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Ignite Creation Date: 2025-12-24 @ 10:31 PM

Ignite Modification Date: 2026-02-13 @ 3:10 AM

Study NCT ID: NCT01695135

Status: COMPLETED

Last Update Posted: 2019-07-18

First Post: 2012-09-25

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study of Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Vietnam']}, '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': 'D000069501', 'term': 'Abiraterone Acetate'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Senior Director', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately up to 3.8 years', 'description': 'Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo + Prednisone (Double-blind)', 'description': 'Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.', 'otherNumAtRisk': 71, 'otherNumAffected': 62, 'seriousNumAtRisk': 71, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Abiraterone Acetate + Prednisone (Double-blind)', 'description': 'Participants received abiraterone acetate (AA) 1000 mg (4\\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.', 'otherNumAtRisk': 143, 'otherNumAffected': 134, 'seriousNumAtRisk': 143, 'seriousNumAffected': 33}, {'id': 'EG002', 'title': 'Placebo + Prednisone (DB) to AA + Prednisone (Open-label)', 'description': "Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.", 'otherNumAtRisk': 49, 'otherNumAffected': 35, 'seriousNumAtRisk': 49, 'seriousNumAffected': 25}, {'id': 'EG003', 'title': 'AA + Prednisone to AA + Prednisone (Open-label)', 'description': "Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.", 'otherNumAtRisk': 80, 'otherNumAffected': 54, 'seriousNumAtRisk': 80, 'seriousNumAffected': 41}], 'otherEvents': [{'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'White blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 29}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}], 'seriousEvents': [{'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Haemorrhagic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Blindness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Blindness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Prostatic haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'DB Phase: Time to Prostate-Specific Antigen Progression (PSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone (Double-blind)', 'description': 'Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate + Prednisone (Double-blind)', 'description': 'Participants received abiraterone acetate (AA) 1000 mg (4\\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.00', 'groupId': 'OG000', 'lowerLimit': '31.00', 'upperLimit': '113.00'}, {'value': '169.00', 'groupId': 'OG001', 'lowerLimit': '141.00', 'upperLimit': '197.00'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.528', 'ciLowerLimit': '0.376', 'ciUpperLimit': '0.740', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 1.8 years', 'description': 'Time to PSA progression was defined as time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the Prostate Specific Antigen Working Group (PSAWG) criteria. PSAWG criteria- Decline from baseline and reach response criteria: greater than or equal to (\\>=) 50 percent (%) increase over the nadir and the increase in the absolute-value by at least 5 nanogram per milliliter (ng/mL) (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: \\>=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: \\>=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'DB Phase: Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone (Double-blind)', 'description': 'Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate + Prednisone (Double-blind)', 'description': 'Participants received abiraterone acetate (AA) 1000 mg (4\\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '561.00', 'groupId': 'OG000', 'lowerLimit': '352.00', 'upperLimit': '787.00'}, {'value': '579.00', 'groupId': 'OG001', 'lowerLimit': '504.00', 'upperLimit': '731.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of death due to any cause (up to approximately 3.8 years)', 'description': 'Overall survival was defined as the time interval from the date of randomization to the date of death from any cause.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'DB Phase: Percentage of Participants Who Achieved PSA Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone (Double-blind)', 'description': 'Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate + Prednisone (Double-blind)', 'description': 'Participants received abiraterone acetate (AA) 1000 mg (4\\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'groupId': 'OG000'}, {'value': '54.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately up to 3.8 years', 'description': 'Percentage of participants who achieved PSA response (defined as \\>= 50% PSA decline from baseline) according to PSAWG criteria were reported. PSAWG criteria- Decline from baseline and reach response criteria: \\>= 50% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: \\>=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: \\>=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'DB Phase: Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone (Double-blind)', 'description': 'Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate + Prednisone (Double-blind)', 'description': 'Participants received abiraterone acetate (AA) 1000 mg (4\\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '17.