Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-04-09 @ 12:18 AM
Study NCT ID:
NCT03148795
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2017-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C586365', 'term': 'talazoparib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study)', 'description': 'Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set was analyzed.', 'eventGroups': [{'id': 'EG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 124, 'seriousNumAtRisk': 127, 'deathsNumAffected': 111, 'seriousNumAffected': 51}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 67}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 27}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 38}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Neutropenic sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Metastases to spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Hemianopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Penile pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Best Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000', 'lowerLimit': '21.2', 'upperLimit': '39.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug to best overall soft tissue response CR or PR (maximum duration of 25 months)', 'description': 'Best ORR was defined as the percentage of participants with best overall soft tissue response of complete response (CR) or partial response (PR) as per RECIST1.1 by an independent central review. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 millimeter (mm). Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference baseline sum diameters.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'DDR deficient measurable disease population included all enrolled participants who had measurable soft tissue disease at screening by investigator assessment, had DDR deficiencies likely to sensitize to PARP inhibitor therapy, and received at least 1 dose of talazoparib.'}, {'type': 'SECONDARY', 'title': 'Time to Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '7.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug to first objective response (maximum duration of 25 months)', 'description': 'Time to objective response was defined as the time from first dose of talazoparib to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per prostate cancer working Group 3 (PCWG3). Soft tissue response is defined as a best overall response of CR or PR per RECIST 1.1 by independent central review. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 % decrease in sum of diameters of target lesions taking as reference baseline sum diameters.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'DDR deficient measurable disease population included all enrolled participants who had measurable soft tissue disease at screening by investigator assessment, had DDR deficiencies likely to sensitize to PARP inhibitor therapy, and received at least 1 dose of talazoparib and participants who achieved a confirmed CR or PR without documentation of confirmed bone progression.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'comment': 'Upper limit of 95% confidence interval (CI) was not estimable as there were less number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first objective evidence of soft tissue response (CR or PR, whichever is earlier) to radiographic progression or death due to any cause without evidence of radiographic progression, whichever occurs first (maximum duration of 25 months)', 'description': 'DOR was defined as the time from the first objective evidence of soft tissue response (CR or PR, whichever is earlier) per RECIST 1.1 and no evidence of confirmed bone disease progression per PCWG3 to the date of first objective evidence of radiographic progression or death due to any cause without evidence of radiographic progression, whichever occurs first. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 % decrease in sum of diameters of target lesions taking as reference baseline sum diameters.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'DDR deficient measurable disease population included all enrolled participants who had measurable soft tissue disease at screening by investigator assessment, had DDR deficiencies likely to sensitize to PARP inhibitor therapy, and received at least 1 dose of talazoparib and participants who achieved a confirmed CR or PR without documentation of confirmed bone progression.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Prostate-Specific Antigen (PSA) Response of Greater Than or Equal to (>=) 50 Percentage (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000', 'lowerLimit': '35.6', 'upperLimit': '56.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of first dose of study treatment until confirmed PSA progression or start of new anticancer treatment given after the first dose of study treatment (maximum duration of 25 months)', 'description': 'Percentage of participants with PSA response of \\>= 50% was reported in this outcome measure. PSA response was calculated as a decline from baseline PSA (ng/mL) by at least 50% measured by central laboratory.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "DDR deficient measurable disease population included all enrolled participants who had measurable soft tissue disease at screening by investigator assessment, had DDR deficiencies likely to sensitize to PARP inhibitor therapy, and received at least 1 dose of talazoparib. Here ''Number of participants analyzed'' signifies number of participants evaluable data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Conversion of Circulating Tumor Cell (CTC) Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000', 'lowerLimit': '45.1', 'upperLimit': '79.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to anytime on study during final analysis of the outcome measure, up to maximum duration of 25 months', 'description': 'Percentage of participants with conversion of CTC count was defined as percentage of participants with a CTC count \\>= 5 CTC per 7.5 milliliter (mL) of blood at baseline that decreased to \\< 5 CTC per 7.5 mL of blood any time on study.