Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-06-25 @ 3:53 AM
Study NCT ID:
NCT02985957
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2016-11-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000074324', 'term': 'Ipilimumab'}, {'id': 'C552428', 'term': 'cabazitaxel'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': '1(800) 332-2056', '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 will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).', 'description': 'The number at Risk for ACM represents all Treated Participants in Cohorts A, B and C and all Randomized Participants in Cohort D. The at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medicine for all Cohorts. For Arm D3 and D4 crossover, data prior to the first dose date received in Arm D1 is also being reported in their originally assigned Arm. Data are collected per cohort as prespecified.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 44, 'seriousNumAtRisk': 45, 'deathsNumAffected': 40, 'seriousNumAffected': 37}, {'id': 'EG002', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 45, 'seriousNumAtRisk': 45, 'deathsNumAffected': 41, 'seriousNumAffected': 39}, {'id': 'EG003', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 66, 'seriousNumAtRisk': 73, 'deathsNumAffected': 67, 'seriousNumAffected': 44}, {'id': 'EG004', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 74, 'otherNumAffected': 64, 'seriousNumAtRisk': 73, 'deathsNumAffected': 65, 'seriousNumAffected': 50}, {'id': 'EG005', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 37, 'seriousNumAtRisk': 38, 'deathsNumAffected': 28, 'seriousNumAffected': 25}, {'id': 'EG006', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.", 'otherNumAtRisk': 72, 'deathsNumAtRisk': 74, 'otherNumAffected': 71, 'seriousNumAtRisk': 72, 'deathsNumAffected': 49, 'seriousNumAffected': 50}, {'id': 'EG007', 'title': 'Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3', 'description': 'Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 10, 'seriousNumAtRisk': 13, 'deathsNumAffected': 9, 'seriousNumAffected': 9}, {'id': 'EG008', 'title': 'Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4', 'description': 'Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 25, 'seriousNumAtRisk': 27, 'deathsNumAffected': 21, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 26}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': "Addison's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hypophysitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Eyelid haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 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'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 1}, 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{'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 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'27.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Diaphragmalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Immune-mediated lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Iliac vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR) Cohorts B and C Per BICR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG001', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '29.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '38.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)', 'description': 'Objective response rate (ORR) is defined as the percent of participants who had confirmed complete or partial best overall response (BOR) per retrospective Blinded Independent Central Review (BICR) among treated participants with measurable disease at baseline. For participants without documented progression by RECIST v1.1 or subsequent therapy, all available response assessments contributed to the BOR assessment.\n\nPartial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nTumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).\n\nConfidence-interval based on Clopper Pearson method.', 'unitOfMeasure': 'Percent of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated Cohort B and C participants with measurable disease at baseline; pre-specified only to be collected for Cohorts B and C.'}, {'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR) Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '21.2'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '28.9'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '21.9'}, {'value': '11.1', 'groupId': 'OG003', 'lowerLimit': '3.7', 'upperLimit': '24.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)', 'description': 'In Cohort D, ORR is defined as the percentage of participants who had confirmed complete or partial BOR by BICR among randomized subjects with measurable disease at baseline as entered in Interactive Response Technologies web-based system (IWRS). For participants without documented progression or subsequent therapy, all available response assessments will contribute to the BOR assessment.\n\nPartial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nTumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).\n\nConfidence-interval based on Clopper Pearson method.', 'unitOfMeasure': 'Percent of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized Cohort D participants with measurable disease at baseline. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.'}, {'type': 'PRIMARY', 'title': 'Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG001', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.59', 'groupId': 'OG000', 'lowerLimit': '3.65', 'upperLimit': '10.22'}, {'value': '5.36', 'groupId': 'OG001', 'lowerLimit': '2.92', 'upperLimit': '7.66'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)', 'description': 'Radiographic progression-free survival (rPFS) is defined as the time between the date of first treatment and the first date of documented radiographic progression or death due to any cause, whichever occurs first.\n\nThe following progressive diseases were collected, documented and assessed as below:\n\nRadiographic progression per retrospective Blinded Independent Central Review (BICR) assessment\n\n1. Bone disease progression by Prostate Cancer Working Group (PCWG2)\n2. Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is 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 (the appearance of one or more new lesions is also considered progression).\n\nBased on Kaplan-Meier estimates.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated Cohort B and C participants. (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of first treatment. Pre-specified only to be collected for Cohorts B and C.'