Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT02041533
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
2014-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], '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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please Email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 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': 'Nivolumab', 'description': 'Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity', 'otherNumAtRisk': 267, 'deathsNumAtRisk': 271, 'otherNumAffected': 245, 'seriousNumAtRisk': 267, 'deathsNumAffected': 233, 'seriousNumAffected': 195}, {'id': 'EG001', 'title': 'Investigator Choice of Chemotherapy', 'description': 'Administered in 3-week cycles for up to 6 cycles:\n\nSquamous:\n\n* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or\n* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or\n* paclitaxel (200 mg/m2) with carboplatin (AUC 6)\n\nNon-Squamous:\n\n* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or\n* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.', 'otherNumAtRisk': 263, 'deathsNumAtRisk': 270, 'otherNumAffected': 252, 'seriousNumAtRisk': 263, 'deathsNumAffected': 92, 'seriousNumAffected': 203}, {'id': 'EG002', 'title': 'Post Chemotherapy Optional Nivolumab', 'description': 'Participants from the Investigator Choice Arm who progressed during Post-Chemotherapy Phase could receive crossover nivolumab treatment after disease progression. These participants received Nivolumab 3 mg/kg IV infusion every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 137, 'seriousNumAtRisk': 159, 'deathsNumAffected': 136, 'seriousNumAffected': 110}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 142}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 38}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 14}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 149}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 77}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 134}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 102}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 37}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition 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'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Laryngeal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Mediastinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pulmonary microemboli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Air embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Leriche syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Vascular occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Vein disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival in Participants With PD-L1 Expression >= 5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity'}, {'id': 'OG001', 'title': 'Investigator Choice of Chemotherapy', 'description': 'Administered in 3-week cycles for up to 6 cycles:\n\nSquamous:\n\n* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or\n* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or\n* paclitaxel (200 mg/m2) with carboplatin (AUC 6)\n\nNon-Squamous:\n\n* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or\n* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.21', 'groupId': 'OG000', 'lowerLimit': '2.96', 'upperLimit': '5.55'}, {'value': '5.88', 'groupId': 'OG001', 'lowerLimit': '5.42', 'upperLimit': '6.93'}]}]}], 'analyses': [{'pValue': '0.2511', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.45', 'estimateComment': "Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Log-rank test stratified by histology (squamous vs. non-squamous) as entered into the IVRS.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)', 'description': 'Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die 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 day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 expression levels \\>= 5%'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival in All Randomized Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity'}, {'id': 'OG001', 'title': 'Investigator Choice of Chemotherapy', 'description': 'Administered in 3-week cycles for up to 6 cycles:\n\nSquamous:\n\n* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or\n* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or\n* paclitaxel (200 mg/m2) with carboplatin (AUC 6)\n\nNon-Squamous:\n\n* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or\n* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.21', 'groupId': 'OG000', 'lowerLimit': '3.06', 'upperLimit': '5.52'}, {'value': '5.82', 'groupId': 'OG001', 'lowerLimit': '5.42', 'upperLimit': '6.90'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.43', 'estimateComment': "Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)', 'description': 'Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die 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 day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Participants With PD-L1 Expression >= 5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity'}, {'id': 'OG001', 'title': 'Investigator Choice of Chemotherapy', 'description': 'Administered in 3-week cycles for up to 6 cycles:\n\nSquamous:\n\n* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or\n* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or\n* paclitaxel (200 mg/m2) with carboplatin (AUC 6)\n\nNon-Squamous:\n\n* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or\n* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.36', 'groupId': 'OG000', 'lowerLimit': '11.66', 'upperLimit': '17.08'}, {'value': '13.21', 'groupId': 'OG001', 'lowerLimit': '10.81', 'upperLimit': '17.28'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.20', 'estimateComment': "Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization to date of death (up to approximately 89 months)', 'description': 'Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 