Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-15 @ 5:05 PM
Study NCT ID:
NCT02598960
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2015-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.
Sponsor:
Organization:
Raw JSON
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(Approximately up to 29 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: BMS-986156 10mg', 'description': 'BMS-986156 10mg Q2W', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Part A: BMS-986156 30mg', 'description': 'Part A: BMS-986156 30mg Q2W', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 5, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Part A: BMS-986156 100mg', 'description': 'BMS-986156 100mg Q2W', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Part A: BMS-986156 240mg', 'description': 'Part A: BMS-986156 240mg Q2W', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 5, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Part A: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 6, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Part C: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Part C: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'Part B: BMS-986156 30mg +Nivo 240mg', 'description': 'BMS-986156 30mg Q2W +Nivo 240mg Q2W', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'Part B: BMS-986156 100mg +Nivo 240mg', 'description': 'BMS-986156 100mg Q2W +Nivo 240mg Q2W', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 6, 'seriousNumAffected': 5}, {'id': 'EG009', 'title': 'Part B: BMS-986156 240mg +Nivo 240mg', 'description': 'BMS-986156 240mg Q2W +Nivo 240mg Q2W', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 11, 'seriousNumAffected': 10}, {'id': 'EG010', 'title': 'Part B: BMS-986156 800mg +Nivo 240mg', 'description': 'BMS-986156 800mg Q2W +Nivo 240mg Q2W', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 8, 'seriousNumAffected': 6}, {'id': 'EG011', 'title': 'Part D: BMS-986156 240mg +Nivo 240mg', 'description': 'BMS-986156 240mg Q2W +Nivo 240mg Q2W', 'otherNumAtRisk': 188, 'deathsNumAtRisk': 188, 'otherNumAffected': 185, 'seriousNumAtRisk': 188, 'deathsNumAffected': 141, 'seriousNumAffected': 121}, {'id': 'EG012', 'title': 'Part E: BMS-986156 480mg +Nivo 480mg', 'description': 'BMS-986156 480mg Q4W +Nivo 480mg Q4W', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 31, 'seriousNumAtRisk': 33, 'deathsNumAffected': 27, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 188, 'numAffected': 30}, {'groupId': 'EG012', 'numAtRisk': 33, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic 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{'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 188, 'numAffected': 10}, {'groupId': 'EG012', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, 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'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 188, 'numAffected': 5}, {'groupId': 'EG012', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 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{'groupId': 'EG012', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 188, 'numAffected': 6}, {'groupId': 'EG012', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '188', 'groupId': 'OG011'}, {'value': '33', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: BMS-986156 10mg', 'description': 'BMS-986156 10mg Q2W'}, {'id': 'OG001', 'title': 'Part A: BMS-986156 30mg', 'description': 'BMS-986156 30mg Q2W'}, {'id': 'OG002', 'title': 'Part A: BMS-986156 100mg', 'description': 'BMS-986156 100mg Q2W'}, {'id': 'OG003', 'title': 'Part A: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'OG004', 'title': 'Part A: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'OG005', 'title': 'Part C: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'OG006', 'title': 'Part C: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'OG007', 'title': 'Part B: BMS-986156 30mg + Nivo 240mg', 'description': 'BMS986156 30mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG008', 'title': 'Part B: BMS-986156 100mg + Nivo 240mg', 'description': 'BMS986156 100mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG009', 'title': 'Part B: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG010', 'title': 'Part B: BMS-986156 800mg + Nivo 240mg', 'description': 'BMS986156 800mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG011', 'title': 'Part D: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG012', 'title': 'Part E: BMS-986156 480mg + Nivo 480mg', 'description': 'BMS986156 480mg Q4W + Nivo 480mg Q4W'}], 'classes': [{'title': 'Adverse Events (AEs)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '188', 'groupId': 'OG011'}, {'value': '33', 'groupId': 'OG012'}]}]}, {'title': 'Serious Adverse Events (SAEs)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '121', 'groupId': 'OG011'}, {'value': '22', 'groupId': 'OG012'}]}]}, {'title': 'AEs leading to Discontinuation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '32', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '141', 'groupId': 'OG011'}, {'value': '27', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first treatment to 100 days post last dose. 