Viewing Study NCT02163694

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Ignite Creation Date: 2025-12-25 @ 1:34 AM

Ignite Modification Date: 2026-04-18 @ 7:06 AM

Study NCT ID: NCT02163694

Status: COMPLETED

Last Update Posted: 2025-02-19

First Post: 2014-05-19

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C521013', 'term': 'veliparib'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality were reported from enrollment to the end of study, median time on follow up was 84.5 and 81.8 months for Placebo + C/P and Veliparib + C/P, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 115.0 and 117.5 days for Placebo + C/P and Veliparib + C/P, respectively.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo + C/P', 'description': 'Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21- day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.', 'otherNumAtRisk': 174, 'deathsNumAtRisk': 174, 'otherNumAffected': 169, 'seriousNumAtRisk': 174, 'deathsNumAffected': 129, 'seriousNumAffected': 68}, {'id': 'EG001', 'title': 'Veliparib + C/P', 'description': 'Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle.\n\nCarboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.', 'otherNumAtRisk': 339, 'deathsNumAtRisk': 339, 'otherNumAffected': 332, 'seriousNumAtRisk': 339, 'deathsNumAffected': 244, 'seriousNumAffected': 135}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 501, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1147, 'numAffected': 256}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 319, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 700, 'numAffected': 133}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'LYMPHOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 33, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 139, 'numAffected': 43}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1286, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 2450, 'numAffected': 292}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 581, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1659, 'numAffected': 257}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PALPITATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 28, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 20, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'TINNITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 43, 'numAffected': 21}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 38, 'numAffected': 24}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DRY EYE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'VISION BLURRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ABDOMINAL DISTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 30, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 81, 'numAffected': 52}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 33, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 90, 'numAffected': 56}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 87, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 183, 'numAffected': 117}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 141, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 337, 'numAffected': 151}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 42, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 88, 'numAffected': 61}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 328, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 772, 'numAffected': 240}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 32, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 74, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'TOOTHACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 30, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 160, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 280, 'numAffected': 118}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 141, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 346, 'numAffected': 85}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 29, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 218, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 383, 'numAffected': 168}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'INFLUENZA LIKE ILLNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 26, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 50, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'MUCOSAL INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 37, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 96, 'numAffected': 69}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PERIPHERAL SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 45, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 83, 'numAffected': 59}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DRUG HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 66, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 91, 'numAffected': 58}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 27, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 26, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 42, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 89, 'numAffected': 60}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 26, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'RESPIRATORY TRACT INFECTION VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 33, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 34, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 27, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 86, 'numAffected': 52}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 43, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 77, 'numAffected': 41}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 61, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 151, 'numAffected': 59}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 62, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 115, 'numAffected': 50}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'BLOOD