Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-02-20 @ 6:03 PM
Study NCT ID:
NCT02975934
Status:
COMPLETED
Last Update Posted:
2025-07-25
First Post:
2016-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C531549', 'term': 'rucaparib'}, {'id': 'D000069501', 'term': 'Abiraterone Acetate'}, {'id': 'C540278', 'term': 'enzalutamide'}, {'id': 'D000077143', 'term': 'Docetaxel'}], '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': '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': 'medinfo@pharmaand.com', 'phone': '+43/1/3560006', 'title': 'Medical Information Department', 'organization': 'pharmaand GmbH'}, 'certainAgreement': {'otherDetails': "Sponsor's agreements with investigators require proposed public disclosures of trial results to be submitted to Sponsor for review prior to publication. Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).', 'description': "All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.", 'eventGroups': [{'id': 'EG000', 'title': 'Rucaparib (Treatment Phase)', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.', 'otherNumAtRisk': 270, 'deathsNumAtRisk': 270, 'otherNumAffected': 270, 'seriousNumAtRisk': 270, 'deathsNumAffected': 6, 'seriousNumAffected': 81}, {'id': 'EG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel (Treatment Phase)', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 135, 'otherNumAffected': 127, 'seriousNumAtRisk': 130, 'deathsNumAffected': 3, 'seriousNumAffected': 36}, {'id': 'EG002', 'title': 'Rucaparib (Cross-over Phase)', 'description': 'Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily. Participants from the Abiraterone Acetate/Enzalutamide/Docetaxel arm who completed the Treatment Phase and radiographically progressed by independent radiology review (IRR) may receive rucaparib treatment during the Cross-Over Phase.\n\nAfter analysis of the primary endpoint, investigator-assessed radiographic disease progression will be used for cross-over eligibility evaluation.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 67, 'seriousNumAtRisk': 70, 'deathsNumAffected': 1, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 435, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 30, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 90, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 37, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 44, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 101, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 118, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 49, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 222, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 44, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 41, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 20, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 98, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 25, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 136, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 36, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 203, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 123, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 41, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 70, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 29, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 29, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 146, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 44, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 120, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 46, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 43, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 17, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 97, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 27, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 64, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 103, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 20, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 65, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 18, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 52, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 27, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 139, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 43, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 27, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 51, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 16, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 17, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 34, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 69, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 41, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 97, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 19, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 48, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 17, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 44, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 48, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 42, 'numAffected': 31}, 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'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Sacral radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bronchopneumopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '13.8'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '8.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.69', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)', 'description': 'The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first).\n\nRadiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with BRCA mutated mCRPC.'}, {'type': 'PRIMARY', 'title': 'Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '11.2'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '8.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.47', 'ciUpperLimit': '0.80', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)', 'description': 'The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first).\n\nRadiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria (Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC).'