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WITH TSH ≤ ULN AT BASELINE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '42', 'groupId': 'OG011'}, {'value': '11', 'groupId': 'OG012'}]}]}, {'title': 'TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '37', 'groupId': 'OG011'}, {'value': '9', 'groupId': 'OG012'}]}]}, {'title': 'TSH < LLN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '38', 'groupId': 'OG011'}, {'value': '10', 'groupId': 'OG012'}]}]}, {'title': 'TSH <LLN WITH TSH ≥ LLN AT BASELINE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '26', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}]}]}, {'title': 'TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '24', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first treatment to 100 days post last dose. Approximately 29 months', 'description': 'Number of Participants with laboratory abnormalities in specific thyroid tests.\n\nTSH = Thyroid stimulating hormone ULN = Upper limit number LLN = Lower limit number', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with at least one on - treatment TSH measurement'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Laboratory Abnormalities in Specific Liver Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '188', 'groupId': 'OG011'}, {'value': '33', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: BMS-986156 10mg', 'description': 'BMS-986156 10mg Q2W'}, {'id': 'OG001', 'title': 'Part A: BMS-986156 30mg', 'description': 'BMS-986156 30mg Q2W'}, {'id': 'OG002', 'title': 'Part A: BMS-986156 100mg', 'description': 'BMS-986156 100mg Q2W'}, {'id': 'OG003', 'title': 'Part A: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'OG004', 'title': 'Part A: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'OG005', 'title': 'Part C: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'OG006', 'title': 'Part C: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'OG007', 'title': 'Part B: BMS-986156 30mg + Nivo 240mg', 'description': 'BMS986156 30mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG008', 'title': 'Part B: BMS-986156 100mg + Nivo 240mg', 'description': 'BMS986156 100mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG009', 'title': 'Part B: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG010', 'title': 'Part B: BMS-986156 800mg + Nivo 240mg', 'description': 'BMS986156 800mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG011', 'title': 'Part D: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG012', 'title': 'Part E: BMS-986156 480mg + Nivo 480mg', 'description': 'BMS986156 480mg Q4W + Nivo 480mg Q4W'}], 'classes': [{'title': 'ALT OR AST > 3*ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '25', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}]}, {'title': 'ALT OR AST> 5*ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '14', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}]}, {'title': 'ALT OR AST> 10*ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'ALT OR AST > 20*ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'TOTAL BILIRUBIN > 2*ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}]}, {'title': 'ALP > 1.5*ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '70', 'groupId': 'OG011'}, {'value': '11', 'groupId': 'OG012'}]}]}, {'title': 'ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 1 DAY', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}]}, {'title': 'ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 30 DAYS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first treatment to 100 days post last dose. Approximately 29 months', 'description': 'Number of Participants with laboratory abnormalities in specific liver tests.\n\nALT = alanine aminotransferase AST = aspartate aminotransferase ALP = alkaline phosphatase', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with at least one on - treatment liver test measurement'}, {'type': 'SECONDARY', 'title': 'Best Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '188', 'groupId': 'OG011'}, {'value': '33', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: BMS-986156 10mg', 'description': 'BMS-986156 10mg Q2W'}, {'id': 'OG001', 'title': 'Part A: BMS-986156 30mg', 'description': 'BMS-986156 30mg Q2W'}, {'id': 'OG002', 'title': 'Part A: BMS-986156 100mg', 'description': 'BMS-986156 100mg Q2W'}, {'id': 'OG003', 'title': 'Part A: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'OG004', 