Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT02952534
Status:
COMPLETED
Last Update Posted:
2023-06-09
First Post:
2016-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Rucaparib in Patients 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': '2022-05-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'C563150', 'term': 'Mental Retardation, X-Linked, With Or Without Seizures, Arx-Related'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531549', 'term': 'rucaparib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@clovisoncology.com', 'phone': '+1 415 409 7220', 'title': 'Medical Information Department', 'organization': 'Clovis Oncology, Inc.'}, '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': 'Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.', 'eventGroups': [{'id': 'EG000', 'title': 'All Patients', 'description': 'All patients received open-label oral rucaparib 600 mg BID (twice a day) in continuous 28-day cycles.', 'otherNumAtRisk': 277, 'deathsNumAtRisk': 277, 'otherNumAffected': 274, 'seriousNumAtRisk': 277, 'deathsNumAffected': 8, 'seriousNumAffected': 96}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 129}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 33}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 76}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 65}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 139}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 67}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 131}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 18}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 72}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 71}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 50}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 32}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 45}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 96}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 27}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Althralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 44}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 50}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 33}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 32}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 53}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 32}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 18}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 21}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 40}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 20}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 33}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Anaemia of malignant disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Aplastic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Torsade de pointes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Mechanical ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abscess oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': "Fournier's gangrene", 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Haemophilus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Infective exacerbation of chronic obstructive airways disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Legionella infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Paraspinal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia legionella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Postoperative respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Urinary tract stoma complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Adenocarcinoma pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Sacral radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Central Independent Radiology Review (IRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BRCA Mutation', 'description': 'Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.'}, {'id': 'OG001', 'title': 'ATM Mutation', 'description': 'Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.'}, {'id': 'OG002', 'title': 'CDK12 Mutation', 'description': 'Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.'}, {'id': 'OG003', 'title': 'CHEK2 Mutation', 'description': 'Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.'}, {'id': 'OG004', 'title': 'Other Gene Mutation', 'description': 'Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000', 'lowerLimit': '34.6', 'upperLimit': '57.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '14.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '41.2', 'groupId': 'OG004', 'lowerLimit': '18.4', 'upperLimit': '67.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.', 'description': 'The primary efficacy endpoint is confirmed radiographic ORR by central IRR. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. CR 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 diameters.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'IRR Efficacy Population - The IRR efficacy population is defined by measurable disease status at baseline using modified RECIST Version 1.1 criteria per independent radiology review.'}, {'type': 'SECONDARY', 'title': 'Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Investigator (INV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BRCA Mutation', 'description': 'Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.'}, {'id': 'OG001', 'title': 'ATM Mutation', 'description': 'Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.'}, {'id': 'OG002', 'title': 'CDK12 Mutation', 'description': 'Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.'}, {'id': 'OG003', 'title': 'CHEK2 Mutation', 'description': 'Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.'