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a baseline CTC assessment and at least 1 post-baseline CTC assessment from the DDR deficient measurable disease population. Participants with a CTC count \\<5 per 7.5 mL of blood at baseline were not analyzed for this conversion outcome measure. Here, "Number of participants analyzed\'\' signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Null CTC Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000', 'lowerLimit': '37.9', 'upperLimit': '68.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to anytime on study during final analysis of the outcome measure, up to maximum duration of 25 months', 'description': 'Percentage of participants with a null CTC count was defined as percentage of participants with CTC count \\>=1 CTC per 7.5 mL of blood at baseline that decreased to CTC = 0 per 7.5 mL of blood any time on study.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a baseline CTC assessment and at least 1 post-baseline CTC assessment from the DDR deficient measurable disease population. Participants with a CTC count 0 per 7.5 mL of blood at baseline were not analyzed for this outcome measure.Here, "Number of participants analyzed\'\' signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Baseline CTC Count <5 CTC Showed Increased CTC Counts at Any Time on Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'groupId': 'OG000', 'lowerLimit': '20.7', 'upperLimit': '57.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to anytime on study during final analysis of the outcome measure, up to maximum duration of 25 months', 'description': 'Percentage of participants with CTC count \\<5 CTC per 7.5 mL of blood at baseline those who showed an increased CTC count, compared to baseline, any time on study was reported in this study.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a baseline CTC assessment and at least 1 post-baseline CTC assessment from the DDR deficient measurable disease population. Here, "Number of participants analyzed\'\' signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Prostate-Specific Antigen (PSA) Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '11.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first dose of study treatment until confirmed PSA progression or start of new anticancer treatment given after the first dose of study treatment (maximum duration of 25 months)', 'description': 'Time to PSA progression was defined as the time from first dose of study treatment to the date of PSA progression, which was subsequently confirmed. The time from first dose of talazoparib to the date that a \\>=25% increase in PSA with an absolute increase of \\>=2micogram per liter (2 nanogram per mL) above the nadir (or baseline for participants with no PSA decline) was documented, confirmed by a second consecutive PSA value obtained \\>=3 weeks (21 days) later. Kaplan-Meier method was used for analysis.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'DDR deficient measurable disease population included all enrolled participants who had measurable soft tissue disease at screening by investigator assessment, had DDR deficiencies likely to sensitize to PARP inhibitor therapy, and received at least 1 dose of talazoparib.'}, {'type': 'SECONDARY', 'title': 'Radiographic Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '8.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of first dose of study drug to first objective evidence of radiographic progression or death without documented radiographic progression, whichever occurs first (maximum duration of 25 months)', 'description': 'Radiographic PFS was defined as the time from date of first dose of talazoparib to first objective evidence of radiographic progression as assessed in soft tissue per modified RECIST 1.1 or confirmed progression in bone per PCWG3 guidelines by independent central review or death without documented radiographic progression, whichever occurs first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'DDR deficient measurable disease population included all enrolled participants who had measurable soft tissue disease at screening by investigator assessment, had DDR deficiencies likely to sensitize to PARP inhibitor therapy, and received at least 1 dose of talazoparib.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '20.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study treatment up to death due to any cause during study or date of last contact (approximately 36 months)', 'description': 'OS was defined as the time from start date (the date of first dose of treatment) to the date of death due to any cause. Participants who had not died were censored at the date of last contact. Kaplan-Meier method was used for analysis.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'DDR deficient measurable disease population included all enrolled participants who had measurable soft tissue disease at screening by investigator assessment, had DDR deficiencies likely to sensitize to PARP inhibitor therapy, and received at least 1 dose of talazoparib.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study drug up to 28 days after last dose of study drug (study treatment was approximately for 36 months, safety follow up to approximately 37 months)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included both serious AEs and all non-serious AEs. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of talazoparib including participants enrolled prior to amendment 3 with non-measurable disease and/or with DDR deficiencies, which may sensitize the tumor to PARP inhibition as assessed using an expanded DDR gene panel.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Permanent Treatment Discontinuation Due to Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During study treatment (approximately up to 36 months)', 'description': 'Treatment discontinuation was defined as permanent cessation of study drug treatment administration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of talazoparib including participants enrolled prior to amendment 3 with non-measurable disease and/or with DDR deficiencies, which may sensitize the tumor to PARP inhibition as assessed using an expanded DDR gene panel.