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately up to 3.8 years', 'description': 'ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Population included only participants with measurable disease at baseline.'}, {'type': 'SECONDARY', 'title': 'DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone (Double-blind)', 'description': 'Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate + Prednisone (Double-blind)', 'description': 'Participants received abiraterone acetate (AA) 1000 mg (4\\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}], 'classes': [{'title': 'Total Score', 'categories': [{'measurements': [{'value': '-19.9', 'spread': '22.07', 'groupId': 'OG000'}, {'value': '-16.1', 'spread': '22.74', 'groupId': 'OG001'}]}]}, {'title': 'Physical Well-being', 'categories': [{'measurements': [{'value': '-6.7', 'spread': '6.52', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '6.85', 'groupId': 'OG001'}]}]}, {'title': 'Functional Well-being', 'categories': [{'measurements': [{'value': '-5.1', 'spread': '6.60', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '7.31', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Well-being', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '4.48', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '4.87', 'groupId': 'OG001'}]}]}, {'title': 'Social Well-being', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '3.82', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '6.55', 'groupId': 'OG001'}]}]}, {'title': 'FACT-G Total Score', 'categories': [{'measurements': [{'value': '-14.6', 'spread': '16.25', 'groupId': 'OG000'}, {'value': '-11.2', 'spread': '17.19', 'groupId': 'OG001'}]}]}, {'title': 'Prostate Cancer Subscale (PCS)', 'categories': [{'measurements': [{'value': '-5.3', 'spread': '7.99', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '7.70', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Outcome Index (FACT-TOI)', 'categories': [{'measurements': [{'value': '-17.1', 'spread': '17.76', 'groupId': 'OG000'}, {'value': '-12.5', 'spread': '17.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])', 'description': 'FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS) (Range 1-156, higher scores better). The FACT-General (FACT-G) is a 28 item Quality of Life (QOL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional (0-24) Well-being. The total range was between 1-108, higher scores better. Functional Assessment of Cancer Therapy-Treatment Outcome Index (FACT-TOI) is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better). PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'DB Phase: Time to Pain Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone (Double-blind)', 'description': 'Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate + Prednisone (Double-blind)', 'description': 'Participants received abiraterone acetate (AA) 1000 mg (4\\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '169.00', 'groupId': 'OG000', 'lowerLimit': '85.00', 'upperLimit': '253.00'}, {'value': '505.00', 'comment': "Here 'NA' represents that upper limit of Confidence Interval (CI) was not estimable due to lesser number of events.", 'groupId': 'OG001', 'lowerLimit': '365.00', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Approximately up to 3.8 years', 'description': 'Time to Pain progression calculated as number of days from date of randomization to date of pain progression. Pain progression- worsening of pain due to metastatic bone disease defined as increase of \\>=30% in worst pain over past 24 hours on BPI-SF numeric rating scale at 2 consecutive evaluations 4 weeks apart without decrease in analgesic usage score (in 2 corresponding consecutive evaluation in analgesic usage score, if there is missing visit, use existing visit only) or increase in analgesic usage score \\>=30% at 2 consecutive evaluations 4 weeks apart. BPI-SF is 11-item questionnaire which includes 4 questions that assess pain intensity and 7 questions that assess impact of pain on daily functions. Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores= greater pain. Analgesic usage was scored on scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'DB Phase: Percentage of Participants Experiencing Pain Palliation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone (Double-blind)', 'description': 'Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate + Prednisone (Double-blind)', 'description': 'Participants received abiraterone acetate (AA) 1000 mg (4\\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000'}, {'value': '54.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately up to 3.8 years', 'description': 'Percentage of participants experiencing pain palliation were reported. A participant is responder if experienced \\>=30% reduction in Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity score over 24 hours observed at 2 consecutive evaluations 4 weeks apart without any increase in analgesic usage score (best response). Analgesic usage was scored on a scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain. BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions. It includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Population included only participants whose pain score was \\>= 4 at baseline.'