}, {'id': 'OG004', 'title': 'Other Gene Mutation', 'description': 'Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'groupId': 'OG000', 'lowerLimit': '37.4', 'upperLimit': '59.2'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '30.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '41.2', 'groupId': 'OG004', 'lowerLimit': '18.4', 'upperLimit': '67.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.', 'description': 'A supportive efficacy endpoint is confirmed radiographic ORR by INV. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. CR 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': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Investigator Efficacy Population - The Investigator efficacy population is defined by measurable disease status at baseline using modified RECIST Version 1.1 criteria per the investigator (INV).'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Central Independent Radiology Review (IRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BRCA Mutation', 'description': 'Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.'}, {'id': 'OG001', 'title': 'Other Gene Mutation', 'description': 'Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.5', 'comment': 'The upper confidence interval was not assessable due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': 'NA'}, {'value': '22.1', 'comment': 'The upper confidence interval was not assessable due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.', 'description': 'A secondary efficacy endpoint is DOR by central IRR. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with a confirmed response in the IRR Efficacy Population. The IRR efficacy population is defined by measurable disease status at baseline using modified RECIST Version 1.1 criteria per independent radiology review. Note, there were no patients with confirmed response by IRR in the ATM, CDK12 and CHEK2 arms.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BRCA Mutation', 'description': 'Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.'}, {'id': 'OG001', 'title': 'ATM Mutation', 'description': 'Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.'}, {'id': 'OG002', 'title': 'CHEK2 Mutation', 'description': 'Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.'}, {'id': 'OG003', 'title': 'Other Gene Mutation', 'description': 'Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '11.6'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '10.4'}, {'value': '16.6', 'comment': 'The median is the actual observed value for this participant. The confidence interval was not assessable due to insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '18.4', 'comment': 'The upper confidence interval was not assessable due to insufficient number of participants with events.', 'groupId': 'OG003', 'lowerLimit': '10.1', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.', 'description': 'A secondary efficacy endpoint is DOR as assessed by the investigator. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with a confirmed response in the Investigator Efficacy Population. The Investigator efficacy population is defined by measurable disease status at baseline using modified RECIST Version 1.1 criteria per the investigator. Note, there were no patients with confirmed response by investigator in the CDK12 arm.'}, {'type': 'SECONDARY', 'title': 'Confirmed PSA Response (≥ 50% Decrease) by Gene as Assessed by Local Laboratory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BRCA Mutation', 'description': 'Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.'}, {'id': 'OG001', 'title': 'ATM Mutation', 'description': 'Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.'}, {'id': 'OG002', 'title': 'CDK12 Mutation', 'description': 'Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.'}, {'id': 'OG003', 'title': 'CHEK2 Mutation', 'description': 'Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.'}, {'id': 'OG004', 'title': 'Other Gene Mutation', 'description': 'Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000', 'lowerLimit': '45.7', 'upperLimit': '61.1'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '11.7'}, {'value': '7.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '33.9'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '57.9'}, {'value': '36.0', 'groupId': 'OG004', 'lowerLimit': '18.0', 'upperLimit': '57.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.', 'description': 'A secondary endpoint is confirmed PSA (prostate-specific antigen) response (≥ 50% reduction) as assessed by local laboratory. Confirmed PSA response is analyzed for all patients who had PSA value at baseline and is defined as the percentage of patients having 2 consecutive PSA values (at least 3 weeks apart) that are at least 50% lower than baseline and that occur prior to PSA progression. PSA progression is defined as a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir in PSA.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who had a PSA value at baseline.'}, {'type': 'SECONDARY', 'title': 'Confirmed PSA Response (≥ 90% Decrease) by Gene as Assessed by Local Laboratory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BRCA Mutation', 'description': 'Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.'}, {'id': 'OG001', 'title': 'ATM Mutation', 'description': 'Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.'}, {'id': 'OG002', 'title': 'CDK12 Mutation', 'description': 'Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.'}, {'id': 'OG003', 'title': 'CHEK2 Mutation', 'description': 'Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.'