expression \\>= 5%'}, {'type': 'SECONDARY', 'title': 'Overall Survival in All Randomized Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity'}, {'id': 'OG001', 'title': 'Investigator Choice of Chemotherapy', 'description': 'Administered in 3-week cycles for up to 6 cycles:\n\nSquamous:\n\n* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or\n* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or\n* paclitaxel (200 mg/m2) with carboplatin (AUC 6)\n\nNon-Squamous:\n\n* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or\n* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.73', 'groupId': 'OG000', 'lowerLimit': '11.76', 'upperLimit': '15.41'}, {'value': '13.80', 'groupId': 'OG001', 'lowerLimit': '11.01', 'upperLimit': '16.99'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.24', 'estimateComment': "Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization to date of death (up to approximately 89 months)', 'description': 'Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity'}, {'id': 'OG001', 'title': 'Investigator Choice of Chemotherapy', 'description': 'Administered in 3-week cycles for up to 6 cycles:\n\nSquamous:\n\n* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or\n* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or\n* paclitaxel (200 mg/m2) with carboplatin (AUC 6)\n\nNon-Squamous:\n\n* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or\n* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '32.5'}, {'value': '33.5', 'groupId': 'OG001', 'lowerLimit': '27.2', 'upperLimit': '40.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.46', 'ciUpperLimit': '1.06', 'estimateComment': 'Stratified by histology (squamous vs.non-squamous) at randomization. Strata adjusted odds ratio (Nivolumab over investigator choice of chemotherapy) using Mantel-Haenszel method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months)', 'description': 'ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by \\>=50% of previously involved sites from nadir.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 expression \\>= 5%'}, {'type': 'SECONDARY', 'title': 'Disease-related Symptom Improvement Rate by Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity'}, {'id': 'OG001', 'title': 'Investigator Choice of Chemotherapy', 'description': 'Administered in 3-week cycles for up to 6 cycles:\n\nSquamous:\n\n* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or\n* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or\n* paclitaxel (200 mg/m2) with carboplatin (AUC 6)\n\nNon-Squamous:\n\n* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or\n* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.4', 'groupId': 'OG000', 'lowerLimit': '29.7', 'upperLimit': '41.4'}, {'value': '33.7', 'groupId': 'OG001', 'lowerLimit': '28.1', 'upperLimit': '39.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization to week 12', 'description': 'The Lung Cancer Symptom Score (LCSS) is a validated instrument designed to assess the impact of treatment on disease-related symptoms. It consists of 6 symptom-specific questions related to dyspnea, cough, fatigue, pain, hemoptysis and anorexia plus 3 summary items: symptom distress, interference with activity, and global HRQoL. The degree of impairment was recorded on a 100 mm visual analogue scale with scores from 0 to 100 with zero representing the best score. Disease-related symptom improvement rate by Week 12 is defined as the proportion of all randomized (all PD-L1+) participants who had 10 points or more decrease from baseline in average symptom burden index score at any time between randomization and Week 12.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity'}, {'id': 'FG001', 'title': 'Investigator Choice of Chemotherapy', 'description': 'Administered in 3-week cycles for up to 6 cycles:\n\nSquamous:\n\n* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or\n* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or\n* paclitaxel (200 mg/m2) with carboplatin (AUC 6)\n\nNon-Squamous:\n\n* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or\n* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.'}], 'periods': [{'title': 'Pre-Treatment Period', 'milestones': [{'type': 'STARTED', 'comment': 'Started = Participants Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '271'}, {'groupId': 'FG001', 'numSubjects': '270'}]}, {'type': 'COMPLETED', 'comment': 'Completed = Participants Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '267'}, {'groupId': 'FG001', 'numSubjects': '263'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Participant no Longer Meets Study Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '267'}, {'groupId': 'FG001', 'numSubjects': '263'}]}, {'type': 'Received Optional Nivolumab', 'comment': 'Participants in the Investigator Choice Arm who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '267'}, {'groupId': 'FG001', 'numSubjects': '235'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '146'}]}, {'type': 'Study drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse event unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Participant request to discontinue study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Maximum clinical benefit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Poor/Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Administrative reason by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Not Reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'BG000'}, {'value': '270', 'groupId': 'BG001'}, {'value': '541', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity'}, {'id': 'BG001', 'title': 'Investigator Choice of Chemotherapy', 'description': 'Administered in 3-week cycles for up to 6 cycles:\n\nSquamous:\n\n* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or\n* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or\n* paclitaxel (200 mg/m2) with carboplatin (AUC 6)\n\nNon-Squamous:\n\n* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or\n* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '10.25', 