Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-03-01 @ 4:45 PM
Study NCT ID:
NCT02305758
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2014-12-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Austria', 'Belgium', 'Germany', 'Hungary', 'Russia', 'Spain', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C521013', 'term': 'veliparib'}, {'id': 'C480833', 'term': 'IFL protocol'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': 'Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of veliparib/placebo administration until 30 days after the last dose of veliparib/placebo (up to 396 days).', 'description': 'TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of veliparib/placebo until 30 days after the last dose of veliparib/placebo and were collected whether elicited or spontaneously reported by the participant.', 'eventGroups': [{'id': 'EG000', 'title': 'Veliparib + Modified FOLFIRI ± Bevacizumab', 'description': 'Dosing of oral veliparib (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Modified FOLFIRI was administered as irinotecan 180 mg/m\\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\\^2 (90-minute infusion ± 30 minutes); and saline bolus (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m\\^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 59, 'seriousNumAtRisk': 65, 'deathsNumAffected': 27, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': 'Placebo + FOLFIRI ± Bevacizumab', 'description': 'Dosing of oral placebo (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Standard FOLFIRI was administered as irinotecan 180 mg/m\\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\\^2 (90-minute infusion ± 30 minutes); and fluorouracil bolus 400 mg/m\\^2 (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m\\^2 (46-hour continuous infusion ± 4 hours) on Day 1 of each 14-day cycle.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 60, 'seriousNumAtRisk': 65, 'deathsNumAffected': 27, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 59, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 28, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 24, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'LYMPHOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 108, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 54, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 37, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 29, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 73, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 103, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'FLATULENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'HAEMORRHOIDS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 69, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 66, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 25, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'TOOTHACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 48, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 38, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 34, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 41, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 38, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 65, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'MUCOSAL INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 27, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'VIRAL UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'BLOOD ALKALINE PHOSPHATASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 36, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 15, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'HYPERURICAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 18, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'HYPOMAGNESAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'HYPONATRAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 12, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'PERIPHERAL SENSORY NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'DYSURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'HAEMATURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'PROTEINURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'DYSPHONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'NASAL DRYNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'PRODUCTIVE COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'RHINORRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 30, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 4}], 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'HICCUPS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS): Time to Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Veliparib + Modified FOLFIRI ± Bevacizumab', 'description': 'Dosing of oral veliparib (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Modified FOLFIRI was administered as irinotecan 180 mg/m\\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\\^2 (90-minute infusion ± 30 minutes); and saline bolus (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m\\^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle.'}, {'id': 'OG001', 'title': 'Placebo + FOLFIRI ± Bevacizumab', 'description': 'Dosing of oral placebo (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Standard FOLFIRI was administered as irinotecan 180 mg/m\\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\\^2 (90-minute infusion ± 30 minutes); and fluorouracil bolus 400 mg/m\\^2 (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m\\^2 (46-hour continuous infusion ± 4 hours) on Day 1 of each 14-day cycle.'}], 'classes': [{'title': '25th Quartile', 'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000', 'lowerLimit': '120', 'upperLimit': '295'}, {'value': '213', 'groupId': 'OG001', 'lowerLimit': '121', 'upperLimit': '233'}]}]}, {'title': '50th Quartile', 'categories': [{'measurements': [{'value': '361', 'groupId': 'OG000', 'lowerLimit': '289', 'upperLimit': '453'}, {'value': '337', 'groupId': 'OG001', 'lowerLimit': '233', 'upperLimit': '421'}]}]}, {'title': '75th Quartile', 'categories': [{'measurements': [{'value': '534', 'comment': 'The upper 95% CI limit was not estimable due to an insufficient number of participants with events, as indicated by NA.', 'groupId': 'OG000', 'lowerLimit': '453', 'upperLimit': 'NA'}, {'value': '512', 'comment': 'The upper 95% CI limit was not estimable due to an insufficient number of participants with events, as indicated by NA.', 'groupId': 'OG001', 'lowerLimit': '421', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.939', 'ciLowerLimit': '0.596', 'ciUpperLimit': '1.480', 'groupDescription': 'Comparisons between treatment groups were performed using the Cox Proportional Hazard Model, stratified by planned bevacizumab use (planned use versus no planned use).