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Participants With a BRCA Alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '25.2'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '18.0', 'upperLimit': '23.1'}]}]}], 'analyses': [{'pValue': '0.5044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.20', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From enrollment to completion of study (up to approximately 7 years)', 'description': 'Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participant was last known to be alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with BRCA mutated mCRPC.'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Participants With a BRCA or ATM Alteration Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '24.2'}, {'value': '21.7', 'groupId': 'OG001', 'lowerLimit': '18.9', 'upperLimit': '23.3'}]}]}], 'analyses': [{'pValue': '0.9368', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.26', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From enrollment to completion of study (up to approximately 7 years)', 'description': 'Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participants was last known to be alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC).'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) by IRR in Participants With a BRCA Alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)', 'description': 'ORR is defined as the percentage of participants with a confirmed best response of Complete response (CR) or Partial Response (PR) in participants with measurable disease at study entry. Modified RECIST Version 1.1 criteria is used to determine ORR (ie, CR or PR by IRR assessment and no progression in bone per PCWG3 by IRR assessment).\n\nCR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with BRCA mutated mCRPC and measurable disease at baseline.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) by IRR in Participants With a BRCA or ATM Alteration Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)', 'description': 'ORR is defined as the percentage of participants with a confirmed best response of Complete response (CR) or Partial Response (PR) in participants with measurable disease at study entry. Modified RECIST Version 1.1 criteria is used to determine ORR (ie, CR or PR by IRR assessment and no progression in bone per PCWG3 by IRR assessment).\n\nCR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC) with measurable disease at baseline.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) by IRR in Participants With a BRCA Alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '12.7'}, {'value': '7.4', 'comment': 'The upper limit of the confidence interval is inestimable likely due to the small number of participants in this treatment group.', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)', 'description': 'DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT Population with BRCA mutated mCRPC and measurable disease at baseline. 'Overall number of participants analyzed' = participants with objective response."}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) by IRR in Participants With a BRCA or ATM Alteration Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '12.7'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '14.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)', 'description': 'DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC) with measurable disease at baseline. 'Overall number of participants analyzed' = participants with objective response."}, {'type': 'SECONDARY', 'title': 'PSA Response in Participants With a BRCA Alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment to primary completion of study (up to approximately 5 years)', 'description': 'Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with BRCA mutated mCRPC.'}, {'type': 'SECONDARY', 'title': 'PSA Response in Participants With a BRCA or ATM Alteration Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment to primary completion of study (up to approximately 5 years)', 'description': 'Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC).'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000'}, {'value': '22.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment to 6 months', 'description': 'Defined as the percentage of participants with a complete response (CR), partial response (PR), and stable disease (SD) according to modified RECIST Version 1.1 with no progression in bone per PCWG3 criteria.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants with BRCA mutated mCRPC who received at least one dose of protocol-specified treatment and had 6 months of follow-up prior to the data cutoff.'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA or ATM Alteration Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'groupId': 'OG000'}, {'value': '25.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment to 6 months', 'description': 'Defined as the percentage of participants with a Complete Response (CR), Partial Response (PR), and Stable Disease (SD), according to Modified RECIST Version 1.1 with no progression in bone per PCWG3 Criteria.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who received at least one dose of protocol-specified treatment and had 6 months of follow-up prior to the data cutoff.'}, {'type': 'SECONDARY', 'title': 'Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA Alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '7.7'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '4.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From enrollment to primary completion of study (up to approximately 5 years)', 'description': 'Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with BRCA mutated mCRPC.'}, {'type': 'SECONDARY', 'title': 'Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA or ATM Alteration Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '6.5'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '4.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From enrollment to primary completion of study (up to approximately 5 years)', 'description': 'Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC).'