ALKALINE PHOSPHATASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 18, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 48, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'WEIGHT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 13, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 40, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 71, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 106, 'numAffected': 81}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 23, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 19, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 65, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'HYPOCALCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 55, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 47, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 95, 'numAffected': 44}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'HYPOMAGNESAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 108, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 196, 'numAffected': 83}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'HYPONATRAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'HYPOPHOSPHATAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 28, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 51, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 98, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 133, 'numAffected': 77}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 62, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 105, 'numAffected': 66}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 39, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 54, 'numAffected': 41}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 25, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'MUSCULOSKELETAL CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 29, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 39, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 88, 'numAffected': 60}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'NECK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 23, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'CANCER PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COLON CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'GASTRIC NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'MALIGNANT NEOPLASM PROGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 26, 'numAffected': 19}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'MALIGNANT PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'METASTASES TO BONE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'METASTASES TO BONE MARROW', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'METASTASES TO CENTRAL NERVOUS SYSTEM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'METASTASES TO LYMPH NODES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'METASTASES TO MENINGES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'MYELODYSPLASTIC SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'SECOND PRIMARY MALIGNANCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'TUMOUR PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'APHASIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'BRAIN OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'CEREBRAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'CERVICAL CORD COMPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DYSARTHRIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'HYDROCEPHALUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'INTRACRANIAL PRESSURE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'LETHARGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'MENINGEAL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PARTIAL SEIZURES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PRESYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'SCIATICA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'SEIZURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'VASCULAR ENCEPHALOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DEVICE BREAKAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'MANIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PSYCHOTIC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ACUTE KIDNEY INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'CHRONIC KIDNEY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'HAEMATURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PELVIC PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ATELECTASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'LARYNGEAL OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PLEURITIC PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PNEUMOMEDIASTINUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PNEUMOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PULMONARY ARTERY THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ANGIOEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ABORTION INDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'AORTIC STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ILIAC ARTERY OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'POOR VENOUS ACCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + C/P', 'description': 'Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.'