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Every 8 weeks from Cycle 1, Day 1 until radiographic progression was observed. The maximum observed follow up duration at the progression-free survival analysis time was 579 days.', 'description': "PFS was defined as the number of days from the date the participant was randomized to the date the participant experienced an event of disease progression or death, whichever occurred first. All events of disease progression were included, whether the participant was still taking or had discontinued study drug. Events of death were included for participants who had not experienced an event of disease progression, if the death occurred within 8 weeks of the last evaluable disease progression assessment. If the participant did not have an event of disease progression and the participant had not died as defined above, data were censored at the date of the participant's last evaluable disease progression assessment. The PFS distribution was estimated using Kaplan-Meier methodology. Point estimates and 95% confidence intervals (95% CIs) for the PFS distribution quartiles are provided.", 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS): Time to Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Veliparib + Modified FOLFIRI ± Bevacizumab', 'description': 'Dosing of oral veliparib (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Modified FOLFIRI was administered as irinotecan 180 mg/m\\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\\^2 (90-minute infusion ± 30 minutes); and saline bolus (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m\\^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle.'}, {'id': 'OG001', 'title': 'Placebo + FOLFIRI ± Bevacizumab', 'description': 'Dosing of oral placebo (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Standard FOLFIRI was administered as irinotecan 180 mg/m\\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\\^2 (90-minute infusion ± 30 minutes); and fluorouracil bolus 400 mg/m\\^2 (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m\\^2 (46-hour continuous infusion ± 4 hours) on Day 1 of each 14-day cycle.'}], 'classes': [{'title': '25th Quartile', 'categories': [{'measurements': [{'value': '557', 'groupId': 'OG000', 'lowerLimit': '391', 'upperLimit': '616'}, {'value': '512', 'groupId': 'OG001', 'lowerLimit': '326', 'upperLimit': '655'}]}]}, {'title': '50th Quartile', 'categories': [{'measurements': [{'value': '770', 'comment': 'The upper 95% CI limit was not estimable due to an insufficient number of participants with events, as indicated by NA.', 'groupId': 'OG000', 'lowerLimit': '609', 'upperLimit': 'NA'}, {'value': '811', 'comment': 'The upper 95% CI limit was not estimable due to an insufficient number of participants with events, as indicated by NA.', 'groupId': 'OG001', 'lowerLimit': '678', 'upperLimit': 'NA'}]}]}, {'title': '75th Quartile', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA= Not calculable due to insufficient survival events', 'groupId': 'OG000', 'lowerLimit': '784', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA= Not calculable due to insufficient survival events', 'groupId': 'OG001', 'lowerLimit': '811', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.261', 'ciLowerLimit': '0.738', 'ciUpperLimit': '2.156', 'groupDescription': 'Comparisons between treatment groups were performed using the Cox Proportional Hazard Model, stratified by planned bevacizumab use (planned use versus no planned use).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Survival information was to be collected 4 wks after the last study visit, continuing every 4 wks for 1 yr, then every 8 wks for up to 2 more yrs or until death. 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Modified FOLFIRI was administered as irinotecan 180 mg/m\\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\\^2 (90-minute infusion ± 30 minutes); and saline bolus (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m\\^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle.'}, {'id': 'OG001', 'title': 'Placebo + FOLFIRI ± Bevacizumab', 'description': 'Dosing of oral placebo (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Standard FOLFIRI was administered as irinotecan 180 mg/m\\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\\^2 (90-minute infusion ± 30 minutes); and fluorouracil bolus 400 mg/m\\^2 (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m\\^2 (46-hour continuous infusion ± 4 hours) on Day 1 of each 14-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.62', 'ciLowerLimit': '-21.4', 'ciUpperLimit': '12.1', 'groupDescription': 'Comparisons between treatment groups were performed using the Mantel-Haenszel method, stratified by planned bevacizumab use (planned use versus no planned use).', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Per protocol, post-baseline tumor assessment was conducted every 8 weeks from Cycle 1 Day 1 until radiographic progression. The maximum observed follow up duration at the progression-free survival analysis time was 579 days.', 'description': 'ORR was defined as the proportion of participants with a complete (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) for target lesions, assessed by computed tomography (CT). Complete response (CR) was defined as disappearance of all target lesions; partial response (PR) ≥30% decrease in the the sum of diameters of target lesions, taking as reference the baseline sum diameters. For participants who underwent surgery, ORR was not evaluated after surgery.