Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-03-02 @ 10:04 PM
Study NCT ID:
NCT04100018
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2019-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-28', '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': 'D011241', 'term': 'Prednisone'}, {'id': 'D000077143', 'term': 'Docetaxel'}], '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'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).', 'description': 'The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.', 'otherNumAtRisk': 510, 'deathsNumAtRisk': 514, 'otherNumAffected': 479, 'seriousNumAtRisk': 510, 'deathsNumAffected': 259, 'seriousNumAffected': 256}, {'id': 'EG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.', 'otherNumAtRisk': 510, 'deathsNumAtRisk': 516, 'otherNumAffected': 494, 'seriousNumAtRisk': 510, 'deathsNumAffected': 227, 'seriousNumAffected': 242}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 157}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 165}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 58}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 14}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 28}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 101}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 175}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 162}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 134}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 59}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 113}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 108}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 141}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 149}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 108}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 54}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 62}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 26}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 46}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 42}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 39}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 97}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 43}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 97}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 85}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 42}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 51}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 52}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 44}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 75}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 47}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 22}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 49}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 38}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 172}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 178}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 41}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 36}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Blood disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Bone marrow infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Febrile bone marrow aplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Myelosuppression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Immune-mediated myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 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'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hepatitis B DNA assay positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Immune-mediated arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Immune-mediated myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 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'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 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510, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Sacral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Bladder 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'EG000', 'numAtRisk': 510, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Ependymoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 27}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Metastases to meninges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Metastases to spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Neuroendocrine carcinoma of the skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 13}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Tongue neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Tumour associated fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Basal ganglia stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cauda equina syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Central nervous system lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Guillain-Barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Malignant spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Superior sagittal sinus thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Needle issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Adjustment disorder with anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Calculus urethral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Immune-mediated nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Urethral obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Urinary tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Immune-mediated lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Respiratory tract haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pemphigoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Radiographic Progressive Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group 3 (PCWG3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'OG000'}, {'value': '516', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.43', 'groupId': 'OG000', 'lowerLimit': '8.48', 'upperLimit': '10.32'}, {'value': '8.74', 'groupId': 'OG001', 'lowerLimit': '8.38', 'upperLimit': '9.99'}]}]}], 'analyses': [{'pValue': '0.5901', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.96', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.19', 'pValueComment': 'Boundary for statistical significance p-value \\< 0.01', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratification factor is visceral disease (YES vs NO) as entered in the IRT.'}], 'paramType': 'MEDIAN', 'timeFrame': 'from randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 31 months)', 'description': 'rPFS for randomized participants is the time between randomization and the first date of documented progression or death due to any cause, whichever occurs first. The rPFS was censored at the last radiographic tumor assessment up to the start of subsequent cancer therapy for those without progression or death. It was also censored at the date of last radiographic tumor assessment prior to the missed tumor assessments for participants who had progressive disease (PD) or death immediately after more than one consecutive missed tumor assessments. Radiographic progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (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 millimeter (mm). The appearance of one or more new lesions is also considered progression.