Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-02-25 @ 8:50 PM
Study NCT ID:
NCT02409368
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2015-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please Email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'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 their enrollment to study completion, (up to approximately 73 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 76 months)', 'eventGroups': [{'id': 'EG000', 'title': 'ECOG Performance Status 0', 'description': 'Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks', 'otherNumAtRisk': 172, 'deathsNumAtRisk': 172, 'otherNumAffected': 149, 'seriousNumAtRisk': 172, 'deathsNumAffected': 131, 'seriousNumAffected': 115}, {'id': 'EG001', 'title': 'ECOG Performance Status 1', 'description': 'Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks', 'otherNumAtRisk': 537, 'deathsNumAtRisk': 537, 'otherNumAffected': 472, 'seriousNumAtRisk': 537, 'deathsNumAffected': 446, 'seriousNumAffected': 375}, {'id': 'EG002', 'title': 'ECOG Performance Status 2', 'description': 'Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 86, 'seriousNumAtRisk': 102, 'deathsNumAffected': 90, 'seriousNumAffected': 84}, {'id': 'EG003', 'title': 'ECOG Performance Status 3', 'description': 'Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 97}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 80}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 100}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 131}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 121}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 147}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 134}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 167}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Catheter site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Oral fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 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1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Immune-mediated lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Lung consolidation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Oesophagobronchial fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Respiratory tract haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Tracheal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Superior vena cava occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 537, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ECOG (PS0)', 'description': 'ECOG Performance Status 0\n\nNivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'OG001', 'title': 'ECOG (PS1)', 'description': 'ECOG Performance Status 1\n\nNivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'OG002', 'title': 'ECOG Performance Status 2', 'description': 'Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks'}], 'classes': [{'title': 'Skin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Endocrine', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hepatic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Pulmonary', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Renal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypersensitivity/ Infusion reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to time of analysis of primary endpoint (approximately up to 34 months)', 'description': 'The total number of participants with high grade treatment related select adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With High Grade Select Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '537', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ECOG (PS0)', 'description': 'ECOG Performance Status 0\n\nnivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'OG001', 'title': 'ECOG (PS1)', 'description': 'ECOG Performance Status 1\n\nnivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'OG002', 'title': 'ECOG Performance Status 2', 'description': 'Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks'}], 'classes': [{'title': 'Skin', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Endocrine', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hepatic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Pulmonary', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Renal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypersensitivity/ Infusion reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 100 days post last dose (up to 76 months)', 'description': 'The total number of participants with high grade select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with ECOG PS Grade 0-2'}, {'type': 'SECONDARY', 'title': 'Median Time to Onset of Any Grade Select Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '537', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ECOG (PS0)', 'description': 'ECOG Performance Status 0\n\nnivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'OG001', 'title': 'ECOG (PS1)', 'description': 'ECOG Performance Status 1\n\nnivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'OG002', 'title': 'ECOG Performance Status 2', 'description': 'Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks'}], 'classes': [{'title': 'Endrocrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.79', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '121.6'}, {'value': '10.14', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '165.1'}, {'value': '19.86', 'groupId': 'OG002', 'lowerLimit': '6.1', 'upperLimit': '55.4'}]}]}, {'title': 'Gastrointestinal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.71', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '88.0'}, {'value': '8.86', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '228.1'}, {'value': '6.00', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '64.3'}]}]}, {'title': 'Hepatic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26.64', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '234.1'}, {'value': '11.43', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '90.1'}, {'value': '8.14', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '88.1'}]}]}, {'title': 'Pulmonary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.43', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '169.4'}, {'value': '11.50', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '166.0'}, {'value': '3.93', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '26.3'}]}]}, {'title': 'Renal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.86', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '129.9'}, {'value': '22.71', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '246.0'}, {'value': '10.29', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '52.9'}]}]}, {'title': 'Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.14', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '92.1'}, {'value': '7.86', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '200.1'}, {'value': '14.71', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '81.7'}]}]}, {'title': 'Hypersensitivity/Infusion Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.93', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '2.1'}, {'value': '2.21', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '20.3'}, {'value': '2.14', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '28.