}, {'type': 'PRIMARY', 'title': 'Radiographic Progression-Free Survival (rPFS) for Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}], 'classes': [{'categories': [{'measurements': [{'value': '3.94', 'groupId': 'OG000', 'lowerLimit': '2.17', 'upperLimit': '7.62'}, {'value': '4.17', 'groupId': 'OG001', 'lowerLimit': '3.32', 'upperLimit': '5.59'}, {'value': '3.48', 'groupId': 'OG002', 'lowerLimit': '2.14', 'upperLimit': '5.78'}, {'value': '7.92', 'groupId': 'OG003', 'lowerLimit': '5.55', 'upperLimit': '9.33'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)', 'description': 'Radiographic progression-free survival (rPFS) is defined as the time between the date of randomization and the first date of documented progression per BICR or death due to any cause, whichever occurs first.\n\nThe following progressive diseases were collected, documented and assessed as below:\n\nRadiographic progression per BICR assessment\n\n1. Bone disease progression by (Prostate Cancer Working Group) PCWG2\n2. Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is 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 (the appearance of one or more new lesions is also considered progression).\n\nBased on Kaplan-Meier estimates.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized Cohort D participants (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.'}, {'type': 'SECONDARY', 'title': 'Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG001', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.34', 'groupId': 'OG000', 'lowerLimit': '2.79', 'upperLimit': '5.49'}, {'value': '3.71', 'groupId': 'OG001', 'lowerLimit': '2.10', 'upperLimit': '4.04'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)', 'description': 'Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first.\n\nRadiographic progression per Investigator assessment:\n\n1. Bone disease progression by Prostate Cancer Working Group (PCWG2)\n2. Non-bone soft tissue disease progression by RECIST v1.1\n\nClinical progression per investigator assessment:\n\n1. Need for palliative radiation therapy involving more than one site, OR\n2. Surgery of kyphoplasty to any neoplastic lesion, OR\n3. Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).\n\nBased on Kaplan-Meier estimates.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated Cohort B, C participants. (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of first treatment. Pre-specified only to be collected for Cohorts B and C.'}, {'type': 'SECONDARY', 'title': 'Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}], 'classes': [{'categories': [{'measurements': [{'value': '2.53', 'groupId': 'OG000', 'lowerLimit': '2.10', 'upperLimit': '3.22'}, {'value': '3.78', 'groupId': 'OG001', 'lowerLimit': '2.23', 'upperLimit': '4.63'}, {'value': '2.66', 'groupId': 'OG002', 'lowerLimit': '2.04', 'upperLimit': '3.71'}, {'value': '5.85', 'groupId': 'OG003', 'lowerLimit': '3.84', 'upperLimit': '7.52'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 93 months)', 'description': 'Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first.\n\nRadiographic progression per Investigator assessment:\n\n1. Bone disease progression by Prostate Cancer Working Group (PCWG2)\n2. Non-bone soft tissue disease progression by RECIST v1.1\n\nClinical progression per investigator assessment:\n\n1. Need for palliative radiation therapy involving more than one site, OR\n2. Surgery of kyphoplasty to any neoplastic lesion, OR\n3. Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).\n\nBased on Kaplan-Meier estimates.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized Cohort D participants (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Cohorts B and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG001', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.75', 'groupId': 'OG000', 'lowerLimit': '13.90', 'upperLimit': '23.56'}, {'value': '15.21', 'groupId': 'OG001', 'lowerLimit': '8.44', 'upperLimit': '17.77'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to the date of death due to any cause (assessed up to approximately 61 months)', 'description': 'Overall survival (OS) is defined as the time from first treatment to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up.\n\nBased on Kaplan-Meier estimates.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohorts B and C; pre-specified only to be collected for Cohorts B and C.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}], 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '13.14', 'upperLimit': '19.29'}, {'value': '14.46', 'groupId': 'OG001', 'lowerLimit': '10.64', 'upperLimit': '17.51'}, {'value': '18.46', 'groupId': 'OG002', 'lowerLimit': '10.28', 'upperLimit': '25.69'}, {'value': '15.15', 'groupId': 'OG003', 'lowerLimit': '11.56', 'upperLimit': '18.56'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of death due to any cause (assessed up to approximately 93 months)', 'description': 'Overall survival (OS) is defined as the time from randomization to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up.\n\nBased on Kaplan-Meier estimates.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in Cohort D.'}, {'type': 'SECONDARY', 'title': 'Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG001', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '34.5'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '23.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)', 'description': 'The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. BBaseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.\n\nConfidence-interval based on Clopper Pearson method.', 'unitOfMeasure': 'Percent of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with PSA values at baseline and at least one postbaseline assessment in Cohorts B and C. Pre-specified only to be collected for Cohorts B and C.'}, {'type': 'SECONDARY', 'title': 'Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}, {'id': 'OG004', 'title': 'Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3', 'description': 'Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG005', 'title': 'Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4', 'description': 'Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '24.3'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '9.8', 'upperLimit': '29.6'}, {'value': '5.4', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '18.2'}, {'value': '23.9', 'groupId': 'OG003', 'lowerLimit': '14.6', 'upperLimit': '35.5'}, {'value': '30.8', 'groupId': 'OG004', 'lowerLimit': '9.1', 'upperLimit': '61.4'}, {'value': '17.4', 'groupId': 'OG005', 'lowerLimit': '5.0', 'upperLimit': '38.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 93 months)', 'description': 'The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.