'title': 'Part A: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'OG005', 'title': 'Part C: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'OG006', 'title': 'Part C: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'OG007', 'title': 'Part B: BMS-986156 30mg + Nivo 240mg', 'description': 'BMS986156 30mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG008', 'title': 'Part B: BMS-986156 100mg + Nivo 240mg', 'description': 'BMS986156 100mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG009', 'title': 'Part B: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG010', 'title': 'Part B: BMS-986156 800mg + Nivo 240mg', 'description': 'BMS986156 800mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG011', 'title': 'Part D: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG012', 'title': 'Part E: BMS-986156 480mg + Nivo 480mg', 'description': 'BMS986156 480mg Q4W + Nivo 480mg Q4W'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '17', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '59', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '91', 'groupId': 'OG011'}, {'value': '15', 'groupId': 'OG012'}]}]}, {'title': 'Not Evaluable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '16', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}]}, {'title': 'Not Available', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to a response or progressive disease (Approximately 50 Months)', 'description': 'BOR will be defined by CR, PR, PD and SD\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest 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).\n\nStable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '188', 'groupId': 'OG011'}, {'value': '33', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: BMS-986156 10mg', 'description': 'BMS-986156 10mg Q2W'}, {'id': 'OG001', 'title': 'Part A: BMS-986156 30mg', 'description': 'BMS-986156 30mg Q2W'}, {'id': 'OG002', 'title': 'Part A: BMS-986156 100mg', 'description': 'BMS-986156 100mg Q2W'}, {'id': 'OG003', 'title': 'Part A: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'OG004', 'title': 'Part A: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'OG005', 'title': 'Part C: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'OG006', 'title': 'Part C: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'OG007', 'title': 'Part B: BMS-986156 30mg + Nivo 240mg', 'description': 'BMS986156 30mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG008', 'title': 'Part B: BMS-986156 100mg + Nivo 240mg', 'description': 'BMS986156 100mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG009', 'title': 'Part B: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG010', 'title': 'Part B: BMS-986156 800mg + Nivo 240mg', 'description': 'BMS986156 800mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG011', 'title': 'Part D: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG012', 'title': 'Part E: BMS-986156 480mg + Nivo 480mg', 'description': 'BMS986156 480mg Q4W + Nivo 480mg Q4W'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '45.9'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '45.9'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '84.2'}, {'value': '0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '11.1', 'groupId': 'OG008', 'lowerLimit': '0.3', 'upperLimit': '48.2'}, {'value': '21.4', 'groupId': 'OG009', 'lowerLimit': '4.7', 'upperLimit': '50.8'}, {'value': '9.1', 'groupId': 'OG010', 'lowerLimit': '0.2', 'upperLimit': '41.3'}, {'value': '11.2', 'groupId': 'OG011', 'lowerLimit': '7.0', 'upperLimit': '16.6'}, {'value': '9.1', 'groupId': 'OG012', 'lowerLimit': '1.9', 'upperLimit': '24.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to CR and PR (Approximately 50 Months)', 'description': 'Defined as the percentage of all treated participants whose BOR is either a complete response(CR) or partial response(PR).\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '188', 'groupId': 'OG011'}, {'value': '33', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: BMS-986156 10mg', 'description': 'BMS-986156 10mg Q2W'}, {'id': 'OG001', 'title': 'Part A: BMS-986156 30mg', 'description': 'BMS-986156 30mg Q2W'}, {'id': 'OG002', 'title': 'Part A: BMS-986156 100mg', 'description': 'BMS-986156 100mg Q2W'}, {'id': 'OG003', 'title': 'Part A: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'OG004', 'title': 'Part A: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'OG005', 'title': 'Part C: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'OG006', 'title': 'Part C: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'OG007', 'title': 'Part B: BMS-986156 30mg + Nivo 240mg', 'description': 'BMS986156 30mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG008', 'title': 'Part B: BMS-986156 100mg + Nivo 240mg', 'description': 'BMS986156 100mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG009', 'title': 'Part B: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG010', 'title': 'Part B: BMS-986156 800mg + Nivo 240mg', 'description': 'BMS986156 800mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG011', 'title': 'Part D: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG012', 'title': 'Part E: BMS-986156 480mg + Nivo 480mg', 'description': 'BMS986156 480mg Q4W + Nivo 480mg Q4W'}], 'classes': [{'categories': [{'measurements': [{'value': '3.48', 'comment': 'Insufficient number of events to calculate', 'groupId': 'OG000', 'lowerLimit': '1.64', 'upperLimit': 'NA'}, {'value': '1.74', 'comment': 'Insufficient number of events to calculate', 'groupId': 'OG001', 'lowerLimit': '1.45', 'upperLimit': 'NA'}, {'value': '2.66', 'comment': 'Insufficient number of events to calculate', 'groupId': 'OG002', 'lowerLimit': '1.64', 'upperLimit': 'NA'}, {'value': '1.64', 'comment': 'Insufficient number of events to calculate', 'groupId': 'OG003', 'lowerLimit': '1.58', 'upperLimit': 'NA'}, {'value': '1.84', 'groupId': 'OG004', 'lowerLimit': '1.64', 'upperLimit': '3.48'}, {'value': '1.64', 'comment': 'Insufficient number of events to calculate', 'groupId': 'OG005', 'lowerLimit': '1.64', 'upperLimit': 'NA'}, {'value': '1.71', 'comment': 'Insufficient number of events to calculate', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.81', 'comment': 'Insufficient number of events to calculate', 'groupId': 'OG007', 'lowerLimit': '1.64', 'upperLimit': 'NA'}, {'value': '1.64', 'groupId': 'OG008', 'lowerLimit': '0.89', 'upperLimit': '22.47'}, {'value': '3.71', 'groupId': 'OG009', 'lowerLimit': '1.64', 'upperLimit': '8.97'}, {'value': '3.52', 'comment': 'Insufficient number of events to calculate', 'groupId': 'OG010', 'lowerLimit': '1.61', 'upperLimit': 'NA'}, {'value': '1.91', 'groupId': 'OG011', 'lowerLimit': '1.81', 'upperLimit': '3.25'}, {'value': '2.92', 'groupId': 'OG012', 'lowerLimit': '1.77', 'upperLimit': '3.52'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to disease progression (Approximately 50 Months)', 'description': 'The time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first.\n\nProgression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest 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 treated participants with evaluable PFS measures'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: BMS-986156 10mg', 'description': 'BMS-986156 10mg Q2W'}, {'id': 'OG001', 'title': 'Part A: BMS-986156 30mg', 'description': 'BMS-986156 30mg Q2W'}, {'id': 'OG002', 'title': 'Part A: BMS-986156 100mg', 'description': 'BMS-986156 100mg Q2W'}, {'id': 'OG003', 'title': 'Part A: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'OG004', 'title': 'Part A: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'OG005', 'title': 'Part C: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'OG006', 'title': 'Part C: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'OG007', 'title': 'Part B: BMS-986156 30mg + Nivo 240mg', 'description': 'BMS986156 30mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG008', 'title': 'Part B: BMS-986156 100mg + Nivo 240mg', 'description': 'BMS986156 100mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG009', 'title': 'Part B: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG010', 'title': 'Part B: BMS-986156 800mg + Nivo 240mg', 'description': 'BMS986156 800mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG011', 'title': 'Part D: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG012', 'title': 'Part E: BMS-986156 480mg + Nivo 480mg', 'description': 'BMS986156 480mg Q4W + Nivo 480mg Q4W'}], 'classes': [{'categories': [{'measurements': [{'value': '20.70', 'groupId': 'OG008', 'lowerLimit': '20.7', 'upperLimit': '20.7'}, {'value': '30.10', 'groupId': 'OG009', 'lowerLimit': '7.4', 'upperLimit': '31.3'}, {'value': 'NA', 'comment': 'Insufficient number of events to calculate', 'groupId': 'OG010', 'lowerLimit': '31.0', 'upperLimit': '31.0'}, {'value': 'NA', 'comment': 'Insufficient number of events to calculate', 'groupId': 'OG011', 'lowerLimit': '0', 'upperLimit': '31.8'}, {'value': 'NA', 'comment': 'Insufficient number of events to calculate', 'groupId': 'OG012', 'lowerLimit': '21.0', 'upperLimit': '22.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to disease progression after a response (Approximately 50 Months)', 'description': 'All treated participants with a BOR of CR or PR, is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first.