}, {'id': 'OG001', 'title': 'Veliparib + C/P', 'description': 'Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '10.6', 'upperLimit': '14.4'}, {'value': '14.6', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '17.7'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'PFS was compared between the treatment groups using the log-rank test, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor \\[ER\\] and/or progesterone receptor \\[PgR\\] positive versus ER/PgR negative).', 'statisticalMethod': 'Log-rank test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Cox proportional hazards', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.728', 'ciLowerLimit': '0.590', 'ciUpperLimit': '0.900', 'groupDescription': 'A Cox proportional hazards model, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor (ER) and/or progesterone receptor (PgR) positive versus ER/PgR negative) was used to estimate the hazard ratio and 95% confidence interval comparing the two treatment arms.', 'statisticalMethod': 'Stratified Cox proportional hazards', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until the primary analysis data cut-off date of 05 April 2019; the median duration of follow-up was 35.5 months', 'description': 'Time to PFS is defined as the number of days from the date the participant was randomized to the date the participant experiences radiographic disease progression (as determined by the investigators), or to the date of death (all causes of mortality) if disease progression is not reached. All events of disease progression occurring on or before the Primary Analysis Cutoff date of 05 April 2019 were to be included, regardless of whether the event occurred while the participant was still taking study drug or had previously discontinued study drug. PFS was estimated for each treatment group using Kaplan-Meier methodology.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population for whom data was collected and available for analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + C/P', 'description': 'Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.'}, {'id': 'OG001', 'title': 'Veliparib + C/P', 'description': 'Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000', 'lowerLimit': '24.7', 'upperLimit': '32.8'}, {'value': '32.4', 'groupId': 'OG001', 'lowerLimit': '27.4', 'upperLimit': '38.1'}]}]}], 'analyses': [{'pValue': '0.410', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.410', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Cox proportional hazards', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.914', 'ciLowerLimit': '0.737', 'ciUpperLimit': '1.333', 'groupDescription': 'A Cox proportional hazards model, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor (ER) and/or progesterone receptor (PgR) positive versus ER/PgR negative) was used to estimate the hazard ratio and 95% confidence interval comparing the two treatment arms.', 'statisticalMethod': 'Stratified Cox proportional hazards', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 84.5 and 81.8 months for Placebo and Veliparib, respectively.', 'description': "Time to death (overall survival) is defined as the number of days from the date the participant was randomized to the date of the participant's death. All events of death which occur up to the analysis cutoff date are to be included, regardless of whether the event occurred while the participant was still taking study drug or after the participant discontinued study drug. If a participant has not died, the data for the participant is to be censored at the date last known to be alive or at the analysis cutoff date if that is earlier.\n\nThe final analysis of OS will occur when the pre-specified number of events has occurred in the ITT population.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population for whom data was collected and available for analysis.'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + C/P', 'description': 'Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.'}, {'id': 'OG001', 'title': 'Veliparib + C/P', 'description': 'Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000', 'lowerLimit': '89.5', 'upperLimit': '95.7'}, {'value': '90.7', 'groupId': 'OG001', 'lowerLimit': '87.9', 'upperLimit': '92.9'}]}]}], 'analyses': [{'pValue': '0.202', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Nominal P value is from Cochran-Mantel-Haenszel test stratified by ER/PgR status and prior platinum therapy use.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Through the end of Week 24', 'description': 'The clinical benefit rate (CBR) is defined as the progression-free rate at 24 weeks (168 days), estimated using Kaplan Meier methodology. All events of disease progression in the primary progression free survival analysis database were to be included, regardless of whether the event occurred while the participant was still taking, or had previously discontinued, study drug. If the participant had not yet progressed then their data was to be censored at the date of the last evaluable disease progression assessment. Participants without post-baseline assessments were to be censored at the date of randomization.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population for whom data was collected and available for analysis.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + C/P', 'description': 'Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.'}, {'id': 'OG001', 'title': 'Veliparib + C/P', 'description': 'Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.1', 'groupId': 'OG000', 'lowerLimit': '66.1', 'upperLimit': '81.1'}, {'value': '75.8', 'groupId': 'OG001', 'lowerLimit': '70.4', 'upperLimit': '80.6'}]}]}], 'analyses': [{'pValue': '0.715', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Nominal P value is from Cochran-Mantel-Haenszel test stratified by ER/PgR status and prior platinum therapy use.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 8 years from randomization', 'description': 'The objective response rate (ORR) is calculated as the percentage of participants who have a confirmed partial response (PR) or complete response (CR) based on assessment by the investigators per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. All participants who had at least one measurable lesion at baseline were to be included in the ORR calculation.\n\nThe final analysis of ORR will occur when the pre-specified number of Overall Survival events have occurred in the ITT population, per the fixed sequence testing procedure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population for whom data was collected and available for analysis.