}, {'type': 'SECONDARY', 'title': 'Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: FACT-P', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '2.23', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From enrollment to up to approximately 25 weeks', 'description': 'Changes in health and pain status from baseline to week 25 using: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P total score, on a scale of 0 to 156 where a higher score is better quality of life). The greater the decrease in score (ie more negative) from baseline to week 25 the greater the decrease in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT Population with BRCA mutated mCRPC. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'title': 'BPI-SF Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.139', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.285', 'groupId': 'OG001'}]}]}, {'title': 'BPI-SF Interference Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.147', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '0.302', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From enrollment to up to approximately 25 weeks', 'description': 'Changes in health and pain status from baseline to week 25 using: Brief Pain Inventory-Short Form (BPI-SF) questionnaire (on a scale of 1 to 10, from mild to severe, for pain and pain-interference scores). A decrease indicates less severe pain/interference. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT Population with BRCA mutated mCRPC. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category."}, {'type': 'SECONDARY', 'title': 'Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'OG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '2.39', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From enrollment to up to approximately 25 weeks', 'description': 'Changes in health and pain status from baseline to week 25 using: EuroQol-5D-5L Visual Analogue Scale (EQ-5D-5L VAS; on a scale from 100 to 0, from best to worst health status). The greater the increase in score (including more negative) from baseline to week 25 the greater the increase in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT Population with BRCA mutated mCRPC. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Trough Plasma PK (Cmin) of Rucaparib Based on Sparse Sampling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '1310', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '4180'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From enrollment to week 5 of dosing', 'description': 'Mean trough PK plasma concentration over time in the safety population with at least one PK sample collected at timepoints week 5, 9, 13 and 17; only Week 5 data presented.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population with at least 1 PK sample collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'FG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}, {'id': 'FG002', 'title': 'Rucaparib (Cross-Over Phase)', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily. Participants from the Abiraterone Acetate/Enzalutamide/Docetaxel arm who completed the Treatment Phase and radiographically progressed by independent radiology review (IRR) may receive rucaparib treatment during the Cross-Over Phase.\n\nAfter analysis of the primary endpoint, investigator-assessed radiographic disease progression will be used for cross-over eligibility evaluation.'}], 'periods': [{'title': 'Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '135'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '130'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '130'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Treatment period completion was defined as discontinuation when criteria for treatment discontinuation were met.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '130'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Never initiated study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Cross-Over Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '70'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '70'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'comment': 'Crossover period completion was defined as discontinuation when criteria for treatment discontinuation were met, or study closure.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '405', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).\n\nRucaparib: Rucaparib will be administered daily.'}, {'id': 'BG001', 'title': 'Abiraterone Acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).\n\nAbiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.\n\nDocetaxel will be administered every 3 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '90'}, {'value': '71', 'groupId': 'BG001', 'lowerLimit': '47', 'upperLimit': '92'}, {'value': '70', 'groupId': 'BG002', 'lowerLimit': '45', 'upperLimit': '92'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'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': '270', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '405', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ECOG Performance Status (at stratification)', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance Status Scale. ECOG 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work or office work)', 'unitOfMeasure': 'Participants'}, {'title': 'Gene Alteration (at stratification)', 'classes': [{'categories': [{'title': 'BRCA1', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'BRCA2', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}, {'title': 'ATM', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline prostate specific antigen (PSA)', 'classes': [{'categories': [{'measurements': [{'value': '26.9', 'groupId': 'BG000', 'lowerLimit': '0.1', 'upperLimit': '1247'}, {'value': '28.8', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '1039'}, {'value': '27.8', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '1247'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'FULL_RANGE'}, {'title': 'Gleason score ≥8 at diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The scale for the Gleason score ranges from 2 to 10, with higher scores indicating a worse prognosis', 