\n\nConfidence-interval based on Clopper Pearson method.', 'unitOfMeasure': 'Percent of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PSA values at baseline and at least one post-baseline assessment in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG001', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG002', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohorts A, B and C'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Experiencing Adverse Events (AEs) in Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}, {'id': 'OG004', 'title': 'Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3', 'description': 'Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG005', 'title': 'Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4', 'description': 'Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG001', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG002', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)', 'description': 'A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohorts A, B and C'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}, {'id': 'OG004', 'title': 'Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3', 'description': 'Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG005', 'title': 'Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4', 'description': 'Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)', 'description': 'A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG001', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG002', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohorts A, B and C'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}, {'id': 'OG004', 'title': 'Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3', 'description': 'Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG005', 'title': 'Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4', 'description': 'Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG001', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG002', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}], 'classes': [{'title': 'Pneumonitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea/Colitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Hepatitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Adrenal Insufficiency', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hypothyroidism/Thyroiditis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Diabetes Mellitus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nephritis and Renal Dysfunction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Hypersensitivity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperthyroidism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypophysitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months)', 'description': 'Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohorts A, B and C.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}, {'id': 'OG004', 'title': 'Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3', 'description': 'Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG005', 'title': 'Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4', 'description': 'Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}], 'classes': [{'title': 'Pneumonitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Diarrhea/Colitis', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Hepatitis', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Adrenal Insufficiency', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Hypothyroidism/Thyroiditis', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Diabetes Mellitus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Nephritis and Renal Dysfunction', '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'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Hypersensitivity', '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'}]}]}, {'title': 'Hyperthyroidism', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Hypophysitis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 100 days after last dose of study therapy (an average of 8.48 months assessed up to approximately 29.09 months)', 'description': 'Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Who Died in Cohorts A, B and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG001', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG002', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months).', 'description': 'Death due to any cause.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohorts A, B and C.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Who Died in Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}, {'id': 'OG004', 'title': 'Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3', 'description': 'Arm D3 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG005', 'title': 'Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4', 'description': 'Arm D4 participants who progressed on or after treatment were eligible to crossover to Arm D1. Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 100 days after last dose of study therapy (an average of 8.48 months assessed up to approximately 29.09 months)', 'description': 'Death due to any cause.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort D. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG001', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG002', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}], 'classes': [{'title': 'Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Platelet Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes (Absolute)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Absolute Neutrophil Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline Phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Amylase, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Lipase, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hypernatremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypocalcemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Hyperglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)', 'description': 'The number of participants with a change in laboratory values from baseline Grade in Cohorts A, B and C.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohorts A, B and C with baseline laboratory measurements.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}], 'classes': [{'title': 'Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}]}, {'title': 'Platelet Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes (Absolute)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}]}, {'title': 'Absolute Neutrophil Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Alkaline Phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Bilirubin, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Amylase, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Lipase, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Hypernatremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Hyponatremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Hyperkalemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Hypokalemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Hypercalcemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hypocalcemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Hyperglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)', 'description': 'The number of participants with an change in laboratory values from baseline Grade in Cohort D.