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Veliparib + Modified FOLFIRI ± Bevacizumab', 'description': 'Dosing of oral veliparib (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Modified FOLFIRI was administered as irinotecan 180 mg/m\\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\\^2 (90-minute infusion ± 30 minutes); and saline bolus (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m\\^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle.'}, {'id': 'FG001', 'title': 'Placebo + FOLFIRI ± Bevacizumab', 'description': 'Dosing of oral placebo (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Standard FOLFIRI was administered as irinotecan 180 mg/m\\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\\^2 (90-minute infusion ± 30 minutes); and fluorouracil bolus 400 mg/m\\^2 (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m\\^2 (46-hour continuous infusion ± 4 hours) on Day 1 of each 14-day cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '65'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Other, not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'All randomized participants. Although the study was terminated by the Sponsor, because all participants were evaluated for the primary end point, the study was considered to have Completed as planned.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Veliparib + Modified FOLFIRI ± Bevacizumab', 'description': 'Dosing of oral veliparib (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Modified FOLFIRI was administered as irinotecan 180 mg/m\\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\\^2 (90-minute infusion ± 30 minutes); and saline bolus (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m\\^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle.'}, {'id': 'BG001', 'title': 'Placebo + FOLFIRI ± Bevacizumab', 'description': 'Dosing of oral placebo (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Standard FOLFIRI was administered as irinotecan 180 mg/m\\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\\^2 (90-minute infusion ± 30 minutes); and fluorouracil bolus 400 mg/m\\^2 (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m\\^2 (46-hour continuous infusion ± 4 hours) on Day 1 of each 14-day cycle.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.9', 'spread': '13.06', 'groupId': 'BG000'}, {'value': '63.8', 'spread': '9.04', 'groupId': 'BG001'}, {'value': '61.3', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-07-16', 'size': 826243, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-09-10T14:22', 'hasProtocol': True}, {'date': '2017-02-23', 'size': 299479, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-09-10T14:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-16', 'studyFirstSubmitDate': '2014-12-01', 'resultsFirstSubmitDate': '2018-09-10', 'studyFirstSubmitQcDate': '2014-12-01', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-16', 'studyFirstPostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS): Time to Event', 'timeFrame': 'Every 8 weeks from Cycle 1, Day 1 until radiographic progression was observed. The maximum observed follow up duration at the progression-free survival analysis time was 579 days.', 'description': "PFS was defined as the number of days from the date the participant was randomized to the date the participant experienced an event of disease progression or death, whichever occurred first. All events of disease progression were included, whether the participant was still taking or had discontinued study drug. Events of death were included for participants who had not experienced an event of disease progression, if the death occurred within 8 weeks of the last evaluable disease progression assessment. If the participant did not have an event of disease progression and the participant had not died as defined above, data were censored at the date of the participant's last evaluable disease progression assessment. The PFS distribution was estimated using Kaplan-Meier methodology. Point estimates and 95% confidence intervals (95% CIs) for the PFS distribution quartiles are provided."}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS): Time to Event', 'timeFrame': 'Survival information was to be collected 4 wks after the last study visit, continuing every 4 wks for 1 yr, then every 8 wks for up to 2 more yrs or until death. The maximum observed follow up duration at the overall survival analysis time was 914 days.', 'description': "Overall survival was defined as the number of days from the date that the participant was randomized to the date of the participant's death. All events of death were included, regardless of whether the event occurred while the participant was still taking or had discontinued study drug. If a participant had not died, the data were censored at the date last known to be alive. The OS distribution was estimated using Kaplan-Meier methodology. Point estimates and 95% confidence intervals (95% CIs) for the OS distribution quartiles are provided."}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Per protocol, post-baseline tumor assessment was conducted every 8 weeks from Cycle 1 Day 1 until radiographic progression. The maximum observed follow up duration at the progression-free survival analysis time was 579 days.', 'description': 'ORR was defined as the proportion of participants with a complete (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) for target lesions, assessed by computed tomography (CT). Complete response (CR) was defined as disappearance of all target lesions; partial response (PR) ≥30% decrease in the the sum of diameters of target lesions, taking as reference the baseline sum diameters. For participants who underwent surgery, ORR was not evaluated after surgery.