}, {'id': 'OG004', 'title': 'Other Gene Mutation', 'description': 'Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': '26.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '57.9'}, {'value': '16.0', 'groupId': 'OG004', 'lowerLimit': '4.5', 'upperLimit': '36.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.', 'description': 'A secondary endpoint is confirmed PSA (prostate-specific antigen) response (≥ 90% reduction) as assessed by local laboratory. Confirmed PSA response is analyzed for all patients who had PSA value at baseline and is defined as the percentage of patients having 2 consecutive PSA values (at least 3 weeks apart) that are at least 90% lower than baseline and that occur prior to PSA progression. PSA progression is defined as a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir in PSA.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who had a PSA value at baseline.'}, {'type': 'SECONDARY', 'title': 'Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Central Independent Radiology Review (IRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BRCA Mutation', 'description': 'Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.'}, {'id': 'OG001', 'title': 'ATM Mutation', 'description': 'Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.'}, {'id': 'OG002', 'title': 'CDK12 Mutation', 'description': 'Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.'}, {'id': 'OG003', 'title': 'CHEK2 Mutation', 'description': 'Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.'}, {'id': 'OG004', 'title': 'Other Gene Mutation', 'description': 'Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '13.2'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '8.9'}, {'value': '3.7', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '8.3'}, {'value': '9.4', 'comment': 'The upper confidence interval was not assessable due to insufficient number of participants with events.', 'groupId': 'OG003', 'lowerLimit': '2.1', 'upperLimit': 'NA'}, {'value': '11.6', 'groupId': 'OG004', 'lowerLimit': '5.1', 'upperLimit': '25.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.', 'description': 'A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by IRR. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression adjudicated by IRR using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients'}, {'type': 'SECONDARY', 'title': 'Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BRCA Mutation', 'description': 'Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.'}, {'id': 'OG001', 'title': 'ATM Mutation', 'description': 'Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.'}, {'id': 'OG002', 'title': 'CDK12 Mutation', 'description': 'Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.'}, {'id': 'OG003', 'title': 'CHEK2 Mutation', 'description': 'Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.'}, {'id': 'OG004', 'title': 'Other Gene Mutation', 'description': 'Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '11.2'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '10.6'}, {'value': '3.7', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '8.1'}, {'value': '3.5', 'groupId': 'OG003', 'lowerLimit': '2.1', 'upperLimit': '11.2'}, {'value': '11.6', 'groupId': 'OG004', 'lowerLimit': '5.8', 'upperLimit': '22.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.', 'description': 'A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by Investigator. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) by Gene', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BRCA Mutation', 'description': 'Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.'}, {'id': 'OG001', 'title': 'ATM Mutation', 'description': 'Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.'}, {'id': 'OG002', 'title': 'CDK12 Mutation', 'description': 'Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.'}, {'id': 'OG003', 'title': 'CHEK2 Mutation', 'description': 'Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.'}, {'id': 'OG004', 'title': 'Other Gene Mutation', 'description': 'Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000', 'lowerLimit': '14.8', 'upperLimit': '20.0'}, {'value': '14.6', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '19.0'}, {'value': '13.9', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': '18.6'}, {'value': '11.1', 'groupId': 'OG003', 'lowerLimit': '3.5', 'upperLimit': '26.7'}, {'value': '11.6', 'comment': 'The upper confidence interval was not assessable due to insufficient number of participants with events.', 'groupId': 'OG004', 'lowerLimit': '8.9', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of first dose until event, loss to follow-up, withdrawal of consent, or study closure: an overall median of approximately 33.1 months', 'description': 'A secondary efficacy endpoint is Overall Survival (OS). OS is defined as the date from first dose of rucaparib to the date of death due to any cause, +1 day.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - The safety population consists of all patients who received at least 1 dose of protocol-specified treatment.'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR) by Gene Per Central Independent Radiology Review (IRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BRCA Mutation', 'description': 'Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.'}, {'id': 'OG001', 'title': 'ATM Mutation', 'description': 'Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.'}, {'id': 'OG002', 'title': 'CDK12 Mutation', 'description': 'Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.'}, {'id': 'OG003', 'title': 'CHEK2 Mutation', 'description': 'Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.'