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose up to 100 days post last dose (up to approximately 65 months)', 'description': 'Median Time to onset of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with ECOG PS Grade 0-2'}, {'type': 'SECONDARY', 'title': 'Median Time to Resolution of Any Grade Select Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '537', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ECOG (PS0)', 'description': 'ECOG Performance Status 0\n\nnivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'OG001', 'title': 'ECOG (PS1)', 'description': 'ECOG Performance Status 1\n\nnivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'OG002', 'title': 'ECOG Performance Status 2', 'description': 'Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks'}], 'classes': [{'title': 'Endrocrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper limit not reached due to insufficient number of events', 'groupId': 'OG000', 'lowerLimit': '109.00', 'upperLimit': 'NA'}, {'value': '169.43', 'comment': 'Upper limit not reached due to insufficient number of events', 'groupId': 'OG001', 'lowerLimit': '17.86', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper limit not reached due to insufficient number of events', 'groupId': 'OG002', 'lowerLimit': '6.14', 'upperLimit': 'NA'}]}]}, {'title': 'Gastrointestinal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.86', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '5.14'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '0.43', 'upperLimit': '5.71'}]}]}, {'title': 'Hepatic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.57', 'groupId': 'OG000', 'lowerLimit': '2.57', 'upperLimit': '6.14'}, {'value': '7.71', 'groupId': 'OG001', 'lowerLimit': '4.86', 'upperLimit': '17.14'}, {'value': '3.57', 'groupId': 'OG002', 'lowerLimit': '2.14', 'upperLimit': '8.14'}]}]}, {'title': 'Pulmonary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.00', 'comment': 'Upper limit not reached due to insufficient number of events', 'groupId': 'OG000', 'lowerLimit': '1.43', 'upperLimit': 'NA'}, {'value': '4.29', 'groupId': 'OG001', 'lowerLimit': '2.14', 'upperLimit': '6.00'}, {'value': '2.29', 'comment': 'Upper limit not reached due to insufficient number of events', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': 'NA'}]}]}, {'title': 'Renal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.14', 'comment': 'Upper limit not reached due to insufficient number of events', 'groupId': 'OG000', 'lowerLimit': '2.14', 'upperLimit': 'NA'}, {'value': '6.14', 'groupId': 'OG001', 'lowerLimit': '2.29', 'upperLimit': '25.14'}, {'value': '59.14', 'groupId': 'OG002', 'lowerLimit': '0.57', 'upperLimit': '59.14'}]}]}, {'title': 'Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper limit not reached due to insufficient number of events', 'groupId': 'OG000', 'lowerLimit': '13.57', 'upperLimit': 'NA'}, {'value': '15.43', 'groupId': 'OG001', 'lowerLimit': '8.71', 'upperLimit': '52.86'}, {'value': '5.71', 'comment': 'Upper limit not reached due to insufficient number of events', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': 'NA'}]}]}, {'title': 'Hypersensitivity/Infusion Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.14', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '2.14'}, {'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '0.14', 'upperLimit': '4.43'}, {'value': '0.14', 'groupId': 'OG002', 'lowerLimit': '0.14', 'upperLimit': '0.71'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to up to 100 days post last dose (up to approximately 45 months)', 'description': 'Median time to resolution of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with ECOG PS Grade 0-2'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '537', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ECOG (PS0)', 'description': 'ECOG Performance Status 0\n\nnivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'OG001', 'title': 'ECOG (PS1)', 'description': 'ECOG Performance Status 1\n\nnivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'OG002', 'title': 'ECOG Performance Status 2', 'description': 'Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '13.4'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '11.3'}, {'value': '5.2', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': '7.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first dosing up to the date of death (up to approximately 76 months)', 'description': 'Overall Survival (OS) is defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive. OS will be followed continuously while subjects are on treatment and every 3 months via in-person or phone contact after subjects discontinue the study drug.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with ECOG PS Grade 0-2'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '456', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ECOG (PS0)', 'description': 'ECOG Performance Status 0\n\nnivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'OG001', 'title': 'ECOG (PS1)', 'description': 'ECOG Performance Status 1\n\nnivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'OG002', 'title': 'ECOG Performance Status 2', 'description': 'Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '13.6'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '14.2'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose up to last dose (up to approximately 76 months)', 'description': 'ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions; PR is defined by at least a 30% decrease in the sum of the longest diameter of target lesions. ORR as assessed by the investigator will be reported.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All response evaluable participants'}, {'type': 'POST_HOC', 'title': 'Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '537', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ECOG (PS0)', 'description': 'ECOG Performance Status 0\n\nNivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'OG001', 'title': 'ECOG (PS1)', 'description': 'ECOG Performance Status 1\n\nNivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'OG002', 'title': 'ECOG Performance Status 2', 'description': 'Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks'}], 'classes': [{'title': 'Skin', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hepatic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Pulmonary', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Renal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypersensitivity/ Infusion reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Endocrine', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to up to 100 days post last dose (up to approximately 76 months)', 'description': 'The total number of participants with high grade treatment related select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4 or 5. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.