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormalities in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'title': 'SBP: Absolute result > 180 mm Hg and increase from baseline >= 40 mm Hg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'SBP: Absolute result < 90 mm Hg and decrease from baseline > 30 mm Hg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'DBP: Absolute result > 110 mm Hg and increase from baseline >= 30 mm Hg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'DBP: Absolute result < 50 mm Hg and decrease from baseline > 20 mm Hg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'DBP: >= 20 mm Hg increase from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Heart rate: Absolute result < 50 bpm and decrease from baseline > 20 bpm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Heart rate: Absolute result > 120 bpm and increase from baseline > 30 bpm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Weight: > 10% decrease from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During study treatment (approximately up to 36 months)', 'description': 'Vital sign abnormalities criteria included: 1) Systolic blood pressure (SBP) in millimeters of mercury (mmHg): absolute result greater than (\\>) 180 mmHg and increase from baseline greater than or equal to (\\>=) 40 mmHg or absolute result \\< 90 mmHg and decrease from baseline \\> 30 mmHg; 2) Diastolic blood pressure (DBP) (mmHg): absolute result \\> 110 mmHg and increase from baseline \\>= 30 mmHg or absolute result \\< 50 mmHg and decrease from baseline \\> 20 mmHg or \\>= 20 mmHg increase from baseline; 3) Heart rate in beats per minutes (bpm): absolute result \\< 50 bpm and decrease from baseline \\> 20 bpm or absolute result \\> 120 bpm and increase from baseline \\> 30 bpm; Weight in kilogram: \\> 10% decrease from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of talazoparib including participants enrolled prior to amendment 3 with non-measurable disease and/or with DDR deficiencies, which may sensitize the tumor to PARP inhibition as assessed using an expanded DDR gene panel. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified rows.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Shift in Laboratory Parameter Values (Hematology) From Grade Less Than Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'title': 'Anemia', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocyte count decreased', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocyte count increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophil count decreased', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count decreased', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell decreased', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During study treatment (approximately up to 36 months)', 'description': 'Hematology parameters included anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, Leukocytosis and white blood cell decreased. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or non-invasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of talazoparib including participants enrolled prior to amendment 3 with non-measurable disease and/or with DDR deficiencies, which may sensitize the tumor to PARP inhibition as assessed using an expanded DDR gene panel. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'title': 'Alanine aminotransferase increased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase increased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase increased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Blood bilirubin increased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chronic kidney disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine increased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'GGT increased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Hypercalcemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hyperglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Hyperkalemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Hypermagnesemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hypernatremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hypoalbuminemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hypocalcemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hypokalemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hypomagnesemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hyponatremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Hypophosphatemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During study treatment (approximately up to 36 months)', 'description': 'Chemistry parameters:alanine aminotransferase increased(inc), alkaline phosphatase inc, aspartate aminotransferase inc, blood bilirubin inc, chronic kidney disease, creatinine inc, gamma-glutamyl transferase (GGT) inc, hypercalcemia, Hyperglycemia, hyperkalemia, hypermagnesemia, hypocalcemia, Hyponatremia, hypoglycemia, hypokalemia, hypomagnesemia, hypernatremia, Hypoalbuminemia and hypophosphatemia. Severity was graded as Grade(G)1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G2:moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G3:severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; G4:life-threatening consequence, urgent intervention indicated; G5: death related to AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of talazoparib including participants enrolled prior to amendment 3 with non-measurable disease and/or with DDR deficiencies, which may sensitize the tumor to PARP inhibition as assessed using an expanded DDR gene panel. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific rows.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Dose Modification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During study treatment (approximately up to 36 months)', 'description': 'Number of participants with dose modification due to adverse events was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of talazoparib including participants enrolled prior to amendment 3 with non-measurable disease and/or with DDR deficiencies, which may sensitize the tumor to PARP inhibition as assessed using an expanded DDR gene panel.'