}, {'id': 'OG004', 'title': 'Other Gene Mutation', 'description': 'Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.'}], 'classes': [{'title': '6 months', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.', 'description': 'A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by IRR. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR) by Gene Per Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BRCA Mutation', 'description': 'Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.'}, {'id': 'OG001', 'title': 'ATM Mutation', 'description': 'Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.'}, {'id': 'OG002', 'title': 'CDK12 Mutation', 'description': 'Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.'}, {'id': 'OG003', 'title': 'CHEK2 Mutation', 'description': 'Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.'}, {'id': 'OG004', 'title': 'Other Gene Mutation', 'description': 'Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.'}], 'classes': [{'title': '6 months', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.', 'description': 'A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by Investigator. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients'}, {'type': 'SECONDARY', 'title': 'Time to PSA Progression by Gene', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BRCA Mutation', 'description': 'Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.'}, {'id': 'OG001', 'title': 'ATM Mutation', 'description': 'Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.'}, {'id': 'OG002', 'title': 'CDK12 Mutation', 'description': 'Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.'}, {'id': 'OG003', 'title': 'CHEK2 Mutation', 'description': 'Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.'}, {'id': 'OG004', 'title': 'Other Gene Mutation', 'description': 'Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '7.5'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '3.7'}, {'value': '3.5', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '4.6'}, {'value': '5.6', 'comment': 'The upper confidence interval was not assessable due to insufficient number of participants with events.', 'groupId': 'OG003', 'lowerLimit': '2.8', 'upperLimit': 'NA'}, {'value': '5.3', 'groupId': 'OG004', 'lowerLimit': '3.0', 'upperLimit': '9.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.', 'description': 'A secondary efficacy endpoint is time to PSA progession. Time to PSA progression is defined as the time from first dose of rucaparib to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline if there was no PSA decline after baseline) in PSA was measured, plus 1 day. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later (unless the PSA progression occurred at the last recorded PSA assessment). If confirmed, the date used for time of PSA progression is the earlier of the 2 PSA dates.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who had a PSA value at baseline.'}, {'type': 'SECONDARY', 'title': 'Steady State Trough (Cmin) Level Rucaparib Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BRCA Mutation', 'description': 'Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.'}, {'id': 'OG001', 'title': 'ATM Mutation', 'description': 'Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.'}, {'id': 'OG002', 'title': 'CDK12 Mutation', 'description': 'Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.'}, {'id': 'OG003', 'title': 'CHEK2 Mutation', 'description': 'Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.'}, {'id': 'OG004', 'title': 'Other Gene Mutation', 'description': 'Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1539.565', 'spread': '966.2604', 'groupId': 'OG000'}, {'value': '1605.002', 'spread': '856.2478', 'groupId': 'OG001'}, {'value': '1639.357', 'spread': '1428.5691', 'groupId': 'OG002'}, {'value': '1286.998', 'spread': '1138.2119', 'groupId': 'OG003'}, {'value': '1189.845', 'spread': '748.3045', 'groupId': 'OG004'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1578.353', 'spread': '1057.8049', 'groupId': 'OG000'}, {'value': '1600.380', 'spread': '1198.3899', 'groupId': 'OG001'}, {'value': '1405.167', 'spread': '806.4642', 'groupId': 'OG002'}, {'value': '1841.667', 'spread': '2106.3362', 'groupId': 'OG003'}, {'value': '1792.499', 'spread': '1672.7732', 'groupId': 'OG004'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1308.704', 'spread': '693.6717', 'groupId': 'OG000'}, {'value': '1505.400', 'spread': '802.0812', 'groupId': 'OG001'}, {'value': '1699.700', 'spread': '991.9922', 'groupId': 'OG002'}, {'value': '815.500', 'spread': '557.9073', 'groupId': 'OG003'}, {'value': '2255.889', 'spread': '1831.9626', 'groupId': 'OG004'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1533.690', 'spread': '889.6130', 'groupId': 'OG000'}, {'value': '1515.300', 'spread': '1291.8497', 'groupId': 'OG001'}, {'value': '1520.700', 'spread': '884.1374', 'groupId': 'OG002'}, {'value': '728.000', 'spread': '469.5189', 'groupId': 'OG003'}, {'value': '1433.875', 'spread': '637.4535', 'groupId': 'OG004'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Participants were assessed at Study Day 29, Day 57, Day 85 and Day 113', 'description': 'Trough (Cmin) concentrations of rucaparib are summarized for all patients with at least one PK sample collected. The absolute values of rucaparib plasma concentration at each time point are presented by gene.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with at least one PK sample collected. The safety population consists of all patients who received at least 1 dose of protocol-specified treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BRCA Mutation', 'description': 'Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.'