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'OG000'}, {'value': '516', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.73', 'groupId': 'OG000', 'lowerLimit': '16.95', 'upperLimit': '21.03'}, {'value': '18.92', 'groupId': 'OG001', 'lowerLimit': '17.31', 'upperLimit': '22.01'}]}]}], 'analyses': [{'pValue': '0.3572', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.41', 'paramValue': '1.09', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.43', 'pValueComment': 'Boundary for statistical significance p-value \\< 0.0059. Additional accuracy for p-value: 0.005866.', 'estimateComment': 'Stratification factor is visceral disease (YES vs NO) as entered in the IRT.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of death from any cause (Up to approximately 31 months)', 'description': 'OS for all randomized participants is the time between randomization and the date of death from any cause. For participants who are alive, their survival time was censored at the last date that they were known to be alive. OS was censored for participants at the date of randomization if they had no follow-up.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '21.5', 'upperLimit': '33.8'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '17.9', 'upperLimit': '30.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.8', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '12.1', 'estimateComment': 'Strata adjusted difference in objective response rate based on DerSimonian and Laird method. Stratified by visceral disease (YES vs NO) as entered in the IRT.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization to the date of objectively documented progression per PCWG3 or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 52 months)', 'description': 'Objective Response Rate per PCWG3 (ORR-PCWG3) is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among randomized participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All response evaluable participants'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.17', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '7.8'}, {'value': '2.20', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '8.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of the first documented CR or PR (Up to approximately 52 months)', 'description': 'Time to Response per PCWG3 (TTR-PCWG3) is the time from randomization to the date of the first documented CR or PR per PCWG3, as determined by BICR. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All Confirmed Responders (PR + CR)'}, {'type': 'SECONDARY', 'title': 'Duration of Response Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.31', 'groupId': 'OG000', 'lowerLimit': '6.18', 'upperLimit': '10.15'}, {'value': '8.11', 'groupId': 'OG001', 'lowerLimit': '6.34', 'upperLimit': '8.74'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization date to the date of first documented radiographic progression or death due to any cause whichever occurs first (Up to approximately 52 months)', 'description': 'Duration of Response per PCWG3 (DOR-PCWG3) is time between the date of first response (CR/PR per PCWG3) to the date of first documented radiographic progression per PCWG3,as determined by BICR, or death due to any cause whichever occurs first. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Radiographic progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Confirmed Responders (PR + CR)'}, {'type': 'SECONDARY', 'title': 'Prostate-specific Antigen (PSA) Response Rate (PSA-RR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '498', 'groupId': 'OG000'}, {'value': '503', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'groupId': 'OG000', 'lowerLimit': '38.0', 'upperLimit': '46.8'}, {'value': '41.6', 'groupId': 'OG001', 'lowerLimit': '37.2', 'upperLimit': '46.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '7.0', 'estimateComment': 'Strata adjusted difference in objective response rate based on DerSimonian and Laird method. Stratified by visceral disease (YES vs NO) as entered in the IRT.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 52 months', 'description': 'PSA Response Rate (PSA-RR) is the percentage of randomized participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response. Baseline was defined as valuations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one post-baseline PSA assessments'}, {'type': 'SECONDARY', 'title': 'Time to PSA Progression (TTP-PSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'OG000'}, {'value': '516', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.28', 'groupId': 'OG000', 'lowerLimit': '5.82', 'upperLimit': '6.97'}, {'value': '6.21', 'groupId': 'OG001', 'lowerLimit': '5.65', 'upperLimit': '6.77'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.16', 'estimateComment': 'Stratification factor is visceral disease (YES vs NO) as entered in the IRT.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'from randomization to the date of PSA Progression (Up to approximately 31 months)', 'description': 'Time to PSA Progression (TTP-PSA) is the time between randomization to the date of PSA progression per PCWG3 in randomized participants. PSA Progression: For participants with an initial PSA decline from baseline, the date of PSA progression is the date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from the nadir are documented and confirmed by a second consecutive PSA value at least 3 weeks later. For participants with no PSA decline from baseline, the date of PSA progression is date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from baseline are documented at or beyond Week 13. Baseline was defined as valuations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. Censored at date of last PSA evaluation on/prior to start of subsequent cancer therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '501', 'groupId': 'OG000'}, {'value': '503', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose and 30 days after last dose of study therapy (Up to approximately 25 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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)', 'description': 'Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death or Is life-threatening or requires inpatient hospitalization or causes prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose and 30 days after last dose of study therapy (Up to approximately 25 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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Endocrine Immune-Mediated Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'title': 'Adrenal insufficiency', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Hypothyroidism', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Thyroiditis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diabetes mellitus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Diabetic ketoacidosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Type 1 diabetes mellitus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperthyroidism', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Immune-mediated hypophysitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypopituitarism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)', 'description': 'Immune-mediated adverse events 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. 