Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-03-03 @ 6:16 AM
Study NCT ID:
NCT03215706
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2017-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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': 'D000074324', 'term': 'Ipilimumab'}, {'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D002945', 'term': 'Cisplatin'}], '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'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, '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': '30 days after last dose, assessed up to October 2024, approximately 72 months', 'description': 'The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment A', 'description': 'Nivolumab + Ipilimumab + Chemotherapy', 'otherNumAtRisk': 358, 'deathsNumAtRisk': 361, 'otherNumAffected': 343, 'seriousNumAtRisk': 358, 'deathsNumAffected': 304, 'seriousNumAffected': 259}, {'id': 'EG001', 'title': 'Treatment B', 'description': 'Chemotherapy Only', 'otherNumAtRisk': 349, 'deathsNumAtRisk': 358, 'otherNumAffected': 329, 'seriousNumAtRisk': 349, 'deathsNumAffected': 318, 'seriousNumAffected': 197}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 122}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 161}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 60}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 38}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 12}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 83}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 68}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 120}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 146}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 61}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 96}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 62}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 88}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 27}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 35}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 36}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 45}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 54}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 36}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Febrile bone marrow aplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 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358, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Immune-mediated nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Acquired hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Balanoposthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Immune-mediated lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pulmonary artery compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Skin toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Nivolumab + Ipilimumab + Chemotherapy'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Chemotherapy only'}], 'classes': [{'categories': [{'measurements': [{'value': '14.13', 'groupId': 'OG000', 'lowerLimit': '13.24', 'upperLimit': '16.16'}, {'value': '10.74', 'groupId': 'OG001', 'lowerLimit': '9.46', 'upperLimit': '12.45'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.56', 'ciUpperLimit': '0.86', 'statisticalMethod': 'Log-rank test stratified', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Treatment A over Treatment B'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization to date of death (assessed up to October 2019, approximately 23 months)', 'description': "OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Participants, Global Population'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) by BICR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Nivolumab + Ipilimumab + Chemotherapy'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Chemotherapy only'}], 'classes': [{'categories': [{'measurements': [{'value': '6.74', 'groupId': 'OG000', 'lowerLimit': '5.55', 'upperLimit': '8.05'}, {'value': '5.26', 'groupId': 'OG001', 'lowerLimit': '4.37', 'upperLimit': '5.59'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.59', 'ciUpperLimit': '0.82', 'statisticalMethod': 'Log-rank test stratified', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Treatment A over Treatment B'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)', 'description': 'PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Participants, Global Population'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) by BICR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Nivolumab + Ipilimumab + Chemotherapy'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Chemotherapy only'}], 'classes': [{'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000', 'lowerLimit': '32.9', 'upperLimit': '43.2'}, {'value': '25.1', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '30.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.7', 'ciLowerLimit': '6.0', 'ciUpperLimit': '19.4', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Treatment A over Treatment B'}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)', 'description': 'ORR was defined as the number of randomized participants with a best overall response (BOR) of confirmed CR or PR based on BICR assessments (using RECIST v1.1 criteria), divided by the number of all randomized participants. BOR was recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of initiation of palliative local therapy or the date of initiation of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or palliative local therapy or subsequent anti-cancer therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial RECIST 1.1 defined progression.