': '2015-002441-61', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nivolumab monotherapy', 'description': 'Nivolumab intravenous fusion', 'interventionNames': ['Biological: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Nivolumab and ipilimumab combination therapy', 'description': 'Nivolumab and ipilimumab intravenous fusion', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['Opdivo'], 'armGroupLabels': ['Nivolumab and ipilimumab combination therapy', 'Nivolumab monotherapy']}, {'name': 'Ipilimumab', 'type': 'BIOLOGICAL', 'otherNames': ['Yervoy'], 'armGroupLabels': ['Nivolumab and ipilimumab combination therapy']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 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