'unitOfMeasure': 'Participants'}, {'title': 'Measurable Disease per Independent Radiological Review (IRR)', 'classes': [{'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Metastases site(s) by IRR', 'classes': [{'title': 'Bone', 'categories': [{'measurements': [{'value': '235', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}]}]}, {'title': 'Nodal', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}, {'title': 'Visceral', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants may be counted in more than one category', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Therapies for CRPC', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': '≥1', 'measurements': [{'value': '222', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior therapy (2nd generation androgen receptor pathway inhibitor (ARPI) or docetaxel only)', 'classes': [{'title': 'Abiraterone acetate', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}]}, {'title': 'Apalutamide', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Enzalutamide', 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}, {'title': 'Docetaxel for hormone-sensitive prostate cancer', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants may be counted in more than one category', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) Population included all randomized participants (participants with breast cancer gene \\[BRCA\\] mutated metastatic castration-resistant prostate cancer \\[mCRPC\\] and participants with ataxia- telangiectasia mutated serine/threonine kinase \\[ATM\\] mutated mCRPC).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-18', 'size': 2939663, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-02T17:43', 'hasProtocol': True}, {'date': '2022-07-01', 'size': 2525595, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-02T17:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 405}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2016-11-19', 'resultsFirstSubmitDate': '2023-06-02', 'studyFirstSubmitQcDate': '2016-11-23', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-11', 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration', 'timeFrame': 'From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)', 'description': 'The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first).\n\nRadiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan).'}, {'measure': 'Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined', 'timeFrame': 'From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)', 'description': 'The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first).\n\nRadiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria (Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan).'}], 'secondaryOutcomes': [{'measure': 'Overall Survival in Participants With a BRCA Alteration', 'timeFrame': 'From enrollment to completion of study (up to approximately 7 years)', 'description': 'Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participant was last known to be alive.'}, {'measure': 'Overall Survival in Participants With a BRCA or ATM Alteration Combined', 'timeFrame': 'From enrollment to completion of study (up to approximately 7 years)', 'description': 'Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participants was last known to be alive.'}, {'measure': 'Objective Response Rate (ORR) by IRR in Participants With a BRCA Alteration', 'timeFrame': 'From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)', 'description': 'ORR is defined as the percentage of participants with a confirmed best response of Complete response (CR) or Partial Response (PR) in participants with measurable disease at study entry. Modified RECIST Version 1.1 criteria is used to determine ORR (ie, CR or PR by IRR assessment and no progression in bone per PCWG3 by IRR assessment).\n\nCR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.'}, {'measure': 'Objective Response Rate (ORR) by IRR in Participants With a BRCA or ATM Alteration Combined', 'timeFrame': 'From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)', 'description': 'ORR is defined as the percentage of participants with a confirmed best response of Complete response (CR) or Partial Response (PR) in participants with measurable disease at study entry. Modified RECIST Version 1.1 criteria is used to determine ORR (ie, CR or PR by IRR assessment and no progression in bone per PCWG3 by IRR assessment).\n\nCR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.'}, {'measure': 'Duration of Response (DOR) by IRR in Participants With a BRCA Alteration', 'timeFrame': 'From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)', 'description': 'DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented.'}, {'measure': 'Duration of Response (DOR) by IRR in Participants With a BRCA or ATM Alteration Combined', 'timeFrame': 'From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)', 'description': 'DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented.'}, {'measure': 'PSA Response in Participants With a BRCA Alteration', 'timeFrame': 'From enrollment to primary completion of study (up to approximately 5 years)', 'description': 'Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory.'}, {'measure': 'PSA Response in Participants With a BRCA or ATM Alteration Combined', 'timeFrame': 'From enrollment to primary completion of study (up to approximately 5 years)', 'description': 'Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory.'}, {'measure': 'Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration', 'timeFrame': 'From enrollment to 6 months', 'description': 'Defined as the percentage of participants with a complete response (CR), partial response (PR), and stable disease (SD) according to modified RECIST Version 1.1 with no progression in bone per PCWG3 criteria.'}, {'measure': 'Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA or ATM Alteration Combined', 'timeFrame': 'From enrollment to 6 months', 'description': 'Defined as the percentage of participants with a Complete Response (CR), Partial Response (PR), and Stable Disease (SD), according to Modified RECIST Version 1.1 with no progression in bone per PCWG3 Criteria.'