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Participants, Global Population'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Nivolumab + Ipilimumab + Chemotherapy'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Chemotherapy only'}], 'classes': [{'categories': [{'measurements': [{'value': '13.01', 'groupId': 'OG000', 'lowerLimit': '8.71', 'upperLimit': '20.21'}, {'value': '5.59', 'groupId': 'OG001', 'lowerLimit': '4.37', 'upperLimit': '7.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)', 'description': 'DoR was defined as the time between the date of first confirmed documented response (CR or PR) to the date of the first documented BICR-assessed tumor progression (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who started subsequent therapy (including palliative local therapy) without a prior reported progression were censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy (including palliative local therapy). Participants who died without a reported prior progression were considered to have progressed on the date of their death. For subjects who neither progressed nor died, DoR was censored on the date of their last evaluable tumor assessment. DoR was evaluated for responders (confirmed CR or PR) only.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All confirmed Responders, Global Population'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Nivolumab + Ipilimumab + Chemotherapy'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Chemotherapy only'}], 'classes': [{'categories': [{'measurements': [{'value': '2.53', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '52.1'}, {'value': '1.58', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '22.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)', 'description': 'TTR was defined as the time from randomization to the date of the first confirmed documented response (CR or PR), as assessed by the BICR. TTR was evaluated for responders (confirmed CR or PR) only.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All Confirmed Responders, Global Population'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Nivolumab + Ipilimumab + Chemotherapy'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Chemotherapy only'}], 'classes': [{'title': 'BASELINE PD-L1 EXPRESSION ≥1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000', 'lowerLimit': '35.8', 'upperLimit': '49.7'}, {'value': '27.5', 'groupId': 'OG001', 'lowerLimit': '21.5', 'upperLimit': '34.1'}]}]}, {'title': 'BASELINE PD-L1 EXPRESSION < 1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000', 'lowerLimit': '23.4', 'upperLimit': '39.6'}, {'value': '20.2', 'groupId': 'OG001', 'lowerLimit': '13.6', 'upperLimit': '28.1'}]}]}, {'title': 'Non-Quantifiable PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '59.3'}, {'value': '32.0', 'groupId': 'OG001', 'lowerLimit': '14.9', 'upperLimit': '53.5'}]}]}, {'title': 'BASELINE PD-L1 EXPRESSION 1 - 49%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'OG000', 'lowerLimit': '29.8', 'upperLimit': '47.3'}, {'value': '23.6', 'groupId': 'OG001', 'lowerLimit': '15.9', 'upperLimit': '32.8'}]}]}, {'title': 'BASELINE PD-L1 EXPRESSION >= 50%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '38.3', 'upperLimit': '61.7'}, {'value': '31.6', 'groupId': 'OG001', 'lowerLimit': '22.6', 'upperLimit': '41.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)', 'description': 'ORR was defined as the proportion of randomized participants with a best overall response (BOR) of confirmed complete or partial response per BICR using RECIST v1.1. BOR was assessed from randomization until documented progression, start of palliative local or subsequent anti-cancer therapy-whichever came first. If none occurred, all response data contributed to BOR. For those treated beyond progression, BOR was based on responses before initial RECIST-defined progression. PD-L1 expression was measured via Dako PD-L1 IHC 28-8 pharmDx test as the percentage of tumor cells with membrane staining among ≥100 evaluable cells. Expression was categorized as ≥1%, \\<1%, not quantifiable, ≥50%, or 1-49%.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Participants, Global Population'}, {'type': 'SECONDARY', 'title': 'PFS by BICR by PD-L1 Tumor Cell Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Nivolumab + Ipilimumab + Chemotherapy'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Chemotherapy only'}], 'classes': [{'title': '< 1% PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.78', 'groupId': 'OG000', 'lowerLimit': '4.40', 'upperLimit': '7.66'}, {'value': '4.96', 'groupId': 'OG001', 'lowerLimit': '4.21', 'upperLimit': '5.78'}]}]}, {'title': '>= 1% PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.87', 'groupId': 'OG000', 'lowerLimit': '5.55', 'upperLimit': '8.94'}, {'value': '4.70', 'groupId': 'OG001', 'lowerLimit': '4.24', 'upperLimit': '5.55'}]}]}, {'title': 'with 1-49% PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.74', 'groupId': 'OG000', 'lowerLimit': '4.50', 'upperLimit': '8.51'}, {'value': '5.29', 'groupId': 'OG001', 'lowerLimit': '4.24', 'upperLimit': '5.68'}]}]}, {'title': 'with >= 50% PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.28', 'groupId': 'OG000', 'lowerLimit': '4.44', 'upperLimit': '12.48'}, {'value': '4.53', 'groupId': 'OG001', 'lowerLimit': '4.14', 'upperLimit': '5.65'}]}]}, {'title': 'Non-Quantifiable PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.95', 'groupId': 'OG000', 'lowerLimit': '3.61', 'upperLimit': '15.08'}, {'value': '6.77', 'groupId': 'OG001', 'lowerLimit': '2.83', 'upperLimit': '13.83'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)', 'description': 'PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Participants, Global Population'}, {'type': 'SECONDARY', 'title': 'OS by PD-L1 Tumor Cell Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Nivolumab + Ipilimumab + Chemotherapy'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Chemotherapy only'}], 'classes': [{'title': '< 1% PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.74', 'groupId': 'OG000', 'lowerLimit': '13.67', 'upperLimit': '20.27'}, {'value': '9.79', 'groupId': 'OG001', 'lowerLimit': '7.69', 'upperLimit': '13.54'}]}]}, {'title': '>= 1% PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.80', 'groupId': 'OG000', 'lowerLimit': '13.77', 'upperLimit': '22.18'}, {'value': '10.89', 'groupId': 'OG001', 'lowerLimit': '9.49', 'upperLimit': '13.17'}]}]}, {'title': 'with 1-49% PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.20', 'groupId': 'OG000', 'lowerLimit': '12.62', 'upperLimit': '21.22'}, {'value': '10.37', 'groupId': 'OG001', 'lowerLimit': '8.67', 'upperLimit': '12.35'}]}]}, {'title': 'with >= 50% PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.91', 'groupId': 'OG000', 'lowerLimit': '13.11', 'upperLimit': '29.11'}, {'value': '12.93', 'groupId': 'OG001', 'lowerLimit': '9.36', 'upperLimit': '17.58'}]}]}, {'title': 'Non-Quantifiable PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.84', 'groupId': 'OG000', 'lowerLimit': '7.16', 'upperLimit': '15.57'}, {'value': '17.05', 'comment': 'Upper Limit Not Reached', 'groupId': 'OG001', 'lowerLimit': '8.64', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization to date of death (assessed up to October 2024, approximately 72 months)', 'description': "OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Participants, Global Population with PD-L1 measurements'}, {'type': 'POST_HOC', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Nivolumab + Ipilimumab + Chemotherapy'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Chemotherapy only'}], 'classes': [{'categories': [{'measurements': [{'value': '15.80', 'groupId': 'OG000', 'lowerLimit': '13.93', 'upperLimit': '19.71'}, {'value': '10.96', 'groupId': 'OG001', 'lowerLimit': '9.49', 'upperLimit': '12.71'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.87', 'statisticalMethod': 'Stratified Cox proportional hazard model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Treatment A over Treatment B'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization to date of death (assessed up to October 2024, approximately 72 months)', 'description': "OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Participants, Global Population'}, {'type': 'SECONDARY', 'title': 'PFS by BICR by Tumor Mutational Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Nivolumab + Ipilimumab + Chemotherapy'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Chemotherapy only'}], 'classes': [{'title': '≥ 10 Mutations/MB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.94', 'groupId': 'OG000', 'lowerLimit': '5.55', 'upperLimit': '13.01'}, {'value': '4.70', 'groupId': 'OG001', 'lowerLimit': '4.14', 'upperLimit': '5.62'}]}]}, {'title': '< 10 Mutations/MB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.62', 'groupId': 'OG000', 'lowerLimit': '4.17', 'upperLimit': '7.20'}, {'value': '5.16', 'groupId': 'OG001', 'lowerLimit': '4.21', 'upperLimit': '5.62'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.37', 'groupId': 'OG000', 'lowerLimit': '5.36', 'upperLimit': '8.21'}, {'value': '4.96', 'groupId': 'OG001', 'lowerLimit': '4.27', 'upperLimit': '5.55'}]}]}, {'title': 'Not Evaluable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.74', 'groupId': 'OG000', 'lowerLimit': '4.24', 'upperLimit': '9.69'}, {'value': '5.45', 'groupId': 'OG001', 'lowerLimit': '4.17', 'upperLimit': '5.82'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)', 'description': 'PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Participants, Global Population with tumor mutational burden measurements'}, {'type': 'SECONDARY', 'title': 'ORR by BICR by Tumor Mutational Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Nivolumab + Ipilimumab + Chemotherapy'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Chemotherapy only'}], 'classes': [{'title': '≥ 10 Mutations/MB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '35.6', 'upperLimit': '55.8'}, {'value': '29.3', 'groupId': 'OG001', 'lowerLimit': '19.7', 'upperLimit': '40.4'}]}]}, {'title': '< 10 Mutations/MB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000', 'lowerLimit': '23.9', 'upperLimit': '40.1'}, {'value': '27.0', 'groupId': 'OG001', 'lowerLimit': '19.8', 'upperLimit': '35.3'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.6', 'groupId': 'OG000', 'lowerLimit': '31.4', 'upperLimit': '44.1'}, {'value': '27.9', 'groupId': 'OG001', 'lowerLimit': '22.0', 'upperLimit': '34.3'}]}]}, {'title': 'Not Evaluable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '27.8', 'upperLimit': '45.8'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '29.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)', 'description': 'ORR was defined as the number of randomized participants with a best overall response (BOR) of confirmed CR or PR based on BICR assessments (using RECIST v1.1 criteria), divided by the number of all randomized participants. BOR was recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of initiation of palliative local therapy or the date of initiation of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or palliative local therapy or subsequent anti-cancer therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial RECIST 1.1 defined progression.