}, {'type': 'SECONDARY', 'title': 'DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone (Double-blind)', 'description': 'Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate + Prednisone (Double-blind)', 'description': 'Participants received abiraterone acetate (AA) 1000 mg (4\\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}], 'classes': [{'title': 'Fatigue Now', 'categories': [{'measurements': [{'value': '2.4', 'spread': '3.59', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '3.34', 'groupId': 'OG001'}]}]}, {'title': 'Usual Fatigue', 'categories': [{'measurements': [{'value': '2.4', 'spread': '3.53', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '3.18', 'groupId': 'OG001'}]}]}, {'title': 'Worst Fatigue', 'categories': [{'measurements': [{'value': '2.6', 'spread': '3.73', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '3.49', 'groupId': 'OG001'}]}]}, {'title': 'General Activity', 'categories': [{'measurements': [{'value': '2.3', 'spread': '3.65', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '3.38', 'groupId': 'OG001'}]}]}, {'title': 'Mood', 'categories': [{'measurements': [{'value': '2.7', 'spread': '3.39', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '3.40', 'groupId': 'OG001'}]}]}, {'title': 'Walking Ability', 'categories': [{'measurements': [{'value': '2.4', 'spread': '3.28', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '3.50', 'groupId': 'OG001'}]}]}, {'title': 'Normal Work', 'categories': [{'measurements': [{'value': '2.2', 'spread': '3.84', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '3.71', 'groupId': 'OG001'}]}]}, {'title': 'Relations with Other People', 'categories': [{'measurements': [{'value': '2.0', 'spread': '3.08', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '3.25', 'groupId': 'OG001'}]}]}, {'title': 'Enjoyment of Life', 'categories': [{'measurements': [{'value': '2.5', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '3.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])', 'description': 'The Brief Fatigue Inventory (BFI) is a brief participant-reported questionnaire that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. BFI has nine items. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient\'s life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes." BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + Prednisone (Double-blind [DB])', 'description': 'Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}, {'id': 'FG001', 'title': 'Abiraterone Acetate + Prednisone (Double-blind)', 'description': 'Participants received abiraterone acetate (AA) 1000 mg (4\\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}, {'id': 'FG002', 'title': 'Placebo + Prednisone (DB) to AA + Prednisone (Open-label)', 'description': "Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation."}, {'id': 'FG003', 'title': 'AA + Prednisone to AA + Prednisone (Open-label)', 'description': "Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation."}], 'periods': [{'title': 'Double-blind Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '143'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '139'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '110'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Noncompliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Open Label Extension Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '70'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Noncompliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 214 participants were enrolled in the study (143 participants in abiraterone acetate group and 71 participants in placebo group).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + Prednisone (Double-blind)', 'description': 'Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}, {'id': 'BG001', 'title': 'Abiraterone Acetate + Prednisone (Double-blind)', 'description': 'Participants received abiraterone acetate (AA) 1000 mg (4\\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.7', 'spread': '7.75', 'groupId': 'BG000'}, {'value': '68.2', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '68', 'spread': '8.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-07', 'studyFirstSubmitDate': '2012-09-25', 'resultsFirstSubmitDate': '2019-05-07', 'studyFirstSubmitQcDate': '2012-09-25', 'lastUpdatePostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-07', 'studyFirstPostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DB Phase: Time to Prostate-Specific Antigen Progression (PSA)', 'timeFrame': 'Up to 1.8 years', 'description': 'Time to PSA progression was defined as time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the Prostate Specific Antigen Working Group (PSAWG) criteria. PSAWG criteria- Decline from baseline and reach response criteria: greater than or equal to (\\>=) 50 percent (%) increase over the nadir and the increase in the absolute-value by at least 5 nanogram per milliliter (ng/mL) (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: \\>=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: \\>=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.'