\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with a CR or PR'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Drug Antibody Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '188', 'groupId': 'OG011'}, {'value': '33', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: BMS-986156 10mg', 'description': 'BMS-986156 10mg Q2W'}, {'id': 'OG001', 'title': 'Part A: BMS-986156 30mg', 'description': 'BMS-986156 30mg Q2W'}, {'id': 'OG002', 'title': 'Part A: BMS-986156 100mg', 'description': 'BMS-986156 100mg Q2W'}, {'id': 'OG003', 'title': 'Part A: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'OG004', 'title': 'Part A: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'OG005', 'title': 'Part C: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'OG006', 'title': 'Part C: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'OG007', 'title': 'Part B: BMS-986156 30mg + Nivo 240mg', 'description': 'BMS986156 30mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG008', 'title': 'Part B: BMS-986156 100mg + Nivo 240mg', 'description': 'BMS986156 100mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG009', 'title': 'Part B: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG010', 'title': 'Part B: BMS-986156 800mg + Nivo 240mg', 'description': 'BMS986156 800mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG011', 'title': 'Part D: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'OG012', 'title': 'Part E: BMS-986156 480mg + Nivo 480mg', 'description': 'BMS986156 480mg Q4W + Nivo 480mg Q4W'}], 'classes': [{'title': 'BMS-986156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '181', 'groupId': 'OG011'}, {'value': '33', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Nivolumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '171', 'groupId': 'OG011'}, {'value': '33', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '32', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Cycle 3 Day 1; where each treatment cycle was 8 weeks', 'description': 'Number of participants with a positive Anti-Drug Antibody to BMS-986156 or nivolumab', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All BMS-986156 or Nivolumab Treated participants with Baseline and at Least One Post-baseline Assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: BMS-986156 10mg', 'description': 'BMS-986156 10mg Q2W'}, {'id': 'FG001', 'title': 'Part A: BMS-986156 30mg', 'description': 'BMS-986156 30mg Q2W'}, {'id': 'FG002', 'title': 'Part A: BMS-986156 100mg', 'description': 'BMS-986156 100mg Q2W'}, {'id': 'FG003', 'title': 'Part A: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'FG004', 'title': 'Part A: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'FG005', 'title': 'Part C: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'FG006', 'title': 'Part C: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'FG007', 'title': 'Part B: BMS-986156 30mg + Nivo 240mg', 'description': 'BMS986156 30mg Q2W + Nivo 240mg Q2W'}, {'id': 'FG008', 'title': 'Part B: BMS-986156 100mg + Nivo 240mg', 'description': 'BMS986156 100mg Q2W + Nivo 240mg Q2W'}, {'id': 'FG009', 'title': 'Part B: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'FG010', 'title': 'Part B: BMS-986156 800mg + Nivo 240mg', 'description': 'BMS986156 800mg Q2W + Nivo 240mg Q2W'}, {'id': 'FG011', 'title': 'Part D: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'FG012', 'title': 'Part E: BMS-986156 480mg + Nivo 480mg', 'description': 'BMS986156 480mg Q4W + Nivo 480mg Q4W'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'comment': '= Starting Initial Treatment Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '9'}, {'groupId': 'FG009', 'numSubjects': '14'}, {'groupId': 'FG010', 'numSubjects': '11'}, {'groupId': 'FG011', 'numSubjects': '188'}, {'groupId': 'FG012', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'comment': '= completing initial treatment period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '23'}, {'groupId': 'FG012', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '7'}, {'groupId': 'FG009', 'numSubjects': '11'}, {'groupId': 'FG010', 'numSubjects': '8'}, {'groupId': 'FG011', 'numSubjects': '165'}, {'groupId': 'FG012', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '7'}, {'groupId': 'FG009', 'numSubjects': '9'}, {'groupId': 'FG010', 'numSubjects': '7'}, {'groupId': 'FG011', 'numSubjects': '143'}, {'groupId': 'FG012', 'numSubjects': '23'}]}, {'type': 'Study drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Adverse Event unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '11'}, {'groupId': 'FG012', 'numSubjects': '2'}]}, {'type': 'participant request to discontinue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'No longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}]}]}, {'title': 'Participants Entering Follow Up Period', 'milestones': [{'type': 'STARTED', 'comment': '= participants entering follow up period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '9'}, {'groupId': 'FG009', 'numSubjects': '14'}, {'groupId': 'FG010', 'numSubjects': '11'}, {'groupId': 'FG011', 