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival on Subsequent Therapy (PFS2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + C/P', 'description': 'Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.'}, {'id': 'OG001', 'title': 'Veliparib + C/P', 'description': 'Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '20.7'}, {'value': '21.5', 'groupId': 'OG001', 'lowerLimit': '19.9', 'upperLimit': '25.3'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Cox proportional hazards', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.737', 'ciLowerLimit': '0.597', 'ciUpperLimit': '0.908', 'statisticalMethod': 'Stratified Cox proportional hazards', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by prior platinum therapy (yes vs no) and receptor status (ER and/or PgR positive vs ER/PgR negative).'}], 'paramType': 'MEDIAN', 'timeFrame': 'Approximately 8 years from randomization', 'description': 'PFS2 is defined as the number of days from the date of randomization to the time of disease progression on subsequent therapy or death from any cause. The distribution of PFS2 was to be estimated for each treatment group using Kaplan-Meier methodology.\n\nThe final analysis of PFS2 will occur when the pre-specified number of Overall Survival events have occurred in the ITT population, per the fixed sequence testing procedure.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population for whom data was collected and available for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + C/P', 'description': 'Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.'}, {'id': 'FG001', 'title': 'Veliparib + C/P', 'description': 'Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '339'}]}, {'type': 'ITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '337'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '339'}]}], 'dropWithdraws': [{'type': 'Adverse event- related to progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Adverse event- not related to progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Sponsor discontinued study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Progressive disease per protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '224'}]}, {'type': 'Other, not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Randomized but Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Determined not to have a suspected deleterious or deleterious mutation in BRCA1/2', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 513 subjects enrolled in the study (N=174 to the placebo + C/P arm, and N=339 to the veliparib + C/P arm). Two subjects form each arm (N= 4) were determined not to have a suspected deleterious or deleterious mutation in BRCA1/2 and were excluded from the ITT population \\[ITT Population (N=509); Placebo + C/P arm (N=172), and Veliparib + C/P arm (N=337)\\]. Of the 4 subjects, 3 subjects received treatment and later discontinued due to disease progression.', 'preAssignmentDetails': 'Subjects randomized to placebo were eligible to crossover to unblinded veliparib monotherapy. After Protocol Amendment 5, investigators and subjects were unblinded to treatment assignment, subjects randomized to placebo discontinued from the study, subjects discontinuing therapy prior to progression no longer remained on study, and no new subjects initiated crossover unblinded veliparib monotherapy treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'BG000'}, {'value': '337', 'groupId': 'BG001'}, {'value': '509', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + C/P', 'description': 'Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.'}, {'id': 'BG001', 'title': 'Veliparib + C/P', 'description': 'Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.8', 'spread': '10.81', 'groupId': 'BG000'}, {'value': '46.8', 'spread': '10.73', 'groupId': 'BG001'}, {'value': '46.8', 'spread': '10.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '333', 'groupId': 'BG001'}, {'value': '502', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '294', 'groupId': 'BG001'}, {'value': '447', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-23', 'size': 4741200, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-11T10:59', 'hasProtocol': True}, {'date': '2019-05-30', 'size': 332730, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-11T11:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 513}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'dispFirstSubmitDate': '2020-04-01', 'completionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2014-05-19', 'dispFirstSubmitQcDate': '2020-04-01', 'resultsFirstSubmitDate': '2022-03-11', 'studyFirstSubmitQcDate': '2014-06-12', 'dispFirstPostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-11', 'studyFirstPostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From randomization until the primary analysis data cut-off date of 05 April 2019; the median duration of follow-up was 35.5 months', 'description': 'Time to PFS is defined as the number of days from the date the participant was randomized to the date the participant experiences radiographic disease progression (as determined by the investigators), or to the date of death (all causes of mortality) if disease progression is not reached. All events of disease progression occurring on or before the Primary Analysis Cutoff date of 05 April 2019 were to be included, regardless of whether the event occurred while the participant was still taking study drug or had previously discontinued study drug. PFS was estimated for each treatment group using Kaplan-Meier methodology.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 84.5 and 81.8 months for Placebo and Veliparib, respectively.', 'description': "Time to death (overall survival) is defined as the number of days from the date the participant was randomized to the date of the participant's death. All events of death which occur up to the analysis cutoff date are to be included, regardless of whether the event occurred while the participant was still taking study drug or after the participant discontinued study drug. If a participant has not died, the data for the participant is to be censored at the date last known to be alive or at the analysis cutoff date if that is earlier.