}], 'secondaryOutcomes': [{'measure': 'DB Phase: Overall Survival', 'timeFrame': 'From randomization to the date of death due to any cause (up to approximately 3.8 years)', 'description': 'Overall survival was defined as the time interval from the date of randomization to the date of death from any cause.'}, {'measure': 'DB Phase: Percentage of Participants Who Achieved PSA Response', 'timeFrame': 'Approximately up to 3.8 years', 'description': 'Percentage of participants who achieved PSA response (defined as \\>= 50% PSA decline from baseline) according to PSAWG criteria were reported. PSAWG criteria- Decline from baseline and reach response criteria: \\>= 50% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: \\>=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: \\>=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.'}, {'measure': 'DB Phase: Objective Response Rate (ORR)', 'timeFrame': 'Approximately up to 3.8 years', 'description': 'ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.'}, {'measure': 'DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment', 'timeFrame': 'Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])', 'description': 'FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS) (Range 1-156, higher scores better). The FACT-General (FACT-G) is a 28 item Quality of Life (QOL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional (0-24) Well-being. The total range was between 1-108, higher scores better. Functional Assessment of Cancer Therapy-Treatment Outcome Index (FACT-TOI) is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better). PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better).'}, {'measure': 'DB Phase: Time to Pain Progression', 'timeFrame': 'Approximately up to 3.8 years', 'description': 'Time to Pain progression calculated as number of days from date of randomization to date of pain progression. Pain progression- worsening of pain due to metastatic bone disease defined as increase of \\>=30% in worst pain over past 24 hours on BPI-SF numeric rating scale at 2 consecutive evaluations 4 weeks apart without decrease in analgesic usage score (in 2 corresponding consecutive evaluation in analgesic usage score, if there is missing visit, use existing visit only) or increase in analgesic usage score \\>=30% at 2 consecutive evaluations 4 weeks apart. BPI-SF is 11-item questionnaire which includes 4 questions that assess pain intensity and 7 questions that assess impact of pain on daily functions. Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores= greater pain. Analgesic usage was scored on scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain.'}, {'measure': 'DB Phase: Percentage of Participants Experiencing Pain Palliation', 'timeFrame': 'Approximately up to 3.8 years', 'description': 'Percentage of participants experiencing pain palliation were reported. A participant is responder if experienced \\>=30% reduction in Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity score over 24 hours observed at 2 consecutive evaluations 4 weeks apart without any increase in analgesic usage score (best response). Analgesic usage was scored on a scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain. BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions. It includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.'}, {'measure': 'DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment', 'timeFrame': 'Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])', 'description': 'The Brief Fatigue Inventory (BFI) is a brief participant-reported questionnaire that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. BFI has nine items. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient\'s life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes." BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate neoplasms', 'Prostate cancer', 'Metastatic castration resistant prostate cancer', 'Abiraterone acetate', 'JNJ-212082'], 'conditions': ['Prostate Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate when co-administered with prednisone in Asian patients with metastatic castration-resistant prostate cancer (mCRPC) who have failed docetaxel-based chemotherapy.', 'detailedDescription': "This is a randomized (the treatment group is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives) placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study with a randomization allocation ratio of 2:1 between the abiraterone acetate group (abiraterone acetate plus prednisone) and the placebo group (placebo plus prednisone). Approximately 200 (133 in the abiraterone acetate group and 67 in the placebo group) medically or surgically castrated male patients with mCRPC who have failed docetaxel-based chemotherapy will be enrolled in this study for up to 27 months. The study protocol includes the following phases: screening (within 28 days prior to randomization on Cycle 1 Day 1), double-blind treatment (28-day cycles until protocol-defined disease progression or unacceptable toxicity), and survival follow-up (up to Month 60). During the follow-up phase, patients with disease progression will be provided open-label (identity of assigned study drug will be known) extension treatment with abiraterone acetate. In the event of a positive study result at the time of the final analysis, participants in the placebo group who have not shown progressive disease in the double-blind treatment Phase of the study will be enrolled in an open-label extension treatment with abiraterone acetate treatment based on the participant's choice and treating physician's endorsement if they meet the criteria for subsequent abiraterone acetate. Abiraterone acetate 1000 mg tablets or placebo will be taken orally (by mouth) once daily plus prednisone 5 mg tablet orally twice daily. Efficacy and safety will be monitored throughout the study."