'numSubjects': '188'}, {'groupId': 'FG012', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '9'}, {'groupId': 'FG009', 'numSubjects': '13'}, {'groupId': 'FG010', 'numSubjects': '10'}, {'groupId': 'FG011', 'numSubjects': '159'}, {'groupId': 'FG012', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '29'}, {'groupId': 'FG012', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '11'}, {'groupId': 'FG012', 'numSubjects': '2'}]}, {'type': 'participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '7'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'lost to follow up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'follow up no longer required per protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '14', 'groupId': 'BG009'}, {'value': '11', 'groupId': 'BG010'}, {'value': '188', 'groupId': 'BG011'}, {'value': '33', 'groupId': 'BG012'}, {'value': '292', 'groupId': 'BG013'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: BMS-986156 10mg', 'description': 'BMS-986156 10mg Q2W'}, {'id': 'BG001', 'title': 'Part A: BMS-986156 30mg', 'description': 'BMS-986156 30mg Q2W'}, {'id': 'BG002', 'title': 'Part A: BMS-986156 100mg', 'description': 'BMS-986156 100mg Q2W'}, {'id': 'BG003', 'title': 'Part A: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'BG004', 'title': 'Part A: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'BG005', 'title': 'Part C: BMS-986156 240mg', 'description': 'BMS-986156 240mg Q2W'}, {'id': 'BG006', 'title': 'Part C: BMS-986156 800mg', 'description': 'BMS-986156 800mg Q2W'}, {'id': 'BG007', 'title': 'Part B: BMS-986156 30mg + Nivo 240mg', 'description': 'BMS986156 30mg Q2W + Nivo 240mg Q2W'}, {'id': 'BG008', 'title': 'Part B: BMS-986156 100mg + Nivo 240mg', 'description': 'BMS986156 100mg Q2W + Nivo 240mg Q2W'}, {'id': 'BG009', 'title': 'Part B: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'BG010', 'title': 'Part B: BMS-986156 800mg + Nivo 240mg', 'description': 'BMS986156 800mg Q2W + Nivo 240mg Q2W'}, {'id': 'BG011', 'title': 'Part D: BMS-986156 240mg + Nivo 240mg', 'description': 'BMS986156 240mg Q2W + Nivo 240mg Q2W'}, {'id': 'BG012', 'title': 'Part E: BMS-986156 480mg + Nivo 480mg', 'description': 'BMS986156 480mg Q4W + Nivo 480mg Q4W'}, {'id': 'BG013', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.3', 'spread': '18.57', 'groupId': 'BG000'}, {'value': '59.7', 'spread': '5.82', 'groupId': 'BG001'}, {'value': '57.5', 'spread': '10.08', 'groupId': 'BG002'}, {'value': '49.5', 'spread': '13.28', 'groupId': 'BG003'}, {'value': '51.0', 'spread': '13.82', 'groupId': 'BG004'}, {'value': '58.3', 'spread': '19.43', 'groupId': 'BG005'}, {'value': '56.5', 'spread': '9.19', 'groupId': 'BG006'}, {'value': '50.7', 'spread': '20.50', 'groupId': 'BG007'}, {'value': '57.2', 'spread': '12.09', 'groupId': 'BG008'}, {'value': '55.6', 'spread': '18.67', 'groupId': 'BG009'}, {'value': '57.0', 'spread': '9.30', 'groupId': 'BG010'}, {'value': '59.0', 'spread': '11.58', 'groupId': 'BG011'}, {'value': '57.2', 'spread': '13.05', 'groupId': 'BG012'}, {'value': '57.9', 'spread': '12.31', 'groupId': 'BG013'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '100', 'groupId': 'BG011'}, {'value': '22', 'groupId': 'BG012'}, {'value': '156', 'groupId': 'BG013'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '88', 'groupId': 'BG011'}, {'value': '11', 'groupId': 'BG012'}, {'value': '136', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '4', 'groupId': 'BG013'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '51', 'groupId': 'BG011'}, {'value': '11', 'groupId': 'BG012'}, {'value': '101', 'groupId': 'BG013'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '136', 'groupId': 'BG011'}, {'value': '21', 'groupId': 'BG012'}, {'value': '187', 'groupId': 'BG013'}]}]}], '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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '13', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '24', 'groupId': 'BG013'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '11', 'groupId': 'BG010'}, {'value': '171', 'groupId': 'BG011'}, {'value': '27', 'groupId': 'BG012'}, {'value': '262', 'groupId': 'BG013'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-08', 'size': 3623631, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-14T12:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 295}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'dispFirstSubmitDate': '2020-12-15', 'completionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-03', 'studyFirstSubmitDate': '2015-10-21', 'dispFirstSubmitQcDate': '2020-12-15', 'resultsFirstSubmitDate': '2022-12-15', 'studyFirstSubmitQcDate': '2015-11-05', 'dispFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-03', 'studyFirstPostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths', 'timeFrame': 'From first treatment to 100 days post last dose. Approximately 29 months', 'description': 'Number of participants with all cause adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and number of participant deaths.