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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-26 @ 11:12 AM

Ignite Modification Date: 2026-04-23 @ 4:48 AM

Study NCT ID: NCT02998528

Status: COMPLETED

Last Update Posted: 2025-01-24

First Post: 2016-12-16

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Africa']}, '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': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000074324', 'term': 'Ipilimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'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': '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': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, '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': 'All-cause mortality was assessed from first dose to primary completion (up to approximately 54 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose of neoadjuvant therapy (up to approximately 5.5 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': 'Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg', 'description': 'Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes.\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 113, 'otherNumAffected': 102, 'seriousNumAtRisk': 111, 'deathsNumAffected': 30, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': 'Arm B: Platinum Doublet Chemo', 'description': 'Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.', 'otherNumAtRisk': 208, 'deathsNumAtRisk': 213, 'otherNumAffected': 200, 'seriousNumAtRisk': 208, 'deathsNumAffected': 76, 'seriousNumAffected': 58}, {'id': 'EG002', 'title': 'Arm C: Nivo 360 mg + Platinum Doublet Chemo', 'description': 'Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.', 'otherNumAtRisk': 176, 'deathsNumAtRisk': 179, 'otherNumAffected': 157, 'seriousNumAtRisk': 176, 'deathsNumAffected': 35, 'seriousNumAffected': 52}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 62}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 30}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 7}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 72}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 63}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 104}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 73}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Incision site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 46}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 20}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pruritus', 'stats': 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'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Postoperative delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Postoperative respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Postoperative wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hepatic enzyme abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Tumour pseudoprogression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Myasthenia gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Posterior reversible encephalopathy syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Bronchopleural fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Chylothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Lung opacity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pulmonary fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Aortic rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event-Free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm B: Platinum Doublet Chemo', 'description': 'Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.'}, {'id': 'OG001', 'title': 'Arm C: Nivo 360 mg + Platinum Doublet Chemo', 'description': 'Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.80', 'groupId': 'OG000', 'lowerLimit': '14.03', 'upperLimit': '26.71'}, {'value': '31.57', 'comment': 'Insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '30.16', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0052', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.38', 'paramValue': '0.63', 'ciLowerLimit': '0.43', 'ciUpperLimit': '0.91', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by PD-L1 (≥ 1% vs \\<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)', 'description': "Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All concurrently randomized participants in Arm C and Arm B'}, {'type': 'PRIMARY', 'title': 'Pathologic Complete Response (pCR) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm B: Platinum Doublet Chemo', 'description': 'Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.'}, {'id': 'OG001', 'title': 'Arm C: Nivo 360 mg + Platinum Doublet Chemo', 'description': 'Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': '% Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '21.6', 'ciLowerLimit': '13.0', 'ciUpperLimit': '30.3', 'estimateComment': 'Strata adjusted difference (Arm C - Concurrent Arm B) based on the CMH method of weighting. Stratified by PD-L1 (≥ 1% vs \\<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '13.94', 'ciLowerLimit': '3.49', 'ciUpperLimit': '55.75', 'estimateComment': 'Strata adjusted odds ratio (Arm C over Concurrent Arm B) the Mantel-Haenszel method. Stratified by PD-L1 (≥ 1% vs \\<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization up to a median of 30 months after randomization.', 'description': 'Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All concurrently randomized participants in Arm C and Arm B'}, {'type': 'SECONDARY', 'title': 'Major Pathologic Response (MPR) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm B: Platinum Doublet Chemo', 'description': 'Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.'