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort D with baseline laboratory measurements. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG001', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG002', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}], 'classes': [{'title': 'ALT OR AST > 3XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'ALT OR AST> 5XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'ALT OR AST> 10XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'ALT OR AST > 20XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'TOTAL BILIRUBIN > 2XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)', 'description': 'The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.\n\nALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants in Cohorts A, B and C with at least one on-treatment liver function measurement.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}], 'classes': [{'title': 'ALT OR AST > 3XULN', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'ALT OR AST> 5XULN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT OR AST> 10XULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT OR AST > 20XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TOTAL BILIRUBIN > 2XULN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALP>1.5XULN', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'CONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>1.5XULN WITHIN 1 DAY', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'CONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>1.5XULN WITHIN 30 DAYS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'CONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>2XULN WITHIN 1 DAY', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'CONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>2XULN WITHIN 30 DAYS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)', 'description': 'The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.\n\nALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants in Cohort D with at least one on-treatment liver function measurement. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG001', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG002', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}], 'classes': [{'title': 'TSH > ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'TSH > ULN WITH TSH <= ULN AT BASELINE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'TSH > ULN WITH FT3/FT4 TEST MISSING', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'TSH < LLN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'TSH <LLN WITH TSH >= LLN AT BASELINE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'TSH < LLN WITH FT3/FT4 TEST MISSING', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)', 'description': 'The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.\n\nTSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants in Cohorts A, B and C with at least one on-treatment TSH measurement. Treated subjects in Cohort B with adequate follow-up of at least 24 weeks are included.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}], 'classes': [{'title': 'TSH > ULN', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'TSH > ULN WITH TSH <= ULN AT BASELINE', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'TSH > ULN WITH FT3/FT4 TEST MISSING', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'TSH < LLN', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'TSH <LLN WITH TSH >= LLN AT BASELINE', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'TSH < LLN WITH FT3/FT4 TEST MISSING', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)', 'description': 'The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.\n\nTSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants in Cohort D with at least one on-treatment TSH measurement. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.'}, {'type': 'SECONDARY', 'title': 'Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG001', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}], 'classes': [{'title': 'Worst pain in the last 24 hours Week 4 (Cycle 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '5'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '6'}]}]}, {'title': 'Least pain in the last 24 hours Week 4 (Cycle 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '1'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '3'}]}]}, {'title': 'Average pain in the last 24 hours Week 4 (Cycle 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '2'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '2'}]}]}, {'title': 'Current pain Week 4 (Cycle 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 4 (Cycle 2)', 'description': 'Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its \'\'worst,\'\' \'\'least,\'\' and \'\'average\'\' in the last 24 hours using an 11-point numerical rating scale with anchors of \'\'0 = no pain\'\' and \'\'10 = pain as bad as you can imagine.\'\' A higher score = a "worse" outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated Cohort B and C participants with baseline and week 4 (cycle 2) scores. Pre-specified only to be collected for Cohorts B and C.'}, {'type': 'SECONDARY', 'title': 'Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}], 'classes': [{'title': 'Worst pain in the last 24 hours Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '8'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '7'}, {'value': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-8', 'upperLimit': '6'}, {'value': '-0.5', 'groupId': 'OG003', 'lowerLimit': '-7', 'upperLimit': '5'}]}]}, {'title': 'Least pain in the last 24 hours Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '8'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '4'}, {'value': '0.2', 'groupId': 'OG002', 'lowerLimit': '-4', 'upperLimit': '5'}, {'value': '-0.3', 'groupId': 'OG003', 'lowerLimit': '-5', 'upperLimit': '3'}]}]}, {'title': 'Average pain in the last 24 hours Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-6', 'upperLimit': '6'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '6'}, {'value': '-0.3', 'groupId': 'OG002', 'lowerLimit': '-5', 'upperLimit': '5'}, {'value': '-0.4', 'groupId': 'OG003', 'lowerLimit': '-5', 'upperLimit': '3'}]}]}, {'title': 'Current pain Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-6', 'upperLimit': '6'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '4'}, {'value': '-0.4', 'groupId': 'OG002', 'lowerLimit': '-6', 'upperLimit': '6'}, {'value': '-0.3', 'groupId': 'OG003', 'lowerLimit': '-6', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and 4 weeks after first dose.', 'description': 'Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its \'\'worst,\'\' \'\'least,\'\' and \'\'average\'\' in the last 24 hours using an 11-point numerical rating scale with anchors of \'\'0 = no pain\'\' and \'\'10 = pain as bad as you can imagine.