}, {'id': 'FG001', 'title': 'ATM Mutation', 'description': 'Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.'}, {'id': 'FG002', 'title': 'CDK12 Mutation', 'description': 'Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.'}, {'id': 'FG003', 'title': 'CHEK2 Mutation', 'description': 'Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.'}, {'id': 'FG004', 'title': 'Other Gene Mutation', 'description': 'Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 277 patients were recruited from 102 sites across 12 countries.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '277', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'BRCA Mutation', 'description': 'Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.'}, {'id': 'BG001', 'title': 'ATM Mutation', 'description': 'Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.'}, {'id': 'BG002', 'title': 'CDK12 Mutation', 'description': 'Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.'}, {'id': 'BG003', 'title': 'CHEK2 Mutation', 'description': 'Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.'}, {'id': 'BG004', 'title': 'Other Gene Mutation', 'description': 'Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '88'}, {'value': '73', 'groupId': 'BG001', 'lowerLimit': '51', 'upperLimit': '84'}, {'value': '64', 'groupId': 'BG002', 'lowerLimit': '49', 'upperLimit': '79'}, {'value': '65', 'groupId': 'BG003', 'lowerLimit': '60', 'upperLimit': '86'}, {'value': '70', 'groupId': 'BG004', 'lowerLimit': '57', 'upperLimit': '83'}, {'value': '71', 'groupId': 'BG005', 'lowerLimit': '49', 'upperLimit': '88'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '277', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '198', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-24', 'size': 2732785, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-31T10:49', 'hasProtocol': True}, {'date': '2019-07-02', 'size': 718705, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-31T10:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 277}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2016-10-24', 'resultsFirstSubmitDate': '2022-04-12', 'studyFirstSubmitQcDate': '2016-10-31', 'lastUpdatePostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-13', 'studyFirstPostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Central Independent Radiology Review (IRR)', 'timeFrame': 'Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.', 'description': 'The primary efficacy endpoint is confirmed radiographic ORR by central IRR. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. CR 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 diameters.'}], 'secondaryOutcomes': [{'measure': 'Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Investigator (INV)', 'timeFrame': 'Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.', 'description': 'A supportive efficacy endpoint is confirmed radiographic ORR by INV. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. CR 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 Gene in Patients With Confirmed Response Per Central Independent Radiology Review (IRR)', 'timeFrame': 'Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.', 'description': 'A secondary efficacy endpoint is DOR by central IRR. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.'}, {'measure': 'Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Investigator', 'timeFrame': 'Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.', 'description': 'A secondary efficacy endpoint is DOR as assessed by the investigator. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.'}, {'measure': 'Confirmed PSA Response (≥ 50% Decrease) by Gene as Assessed by Local Laboratory', 'timeFrame': 'PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.', 'description': 'A secondary endpoint is confirmed PSA (prostate-specific antigen) response (≥ 50% reduction) as assessed by local laboratory. Confirmed PSA response is analyzed for all patients who had PSA value at baseline and is defined as the percentage of patients having 2 consecutive PSA values (at least 3 weeks apart) that are at least 50% lower than baseline and that occur prior to PSA progression. PSA progression is defined as a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir in PSA.'}, {'measure': 'Confirmed PSA Response (≥ 90% Decrease) by Gene as Assessed by Local Laboratory', 'timeFrame': 'PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.', 'description': 'A secondary endpoint is confirmed PSA (prostate-specific antigen) response (≥ 90% reduction) as assessed by local laboratory. Confirmed PSA response is analyzed for all patients who had PSA value at baseline and is defined as the percentage of patients having 2 consecutive PSA values (at least 3 weeks apart) that are at least 90% lower than baseline and that occur prior to PSA progression. PSA progression is defined as a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir in PSA.'}, {'measure': 'Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Central Independent Radiology Review (IRR)', 'timeFrame': 'Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.', 'description': 'A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by IRR. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression adjudicated by IRR using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.'}, {'measure': 'Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Investigator', 'timeFrame': 'Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.', 'description': 'A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by Investigator. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.'