}, {'id': 'OG001', 'title': 'Arm C: Nivo 360 mg + Platinum Doublet Chemo', 'description': 'Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': '% Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.9', 'ciLowerLimit': '19.6', 'ciUpperLimit': '36.1', 'estimateComment': 'Strata adjusted difference (Arm C - Concurrent Arm B) based on the CMH method of weighting. Stratified by PD-L1 (≥ 1% vs \\<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.70', 'ciLowerLimit': '3.16', 'ciUpperLimit': '10.26', 'estimateComment': 'Stratified by PD-L1 (≥ 1% vs \\<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization up to a median of 30 months after randomization.', 'description': 'Major pathologic response (MPR) rate is defined as number of randomized participants with \\</= 10% residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All concurrently randomized participants in Arm C and Arm B'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'timeFrame': 'From randomization to the date of death', 'description': 'Overall survival (OS) is defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2028-11'}, {'type': 'SECONDARY', 'title': 'Time to Death or Distant Metastases (TTDM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm B: Platinum Doublet Chemo', 'description': 'Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.'}, {'id': 'OG001', 'title': 'Arm C: Nivo 360 mg + Platinum Doublet Chemo', 'description': 'Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.71', 'comment': 'Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '22.41', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '36.60', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.77', 'estimateComment': 'Stratified by: PD-L1 status (≥ 1% vs \\<1%/not evaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to a median of 30 months)', 'description': 'TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All concurrently randomized participants in Arm C and Arm B'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg', 'description': 'Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes.\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.'}, {'id': 'FG001', 'title': 'Arm B: Platinum Doublet Chemo', 'description': 'Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.'}, {'id': 'FG002', 'title': 'Arm C: Nivo 360 mg + Platinum Doublet Chemo', 'description': 'Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.'}], 'periods': [{'title': 'Randomization Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '213'}, {'groupId': 'FG002', 'numSubjects': '179'}]}, {'type': 'All Concurrently Randomized Participants in Arms B and C', 'comment': 'The primary population for efficacy analyses', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '179'}, {'groupId': 'FG002', 'numSubjects': '179'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '207'}, {'groupId': 'FG002', 'numSubjects': '176'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse event unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Neoadjuvant Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '208'}, {'groupId': 'FG002', 'numSubjects': '176'}]}, {'type': 'All Treated Participants From Concurrently Randomized Arms B and C', 'comment': 'The primary population for safety analyses', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '176'}, {'groupId': 'FG002', 'numSubjects': '176'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '177'}, {'groupId': 'FG002', 'numSubjects': '165'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Participant request to discontinue study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Study drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse event unrelated to study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Systemic Adjuvant Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Study drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse event unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Participant request to discontinue treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm A for baseline and efficacy analyses (analyses based on the randomized population) and is counted in Arm B (chemo) for exposure and safety analyses (based on the treated population). This participant was randomized prior to Revised Protocol 02 and is not included in the All Treated Participants from the Concurrently Randomized Arms B and C population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}, {'value': '505', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg', 'description': 'Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes.\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.'}, {'id': 'BG001', 'title': 'Arm B: Platinum Doublet Chemo', 'description': 'Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.'}, {'id': 'BG002', 'title': 'Arm C: Nivo 360 mg + Platinum Doublet Chemo', 'description': 'Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 65', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}]}, {'title': '>= 65 AND < 75', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}]}]}, {'title': '>= 75 AND < 85', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}, {'title': '>= 85', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}, {'value': '349', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '258', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '240', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '223', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '261', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-18', 'size': 1644297, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-31T15:21', 'hasProtocol': True}, {'date': '2021-08-11', 'size': 922903, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-08-31T15:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 505}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03126643', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2016-12-16', 'resultsFirstSubmitDate': '2022-08-31', 'studyFirstSubmitQcDate': '2016-12-16', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-31', 'studyFirstPostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-Free Survival (EFS)', 'timeFrame': 'From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)', 'description': "Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)."}, {'measure': 'Pathologic Complete Response (pCR) Rate', 'timeFrame': 'From randomization up to a median of 30 months after randomization.', 'description': 'Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).'