\n\nThe final analysis of OS will occur when the pre-specified number of events has occurred in the ITT population."}, {'measure': 'Clinical Benefit Rate (CBR)', 'timeFrame': 'Through the end of Week 24', 'description': 'The clinical benefit rate (CBR) is defined as the progression-free rate at 24 weeks (168 days), estimated using Kaplan Meier methodology. All events of disease progression in the primary progression free survival analysis database were to be included, regardless of whether the event occurred while the participant was still taking, or had previously discontinued, study drug. If the participant had not yet progressed then their data was to be censored at the date of the last evaluable disease progression assessment. Participants without post-baseline assessments were to be censored at the date of randomization.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Approximately 8 years from randomization', 'description': 'The objective response rate (ORR) is calculated as the percentage of participants who have a confirmed partial response (PR) or complete response (CR) based on assessment by the investigators per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. All participants who had at least one measurable lesion at baseline were to be included in the ORR calculation.\n\nThe final analysis of ORR will occur when the pre-specified number of Overall Survival events have occurred in the ITT population, per the fixed sequence testing procedure.'}, {'measure': 'Progression-Free Survival on Subsequent Therapy (PFS2)', 'timeFrame': 'Approximately 8 years from randomization', 'description': 'PFS2 is defined as the number of days from the date of randomization to the time of disease progression on subsequent therapy or death from any cause. The distribution of PFS2 was to be estimated for each treatment group using Kaplan-Meier methodology.\n\nThe final analysis of PFS2 will occur when the pre-specified number of Overall Survival events have occurred in the ITT population, per the fixed sequence testing procedure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PARP Inhibitor', 'Veliparib', 'BRCA1', 'BRCA2', 'HER2-negative', 'Locally recurrent', 'Breast Cancer', 'Metastatic Breast Cancer', 'ABT-888', 'Genetic breast cancer', 'Paclitaxel', 'BRCA Mutation', 'PARP', 'Carboplatin', 'BROCADE3'], 'conditions': ['Metastatic Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '35403245', 'type': 'DERIVED', 'citation': 'Stodtmann S, Eckert D, Joshi R, Nuthalapati S, Ratajczak CK, Menon R, Mensing S, Xiong H. Exposure-Response Model With Time-Varying Predictors to Estimate the Effects of Veliparib in Combination With Carboplatin/Paclitaxel and as Monotherapy: Veliparib Phase 3 Study in BRCA-Mutated Advanced Breast Cancer (BROCADE3) Trial. J Clin Pharmacol. 2022 Oct;62(10):1236-1246. doi: 10.1002/jcph.2061. Epub 2022 May 5.'}, {'pmid': '34917174', 'type': 'DERIVED', 'citation': 'Ayoub JP, Wildiers H, Friedlander M, Arun BK, Han HS, Puhalla S, Shparyk Y, Jakobsen EH, Wu M, Bach BA, Feng D, Ratajczak CK, Maag D, Dieras V. Safety and efficacy of veliparib plus carboplatin/paclitaxel in patients with HER2-negative metastatic or locally advanced breast cancer: subgroup analyses by germline BRCA1/2 mutations and hormone receptor status from the phase-3 BROCADE3 trial. Ther Adv Med Oncol. 2021 Dec 9;13:17588359211059601. doi: 10.1177/17588359211059601. eCollection 2021.'}, {'pmid': '34243076', 'type': 'DERIVED', 'citation': 'Arun BK, Han HS, Kaufman B, Wildiers H, Friedlander M, Ayoub JP, Puhalla SL, Bell-McGuinn KM, Bach BA, Kundu MG, Ratajczak CK, Maag D, Dieras V. Efficacy and safety of first-line veliparib and carboplatin-paclitaxel in patients with HER2- advanced germline BRCA+ breast cancer: Subgroup analysis of a randomised clinical trial. Eur J Cancer. 2021 Sep;154:35-45. doi: 10.1016/j.ejca.2021.05.037. Epub 2021 Jul 6.'}, {'pmid': '34131001', 'type': 'DERIVED', 'citation': 'Puhalla SL, Dieras V, Arun BK, Kaufman B, Wildiers H, Han HS, Ayoub JP, Stearns V, Yuan Y, Helsten T, Riley-Gillis B, Murphy E, Kundu MG, Wu M, Maag D, Ratajczak CK, Ramathal CY, Friedlander M. Relevance of Platinum-free Interval and BRCA Reversion Mutations for Veliparib Monotherapy after Progression on Carboplatin/Paclitaxel for gBRCA Advanced Breast Cancer (BROCADE3 Crossover). Clin Cancer Res. 2021 Sep 15;27(18):4983-4993. doi: 10.1158/1078-0432.CCR-21-0748. Epub 2021 Jun 15.'}, {'pmid': '32861273', 'type': 'DERIVED', 'citation': 'Dieras V, Han HS, Kaufman B, Wildiers H, Friedlander M, Ayoub JP, Puhalla SL, Bondarenko I, Campone M, Jakobsen EH, Jalving M, Oprean C, Palacova M, Park YH, Shparyk Y, Yanez E, Khandelwal N, Kundu MG, Dudley M, Ratajczak CK, Maag D, Arun BK. Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1269-1282. doi: 10.1016/S1470-2045(20)30447-2. Epub 2020 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic or locally advanced unresectable breast cancer. The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR) through the end of Week 24, objective response rate (ORR) and PFS on subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P versus placebo in combination with C/P.', 'detailedDescription': 'This is a Phase 3, randomized, double-blind, multinational, multicenter study to evaluate the efficacy and tolerability of veliparib in combination with C/P compared to placebo in combination with C/P in participants with a BRCA1 or BRCA2 mutation, as documented by the Sponsor core laboratory, with HER2-negative metastatic or locally advanced unresectable breast cancer who received no more than 2 prior lines of cytotoxic therapy for metastatic disease. For the purposes of eligibility, HER2-negative status was based on the most recent tumor biopsy. Participants were randomized in a 2:1 ratio, with a total of approximately 500 participants planned to be randomized. Veliparib 120 mg/placebo twice a day (BID) was dosed Days -2 through 5 with carboplatin target area under the concentration-time curve (AUC) 6 administered on Day 1 and paclitaxel 80 mg/m2 administered weekly on Days 1, 8, and 15 of each 21-day cycle.