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PARP inhibitor', 'veliparib', 'metastatic colorectal cancer', 'ABT-888', 'first line', 'previously untreated', 'colorectal cancer', 'colon cancer', 'rectal cancer', 'FOLFIRI', 'fluorouracil', '5-FU', 'leucovorin', 'irinotecan'], 'conditions': ['Untreated Metastatic Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This was a blinded, randomized, placebo-controlled Phase 2 multicenter study evaluating the efficacy and tolerability of veliparib plus irinotecan, fluorouracil, and leucovorin chemotherapy regimen (FOLFIRI) compared to placebo plus FOLFIRI in participants with previously untreated metastatic colorectal cancer. Participants could also have been treated with bevacizumab at the discretion of the Investigator.', 'detailedDescription': 'Participants were randomized to one of 2 groups: veliparib plus FOLFIRI ± bevacizumab (veliparib group) or placebo plus FOLFIRI ± bevacizumab (placebo group), and stratified by planned use of bevacizumab (planned bevacizumab use compared to unplanned use of bevacizumab) and regions of the world (North America versus rest of world). In this study, the term FOLFIRI was used to describe both the standard regimen containing a fluorouracil bolus that was administered to participants randomized to the placebo arm, and a modified regimen with a saline bolus that was administered to participants randomized to the veliparib arm. One cycle of protocol therapy consisted of 14 days, defined as Day -2 through Day 12. Dosing of oral veliparib/placebo began 2 days prior to the start of FOLFIRI and continued twice a day for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab could be administered intravenously immediately preceding FOLFIRI. Study visits were conducted on Day 1 and Day 8 of the first and second cycles, then on Day 1 of each subsequent cycle. Participants were to continue protocol therapy and study visits until they met one of the defined discontinuation criteria. When the Investigator determined that a participant met the criteria for discontinuation, a final visit was conducted. Participants were to have had one follow-up visit approximately 30 days after the last dose of protocol therapy. Sites began collecting post-treatment and survival information 4 weeks after the last clinical assessment. Post-baseline radiographic tumor assessment was to be conducted every 8 weeks from Cycle 1, Day 1 (prior to the start of a new cycle) until radiographic progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum\n* At least 1 unresectable lesion on a CT (Computerized Tomography) scan that is measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1\n* ECOG (Eastern Cooperative Oncology Group) performance score of 0 or 1\n* Adequate hematologic, renal and hepatic function\n\nExclusion Criteria:\n\n* Prior anti-cancer treatment for metastatic colorectal cancer\n* Prior exposure to PARP (poly ADP-ribose polymerase) inhibitors\n* The last course of adjuvant or neoadjuvant chemotherapy must have ended \\> 12 months prior to Cycle 1 Day -2\n* Any clinically significant and uncontrolled major medical condition\n* Participant is pregnant or lactating\n* Any medical condition, which in the opinion of the study Investigator, places the participant at an unacceptably high risk for toxicities\n* For those receiving bevacizumab, standard medical exclusionary conditions apply'}, 'identificationModule': {'nctId': 'NCT02305758', 'briefTitle': 'Study Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Randomized, Blinded, Multicenter, Phase 2 Study Comparing Veliparib Plus FOLFIRI ± Bevacizumab Versus Placebo Plus FOLFIRI ± Bevacizumab in Previously Untreated Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'M14-217'}, 'secondaryIdInfos': [{'id': '2014-002866-65', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Veliparib + modified FOLFIRI ± bevacizumab', 'description': 'Dosing of oral veliparib (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Modified FOLFIRI was administered as irinotecan 180 mg/m\\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\\^2 (90-minute infusion ± 30 minutes); and saline bolus (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m\\^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle.', 'interventionNames': ['Drug: Veliparib', 'Drug: Modified FOLFIRI', 'Drug: Bevacizumab', 'Drug: Fluorouracil infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + FOLFIRI ± bevacizumab', 'description': 'Dosing of oral placebo (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Standard FOLFIRI was administered as irinotecan 180 mg/m\\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\\^2 (90-minute infusion ± 30 minutes); and fluorouracil bolus 400 mg/m\\^2 (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m\\^2 (46-hour continuous infusion ± 4 hours) on Day 1 of each 14-day cycle.', 'interventionNames': ['Drug: Placebo', 'Drug: FOLFIRI', 'Drug: Bevacizumab', 'Drug: Fluorouracil infusion']}], 'interventions': [{'name': 'Veliparib', 'type': 'DRUG', 'otherNames': ['ABT-888'], 'description': '200 mg oral dose beginning 2 days prior to the start of FOLFIRI and continuing twice a day (BID) for a total of 7 consecutive days', 'armGroupLabels': ['Veliparib + modified FOLFIRI ± bevacizumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '200 mg oral dose beginning 2 days prior to the start of FOLFIRI and continuing twice a day (BID) for a total of 7 consecutive days', 'armGroupLabels': ['Placebo + FOLFIRI ± bevacizumab']}, {'name': 'Modified FOLFIRI', 'type': 'DRUG', 'description': 'Irinotecan 180 mg/m\\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\\^2 (90-minute infusion ± 30 minutes); and saline bolus (up to 15-minute infusion) on Day 1 of each 14-day cycle', 'armGroupLabels': ['Veliparib + modified FOLFIRI ± bevacizumab']}, {'name': 'FOLFIRI', 'type': 'DRUG', 'description': 'Irinotecan 180 mg/m\\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\\^2 (90-minute infusion ± 30 minutes); and fluorouracil bolus 400 mg/m\\^2 (up to 15-minute infusion) on Day 1 of each 14-day cycle', 'armGroupLabels': ['Placebo + FOLFIRI ± bevacizumab']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'At the discretion of the Investigator, 5 mg/kg may be administered intravenously immediately preceding FOLFIRI dosing', 'armGroupLabels': ['Placebo + FOLFIRI ± bevacizumab', 'Veliparib + modified FOLFIRI ± bevacizumab']}, {'name': 'Fluorouracil infusion', 'type': 'DRUG', 'otherNames': ['5-FU'], 'description': '2400 mg/m\\^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle', 'armGroupLabels': ['Placebo + FOLFIRI ± bevacizumab', 'Veliparib + modified FOLFIRI ± bevacizumab']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}