\'\' A higher score = a "worse" outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized Cohort D participants with baseline and week 4 scores'}, {'type': 'SECONDARY', 'title': 'Change in Cancer-Related Symptoms and Quality of Life (QoL) by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}], 'classes': [{'categories': [{'measurements': [{'value': '6.73', 'groupId': 'OG000', 'lowerLimit': '-60.2', 'upperLimit': '116.4'}, {'value': '-4.74', 'groupId': 'OG001', 'lowerLimit': '-81.0', 'upperLimit': '72.7'}, {'value': '-3.64', 'groupId': 'OG002', 'lowerLimit': '-91.5', 'upperLimit': '65'}, {'value': '-0.28', 'groupId': 'OG003', 'lowerLimit': '-71.7', 'upperLimit': '53.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and 4 weeks after first dose.', 'description': 'The Functional Assessment of Cancer Therapy - Prostate (FACT-P) is a multidimensional, self-report Quality of Life (QoL) instrument designed for use with prostate cancer patients. It consists of 27 core items. The Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, which assesses patient function in 4 domains: Physical, Social/Family, Emotional, and Functional well-being. This is further supplemented by the Prostate Cancer Subscale (PCS), 12 disease-specific items to assess for prostate-related symptoms. Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores for each domain, a Trial Outcome Index which is based on the Physical and Functional well-being scales and the PCS as well as a total score which ranges from 0 to 156. Higher scores represent better QoL. Baseline evaluations or events were defined as those that occur before or on the date and time of the first dose of study treatment.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized Cohort D participants with baseline and week 4 scores; pre-specified for data to be collected only from Cohort D participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'OG001', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0083', 'groupId': 'OG000', 'lowerLimit': '-0.311', 'upperLimit': '0.275'}, {'value': '-0.0074', 'groupId': 'OG001', 'lowerLimit': '-0.327', 'upperLimit': '0.628'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and at Week 4 of Cycle 2.', 'description': "The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated Cohort B and C participants with baseline and week 4 (cycle 2) scores. Pre-specified only to be collected for Cohorts B and C.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}], 'classes': [{'categories': [{'measurements': [{'value': '0.0032', 'groupId': 'OG000', 'lowerLimit': '-0.736', 'upperLimit': '0.791'}, {'value': '-0.0328', 'groupId': 'OG001', 'lowerLimit': '-0.574', 'upperLimit': '0.532'}, {'value': '0.0113', 'groupId': 'OG002', 'lowerLimit': '-0.532', 'upperLimit': '0.463'}, {'value': '0.0219', 'groupId': 'OG003', 'lowerLimit': '-0.514', 'upperLimit': '0.697'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and 4 weeks after first dose.', 'description': "The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized Cohort D participants with baseline and week 4 scores'}, {'type': 'POST_HOC', 'title': 'Objective Response Rate (ORR) Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '26.8'}, {'value': '17.4', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '31.4'}, {'value': '8.7', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '28.0'}, {'value': '8.9', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '21.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 93 months)', 'description': 'In Cohort D, ORR is defined as the percentage of participants who had confirmed complete or partial BOR by BICR among randomized subjects with measurable disease at baseline as entered in Interactive Response Technologies web-based system (IWRS). For participants without documented progression or subsequent therapy, all available response assessments will contribute to the BOR assessment.\n\nPartial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nTumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).\n\nConfidence-interval based on Clopper Pearson method.', 'unitOfMeasure': 'Percent of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized Cohort D participants with measurable disease at baseline. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.'}, {'type': 'POST_HOC', 'title': 'Radiographic Progression-Free Survival (rPFS) for Cohort D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'OG001', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'OG002', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'OG003', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}], 'classes': [{'categories': [{'measurements': [{'value': '3.70', 'groupId': 'OG000', 'lowerLimit': '2.37', 'upperLimit': '5.36'}, {'value': '3.81', 'groupId': 'OG001', 'lowerLimit': '2.23', 'upperLimit': '4.63'}, {'value': '3.09', 'groupId': 'OG002', 'lowerLimit': '2.04', 'upperLimit': '4.37'}, {'value': '6.34', 'groupId': 'OG003', 'lowerLimit': '5.22', 'upperLimit': '8.31'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 93 months)', 'description': 'Radiographic progression-free survival (rPFS) is defined as the time between the date of randomization and the first date of documented progression per BICR or death due to any cause, whichever occurs first.\n\nThe following progressive diseases were collected, documented and assessed as below:\n\nRadiographic progression per BICR assessment\n\n1. Bone disease progression by (Prostate Cancer Working Group) PCWG2\n2. Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is 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 (the appearance of one or more new lesions is also considered progression).\n\nBased on Kaplan-Meier estimates.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized Cohort D participants (i) Participants who did not progress or die were censored on the date of their last evaluable tumor assessment (ie, bone scan, CT, MRI). (ii) Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. For Arm D3 and D4 crossover participants, the data prior to the first dose date received in Arm D1 is being reported in their originally assigned Arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'FG001', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'FG002', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'FG003', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'FG004', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'FG005', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'FG006', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}], 'periods': [{'title': 'Pre-Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '73'}, {'groupId': 'FG004', 'numSubjects': '74'}, {'groupId': 'FG005', 'numSubjects': '38'}, {'groupId': 'FG006', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '73'}, {'groupId': 