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration in Pain Symptom Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95 % confidence interval could not be estimated due to insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline till final analysis of the outcome measure, up to maximum duration of 25 months', 'description': 'Time deterioration is based on BPI-SF question 3: "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours." Pain intensity was to be answered on a range of 0 to 10, where 0 corresponded to no pain and 10 worst pain. Time to this event is defined as the time from the date of first dose of study treatment to onset of pain progression, where pain progression is defined as a 2-point or more increase from baseline in the question 3 score. Kaplan-Meier method was used for analysis. Average of all assessments visits is reported in this outcome measure.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.51', 'spread': '2.04', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.39', 'spread': '2.55', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.20', 'spread': '2.89', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.25', 'spread': '2.38', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.85', 'spread': '2.51', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.06', 'spread': '2.73', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.89', 'spread': '2.77', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.14', 'spread': '3.14', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': '2.30', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.53', 'spread': '3.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.50', 'spread': '3.42', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 73', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.80', 'spread': '5.17', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.50', 'spread': '3.54', 'groupId': 'OG000'}]}]}, {'title': 'Change at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.25', 'spread': '3.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 3, 5, 7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]', 'description': "BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-SF have 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. BPI-SF question 3 was related to participant experiencing pain at its worst in last 24 hours, score range 0 to 10, where large values corresponded to worse outcomes.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment. All participants reported under \'Overall Number of Participants Analyzed\' contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.16', 'spread': '17.25', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.44', 'spread': '17.26', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.61', 'spread': '17.20', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.18', 'spread': '20.21', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.68', 'spread': '16.85', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.84', 'spread': '19.40', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.63', 'spread': '19.26', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.34', 'spread': '21.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.65', 'spread': '19.01', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.96', 'spread': '17.55', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.75', 'spread': '19.02', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 73', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.25', 'spread': '24.89', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.50', 'spread': '25.01', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.87', 'spread': '21.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]', 'description': 'The EQ-5D VAS score was a participant rated questionnaire where participants rated how they felt at assessment visit on a vertical VAS that ranged from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating a better health condition.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment. All participants reported under \'Overall Number of Participants Analyzed\' contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '37', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '38', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 73', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]', 'description': 'EQ-5D-5L: participant rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D mobility domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment. All participants reported under \'Overall Number of Participants Analyzed\' contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '65', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '63', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '62', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '59', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '64', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '51', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '55', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '44', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 73', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]', 'description': 'EQ-5D-5L: participant rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D self-care domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment. All participants reported under \'Overall Number of Participants Analyzed\' contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '34', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '41', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 73', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]', 'description': 'EQ-5D-5L: participant rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D usual activities domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment. All participants reported under \'Overall Number of Participants Analyzed\' contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '34', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 73', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]', 