}, {'measure': 'Overall Survival (OS) by Gene', 'timeFrame': 'From date of first dose until event, loss to follow-up, withdrawal of consent, or study closure: an overall median of approximately 33.1 months', 'description': 'A secondary efficacy endpoint is Overall Survival (OS). OS is defined as the date from first dose of rucaparib to the date of death due to any cause, +1 day.'}, {'measure': 'Clinical Benefit Rate (CBR) by Gene Per Central Independent Radiology Review (IRR)', 'timeFrame': 'Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.', 'description': 'A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by IRR. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.'}, {'measure': 'Clinical Benefit Rate (CBR) by Gene Per Investigator', 'timeFrame': 'Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.', 'description': 'A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by Investigator. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.'}, {'measure': 'Time to PSA Progression by Gene', 'timeFrame': 'PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.', 'description': 'A secondary efficacy endpoint is time to PSA progession. Time to PSA progression is defined as the time from first dose of rucaparib to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline if there was no PSA decline after baseline) in PSA was measured, plus 1 day. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later (unless the PSA progression occurred at the last recorded PSA assessment). If confirmed, the date used for time of PSA progression is the earlier of the 2 PSA dates.'}, {'measure': 'Steady State Trough (Cmin) Level Rucaparib Concentrations', 'timeFrame': 'Participants were assessed at Study Day 29, Day 57, Day 85 and Day 113', 'description': 'Trough (Cmin) concentrations of rucaparib are summarized for all patients with at least one PK sample collected. The absolute values of rucaparib plasma concentration at each time point are presented by gene.'}]}, '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', 'BARD1', 'BRIP1', 'CDK12', 'CHEK2', 'FANCA', 'NBN', 'PALB2', 'RAD51', 'RAD51B', 'RAD51C', 'RAD51D', 'RAD54L', 'germline', 'somatic', 'mCRPC'], 'conditions': ['Metastatic Castration Resistant Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '37277275', 'type': 'DERIVED', 'citation': 'Abida W, Campbell D, Patnaik A, Bryce AH, Shapiro J, Bambury RM, Zhang J, Burke JM, Castellano D, Font A, Ganju V, Hardy-Bessard AC, McDermott R, Sautois B, Spaeth D, Voog E, Piulats JM, Pintus E, Ryan CJ, Merseburger AS, Daugaard G, Heidenreich A, Fizazi K, Loehr A, Despain D, Simmons AD, Dowson M, Go J, Watkins SP, Chowdhury S. Rucaparib for the Treatment of Metastatic Castration-resistant Prostate Cancer Associated with a DNA Damage Repair Gene Alteration: Final Results from the Phase 2 TRITON2 Study. Eur Urol. 2023 Sep;84(3):321-330. doi: 10.1016/j.eururo.2023.05.021. Epub 2023 Jun 3.'}, {'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': '35397664', 'type': 'DERIVED', 'citation': 'Green ML, Ma SC, Goble S, Giordano H, Maloney L, Simmons AD, Beltman J, Harding TC, Xiao JJ. Population pharmacokinetics of rucaparib in patients with advanced ovarian cancer or other solid tumors. Cancer Chemother Pharmacol. 2022 May;89(5):671-682. doi: 10.1007/s00280-022-04413-7. Epub 2022 Apr 10.'}, {'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 patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib.'}, '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 form is signed\n* Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate\n* Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)\n* Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease\n* Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency\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, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy\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 rucaparib'}, 'identificationModule': {'nctId': 'NCT02952534', 'acronym': 'TRITON2', 'briefTitle': 'A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'pharmaand GmbH'}, 'officialTitle': 'TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency', 'orgStudyIdInfo': {'id': 'CO-338-052'}, 'secondaryIdInfos': [{'id': '2016-003162-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rucaparib', 'description': 'Oral rucaparib (monotherapy)', 'interventionNames': ['Drug: Rucaparib']}], 'interventions': [{'name': 'Rucaparib', 'type': 'DRUG', 'otherNames': ['CO-338'], 'description': 'Rucaparib will be administered daily', 'armGroupLabels': ['Rucaparib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85259', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinc', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Alliance Research Centers', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Healthcare System', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90211', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Memorial Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Hematology Oncology Associates', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco VA Health Care System', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95406', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Redwood Regional Medical Group', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '94589', 'city': 'Vallejo', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center (Vallejo)', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': '4701 Ogletown Stanton Rd.', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Boca Raton Community Hospital, Inc.', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33980', 'city': 'Fort Myers', 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