\n\nSafety and efficacy data through the prespecified primary analysis cutoff date of 05 April 2019 are included in the interim analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed breast cancer that is either locally advanced or metastatic. Locally advanced breast cancer must not be amenable to surgical resection or radiation with curative intent.\n2. Suspected deleterious or deleterious Breast Cancer Gene 1 (BRCA1) and/or Breast Cancer Gene 2 (BRCA2) germline mutation.\n3. Breast cancer must be Human Epidermal Growth Factor Receptor 2 (HER2)-negative.\n4. Measurable or non-measurable (but radiologically evaluable) disease per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1 on computed tomography (CT) scan (within 28 days of randomization) with at least one lesion outside previously irradiated areas.\n5. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.\n6. Adequate hematologic, renal, and hepatic function (within 28 days of randomization).\n\nExclusion Criteria:\n\n1. More than two prior lines of cytotoxic chemotherapy (e.g., gemcitabine, doxorubicin, capecitabine) for metastatic disease.\n\n * Regimens received in the adjuvant/neoadjuvant setting or for locally advanced breast cancer within the past 6 months will also be considered toward the maximum of 2 prior lines of therapy. Adjuvant/neoadjuvant chemotherapy for one cancer event will count as one prior line of therapy, if received within the past 6 months.\n * Previous treatments with hormonal therapy (tamoxifen, aromatase inhibitors) and signal transduction agents (e.g., erlotinib, gefitinib, everolimus, bevacizumab) are allowed and are not counted towards the prior line of therapy.\n2. Progressed or recurred within 12 months of completing platinum therapy or received \\> 1 prior line of platinum therapy for breast cancer in any setting (adjuvant, neoadjuvant, or metastatic).\n3. Prior therapy with Poly(ADP-ribose)-Polymerase (PARP) inhibitors.\n4. Prior taxane therapy administered for the treatment of metastatic breast cancer with the below exceptions.\n\n * Prior taxane therapy for metastatic breast cancer is allowed if the patient received ≤ 1 full cycle (i.e., therapy discontinued within 4 weeks for subjects receiving weekly paclitaxel or Abraxane; therapy discontinued within 3 weeks for subjects receiving paclitaxel or docetaxel every 3 weeks) in the absence of progression or if taxane therapy for metastatic disease was \\> 12 months prior to Cycle 1 Day-2 (C1D-2).\n * Use of taxanes as adjuvant therapy or to treat locally advanced disease is permitted, if given more than 6 months prior to C1D-2\n5. Known history of allergic reaction to cremophor-paclitaxel, carboplatin, Azo-Colourant Tartrazine (also known as FD\\&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also known as FD\\&C Yellow 6 or E110) or known contraindications to any study supplied drug.\n6. Active CNS metastases or leptomeningeal disease.'}, 'identificationModule': {'nctId': 'NCT02163694', 'briefTitle': 'A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer', 'orgStudyIdInfo': {'id': 'M12-914'}, 'secondaryIdInfos': [{'id': '2014-000345-70', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Veliparib Placebo with Carboplatin and Paclitaxel', 'description': 'Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.', 'interventionNames': ['Drug: Veliparib Placebo', 'Drug: Carboplatin', 'Drug: Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Veliparib with Carboplatin and Paclitaxel', 'description': 'Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.', 'interventionNames': ['Drug: Veliparib', 'Drug: Carboplatin', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'Veliparib Placebo', 'type': 'DRUG', 'description': 'Supplied as 40 mg, 50 mg, or 100 mg capsules for oral administration twice daily (BID) on Days -2 through 5 of a 21-day cycle.', 'armGroupLabels': ['Veliparib Placebo with Carboplatin and Paclitaxel']}, {'name': 'Veliparib', 'type': 'DRUG', 'otherNames': ['ABT-888'], 'description': 'Supplied as 40 mg, 50 mg, or 100 mg capsules for oral administration twice daily (BID) on Days -2 through 5 of a 21-day cycle.', 'armGroupLabels': ['Veliparib with Carboplatin and Paclitaxel']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Administered intravenously over approximately 15 to 30 minutes at an area under the curve (AUC) of 6 mg/mL/min immediately following paclitaxel infusion on Day 1 of every cycle. The duration of carboplatin infusion may be lengthened according to institutional guidelines.', 'armGroupLabels': ['Veliparib Placebo with Carboplatin and Paclitaxel', 'Veliparib with Carboplatin and Paclitaxel']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Administered by intravenous infusion over approximately 1 hour at a dose of 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle. Paclitaxel is to be infused prior to carboplatin on Day 1. Dosing of veliparib/placebo is to be completed before the carboplatin or paclitaxel infusions.', 'armGroupLabels': ['Veliparib Placebo with Carboplatin and Paclitaxel', 'Veliparib with Carboplatin and Paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Ctr /ID# 125011', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences /ID# 124992', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope /ID# 127117', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'California Cancer Associates for Research & Excellence (cCARE) /ID# 136078', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Moores Cancer Center at UC San Diego /ID# 124991', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Hematology and Oncology Assoc /ID# 130058', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Cancer Research Collaboration /ID# 