'description': 'EQ-5D-5L: participant rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D pain and discomfort domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment. All participants reported under \'Overall Number of Participants Analyzed\' contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '48', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '45', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '43', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '45', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '49', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '40', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '40', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '41', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 73', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No Problem', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Slight Problem', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Moderate Problem', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Severe Problem', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Extreme Problem', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]', 'description': 'EQ-5D-5L: participant rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D anxiety and depression domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment. All participants reported under \'Overall Number of Participants Analyzed\' contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified time points.'}, {'type': 'SECONDARY', 'title': 'Pre-dose Plasma Concentration (Ctrough) of Talazoparib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'title': 'At Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2631.898', 'spread': '23.2043', 'groupId': 'OG000'}]}]}, {'title': 'At Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4748.147', 'spread': '63.2488', 'groupId': 'OG000'}]}]}, {'title': 'At Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4213.250', 'spread': '52.8028', 'groupId': 'OG000'}]}]}, {'title': 'At Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4378.123', 'spread': '47.5360', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose at Week 1, 5, 9 and 13', 'description': 'Ctrough was defined as pre-dose plasma concentration during dosing and observed directly from data.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population included all participants from the safety population who had at least 1 reportable drug concentration data point. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Post-dose Plasma Concentration (Ctrough) of Talazoparib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'classes': [{'title': 'At week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2289.540', 'spread': '51.0724', 'groupId': 'OG000'}]}]}, {'title': 'At Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10713.918', 'spread': '49.4248', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2 hours post-dose at Week 1 and 5', 'description': 'Plasma concentration was measured 2 hours after dosing and observed directly from data.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all participants from the safety population who had at least 1 reportable drug concentration data point. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable at specified time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants with measurable soft tissue disease as per response evaluation criteria in solid tumors (RECIST) 1.1 and progressive metastatic castration-resistant prostate cancer (CRPC) and deoxyribonucleic acid (DNA) damage repair deficiencies, who previously received 1 to 2 taxane-based chemotherapy, and progressed on at least 1 line of novel hormonal therapy (enzalutamide and/or abiraterone acetate/prednisone) were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Talazoparib', 'description': 'Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Mean', 'categories': [{'measurements': [{'value': '68.16', 'spread': '8.02', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '127', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '106', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '110', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants who received at least 1 dose of talazoparib including participants enrolled prior to protocol amendment 3 with non-measurable disease and with deoxyribonucleic acid damage response (DDR) deficiencies which was likely or might sensitized the tumor to poly adenosine diphosphate-ribose polymerase (PARP) inhibition as assessed using an expanded DDR gene panel.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-15', 'size': 5817056, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-11T15:59', 'hasProtocol': True}, {'date': '2020-10-01', 'size': 14948729, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-07T02:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2017-05-09', 'resultsFirstSubmitDate': '2021-08-11', 'studyFirstSubmitQcDate': '2017-05-09', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-11', 'studyFirstPostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Objective Response Rate (ORR)', 'timeFrame': 'From first dose of study drug to best overall soft tissue response CR or PR (maximum duration of 25 months)', 'description': 'Best ORR was defined as the percentage of participants with best overall soft tissue response of complete response (CR) or partial response (PR) as per RECIST1.1 by an independent central review. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 millimeter (mm). Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference baseline sum diameters.'}], 'secondaryOutcomes': [{'measure': 'Time to Objective Response', 'timeFrame': 'From first dose of study drug to first objective response (maximum duration of 25 months)', 'description': 'Time to objective response was defined as the time from first dose of talazoparib to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per prostate cancer working Group 3 (PCWG3). Soft tissue response is defined as a best overall response of CR or PR per RECIST 1.1 by independent central review. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 % decrease in sum of diameters of target lesions taking as reference baseline sum diameters.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From the first objective evidence of soft tissue response (CR or PR, whichever is earlier) to radiographic progression or death due to any cause without evidence of radiographic progression, whichever occurs first (maximum duration of 25 months)', 'description': 'DOR was defined as the time from the first objective evidence of soft tissue response (CR or PR, whichever is earlier) per RECIST 1.1 and no evidence of confirmed bone disease progression per PCWG3 to the date of first objective evidence of radiographic progression or death due to any cause without evidence of radiographic progression, whichever occurs first. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 % decrease in sum of diameters of target lesions taking as reference baseline sum diameters.'}, {'measure': 'Percentage of Participants With Prostate-Specific Antigen (PSA) Response of Greater Than or Equal to (>=) 50 Percentage (%)', 'timeFrame': 'From the date of first dose of study treatment until confirmed PSA progression or start of new anticancer treatment given after the first dose of study treatment (maximum duration of 25 months)', 'description': 'Percentage of participants with PSA response of \\>= 50% was reported in this outcome measure. PSA response was calculated as a decline from baseline PSA (ng/mL) by at least 50% measured by central laboratory.'}, {'measure': 'Percentage of Participants With Conversion of Circulating Tumor Cell (CTC) Count', 'timeFrame': 'Baseline to anytime on study during final analysis of the outcome measure, up to maximum duration of 25 months', 'description': 'Percentage of participants with conversion of CTC count was defined as percentage of participants with a CTC count \\>= 5 CTC per 7.5 milliliter (mL) of blood at baseline that decreased to \\< 5 CTC per 7.5 mL of blood any time on study.'}, {'measure': 'Percentage of Participants With a Null CTC Count', 'timeFrame': 'Baseline to anytime on study during final analysis of the outcome measure, up to maximum duration of 25 months', 'description': 'Percentage of participants with a null CTC count was defined as percentage of participants with CTC count \\>=1 CTC per 7.5 mL of blood at baseline that decreased to CTC = 0 per 7.5 mL of blood any time on study.'}, {'measure': 'Percentage of Participants With Baseline CTC Count <5 CTC Showed Increased CTC Counts at Any Time on Study', 'timeFrame': 'Baseline to anytime on study during final analysis of the outcome measure, up to maximum duration of 25 months', 'description': 'Percentage of participants with CTC count \\<5 CTC per 7.5 mL of blood at baseline those who showed an increased CTC count, compared to baseline, any time on study was reported in this study.'}, {'measure': 'Time to Prostate-Specific Antigen (PSA) Progression', 'timeFrame': 'From the date of first dose of study treatment until confirmed PSA progression or start of new anticancer treatment given after the first dose of study treatment (maximum duration of 25 months)', 'description': 'Time to PSA progression was defined as the time from first dose of study treatment to the date of PSA progression, which was subsequently confirmed. The time from first dose of talazoparib to the date that a \\>=25% increase in PSA with an absolute increase of \\>=2micogram per liter (2 nanogram per mL) above the nadir (or baseline for participants with no PSA decline) was documented, confirmed by a second consecutive PSA value obtained \\>=3 weeks (21 days) later. Kaplan-Meier method was used for analysis.'}, {'measure': 'Radiographic Progression-Free Survival (PFS)', 'timeFrame': 'From date of first dose of study drug to first objective evidence of radiographic progression or death without documented radiographic progression, whichever occurs first (maximum duration of 25 months)', 'description': 'Radiographic PFS was defined as the time from date of first dose of talazoparib to first objective evidence of radiographic progression as assessed in soft tissue per modified RECIST 1.1 or confirmed progression in bone per PCWG3 guidelines by independent central review or death without documented radiographic progression, whichever occurs first.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From first dose of study treatment up to death due to any cause during study or date of last contact (approximately 36 months)', 'description': 'OS was defined as the time from start date (the date of first dose of treatment) to the date of death due to any cause. Participants who had not died were censored at the date of last contact. Kaplan-Meier method was used for analysis.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'First dose of study drug up to 28 days after last dose of study drug (study treatment was approximately for 36 months, safety follow up to approximately 37 months)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included both serious AEs and all non-serious AEs. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Permanent Treatment Discontinuation Due to Adverse Events', 'timeFrame': 'During study treatment (approximately up to 36 months)', 'description': 'Treatment discontinuation was defined as permanent cessation of study drug treatment administration.'}, {'measure': 'Number of Participants With Clinically Significant Abnormalities in Vital Signs', 'timeFrame': 'During study treatment (approximately up to 36 months)', 'description': 'Vital sign abnormalities criteria included: 1) Systolic blood pressure (SBP) in millimeters of mercury (mmHg): absolute result greater than (\\>) 180 mmHg and increase from baseline greater than or equal to (\\>=) 40 mmHg or absolute result \\< 90 mmHg and decrease from baseline \\> 30 mmHg; 2) Diastolic blood pressure (DBP) (mmHg): absolute result \\> 110 mmHg and increase from baseline \\>= 30 mmHg or absolute result \\< 50 mmHg and decrease from baseline \\> 20 mmHg or \\>= 20 mmHg increase from baseline; 3) Heart rate in beats per minutes (bpm): absolute result \\< 50 bpm and decrease from baseline \\> 20 bpm or absolute result \\> 120 bpm and increase from baseline \\> 30 bpm; Weight in kilogram: \\> 10% decrease from baseline.'