'FG004', 'numSubjects': '73'}, {'groupId': 'FG005', 'numSubjects': '38'}, {'groupId': 'FG006', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Participant 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': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', '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': '1'}]}, {'type': 'Adverse event unrelated to study drug', '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': '1'}]}]}, {'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'comment': 'Started Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '73'}, {'groupId': 'FG004', 'numSubjects': '73'}, {'groupId': 'FG005', 'numSubjects': '38'}, {'groupId': 'FG006', 'numSubjects': '72'}]}, {'type': 'Eligible Participants Who Progressed and Received Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '19'}, {'groupId': 'FG006', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '68'}, {'groupId': 'FG004', 'numSubjects': '70'}, {'groupId': 'FG005', 'numSubjects': '19'}, {'groupId': 'FG006', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'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': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Not reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Maximum clinical benefit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Adverse event unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '7'}]}, {'type': 'Study drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '5'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '29'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '28'}]}, {'type': 'Participant request to discontinue study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': 'Poor/Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Cohort A: Asymptomatic or minimally symptomatic, not previously received second generation hormone therapies or cytotoxic chemotherapy.\n\nCohort B: Asymptomatic or minimally symptomatic, progressed after second generation hormone therapies and had not been treated with cytotoxic chemotherapy.\n\nCohort C: Progressed after prior taxane-based cytotoxic chemotherapy. Cohort D: Progressed after prior docetaxel-containing therapy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}, {'value': '38', 'groupId': 'BG005'}, {'value': '74', 'groupId': 'BG006'}, {'value': '351', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Not reached for this cohort - Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'BG001', 'title': 'Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'BG002', 'title': 'Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg', 'description': 'Part 1: Nivolumab 1 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4), then ipilimumab 3 mg/kg as a 30-minute IV infusion, on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1-4). Part 2: Six weeks after the last co-administered dose in Part 1, a flat dose of 480 mg nivolumab on Day 1 of each 4-week treatment cycle given IV given over approximately 30 minutes every 4 weeks until unacceptable toxicity or disease progression.'}, {'id': 'BG003', 'title': 'Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W', 'description': 'Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg every 3 weeks for up to 4 doses (Cycles 1 to 4), followed by nivolumab 480 mg administered every 4 weeks (Cycle 5 and beyond). Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted re-induction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occured first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ends, whichever occurred first.'}, {'id': 'BG004', 'title': 'Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W', 'description': 'Nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 2 cycles (ie, every 6 weeks) for up to 4 ipilimumab doses, followed by nivolumab 480 mg every 4 weeks. Participants receiving maintenance nivolumab with ongoing disease control or with radiographic progression were permitted reinduction with the combination of ipilimumab and nivolumab at their original combination dose upon PSA progression or radiographic progression (whichever occurred first). Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, 2-year maximum treatment duration, or the study ended, whichever occurred first.'}, {'id': 'BG005', 'title': 'Cohort D Arm 3: Ipilimumab 3 mg/kg', 'description': 'Ipilimumab 3 mg/kg every 3 weeks for up to 4 doses. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 4 cycles, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1.'}, {'id': 'BG006', 'title': 'Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg', 'description': "Cabazitaxel 20 mg/m2 or 25 mg/m2 (at investigator's discretion and according to country-specific label) every 3 weeks in combination with oral prednisone or prednisolone 10 mg daily for up to 10 cycles. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, completion of 10 cycles of treatment, or the study ended, whichever occurred first. Participants who progressed on or after treatment were eligible to crossover to Arm D1."}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '124', 'groupId': 'BG007'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '51', 'groupId': 'BG006'}, {'value': '227', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', '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'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}, {'value': '38', 'groupId': 'BG005'}, {'value': '74', 'groupId': 'BG006'}, {'value': '351', 'groupId': 'BG007'}]}]}], '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': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '51', 'groupId': 'BG006'}, {'value': '270', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}, {'value': '78', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '67', 'groupId': 'BG006'}, {'value': '313', 'groupId': 'BG007'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '24', 'groupId': 'BG007'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'description': 'Race', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-01', 'size': 2963245, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-24T08:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 351}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2016-11-22', 'resultsFirstSubmitDate': '2023-03-30', 'studyFirstSubmitQcDate': '2016-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-04-20', 'studyFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) Cohorts B and C Per BICR', 'timeFrame': 'From first dose to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)', 'description': 'Objective response rate (ORR) is defined as the percent of participants who had confirmed complete or partial best overall response (BOR) per retrospective Blinded Independent Central Review (BICR) among treated participants with measurable disease at baseline. For participants without documented progression by RECIST v1.1 or subsequent therapy, all available response assessments contributed to the BOR assessment.