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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Non-Endocrine Immune-Mediated Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'title': 'Pneumonitis', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Interstitial lung disease', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Immune-mediated lung disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Colitis', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Enterocolitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase increased', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypertransaminasaemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Autoimmune hepatitis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Immune-mediated hepatitis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood bilirubin increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cholangitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood creatinine increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Acute kidney injury', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Immune-mediated nephritis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Rash maculo-papular', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rash pustular', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis acneiform', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Drug eruption', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pemphigoid', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema multiforme', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Immune-mediated dermatitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rash macular', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion related reaction', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hypersensitivity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion related hypersensitivity reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)', 'description': 'Immune-mediated adverse events 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. 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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Select Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}]}, {'title': 'Colitis', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Enterocolitis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Frequent bowel movements', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase increased', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Blood alkaline phosphatase increased', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Blood bilirubin increased', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Gamma-glutamyltransferase increased', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hepatic cytolysis', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Transaminases increased', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Autoimmune hepatitis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cholangitis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperbilirubinaemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypertransaminasaemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hepatic enzyme increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hepatitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Immune-mediated hepatitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Liver injury', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Liver disorder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonitis', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Interstitial lung disease', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Acute respiratory failure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Immune-mediated lung disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lung infiltration', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Idiopathic interstitial pneumonia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blood creatinine increased', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Acute kidney injury', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Renal failure', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Blood urea increased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Immune-mediated nephritis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Eczema', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Rash maculo-papular', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Palmar-plantar erythrodysaesthesia syndrome', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Urticaria', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Psoriasis', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Skin exfoliation', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis acneiform', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rash macular', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis allergic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rash erythematous', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Rash pustular', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vitiligo', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blister', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis atopic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis exfoliative', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Drug eruption', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema multiforme', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Exfoliative rash', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pemphigoid', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Photosensitivity reaction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rash papular', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rash pruritic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Immune-mediated dermatitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion related reaction', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Hypersensitivity', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Anaphylactic reaction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Anaphylactic shock', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bronchospasm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion related hypersensitivity reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose and 30 days after last dose of study therapy (Up to approximately 25 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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 52 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'title': 'HEMOGLOBIN Grade 0 to Grade 3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HEMOGLOBIN Grade 0 to Grade 4', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Per Anemia criteria in CTC version 5.0 there is no grade 4 for hemoglobin', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Per Anemia criteria in CTC version 5.0 there is no grade 4 for hemoglobin', 'groupId': 'OG001'}]}]}, {'title': 'HEMOGLOBIN Grade 1 to Grade 3', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'HEMOGLOBIN Grade 1 to Grade 4', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Per Anemia criteria in CTC version 5.0 there is no grade 4 for hemoglobin', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Per