}, {'measure': 'Number of Participants With Shift in Laboratory Parameter Values (Hematology) From Grade Less Than Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-baseline', 'timeFrame': 'During study treatment (approximately up to 36 months)', 'description': 'Hematology parameters included anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, Leukocytosis and white blood cell decreased. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or non-invasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.'}, {'measure': 'Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline', 'timeFrame': 'During study treatment (approximately up to 36 months)', 'description': 'Chemistry parameters:alanine aminotransferase increased(inc), alkaline phosphatase inc, aspartate aminotransferase inc, blood bilirubin inc, chronic kidney disease, creatinine inc, gamma-glutamyl transferase (GGT) inc, hypercalcemia, Hyperglycemia, hyperkalemia, hypermagnesemia, hypocalcemia, Hyponatremia, hypoglycemia, hypokalemia, hypomagnesemia, hypernatremia, Hypoalbuminemia and hypophosphatemia. Severity was graded as Grade(G)1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G2:moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G3:severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; G4:life-threatening consequence, urgent intervention indicated; G5: death related to AEs.'}, {'measure': 'Number of Participants With Dose Modification', 'timeFrame': 'During study treatment (approximately up to 36 months)', 'description': 'Number of participants with dose modification due to adverse events was reported.'}, {'measure': 'Time to Deterioration in Pain Symptom Scores', 'timeFrame': 'Baseline till final analysis of the outcome measure, up to maximum duration of 25 months', 'description': 'Time deterioration is based on BPI-SF question 3: "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours." Pain intensity was to be answered on a range of 0 to 10, where 0 corresponded to no pain and 10 worst pain. Time to this event is defined as the time from the date of first dose of study treatment to onset of pain progression, where pain progression is defined as a 2-point or more increase from baseline in the question 3 score. Kaplan-Meier method was used for analysis. Average of all assessments visits is reported in this outcome measure.'}, {'measure': 'Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3', 'timeFrame': 'Baseline, Week 1, 3, 5, 7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]', 'description': "BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-SF have 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. BPI-SF question 3 was related to participant experiencing pain at its worst in last 24 hours, score range 0 to 10, where large values corresponded to worse outcomes."}, {'measure': 'Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS)', 'timeFrame': 'Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]', 'description': 'The EQ-5D VAS score was a participant rated questionnaire where participants rated how they felt at assessment visit on a vertical VAS that ranged from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating a better health condition.'}, {'measure': 'Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain', 'timeFrame': 'Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]', 'description': 'EQ-5D-5L: participant rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D mobility domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem.'}, {'measure': 'Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain', 'timeFrame': 'Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]', 'description': 'EQ-5D-5L: participant rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D self-care domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem.'}, {'measure': 'Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain', 'timeFrame': 'Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]', 'description': 'EQ-5D-5L: participant rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D usual activities domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem.'}, {'measure': 'Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain', 'timeFrame': 'Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]', 'description': 'EQ-5D-5L: participant rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D pain and discomfort domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem.'}, {'measure': 'Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain', 'timeFrame': 'Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]', 'description': 'EQ-5D-5L: participant rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D anxiety and depression domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem.'}, {'measure': 'Pre-dose Plasma Concentration (Ctrough) of Talazoparib', 'timeFrame': 'Pre-dose at Week 1, 5, 9 and 13', 'description': 'Ctrough was defined as pre-dose plasma concentration during dosing and observed directly from data.'}, {'measure': 'Post-dose Plasma Concentration (Ctrough) of Talazoparib', 'timeFrame': '2 hours post-dose at Week 1 and 5', 'description': 'Plasma concentration was measured 2 hours after dosing and observed directly from data.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '36124924', 'type': 'DERIVED', 'citation': 'Mehra N, Fizazi K, de Bono JS, Barthelemy P, Dorff T, Stirling A, Machiels JP, Bimbatti D, Kilari D, Dumez H, Buttigliero C, van Oort IM, Castro E, Chen HC, Di Santo N, DeAnnuntis L, Healy CG, Scagliotti GV. Talazoparib, a Poly(ADP-ribose) Polymerase Inhibitor, for Metastatic Castration-resistant Prostate Cancer and DNA Damage Response Alterations: TALAPRO-1 Safety Analyses. Oncologist. 2022 Oct 1;27(10):e783-e795. doi: 10.1093/oncolo/oyac172.'}, {'pmid': '34388386', 'type': 'DERIVED', 'citation': 'de Bono JS, Mehra N, Scagliotti GV, Castro E, Dorff T, Stirling A, Stenzl A, Fleming MT, Higano CS, Saad F, Buttigliero C, van Oort IM, Laird AD, Mata M, Chen HC, Healy CG, Czibere A, Fizazi K. Talazoparib monotherapy in metastatic castration-resistant prostate cancer with DNA repair alterations (TALAPRO-1): an open-label, phase 2 trial. Lancet Oncol. 