128860', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Icri /Id# 128520', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Univ of Colorado Cancer Center /ID# 124983', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Saint Joseph Hospital /ID# 131768', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06856', 'city': 'Norwalk', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Norwalk Hospital /ID# 133509', 'geoPoint': {'lat': 41.1176, 'lon': -73.4079}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Lynn Cancer Institute, Boca /ID# 125013', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Hospital /ID# 125012', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Sacred Heart Hospital /ID# 128279', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33612-9416', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center /ID# 124990', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists - East /ID# 125007', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Midtown Infectious Disease Clinic /ID# 133192', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Cancer Ctr at DeKalb Med C /ID# 125024', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois - Chicago /ID# 127576', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University HealthSystem /ID# 124996', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '60099', 'city': 'Zion', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwestern Regional CTC /ID# 124986', 'geoPoint': {'lat': 42.44613, 'lon': -87.83285}}, {'zip': '50010', 'city': 'Ames', 'state': 'Iowa', 'country': 'United States', 'facility': 'McFarland Clinic, PC /ID# 129904', 'geoPoint': {'lat': 42.03471, 'lon': -93.61994}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University /ID# 125015', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center /ID# 139461', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMass Chan Medical School /ID# 129067', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System /ID# 134497', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health Medical Group /ID# 133568', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health Medical Group /ID# 148471', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48073-6710', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital /ID# 125019', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '39216-4643', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Univ of Mississippi Med Ctr,US /ID# 131352', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '64111-5905', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Lukes Cancer Institute /ID# 125023', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University-School of Medicine /ID# 127575', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68506', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Nebraska Hematology Oncology /ID# 132711', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey /ID# 125017', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '87102-4517', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico /ID# 125349', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Medical Center /ID# 125001', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10025', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Mount Sinai St. Luke's /ID# 125003", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mission Cancer Center /ID# 134248', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27710-3000', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Cancer Center /ID# 124999', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University /ID# 125022', 'geoPoint': {'lat': 39.96118, 'lon': 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Hershey Medical Center /ID# 124997', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital /ID# 135094', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15260', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh MC /ID# 125005', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '76012', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Health Physicians Group /ID# 137740', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '75390-7208', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center /ID# 124989', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center /ID# 125353', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '05401-1473', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont Medical Center /ID# 125350', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '98029-6201', 'city': 'Issaquah', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Institute - Issaquah /ID# 131534', 'geoPoint': {'lat': 47.5301, 'lon': -122.03262}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Institute - Edmonds /ID# 131549', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center /ID# 125021', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98107-3932', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Insititute - Ballard /ID# 131548', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Medical Specialties - Tacoma /ID# 125344', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '1884', 'city': 'Berazategui', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'COIBA Centro de Oncologia e Investigacion de Buenos Aires /ID# 124839', 'geoPoint': {'lat': -34.76531, 'lon': -58.21278}}, {'zip': '2700', 'city': 'Pergamino', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Clinica Pergamino /ID# 127158', 'geoPoint': {'lat': -33.89101, 'lon': -60.57462}}, {'zip': '2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Instituto de Oncoloia de Rosario /ID# 127157', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '5300', 'city': 'La Rioja', 'country': 'Argentina', 'facility': 'Centro Oncologico Riojano Integral /ID# 127938', 'geoPoint': {'lat': -29.41328, 'lon': -66.85637}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'St George Hospital /ID# 129416', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Duplicate_The Prince of Wales Hospital /ID# 