Anemia criteria in CTC version 5.0 there is no grade 4 for hemoglobin', 'groupId': 'OG001'}]}]}, {'title': 'HEMOGLOBIN Grade 2 to Grade 3', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'HEMOGLOBIN Grade 2 to Grade 4', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Per Anemia criteria in CTC version 5.0 there is no grade 4 for hemoglobin', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Per Anemia criteria in CTC version 5.0 there is no grade 4 for hemoglobin', 'groupId': 'OG001'}]}]}, {'title': 'HEMOGLOBIN Grade 3 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HEMOGLOBIN Grade 3 to Grade 4', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Per Anemia criteria in CTC version 5.0 there is no grade 4 for hemoglobin', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Per Anemia criteria in CTC version 5.0 there is no grade 4 for hemoglobin', 'groupId': 'OG001'}]}]}, {'title': 'PLATELET COUNT Grade 0 to Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'PLATELET COUNT Grade 0 to Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'PLATELET COUNT Grade 1 to Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'PLATELET COUNT Grade 1 to Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'PLATELET COUNT Grade 2 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'PLATELET COUNT Grade 2 to Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'PLATELET COUNT Grade 3 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'PLATELET COUNT Grade 3 to Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'PLATELET COUNT Grade 4 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'PLATELET COUNT Grade 4 to Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LEUKOCYTES Grade 0 to Grade 3', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'LEUKOCYTES Grade 0 to Grade 4', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'LEUKOCYTES Grade 1 to Grade 3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'LEUKOCYTES Grade 1 to Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'LEUKOCYTES Grade 2 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'LEUKOCYTES Grade 2 to Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 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{'title': 'HYPERMAGNESEMIA Grade 3 to Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPERMAGNESEMIA Grade 4 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPERMAGNESEMIA Grade 4 to Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOMAGNESEMIA Grade 0 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOMAGNESEMIA Grade 0 to Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOMAGNESEMIA Grade 1 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOMAGNESEMIA Grade 1 to Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOMAGNESEMIA Grade 2 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOMAGNESEMIA Grade 2 to Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOMAGNESEMIA Grade 3 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOMAGNESEMIA Grade 3 to Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOMAGNESEMIA Grade 4 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOMAGNESEMIA Grade 4 to Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOGLYCEMIA Grade 0 to Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HYPOGLYCEMIA Grade 0 to Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOGLYCEMIA Grade 1 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOGLYCEMIA Grade 1 to Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOGLYCEMIA Grade 2 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOGLYCEMIA Grade 2 to Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOGLYCEMIA Grade 3 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOGLYCEMIA Grade 3 to Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOGLYCEMIA Grade 4 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HYPOGLYCEMIA Grade 4 to Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)', 'description': 'The severity of laboratory test results were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0); Hematology parameters were evaluated for severity according to the following scale: Grade 0 is defined as absence of an AE or within normal limits; Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening. Number of participants with worst grade change results to Grade 3 or Grade 4 laboratory test results is presented. E.g., the row title HEMOGLOBIN Grade 0 to Grade 3, Grade 0 is baseline and Grade 3 is post baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'title': 'TSH > (Upper Limit of Normal) ULN', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'TSH > ULN with TSH <= Upper limit of Normal (ULN) AT Baseline', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'TSH > ULN with at Least One FT3/FT4 Test Value < LLN', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'TSH > ULN With All Other FT3/FT4 Test Values >= LLN', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'TSH > ULN with FT3/FT4 Test Missing', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'TSH < Lower Limit of Normal (LLN)', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}, {'title': 'TSH < LLN with TSH >= LLN at Baseline', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'TSH < LLN with at Least One FT3/FT4 Test Value > ULN', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'TSH < LLN with all other FT3/FT4 Test Values <= ULN', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'TSH < LLN with FT3/FT4 Test Missing', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)', 'description': 'Blood samples were collected for conducting specific thyroid test. Baseline is defined as evaluations or events that occur before the date and time of the first dose of study treatment. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with at least One on-treatment thyroid stimulating hormone (TSH) measurement'}, {'type': 'SECONDARY', 'title': 'Time to Pain Progression as Assessed by Brief Pain Inventory-Short Form (BPI-SF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'OG000'}, {'value': '516', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.53', 'groupId': 'OG000', 'lowerLimit': '10.28', 'upperLimit': '13.57'}, {'value': '12.42', 'groupId': 'OG001', 'lowerLimit': '11.07', 'upperLimit': '13.63'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to 1st pain symptoms at their worst over the last 24 hours (Up to approximately 31 months', 'description': 'The BPI-SF is an instrument to assess pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire designed to assess severity and impact of pain on daily function. Participants rate severity of pain at its "worst," "least," and "average" in last 24 hours using an 11-point numerical rating scale with anchors of "no pain" and "pain as bad. The participant\'s assessment of pain with BPI-SF Item number 3 (pain symptoms at their worst over the last 24 hours) form basis for analysis. Time to pain progression is time between date of randomization and date of first increase in worst pain intensity. Pain progression occurred if an increase in worst pain intensity of \\>= 2 points is observed from baseline and maintained over 2 consecutive time periods. Baseline was evaluations or events that occur before date and time of first dose of study treatment or evaluations on same date and time of first dose of study treatment were also considered as baseline.