}, {'measure': 'Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA Alteration', 'timeFrame': 'From enrollment to primary completion of study (up to approximately 5 years)', 'description': 'Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.'}, {'measure': 'Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA or ATM Alteration Combined', 'timeFrame': 'From enrollment to primary completion of study (up to approximately 5 years)', 'description': 'Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.'}, {'measure': 'Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: FACT-P', 'timeFrame': 'From enrollment to up to approximately 25 weeks', 'description': 'Changes in health and pain status from baseline to week 25 using: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P total score, on a scale of 0 to 156 where a higher score is better quality of life). The greater the decrease in score (ie more negative) from baseline to week 25 the greater the decrease in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.'}, {'measure': 'Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF', 'timeFrame': 'From enrollment to up to approximately 25 weeks', 'description': 'Changes in health and pain status from baseline to week 25 using: Brief Pain Inventory-Short Form (BPI-SF) questionnaire (on a scale of 1 to 10, from mild to severe, for pain and pain-interference scores). A decrease indicates less severe pain/interference. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.'}, {'measure': 'Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L', 'timeFrame': 'From enrollment to up to approximately 25 weeks', 'description': 'Changes in health and pain status from baseline to week 25 using: EuroQol-5D-5L Visual Analogue Scale (EQ-5D-5L VAS; on a scale from 100 to 0, from best to worst health status). The greater the increase in score (including more negative) from baseline to week 25 the greater the increase in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.'}, {'measure': 'Trough Plasma PK (Cmin) of Rucaparib Based on Sparse Sampling', 'timeFrame': 'From enrollment to week 5 of dosing', 'description': 'Mean trough PK plasma concentration over time in the safety population with at least one PK sample collected at timepoints week 5, 9, 13 and 17; only Week 5 data presented.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CRPC', 'PARP inhibitor', 'PARPi', 'BRCA', 'ATM', 'HRD', 'TRITON', 'homologous recombination', 'DNA repair', 'DNA defect', 'DNA anomaly', 'germline', 'somatic', 'mCRPC'], 'conditions': ['Metastatic Castration Resistant Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '36795891', 'type': 'RESULT', 'citation': "Fizazi K, Piulats JM, Reaume MN, Ostler P, McDermott R, Gingerich JR, Pintus E, Sridhar SS, Bambury RM, Emmenegger U, Lindberg H, Morris D, Nole F, Staffurth J, Redfern C, Saez MI, Abida W, Daugaard G, Heidenreich A, Krieger L, Sautois B, Loehr A, Despain D, Heyes CA, Watkins SP, Chowdhury S, Ryan CJ, Bryce AH; TRITON3 Investigators. Rucaparib or Physician's Choice in Metastatic Prostate Cancer. N Engl J Med. 2023 Feb 23;388(8):719-732. doi: 10.1056/NEJMoa2214676. Epub 2023 Feb 16."}, {'pmid': '36898948', 'type': 'DERIVED', 'citation': 'Collins K, Cheng L. Reprint of: morphologic spectrum of treatment-related changes in prostate tissue and prostate cancer: an updated review. Hum Pathol. 2023 Mar;133:92-101. doi: 10.1016/j.humpath.2023.02.007. Epub 2023 Mar 8.'}, {'pmid': '32203306', 'type': 'DERIVED', 'citation': 'Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine how participants with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be 18 years old at the time the informed consent is signed\n* Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate that is metastatic\n* Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)\n* Be eligible for treatment with physician's choice of comparator treatment (abiraterone acetate, enzalutamide or docetaxel)\n* Experienced disease progression after having received 1 prior next generation androgen receptor-targeted therapy\n* Have a deleterious mutation in a BRCA1/2 or ATM gene\n\nExclusion Criteria:\n\n* Active second malignancy, with the exception of curatively treated non melanoma skin cancer, carcinoma in situ, or superficial bladder cancer\n* Prior treatment with any PARP inhibitor\n* Prior treatment with chemotherapy for metastatic castration-resistant prostate cancer\n* Symptomatic and/or untreated central nervous system metastases\n* Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of study drug"}, 'identificationModule': {'nctId': 'NCT02975934', 'acronym': 'TRITON3', 'briefTitle': "A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency", 'organization': {'class': 'INDUSTRY', 'fullName': 'pharmaand GmbH'}, 'officialTitle': "TRITON3: A Multicenter, Randomized, Open Label Phase 3 Study of Rucaparib Versus Physician's Choice of Therapy for Patients With Metastatic Castration Resistant Prostate Cancer Associated With Homologous Recombination Deficiency", 'orgStudyIdInfo': {'id': 'CO-338-063'}, 'secondaryIdInfos': [{'id': '2016-003163-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy).', 'interventionNames': ['Drug: Rucaparib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Abiraterone acetate or Enzalutamide or Docetaxel', 'description': 'Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).', 'interventionNames': ['Drug: Abiraterone acetate or Enzalutamide or Docetaxel']}], 'interventions': [{'name': 'Rucaparib', 'type': 'DRUG', 'otherNames': ['CO-338'], 'description': 'Rucaparib will be administered daily.', 'armGroupLabels': ['Rucaparib']}, {'name': 'Abiraterone acetate or Enzalutamide or Docetaxel', 'type': 'DRUG', 'otherNames': ['Zytiga (abiraterone acetate) or Xtandi (enzalutamide) or Taxotere (docetaxel)'], 'description': 'Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.', 'armGroupLabels': ['Abiraterone acetate or Enzalutamide or Docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic - Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates - USOR', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 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