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Participants, Global Population with tumor mutational burden measurements'}, {'type': 'SECONDARY', 'title': 'OS by Tumor Mutational Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Nivolumab + Ipilimumab + Chemotherapy'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Chemotherapy only'}], 'classes': [{'title': '≥ 10 Mutations/MB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.05', 'groupId': 'OG000', 'lowerLimit': '12.45', 'upperLimit': '20.76'}, {'value': '10.76', 'groupId': 'OG001', 'lowerLimit': '7.85', 'upperLimit': '15.41'}]}]}, {'title': '< 10 Mutations/MB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.51', 'groupId': 'OG000', 'lowerLimit': '11.99', 'upperLimit': '19.98'}, {'value': '12.55', 'groupId': 'OG001', 'lowerLimit': '10.38', 'upperLimit': '14.92'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.57', 'groupId': 'OG000', 'lowerLimit': '13.34', 'upperLimit': '19.38'}, {'value': '12.06', 'groupId': 'OG001', 'lowerLimit': '10.35', 'upperLimit': '14.06'}]}]}, {'title': 'Not Evaluable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.10', 'groupId': 'OG000', 'lowerLimit': '13.47', 'upperLimit': '25.49'}, {'value': '9.46', 'groupId': 'OG001', 'lowerLimit': '8.15', 'upperLimit': '11.79'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization to date of death (assessed up to October 2024, approximately 72 months)', 'description': "OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Participants, Global Population with tumor mutational burden measurements'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment A', 'description': 'Nivolumab + Ipilimumab + Chemotherapy'}, {'id': 'FG001', 'title': 'Treatment B', 'description': 'Chemotherapy only'}], 'periods': [{'title': 'Randomization', 'milestones': [{'type': 'STARTED', 'comment': '= Participants Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '361'}, {'groupId': 'FG001', 'numSubjects': '358'}]}, {'type': 'COMPLETED', 'comment': '= Participants treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '358'}, {'groupId': 'FG001', 'numSubjects': '349'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'comment': '= Participants treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '358'}, {'groupId': 'FG001', 'numSubjects': '349'}]}, {'type': 'COMPLETED', 'comment': '= completing treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '249'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '174'}]}, {'type': 'Study Drug Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse event unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Request to D/C treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Administrative reason by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Not reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '707 Randomized and treated'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '719', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment A', 'description': 'Nivolumab + Ipilimumab + Chemotherapy'}, {'id': 'BG001', 'title': 'Treatment B', 'description': 'Chemotherapy only'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '65.0', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '65.0', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '˂65 years old', 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '49.2', 'groupId': 'BG002'}]}]}, {'title': '≥65 and ˂75 years old', 'categories': [{'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '41.0', 'groupId': 'BG002'}]}]}, {'title': '≥75 years old', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '9.7', 'groupId': 'BG002'}]}]}, {'title': '≥85 years old', 'categories': 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Survival follow-up was to be conducted every 3 months after participants's off-treatment date."}, {'measure': 'PFS by BICR by Tumor Mutational Burden', 'timeFrame': 'From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)', 'description': 'PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. 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Survival follow-up was to be conducted every 3 months after participants's off-treatment date."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '39369790', 'type': 'DERIVED', 'citation': "Peters S, Paz-Ares LG, Reck M, Carbone DP, Brahmer JR, Borghaei H, Lu S, O'Byrne KJ, John T, Ciuleanu TE, Schenker M, Bernabe Caro R, Nishio M, Cobo M, Lee JS, Zurawski B, Pluzanski A, Aoyama T, Tschaika M, Devas V, Grootendorst DJ, Ramalingam SS. Long-Term Survival Outcomes With First-Line Nivolumab Plus Ipilimumab-Based Treatment in Patients With Metastatic NSCLC and Tumor Programmed Death-Ligand 1 Lower Than 1%: A Pooled Analysis. J Thorac Oncol. 2025 Jan;20(1):94-108. doi: 10.1016/j.jtho.2024.09.1439. Epub 2024 Oct 4."}, {'pmid': '39270380', 'type': 'DERIVED', 'citation': 'Reck M, Ciuleanu TE, Schenker M, Bordenave S, Cobo M, Juan-Vidal O, Reinmuth N, Richardet E, Felip E, Menezes J, Cheng Y, Mizutani H, Zurawski B, Alexandru A, Carbone DP, Lu S, John T, Aoyama T, Grootendorst DJ, Hu N, Eccles LJ, Paz-Ares LG. Five-year outcomes with first-line nivolumab plus ipilimumab with 2 cycles of chemotherapy versus 4 cycles of chemotherapy alone in patients with metastatic non-small cell lung cancer in the randomized CheckMate 9LA trial. Eur J Cancer. 2024 Nov;211:114296. doi: 10.1016/j.ejca.2024.114296. Epub 2024 Aug 25.'}, {'pmid': '33476593', 'type': 'DERIVED', 'citation': 'Paz-Ares L, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Bennouna J, Felip E, Juan-Vidal O, Alexandru A, Sakai H, Lingua A, Salman P, Souquet PJ, De Marchi P, Martin C, Perol M, Scherpereel A, Lu S, John T, Carbone DP, Meadows-Shropshire S, Agrawal S, Oukessou A, Yan J, Reck M. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):198-211. doi: 10.1016/S1470-2045(20)30641-0. Epub 2021 Jan 18.'}], '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': 'The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1\n* Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria\n* Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period\n\nExclusion Criteria:\n\n* Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 \\[L858R\\] substitution mutations) are excluded\n* Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded\n* Participants with untreated CNS metastases are excluded. 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