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'FG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}], 'periods': [{'title': 'Pre-Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '514'}, {'groupId': 'FG001', 'numSubjects': '516'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '510'}, {'groupId': 'FG001', 'numSubjects': '510'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Not Reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Subject no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Poor/Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant request to discontinue study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '510'}, {'groupId': 'FG001', 'numSubjects': '510'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '491'}, {'groupId': 'FG001', 'numSubjects': '499'}]}], 'dropWithdraws': [{'type': 'Ongoing Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'Completed treatment as per protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Maximum clinical benefit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse event unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Study drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '327'}]}, {'type': 'Administrative reasons by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Poor/Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Participant request to discontinue study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'BG000'}, {'value': '516', 'groupId': 'BG001'}, {'value': '1030', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nivolumab + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'BG001', 'title': 'Placebo + Docetaxel + Prednisone', 'description': 'Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.9', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '69.6', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '69.2', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '514', 'groupId': 'BG000'}, {'value': '515', 'groupId': 'BG001'}, {'value': '1029', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '333', 'groupId': 'BG000'}, {'value': '329', 'groupId': 'BG001'}, {'value': '662', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or other pacific islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Chinese', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}, {'title': 'Japanese', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}, {'title': 'Asian other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Asian Indian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-22', 'size': 32041912, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-30T10:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-Blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1030}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2019-09-20', 'resultsFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2019-09-20', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-18', 'studyFirstPostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic Progressive Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group 3 (PCWG3)', 'timeFrame': 'from randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 31 months)', 'description': 'rPFS for randomized participants is the time between randomization and the first date of documented progression or death due to any cause, whichever occurs first. The rPFS was censored at the last radiographic tumor assessment up to the start of subsequent cancer therapy for those without progression or death. It was also censored at the date of last radiographic tumor assessment prior to the missed tumor assessments for participants who had progressive disease (PD) or death immediately after more than one consecutive missed tumor assessments. Radiographic progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (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 millimeter (mm). The appearance of one or more new lesions is also considered progression.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization to the date of death from any cause (Up to approximately 31 months)', 'description': 'OS for all randomized participants is the time between randomization and the date of death from any cause. For participants who are alive, their survival time was censored at the last date that they were known to be alive. OS was censored for participants at the date of randomization if they had no follow-up.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)', 'timeFrame': 'From date of randomization to the date of objectively documented progression per PCWG3 or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 52 months)', 'description': 'Objective Response Rate per PCWG3 (ORR-PCWG3) is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among randomized participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.'}, {'measure': 'Time to Response (TTR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)', 'timeFrame': 'From randomization to the date of the first documented CR or PR (Up to approximately 52 months)', 'description': 'Time to Response per PCWG3 (TTR-PCWG3) is the time from randomization to the date of the first documented CR or PR per PCWG3, as determined by BICR. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Duration of Response Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)', 'timeFrame': 'From randomization date to the date of first documented radiographic progression or death due to any cause whichever occurs first (Up to approximately 52 months)', 'description': 'Duration of Response per PCWG3 (DOR-PCWG3) is time between the date of first response (CR/PR per PCWG3) to the date of first documented radiographic progression per PCWG3,as determined by BICR, or death due to any cause whichever occurs first. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Radiographic progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.'}, {'measure': 'Prostate-specific Antigen (PSA) Response Rate (PSA-RR)', 'timeFrame': 'Up to approximately 52 months', 'description': 'PSA Response Rate (PSA-RR) is the percentage of randomized participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response. Baseline was defined as valuations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.'}, {'measure': 'Time to PSA Progression (TTP-PSA)', 'timeFrame': 'from randomization to the date of PSA Progression (Up to approximately 31 months)', 'description': 'Time to PSA Progression (TTP-PSA) is the time between randomization to the date of PSA progression per PCWG3 in randomized participants. PSA Progression: For participants with an initial PSA decline from baseline, the date of PSA progression is the date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from the nadir are documented and confirmed by a second consecutive PSA value at least 3 weeks later. For participants with no PSA decline from baseline, the date of PSA progression is date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from baseline are documented at or beyond Week 13. Baseline was defined as valuations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. Censored at date of last PSA evaluation on/prior to start of subsequent cancer therapy.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From first dose and 30 days after last dose of study therapy (Up to approximately 25 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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.'