\n\nAEs and laboratory values will be graded according to the NCI CTCAE version 4.03.'}, {'measure': 'Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests', 'timeFrame': 'From first treatment to 100 days post last dose. Approximately 29 months', 'description': 'Number of Participants with laboratory abnormalities in specific thyroid tests.\n\nTSH = Thyroid stimulating hormone ULN = Upper limit number LLN = Lower limit number'}, {'measure': 'Number of Participants With Laboratory Abnormalities in Specific Liver Tests', 'timeFrame': 'From first treatment to 100 days post last dose. Approximately 29 months', 'description': 'Number of Participants with laboratory abnormalities in specific liver tests.\n\nALT = alanine aminotransferase AST = aspartate aminotransferase ALP = alkaline phosphatase'}], 'secondaryOutcomes': [{'measure': 'Best Overall Response', 'timeFrame': 'From first dose to a response or progressive disease (Approximately 50 Months)', 'description': 'BOR will be defined by CR, PR, PD and SD\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest 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).\n\nStable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.'}, {'measure': 'Overall Response Rate', 'timeFrame': 'From first dose to CR and PR (Approximately 50 Months)', 'description': 'Defined as the percentage of all treated participants whose BOR is either a complete response(CR) or partial response(PR).\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From first dose to disease progression (Approximately 50 Months)', 'description': 'The time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first.\n\nProgression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest 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': 'Duration of Response', 'timeFrame': 'From first dose to disease progression after a response (Approximately 50 Months)', 'description': 'All treated participants with a BOR of CR or PR, is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first.\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Number of Participants With Anti-Drug Antibody Response', 'timeFrame': 'At Cycle 3 Day 1; where each treatment cycle was 8 weeks', 'description': 'Number of participants with a positive Anti-Drug Antibody to BMS-986156 or nivolumab'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '36863094', 'type': 'DERIVED', 'citation': 'Wang R, Baxi V, Li Z, Locke D, Hedvat C, Sun Y, Walsh AM, Shao X, Basavanhally T, Greenawalt DM, Patah P, Novosiadly R. Pharmacodynamic activity of BMS-986156, a glucocorticoid-induced TNF receptor-related protein agonist, alone or in combination with nivolumab in patients with advanced solid tumors. ESMO Open. 2023 Apr;8(2):100784. doi: 10.1016/j.esmoop.2023.100784. Epub 2023 Feb 28.'}, {'pmid': '31697308', 'type': 'DERIVED', 'citation': "Heinhuis KM, Carlino M, Joerger M, Di Nicola M, Meniawy T, Rottey S, Moreno V, Gazzah A, Delord JP, Paz-Ares L, Britschgi C, Schilder RJ, O'Byrne K, Curigliano G, Romano E, Patah P, Wang R, Liu Y, Bajaj G, Siu LL. Safety, Tolerability, and Potential Clinical Activity of a Glucocorticoid-Induced TNF Receptor-Related Protein Agonist Alone or in Combination With Nivolumab for Patients With Advanced Solid Tumors: A Phase 1/2a Dose-Escalation and Cohort-Expansion Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):100-107. doi: 10.1001/jamaoncol.2019.3848."}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.'}, '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* For Dose Escalation:\n\n * Subjects with any previously treated advanced (metastatic or refractory) solid tumor\n* For Cohort Expansion:\n\n * Subjects must have a previously treated advanced solid tumor to be eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy\n* Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men\n\nExclusion Criteria:\n\n* Known central nervous system metastases or central nervous system as the only source of disease\n* Other concomitant malignancies (with some exceptions per protocol)\n* Active, known or suspected autoimmune disease\n* Uncontrolled or significant cardiovascular disease\n* History of active or chronic hepatitis (e.g. Hep B or C)\n* Impaired liver or bone marrow function\n* Major surgery less than 1 month before start of the study'}, 'identificationModule': {'nctId': 'NCT02598960', 'briefTitle': 'An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'CA009-002'}, 'secondaryIdInfos': [{'id': '2015-002505-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-986156: Dose 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