'groupId': 'BG000'}, {'value': '63.4', 'spread': '9.63', 'groupId': 'BG001'}, {'value': '63.1', 'spread': '9.94', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '332', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '228', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '470', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Race', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 541}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2014-01-19', 'resultsFirstSubmitDate': '2017-06-26', 'studyFirstSubmitQcDate': '2014-01-19', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-26', 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival in Participants With PD-L1 Expression >= 5%', 'timeFrame': 'From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)', 'description': 'Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die 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 day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival in All Randomized Participants', 'timeFrame': 'From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)', 'description': 'Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die 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 day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.'}, {'measure': 'Overall Survival in Participants With PD-L1 Expression >= 5%', 'timeFrame': 'From date of randomization to date of death (up to approximately 89 months)', 'description': 'Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.'}, {'measure': 'Overall Survival in All Randomized Participants', 'timeFrame': 'From date of randomization to date of death (up to approximately 89 months)', 'description': 'Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.'}, {'measure': 'Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%', 'timeFrame': 'From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months)', 'description': 'ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by \\>=50% of previously involved sites from nadir.'}, {'measure': 'Disease-related Symptom Improvement Rate by Week 12', 'timeFrame': 'From date of randomization to week 12', 'description': 'The Lung Cancer Symptom Score (LCSS) is a validated instrument designed to assess the impact of treatment on disease-related symptoms. It consists of 6 symptom-specific questions related to dyspnea, cough, fatigue, pain, hemoptysis and anorexia plus 3 summary items: symptom distress, interference with activity, and global HRQoL. The degree of impairment was recorded on a 100 mm visual analogue scale with scores from 0 to 100 with zero representing the best score. Disease-related symptom improvement rate by Week 12 is defined as the proportion of all randomized (all PD-L1+) participants who had 10 points or more decrease from baseline in average symptom burden index score at any time between randomization and Week 12.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stage IV or Recurrent Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '38383458', 'type': 'DERIVED', 'citation': 'Mason M, Lapuente-Santana O, Halkola AS, Wang W, Mall R, Xiao X, Kaufman J, Fu J, Pfeil J, Banerjee J, Chung V, Chang H, Chasalow SD, Lin HY, Chai R, Yu T, Finotello F, Mirtti T, Mayranpaa MI, Bao J, Verschuren EW, Ahmed EI, Ceccarelli M, Miller LD, Monaco G, Hendrickx WRL, Sherif S, Yang L, Tang M, Gu SS, Zhang W, Zhang Y, Zeng Z, Das Sahu A, Liu Y, Yang W, Bedognetti D, Tang J, Eduati F, Laajala TD, Geese WJ, Guinney J, Szustakowski JD, Vincent BG, Carbone DP. A community challenge to predict clinical outcomes after immune checkpoint blockade in non-small cell lung cancer. J Transl Med. 2024 Feb 21;22(1):190. doi: 10.1186/s12967-023-04705-3.'}, {'pmid': '28636851', 'type': 'DERIVED', 'citation': 'Carbone DP, Reck M, Paz-Ares L, Creelan B, Horn L, Steins M, Felip E, van den Heuvel MM, Ciuleanu TE, Badin F, Ready N, Hiltermann TJN, Nair S, Juergens R, Peters S, Minenza E, Wrangle JM, Rodriguez-Abreu D, Borghaei H, Blumenschein GR Jr, Villaruz LC, Havel L, Krejci J, Corral Jaime J, Chang H, Geese WJ, Bhagavatheeswaran P, Chen AC, Socinski MA; CheckMate 026 Investigators. First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Jun 22;376(25):2415-2426. doi: 10.1056/NEJMoa1613493.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}, {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'Investigator Inquiry Form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1\n* Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy\n* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria\n* PD-L1+ on immunohistochemistry testing performed by central lab\n* Men and women, ages ≥ 18 years of age\n\nExclusion Criteria:\n\n* Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy\n* Known anaplastic lymphoma kinase (ALK) translocations\n* Untreated central nervous system (CNS) metastases\n* Previous malignancies\n* Active, known or suspected autoimmune disease'}, 'identificationModule': {'nctId': 'NCT02041533', 'briefTitle': "An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': "An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer", 'orgStudyIdInfo': {'id': 'CA209-026'}, 'secondaryIdInfos': [{'id': '2012-004502-93', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Nivolumab subjects', 'description': 'Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure', 'interventionNames': ['Biological: Nivolumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': "Arm B: Investigator's Choice Chemotherapy", 'description': "Investigator's Choice Chemotherapy administered in 3-week cycles up to a maximum of 6 cycles of Intravenous injection until disease progression, unacceptable toxicity or completion of the 6 cycles, whichever comes first\n\nSquamous subjects:\n\n* Gemcitabine 1250 mg/mg(2) administered on Day 1 and Day 8 with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle; 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