124845', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2500', 'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Southern Medical Day Care Centre /ID# 124844', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'zip': '4814', 'city': 'Douglas', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Townsville University Hospital /ID# 126731', 'geoPoint': {'lat': -19.32394, 'lon': 146.75234}}, {'zip': '5042', 'city': 'Bedford Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Duplicate_Flinders Centre for Innovation /ID# 127535', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'zip': '7000', 'city': 'Hobart', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Royal Hobart Hospital /ID# 124849', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Royal Melbourne Hospital /ID# 124846', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Hollywood Private Hospital /ID# 124843', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Medizinische Universitaet Graz /ID# 126450', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '4010', 'city': 'Linz', 'state': 'Upper Austria', 'country': 'Austria', 'facility': 'Ordensklinikum Linz GmbH Elisabethinen /ID# 126185', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universitaet Wien /ID# 126184', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 126449', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '213825', 'city': 'Babruysk', 'country': 'Belarus', 'facility': 'Bobruysk Interdistrict Onco. /ID# 137729', 'geoPoint': {'lat': 53.14636, 'lon': 29.20552}}, {'zip': '223040', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'State Institution Republican Scientific Practical Center of Oncology and Medical /ID# 125223', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '212018', 'city': 'Mogilev', 'country': 'Belarus', 'facility': 'Duplicate_Mogilev Reg Clin Oncology Dis /ID# 137728', 'geoPoint': {'lat': 53.90876, 'lon': 30.34044}}, {'zip': '210603', 'city': 'Vitebsk', 'country': 'Belarus', 'facility': 'Vitebsk Regional Clinical Oncology Dispensary /ID# 125219', 'geoPoint': {'lat': 55.1904, 'lon': 30.2049}}, {'zip': '2650', 'city': 'Edegem', 'state': 'Antwerpen', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen /ID# 124977', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '1200', 'city': 'Woluwe-Saint-Lambert', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'UCL Saint-Luc /ID# 124976', 'geoPoint': {'lat': 50.84389, 'lon': 4.42912}}, {'zip': '6000', 'city': 'Charleroi', 'state': 'Hainaut', 'country': 'Belgium', 'facility': 'Grand Hôpital de Charleroi /ID# 124981', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Leuven /ID# 124980', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '8000', 'city': 'Bruges', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Duplicate_AZ St-Jan Brugge-Oostende AV 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'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '581 85', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Linkoping University Hospital /ID# 126795', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '171 64', 'city': 'Solna', 'country': 'Sweden', 'facility': 'Duplicate_Karolinska Univ Sjukhuset /ID# 124964', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}, {'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital /ID# 126512', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 125575', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital /ID# 125324', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University Faculty of Medicine /ID# 125336', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06200', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 125337', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '07059', 'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Duplicate_Akdeniz University Medical Fac /ID# 125339', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}, {'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmi Alem Univ Med Fac Hosp /ID# 127901', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University Istanbul Medical Faculty /ID# 145144', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '49102', 'city': 'Dnipro', 'country': 'Ukraine', 'facility': 'Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 124968', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '83092', 'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'Donetsk Regional Antitumor Ctr /ID# 124970', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'zip': '61070', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Communal non-profit enterprise Regional Center of Oncology /ID# 124972', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '50048', 'city': 'Kryvyi Rih', 'country': 'Ukraine', 'facility': 'ME Kryviy Rih Oncology Dispensary /ID# 129806', 'geoPoint': {'lat': 47.90572, 'lon': 33.39404}}, {'zip': '79031', 'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 124974', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': '36011', 'city': 'Poltava', 'country': 'Ukraine', 'facility': 'Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 124969', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}, {'zip': '69040', 'city': 'Zaporizhia', 'country': 'Ukraine', 'facility': 'Zaporizhzhia Med. Academy MOH /ID# 129800'}, {'zip': 'BS2 8ED', 'city': 'Bristol', 'state': 'Bristol, City of', 'country': 'United Kingdom', 'facility': 'University Hospitals Bristol /ID# 128343', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'HU3 2JZ', 'city': 'Hull', 'state': 'East Riding Of Yorkshire', 'country': 'United Kingdom', 'facility': 'Hull University Teaching Hospitals NHS Trust /ID# 133030', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust /ID# 125340', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'B15 2TH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'University Hospitals Birmingham NHS Foundation Trust /ID# 125342', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing, please refer to the link below.', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}