}, {'measure': 'Number of Participants With Serious Adverse Events', 'timeFrame': 'From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)', 'description': 'Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death or Is life-threatening or requires inpatient hospitalization or causes prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.'}, {'measure': 'Number of Participants With Adverse Events Leading to Discontinuation', 'timeFrame': 'From first dose and 30 days after last dose of study therapy (Up to approximately 25 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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.'}, {'measure': 'Number of Participants With Endocrine Immune-Mediated Adverse Events', 'timeFrame': 'From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)', 'description': 'Immune-mediated adverse events 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. 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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.'}, {'measure': 'Number of Participants With Non-Endocrine Immune-Mediated Adverse Events', 'timeFrame': 'From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)', 'description': 'Immune-mediated adverse events 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. 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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.'}, {'measure': 'Number of Participants With Select Adverse Events', 'timeFrame': 'From first dose and 30 days after last dose of study therapy (Up to approximately 25 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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.'}, {'measure': 'Number of Participants Who Died', 'timeFrame': 'Up to approximately 52 months'}, {'measure': 'Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline', 'timeFrame': 'From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)', 'description': 'The severity of laboratory test results were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0); Hematology parameters were evaluated for severity according to the following scale: Grade 0 is defined as absence of an AE or within normal limits; Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening. Number of participants with worst grade change results to Grade 3 or Grade 4 laboratory test results is presented. E.g., the row title HEMOGLOBIN Grade 0 to Grade 3, Grade 0 is baseline and Grade 3 is post baseline.'}, {'measure': 'Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests', 'timeFrame': 'From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)', 'description': 'Blood samples were collected for conducting specific thyroid test. Baseline is defined as evaluations or events that occur before the date and time of the first dose of study treatment. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.'}, {'measure': 'Time to Pain Progression as Assessed by Brief Pain Inventory-Short Form (BPI-SF)', 'timeFrame': 'From randomization to 1st pain symptoms at their worst over the last 24 hours (Up to approximately 31 months', 'description': 'The BPI-SF is an instrument to assess pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire designed to assess severity and impact of pain on daily function. Participants rate severity of pain at its "worst," "least," and "average" in last 24 hours using an 11-point numerical rating scale with anchors of "no pain" and "pain as bad. The participant\'s assessment of pain with BPI-SF Item number 3 (pain symptoms at their worst over the last 24 hours) form basis for analysis. Time to pain progression is time between date of randomization and date of first increase in worst pain intensity. Pain progression occurred if an increase in worst pain intensity of \\>= 2 points is observed from baseline and maintained over 2 consecutive time periods. Baseline was evaluations or events that occur before date and time of first dose of study treatment or evaluations on same date and time of first dose of study treatment were also considered as baseline.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'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 assess the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologic confirmation of adenocarcinoma of the prostate without small cell features\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* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy\n* Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening\n* Chemotherapy-naïve for metastatic castration-resistant prostate cancer (mCRPC), with 1 to 2 prior second generation hormonal therapies in the recurrent non-metastatic setting and/or metastatic setting, and no more than 1 second generation hormonal therapy in the mCRPC setting. Must have progressed during or after second generation hormonal therapy or have documented intolerance to second generation hormonal therapy\n* Participants must meet one of the following criteria regarding tissue submission: Sufficient tumor samples from a newly obtained ("fresh") biopsy (obtained during screening); or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides. For participants with bone-only disease or inaccessible soft tissue lesions or if the biopsy procedure would pose an unacceptable clinical risk for the participant, submission of tumor tissue obtained from a fresh biopsy is not required.\n* Men must agree to follow specific methods of contraception, if applicable\n\nExclusion Criteria:\n\n* Active brain metastases\n* Active, known, or suspected autoimmune disease\n* Condition requiring systemic treatment with corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids or adrenal replacement steroid doses are permitted in the absence of active autoimmune disease\n* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways\n* Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for metastatic castration-sensitive prostate cancer is permitted if at least 12 months have elapsed from last dose of docetaxel\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04100018', 'acronym': 'CheckMate 7DX', 'briefTitle': 'A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer', 'orgStudyIdInfo': {'id': 'CA209-7DX'}, 'secondaryIdInfos': [{'id': '2019-002030-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Nivolumab + docetaxel + prednisone', 'interventionNames': ['Biological: Nivolumab', 'Drug: Prednisone', 'Drug: Docetaxel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm B: Placebo + docetaxel + prednisone', 'interventionNames': ['Drug: Prednisone', 'Drug: Docetaxel', 'Other: Placebo']}], 'interventions': [{'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['OPDIVO,', 'BMS-936558-01'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm A: Nivolumab + docetaxel + prednisone']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm A: Nivolumab + docetaxel + prednisone', 'Arm B: Placebo + docetaxel + prednisone']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm A: Nivolumab + docetaxel + prednisone', 'Arm B: Placebo + docetaxel + prednisone']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm B: Placebo + docetaxel + prednisone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608-1753', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution - 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