2021 Sep;22(9):1250-1264. doi: 10.1016/S1470-2045(21)00376-4. Epub 2021 Aug 10.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=MDV3800-06', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this international, phase 2, open-label, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with DNA repair defects metastatic castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone acetate/prednisone).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Histologically or cytologically confirmed adenocarcinoma of the prostate without signet cell, or small cell features.\n3. Patients must have measurable soft tissue disease per RECIST 1.1\n4. DNA damage repair deficiency as assessed centrally by a gene mutation biomarker panel (testing of de novo or archival tumor tissue (via central laboratory) or prior historical testing (with Sponsor approval) using the Foundation Medicine, FoundationOne CDx™ NGS gene panel test.\n5. Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n6. Serum testosterone ≤ 1.73 nmol/L (50 ng/dL) at screening.\n7. Bilateral orchiectomy or ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist (surgical or medical castration).\n8. Progressive disease at study entry defined as 1 or more of the following 3 criteria:\n\n * A minimum of 3 rising PSA values with an interval of at least 1 week between determinations. The screening central laboratory PSA value must be ≥ 2 μg/L (2 ng/mL) if qualifying solely by PSA progression.\n * Soft tissue disease progression as defined by RECIST 1.1.\n * Bone disease progression defined by PCWG3 with 2 or more new metastatic lesions on bone scan.\n9. Metastatic disease.\n10. Previous treatment with 1 or 2 chemotherapy regimens including at least 1 taxane-based regimen for metastatic (non castrate or castrate) prostate cancer. Patients may have received radium-223 and/or cabazitaxel, or were deemed unsuitable, declined, or did not have access to these therapies.\n11. Documented disease progression (either radiographic or biochemical) on at least 1 novel hormonal therapy (enzalutamide and/or abiraterone acetate/prednisone) for the treatment of metastatic CRPC, irrespective of prior NHT treatment for non castrate prostate cancer or nonmetastatic (M0) CRPC.\n12. Bisphosphonate or denosumab dosage must have been stable for at least 4 weeks before day 1 for patients receiving these therapies.\n13. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n14. Estimated life expectancy of ≥ 6 months as assessed by the investigator.\n15. Able to swallow the study drug, have no known intolerance to study drugs or excipients, and comply with study requirements.\n16. Must use a condom when having sex from the time of the first dose of study drug through 4 months after last dose of study drug. A highly effective form of contraception must be used from the time of the first dose of study drug through 4 months after last dose of study drug when having sex with a non pregnant female partner of childbearing potential.\n17. Must agree not to donate sperm from the first dose of study drug to 4 months after the last dose of study drug.\n18. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n1. 1\\. Use of systemic chemotherapeutic (including but not limited to taxanes), hormonal, biologic, or radionuclide therapy for treatment of metastatic prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist) or any other investigational agent within 4 weeks before day 1.\n2. Prior treatment with a PARP inhibitor, cyclophosphamide, or mitoxantrone chemotherapy. Patients who discontinued prior platinum based chemotherapy \\<=6 months prior to screening or whose disease previously progressed on platinum based therapy at any time in the past are also excluded.\n3. Treatment with any concurrent cytotoxic chemotherapy or investigational drug(s) within 4 weeks or 5 half lives of the drug (whichever is longer) before Day 1 and/or during study participation\n4. Radiation therapy within 3 weeks (within 2 weeks, if single fraction of radiotherapy) before day 1.\n5. Major surgery within 2 weeks before day 1.\n6. Clinically significant cardiovascular disease.\n7. Significant renal, hepatic, or bone marrow organ dysfunction.\n8. Known or suspected brain metastasis or active leptomeningeal disease.\n9. Symptomatic or impending spinal cord compression or cauda equina syndrome.\n10. Prior diagnosis of myelodysplastic syndrome or acute myeloid leukemia\n11. History of another cancer within 3 years before enrollment with the exception of nonmelanoma skin cancers, or American Joint Committee on Cancer stage 0 or stage 1 cancer that has a remote probability of recurrence in the opinion of the investigator and the sponsor.\n12. Gastrointestinal disorder affecting absorption.\n13. Current or anticipated use within 7 days prior to first dose of study drug or anticipated use during the study of the following P gp inhibitors (amiodarone, carvedilol, clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, telaprevir, tipranavir, verapamil, and valspodar).\n14. Any other acute or chronic medical or psychiatric condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of data, in the opinion of the investigator or sponsor, including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n15. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.\n16. Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 4 months after the last dose of investigational product.'}, 'identificationModule': {'nctId': 'NCT03148795', 'briefTitle': 'A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'TALAPRO-1: A PHASE 2, OPEN-LABEL, RESPONSE RATE STUDY OF TALAZOPARIB IN MEN WITH DNA REPAIR DEFECTS AND METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO PREVIOUSLY RECEIVED TAXANE-BASED CHEMOTHERAPY AND PROGRESSED ON AT LEAST 1 NOVEL HORMONAL AGENT (ENZALUTAMIDE AND/OR ABIRATERONE ACETATE/PREDNISONE)', 'orgStudyIdInfo': {'id': 'MDV3800-06'}, 'secondaryIdInfos': [{'id': 'C3441006', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': '2016-002036-32', 'type': 'EUDRACT_NUMBER'}]}, 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