\n\nPartial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nTumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).\n\nConfidence-interval based on Clopper Pearson method.'}, {'measure': 'Objective Response Rate (ORR) Cohort D', 'timeFrame': 'From randomization to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)', 'description': 'In Cohort D, ORR is defined as the percentage of participants who had confirmed complete or partial BOR by BICR among randomized subjects with measurable disease at baseline as entered in Interactive Response Technologies web-based system (IWRS). For participants without documented progression or subsequent therapy, all available response assessments will contribute to the BOR assessment.\n\nPartial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm.\n\nTumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).\n\nConfidence-interval based on Clopper Pearson method.'}, {'measure': 'Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR', 'timeFrame': 'From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)', 'description': 'Radiographic progression-free survival (rPFS) is defined as the time between the date of first treatment and the first date of documented radiographic progression or death due to any cause, whichever occurs first.\n\nThe following progressive diseases were collected, documented and assessed as below:\n\nRadiographic progression per retrospective Blinded Independent Central Review (BICR) assessment\n\n1. Bone disease progression by Prostate Cancer Working Group (PCWG2)\n2. Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is 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 (the appearance of one or more new lesions is also considered progression).\n\nBased on Kaplan-Meier estimates.'}, {'measure': 'Radiographic Progression-Free Survival (rPFS) for Cohort D', 'timeFrame': 'From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)', 'description': 'Radiographic progression-free survival (rPFS) is defined as the time between the date of randomization and the first date of documented progression per BICR or death due to any cause, whichever occurs first.\n\nThe following progressive diseases were collected, documented and assessed as below:\n\nRadiographic progression per BICR assessment\n\n1. Bone disease progression by (Prostate Cancer Working Group) PCWG2\n2. Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is 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 (the appearance of one or more new lesions is also considered progression).\n\nBased on Kaplan-Meier estimates.'}], 'secondaryOutcomes': [{'measure': 'Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C', 'timeFrame': 'From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)', 'description': 'Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first.\n\nRadiographic progression per Investigator assessment:\n\n1. Bone disease progression by Prostate Cancer Working Group (PCWG2)\n2. Non-bone soft tissue disease progression by RECIST v1.1\n\nClinical progression per investigator assessment:\n\n1. Need for palliative radiation therapy involving more than one site, OR\n2. Surgery of kyphoplasty to any neoplastic lesion, OR\n3. Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).\n\nBased on Kaplan-Meier estimates.'}, {'measure': 'Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D', 'timeFrame': 'From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 93 months)', 'description': 'Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first.\n\nRadiographic progression per Investigator assessment:\n\n1. Bone disease progression by Prostate Cancer Working Group (PCWG2)\n2. Non-bone soft tissue disease progression by RECIST v1.1\n\nClinical progression per investigator assessment:\n\n1. Need for palliative radiation therapy involving more than one site, OR\n2. Surgery of kyphoplasty to any neoplastic lesion, OR\n3. Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).\n\nBased on Kaplan-Meier estimates.'}, {'measure': 'Overall Survival (OS) Cohorts B and C', 'timeFrame': 'From first dose to the date of death due to any cause (assessed up to approximately 61 months)', 'description': 'Overall survival (OS) is defined as the time from first treatment to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up.\n\nBased on Kaplan-Meier estimates.'}, {'measure': 'Overall Survival (OS) Cohort D', 'timeFrame': 'From randomization to the date of death due to any cause (assessed up to approximately 93 months)', 'description': 'Overall survival (OS) is defined as the time from randomization to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up.\n\nBased on Kaplan-Meier estimates.'}, {'measure': 'Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C', 'timeFrame': 'From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)', 'description': 'The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. BBaseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.\n\nConfidence-interval based on Clopper Pearson method.'}, {'measure': 'Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D', 'timeFrame': 'From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 93 months)', 'description': 'The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.\n\nConfidence-interval based on Clopper Pearson method.'}, {'measure': 'The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.'}, {'measure': 'The Number of Participants Experiencing Adverse Events (AEs) in Cohort D', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.'}, {'measure': 'The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)', 'description': 'A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.'}, {'measure': 'The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)', 'description': 'A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.'}, {'measure': 'The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.'}, {'measure': 'The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.'}, {'measure': 'The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C', 'timeFrame': 'From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months)', 'description': 'Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.'}, {'measure': 'The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D', 'timeFrame': 'From first dose to 100 days after last dose of study therapy (an average of 8.48 months assessed up to approximately 29.09 months)', 'description': 'Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.'}, {'measure': 'The Number of Participants Who Died in Cohorts A, B and C', 'timeFrame': 'From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months).', 'description': 'Death due to any cause.'}, {'measure': 'The Number of Participants Who Died in Cohort D', 'timeFrame': 'From first dose to 100 days after last dose of study therapy (an average of 8.48 months assessed up to approximately 29.09 months)', 'description': 'Death due to any cause.'