\n\nNote: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with ECOG PS Grade 0-2'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ECOG (PS0)', 'description': 'ECOG Performance Status 0\n\nNivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'FG001', 'title': 'ECOG (PS1)', 'description': 'ECOG Performance Status 1\n\nnivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'FG002', 'title': 'ECOG Performance Status 2', 'description': 'Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks'}, {'id': 'FG003', 'title': 'ECOG (PS3)', 'description': 'ECOG Performance Status 3\n\nnivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}], 'periods': [{'title': 'Original Classification', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '534'}, {'groupId': 'FG002', 'numSubjects': '103'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '534'}, {'groupId': 'FG002', 'numSubjects': '103'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'ECOG Reclassification', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '537'}, {'groupId': 'FG002', 'numSubjects': '102'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '537'}, {'groupId': 'FG002', 'numSubjects': '102'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse event unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '382'}, {'groupId': 'FG002', 'numSubjects': '70'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Maximum clinical benefit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Poor/non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Study drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Participant no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Participant request to discontinue study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Administrative reason by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '1 participant was ECOG PS 3 and thus outside the scope of the protocol and excluded from analysis.\n\nThere were 2 ECOG classification periods during the course of this study. The population from the first was used in the Primary Outcome Measure analysis. The population from the second was used in the Baseline Characteristics, Secondary Outcome Measures, and Adverse Event analysis. 1 participant was lost from the Primary Completion ECOG Classification that was accounted for at Study Completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'BG000'}, {'value': '537', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '812', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'ECOG (PS0)', 'description': 'ECOG Performance Status 0\n\nNivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'BG001', 'title': 'ECOG (PS1)', 'description': 'ECOG Performance Status 1\n\nnivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'BG002', 'title': 'ECOG Performance Status 2', 'description': 'Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks'}, {'id': 'BG003', 'title': 'ECOG (PS3)', 'description': 'ECOG Performance Status 3\n\nnivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'spread': '8.28', 'groupId': 'BG000'}, {'value': '66.1', 'spread': '8.27', 'groupId': 'BG001'}, {'value': '67.9', 'spread': '7.29', 'groupId': 'BG002'}, {'value': '71', 'spread': 'NA', 'comment': 'Standard deviation not calculated due to insufficient data', 'groupId': 'BG003'}, {'value': '65.8', 'spread': '8.24', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '171', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '426', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '641', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '751', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '530', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '798', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics are listed for all treated participants from the Study Completion ECOG Classification.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-10', 'size': 613320, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-31T12:30', 'hasProtocol': True}, {'date': '2018-11-29', 'size': 458951, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-31T12:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 812}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2015-04-01', 'resultsFirstSubmitDate': '2021-03-31', 'studyFirstSubmitQcDate': '2015-04-03', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-09', 'studyFirstPostDateStruct': {'date': '2015-04-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events', 'timeFrame': 'From first dose to time of analysis of primary endpoint (approximately up to 34 months)', 'description': 'The total number of participants with high grade treatment related select adverse events.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With High Grade Select Adverse Events', 'timeFrame': 'From first dose up to 100 days post last dose (up to 76 months)', 'description': 'The total number of participants with high grade select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.'}, {'measure': 'Median Time to Onset of Any Grade Select Adverse Events', 'timeFrame': 'From first dose up to 100 days post last dose (up to approximately 65 months)', 'description': 'Median Time to onset of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.'}, {'measure': 'Median Time to Resolution of Any Grade Select Adverse Events', 'timeFrame': 'From first dose to up to 100 days post last dose (up to approximately 45 months)', 'description': 'Median time to resolution of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.'}, {'measure': 'Overall Survival', 'timeFrame': 'From the first dosing up to the date of death (up to approximately 76 months)', 'description': 'Overall Survival (OS) is defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive. OS will be followed continuously while subjects are on treatment and every 3 months via in-person or phone contact after subjects discontinue the study drug.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From first dose up to last dose (up to approximately 76 months)', 'description': 'ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions; PR is defined by at least a 30% decrease in the sum of the longest diameter of target lesions. ORR as assessed by the investigator will be reported.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '32028209', 'type': 'DERIVED', 'citation': 'Felip E, Ardizzoni A, Ciuleanu T, Cobo M, Laktionov K, Szilasi M, Califano R, Carcereny E, Griffiths R, Paz-Ares L, Duchnowska R, Garcia MA, Isla D, Jassem J, Appel W, Milanowski J, Van Meerbeeck JP, Wolf J, Li A, Acevedo A, Popat S. CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations. Eur J Cancer. 2020 Mar;127:160-172. doi: 10.1016/j.ejca.2019.11.019. Epub 2020 Feb 3.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSStudyConnect.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in patients with advanced or metastatic Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or after at least 1 systemic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* ECOG Status: PS 0-1 \\& PS 2\n* Subjects with histologically or cytologically-documented SqNSCLC\n* Subjects must have experienced disease progression or recurrence during or after one prior platinum doublet-based chemotherapy regimen\n* Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria\n* Subjects with treated or asymptomatic CNS metastases\n* Prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration\n* Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy, immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or standard or investigational agents for treatment of NSCLC, must be completed 28 days prior to the first dose of nivolumab\n* Males and Females, ages 18 or older\n\nExclusion Criteria:\n\n* Subjects with untreated, symptomatic CNS metastases\n* Subjects with carcinomatous meningitis\n* Subjects with active, known or suspected autoimmune disease.\n* Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.'}, 'identificationModule': {'nctId': 'NCT02409368', 'acronym': 'Checkmate 171', 'briefTitle': 'An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC', 'orgStudyIdInfo': {'id': 'CA209-171'}, 'secondaryIdInfos': [{'id': '2014-001285-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A: Treatment - 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