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate except neuroendocrine carcinoma including small cell carcinoma\n* Disease progressed on or after prior docetaxel-containing chemotherapy\n* Prior 1 or 2 cytotoxic chemotherapy regimens for metastatic castration-resistant prostate cancer, at least 1 of which contains docetaxel\n* Documented prostate cancer progression as documented by prostate specific antigen progression according to Prostate Specific Antigen Working Group criteria or radiographic progression in soft tissue or bone\n* Surgically or medically castrated, with serum testosterone level \\<50 ng/dL (1.7 nmol/L)\n* Eastern Cooperative Oncology Group performance status score of \\<=2\n* Protocol-defined laboratory values\n* Agrees to protocol-defined use of effective contraception\n\nExclusion Criteria:\n\n* Active infection or other medical condition that would make prednisone (corticosteroid) use contraindicated\n* Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone twice daily\n* Pathological finding consistent with neuroendocrine carcinoma of prostate including small cell carcinoma\n* Uncontrolled hypertension (systolic BP \\>=160 mmHg or diastolic BP \\>=95 mmHg; patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy)\n* Active or symptomatic viral hepatitis or chronic liver disease, have a known infection with human immunodeficiency virus and/or hepatitis B virus or hepatitis C virus\n* History of pituitary or adrenal dysfunction.\n* Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class III or IV heart disease or cardiac ejection fraction measurement of \\<50% at baseline\n* Atrial fibrillation, or other cardiac arrhythmia requiring therapy\n* Other malignancy within past 3 years (except basal or nonmetastatic squamous cell carcinoma of the skin)\n* Known brain metastasis\n* Prior therapy with abiraterone acetate or other CYP17 inhibitor(s), or investigational agent(s) targeting the androgen receptor for metastatic prostate cancer\n* Prior therapy with ketoconazole for prostate cancer\n* Surgery or local prostatic intervention within 30 days of the first dose\n* Radiotherapy, chemotherapy, or immunotherapy within 30 days, or single fraction of palliative radiotherapy within 14 days of administration of Cycle 1 Day 1\n* Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a National Cancer Institute-Common Terminology Criteria for Adverse Events grade of \\<=1 (chemotherapy induced alopecia and grade 2 peripheral neuropathy is allowed)\n* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Cycle 1 Day 1\n* Anti-androgen treatment must not be given within 4 weeks (flutamide) or 6 weeks (bicalutamide or nilutamide) prior to Cycle 1 Day 1\n* Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole) within 4 weeks prior to Cycle 1 Day 1\n* Has known allergies, hypersensitivity, or intolerance to abiraterone acetate or its excipients\n* Has contraindications to the use of prednisone per local prescribing information\n* Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments'}, 'identificationModule': {'nctId': 'NCT01695135', 'briefTitle': 'A Study of Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy', 'orgStudyIdInfo': {'id': 'CR100010'}, 'secondaryIdInfos': [{'id': 'ABI-PRO-3001', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abiraterone acetate plus prednisone', 'interventionNames': ['Drug: Abiraterone acetate', 'Drug: Prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo plus prednisone', 'interventionNames': ['Drug: Placebo', 'Drug: Prednisone']}], 'interventions': [{'name': 'Abiraterone acetate', 'type': 'DRUG', 'description': 'Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily', 'armGroupLabels': ['Abiraterone acetate plus prednisone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (4 tablets) taken orally once daily', 'armGroupLabels': ['Placebo plus prednisone']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Prednisone 5 mg tablet taken orally twice daily', 'armGroupLabels': ['Abiraterone acetate plus prednisone', 'Placebo plus prednisone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changsha', 'country': 'China', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Chongqing', 'country': 'China', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Guangzhou', 'country': 'China', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hangzhou', 'country': 'China', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Nanjing', 'country': 'China', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Suzhou', 'country': 'China', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Tianjin', 'country': 'China', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Wenzhou', 'country': 'China', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'city': 'Wuhan', 'country': 'China', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}