}, {'measure': 'The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)', 'description': 'The number of participants with a change in laboratory values from baseline Grade in Cohorts A, B and C.'}, {'measure': 'The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)', 'description': 'The number of participants with an change in laboratory values from baseline Grade in Cohort D.'}, {'measure': 'The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)', 'description': 'The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.\n\nALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal'}, {'measure': 'The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)', 'description': 'The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.\n\nALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal'}, {'measure': 'The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)', 'description': 'The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.\n\nTSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal'}, {'measure': 'The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D', 'timeFrame': 'From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)', 'description': 'The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.\n\nTSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal'}, {'measure': 'Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C', 'timeFrame': 'At baseline and Week 4 (Cycle 2)', 'description': 'Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its \'\'worst,\'\' \'\'least,\'\' and \'\'average\'\' in the last 24 hours using an 11-point numerical rating scale with anchors of \'\'0 = no pain\'\' and \'\'10 = pain as bad as you can imagine.\'\' A higher score = a "worse" outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.'}, {'measure': 'Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D', 'timeFrame': 'At baseline and 4 weeks after first dose.', 'description': 'Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its \'\'worst,\'\' \'\'least,\'\' and \'\'average\'\' in the last 24 hours using an 11-point numerical rating scale with anchors of \'\'0 = no pain\'\' and \'\'10 = pain as bad as you can imagine.\'\' A higher score = a "worse" outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.'}, {'measure': 'Change in Cancer-Related Symptoms and Quality of Life (QoL) by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Cohort D', 'timeFrame': 'At baseline and 4 weeks after first dose.', 'description': 'The Functional Assessment of Cancer Therapy - Prostate (FACT-P) is a multidimensional, self-report Quality of Life (QoL) instrument designed for use with prostate cancer patients. It consists of 27 core items. The Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, which assesses patient function in 4 domains: Physical, Social/Family, Emotional, and Functional well-being. This is further supplemented by the Prostate Cancer Subscale (PCS), 12 disease-specific items to assess for prostate-related symptoms. Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores for each domain, a Trial Outcome Index which is based on the Physical and Functional well-being scales and the PCS as well as a total score which ranges from 0 to 156. Higher scores represent better QoL. Baseline evaluations or events were defined as those that occur before or on the date and time of the first dose of study treatment.'}, {'measure': 'Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C', 'timeFrame': 'At baseline and at Week 4 of Cycle 2.', 'description': "The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations."}, {'measure': 'Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D', 'timeFrame': 'At baseline and 4 weeks after first dose.', 'description': "The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '32916128', 'type': 'DERIVED', 'citation': 'Sharma P, Pachynski RK, Narayan V, Flechon A, Gravis G, Galsky MD, Mahammedi H, Patnaik A, Subudhi SK, Ciprotti M, Simsek B, Saci A, Hu Y, Han GC, Fizazi K. Nivolumab Plus Ipilimumab for Metastatic Castration-Resistant Prostate Cancer: Preliminary Analysis of Patients in the CheckMate 650 Trial. Cancer Cell. 2020 Oct 12;38(4):489-499.e3. doi: 10.1016/j.ccell.2020.08.007. Epub 2020 Sep 10.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness, safety and tolerability of nivolumab followed by ipilimumab, in subjects with metastatic castration resistant prostate cancer (mCRPC).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI).\n* Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of ≤1.73nmol/L (50ng/dL)\n\nFor crossover phase for participants originally randomized to Arm D3 or Arm D4 only:\n\n* Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization\n\nExclusion Criteria:\n\n* Presence of visceral metastases in the liver\n* Active brain metastases or leptomeningeal metastases\n* Active, known, or suspected autoimmune disease or infection\n* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways\n\nFor crossover phase for participants originally randomized to Arm D3 or Arm D4 only:\n\n* Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab\n* Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel)\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT02985957', 'acronym': 'CheckMate 650', 'briefTitle': 'A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer', 'orgStudyIdInfo': {'id': 'CA209-650'}, 'secondaryIdInfos': [{'id': '2016-001928-54', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A (Arm A)', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B (Arm B)', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C (Arm C)', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort D (Arm D1)', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort D (Arm D2)', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort D (Arm D3)', 'interventionNames': ['Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort D (Arm D4)', 'interventionNames': ['Drug: Cabazitaxel', 'Drug: Prednisone']}], 'interventions': [{'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['BMS-936558', 'Opdivo'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Cohort A (Arm A)', 'Cohort B (Arm B)', 'Cohort C (Arm C)', 'Cohort D (Arm D1)', 'Cohort D (Arm D2)']}, {'name': 'Ipilimumab', 'type': 'BIOLOGICAL', 'otherNames': ['BMS-734016', 'Yervoy'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Cohort A (Arm A)', 'Cohort B (Arm B)', 'Cohort C (Arm C)', 'Cohort D (Arm D1)', 'Cohort D (Arm D2)', 'Cohort D (Arm D3)']}, {'name': 'Cabazitaxel', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Cohort D (Arm D4)']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Cohort D (Arm D4)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85711', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution - 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