}], 'secondaryOutcomes': [{'measure': 'Major Pathologic Response (MPR) Rate', 'timeFrame': 'From randomization up to a median of 30 months after randomization.', 'description': 'Major pathologic response (MPR) rate is defined as number of randomized participants with \\</= 10% residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization to the date of death', 'description': 'Overall survival (OS) is defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive.'}, {'measure': 'Time to Death or Distant Metastases (TTDM)', 'timeFrame': 'From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to a median of 30 months)', 'description': 'TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '40454642', 'type': 'DERIVED', 'citation': 'Forde PM, Spicer JD, Provencio M, Mitsudomi T, Awad MM, Wang C, Lu S, Felip E, Swanson SJ, Brahmer JR, Kerr K, Taube JM, Ciuleanu TE, Tanaka F, Saylors GB, Chen KN, Ito H, Liberman M, Martin C, Broderick S, Wang L, Cai J, Duong Q, Meadows-Shropshire S, Fiore J, Bhatia S, Girard N; CheckMate 816 Investigators. Overall Survival with Neoadjuvant Nivolumab plus Chemotherapy in Lung Cancer. N Engl J Med. 2025 Aug 21;393(8):741-752. doi: 10.1056/NEJMoa2502931. Epub 2025 Jun 2.'}, {'pmid': '39778121', 'type': 'DERIVED', 'citation': 'Awad MM, Forde PM, Girard N, Spicer J, Wang C, Lu S, Mitsudomi T, Felip E, Broderick SR, Swanson SJ, Brahmer J, Kerr K, Saylors GB, Chen KN, Gharpure V, Neely J, Balli D, Hu N, Provencio Pulla M. Neoadjuvant Nivolumab Plus Ipilimumab Versus Chemotherapy in Resectable Lung Cancer. J Clin Oncol. 2025 Apr 20;43(12):1453-1462. doi: 10.1200/JCO-24-02239. Epub 2025 Jan 8.'}, {'pmid': '37903504', 'type': 'DERIVED', 'citation': 'Deutsch JS, Cimino-Mathews A, Thompson E, Provencio M, Forde PM, Spicer J, Girard N, Wang D, Anders RA, Gabrielson E, Illei P, Jedrych J, Danilova L, Sunshine J, Kerr KM, Tran M, Bushong J, Cai J, Devas V, Neely J, Balli D, Cottrell TR, Baras AS, Taube JM. Association between pathologic response and survival after neoadjuvant therapy in lung cancer. Nat Med. 2024 Jan;30(1):218-228. doi: 10.1038/s41591-023-02660-6. Epub 2023 Oct 30.'}, {'pmid': '37141544', 'type': 'DERIVED', 'citation': 'Akinboro O, Drezner N, Amatya A, Runyan J, Fourie-Zirkelbach J, Zhao M, Bi Y, Korsah K, Mixter B, Tang S, Larkins E, Pazdur R, Beaver JA, Singh H. US Food and Drug Administration Approval Summary: Nivolumab Plus Platinum-Doublet Chemotherapy for the Neoadjuvant Treatment of Patients With Resectable Non-Small-Cell Lung Cancer. J Clin Oncol. 2023 Jun 10;41(17):3249-3259. doi: 10.1200/JCO.22.02509. Epub 2023 May 4.'}, {'pmid': '36815433', 'type': 'DERIVED', 'citation': 'Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N. Plain language summary of the CheckMate 816 study results: nivolumab plus chemotherapy given before surgery for non-small-cell lung cancer. Future Oncol. 2023 Mar;19(8):549-557. doi: 10.2217/fon-2023-0007. Epub 2023 Feb 23.'}, {'pmid': '35403841', 'type': 'DERIVED', 'citation': 'Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.'}], '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 neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.\n\nThis study has multiple primary endpoints."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue\n* Lung function capacity capable of tolerating the proposed lung surgery\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\n* Available tissue of primary lung tumor\n\nExclusion Criteria:\n\n* Presence of locally advanced, inoperable or metastatic disease\n* Participants with active, known or suspected autoimmune disease\n* Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)\n\nOther protocol defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT02998528', 'acronym': 'CheckMate 816', 'briefTitle': 'A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC', 'orgStudyIdInfo': {'id': 'CA209-816'}, 'secondaryIdInfos': [{'id': '2016-003536-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Platinum doublet chemotherapy', 'description': 'Specified dose on specified days', 'interventionNames': ['Drug: Cisplatin', 'Drug: Vinorelbine', 'Drug: Gemcitabine', 'Drug: Docetaxel', 'Drug: Pemetrexed', 'Drug: Carboplatin', 'Drug: Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Nivolumab plus platinum doublet chemotherapy', 'description': 'Specified dose on specified days', 'interventionNames': ['Biological: Nivolumab', 'Drug: Cisplatin', 'Drug: Gemcitabine', 'Drug: Pemetrexed', 'Drug: Carboplatin', 'Drug: Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Nivolumab plus Ipilimumab', 'description': 'Specified dose on specified days', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}], 'interventions': [{'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['BMS-936558', 'Opdivo'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Nivolumab plus Ipilimumab', 'Nivolumab plus platinum doublet chemotherapy']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Nivolumab plus platinum doublet chemotherapy', 'Platinum doublet chemotherapy']}, {'name': 'Vinorelbine', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Platinum doublet chemotherapy']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Nivolumab plus platinum doublet chemotherapy', 'Platinum doublet chemotherapy']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Platinum doublet chemotherapy']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Nivolumab plus platinum doublet chemotherapy', 'Platinum doublet chemotherapy']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Nivolumab plus platinum doublet chemotherapy', 'Platinum doublet chemotherapy']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Nivolumab plus platinum doublet chemotherapy', 'Platinum doublet chemotherapy']}, {'name': 'Ipilimumab', 'type': 'BIOLOGICAL', 'otherNames': ['BMS-734016', 'Yervoy'], 'description': 'This arm is closed and no longer enrolling patients.', 'armGroupLabels': ['Nivolumab plus Ipilimumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution - 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