Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-02-21 @ 12:13 AM
Study NCT ID:
NCT02184195
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2014-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531550', 'term': 'olaparib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Leader', 'organization': 'AstraZeneca AB'}, 'certainAgreement': {'otherDetails': 'This submission /document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years).', 'description': 'Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.', 'eventGroups': [{'id': 'EG000', 'title': 'Olaparib 300 mg Twice Daily (bd)', 'description': 'Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 92, 'otherNumAffected': 89, 'seriousNumAtRisk': 90, 'deathsNumAffected': 68, 'seriousNumAffected': 28}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 62, 'otherNumAffected': 56, 'seriousNumAtRisk': 61, 'deathsNumAffected': 52, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 66, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 49, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 39, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 33, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 49, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 47, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 24, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 28, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 35, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 29, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 21, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 16, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}], 'seriousEvents': [{'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Bartholinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Vascular stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Duodenal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Gastric varices haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Incarcerated inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Obstruction gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Anastomotic haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Stent malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Bladder papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg Twice Daily (bd)', 'description': 'Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '4.14', 'upperLimit': '11.01'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '3.52', 'upperLimit': '4.86'}]}]}], 'analyses': [{'pValue': '0.0038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.531', 'ciLowerLimit': '0.346', 'ciUpperLimit': '0.815', 'statisticalMethod': 'Log-rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 4 years', 'description': 'To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg Twice Daily (bd)', 'description': 'Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '15.28', 'upperLimit': '26.32'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '14.32', 'upperLimit': '26.12'}]}]}], 'analyses': [{'pValue': '0.3487', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.831', 'ciLowerLimit': '0.564', 'ciUpperLimit': '1.224', 'statisticalMethod': 'Log-rank test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Upto 4 years', 'description': 'To determine the efficacy by assessment of OS of olaparib maintenance monotherapy compared to placebo. The OS was defined as the time from the date of randomization until death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.'}, {'type': 'SECONDARY', 'title': 'Time From Randomisation to Second Progression (PFS2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg Twice Daily (bd)', 'description': 'Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '8.21', 'upperLimit': '23.85'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '8.15', 'upperLimit': '13.54'}]}]}], 'analyses': [{'pValue': '0.0613', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.659', 'ciLowerLimit': '0.426', 'ciUpperLimit': '1.020', 'statisticalMethod': 'Log-rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 4 years', 'description': 'To determine efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or death.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.'}, {'type': 'SECONDARY', 'title': 'Time From Randomisation to Second Subsequent Therapy or Death (TSST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg Twice Daily (bd)', 'description': 'Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '9.13', 'upperLimit': '19.78'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '8.34', 'upperLimit': '12.98'}]}]}], 'analyses': [{'pValue': '0.0111', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.611', 'ciLowerLimit': '0.418', 'ciUpperLimit': '0.894', 'statisticalMethod': 'Log-rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 4 years', 'description': 'To determine the efficacy by assessment of TSST of olaparib maintenance monotherapy compared to placebo. The TSST was defined as time to second subsequent therapy or death.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.'}, {'type': 'SECONDARY', 'title': 'Time From Randomisation to First Subsequent Therapy or Death (TFST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg Twice Daily (bd)', 'description': 'Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '6.21', 'upperLimit': '12.85'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '3.94', 'upperLimit': '6.21'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.442', 'ciLowerLimit': '0.297', 'ciUpperLimit': '0.658', 'statisticalMethod': 'Log-rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 4 years', 'description': 'To determine the efficacy by assessment of TFST of olaparib maintenance monotherapy compared to placebo. The TFST was defined as time to first subsequent therapy or death.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.'}, {'type': 'SECONDARY', 'title': 'Time From Randomisation to Study Treatment Discontinuation or Death (TDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg Twice Daily (bd)', 'description': 'Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '5.52', 'upperLimit': '10.97'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '3.61', 'upperLimit': '4.80'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.425', 'ciLowerLimit': '0.289', 'ciUpperLimit': '0.627', 'statisticalMethod': 'Log-rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 4 years', 'description': 'To determine the efficacy by assessment of TDT compared to placebo. compared to placebo. The TDT was defined as time to study treatment discontinuation or death.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg Twice Daily (bd)', 'description': 'Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3273', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.520', 'ciLowerLimit': '0.668', 'ciUpperLimit': '3.610', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4 years', 'description': 'To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. The ORR is defined as the number of with a BoR of CR and PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised patients with measurable disease at baseline.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg Twice Daily (bd)', 'description': 'Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Not evaluable/missing', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 16 weeks', 'description': 'Efficacy by assessment of disease control rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT): All randomised patients'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg Twice Daily (bd)', 'description': 'Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.03', 'groupId': 'OG000', 'lowerLimit': '-3.826', 'upperLimit': '1.759'}, {'value': '1.18', 'groupId': 'OG001', 'lowerLimit': '-2.585', 'upperLimit': '4.939'}]}]}], 'analyses': [{'pValue': '0.355', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.21', 'ciLowerLimit': '-6.917', 'ciUpperLimit': '2.496', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to 6 months', 'description': 'To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100.\n\nA higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful.\n\nbd twice daily.', 'unitOfMeasure': 'Unit on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient reported outcome (PRO) analysis set was defined as the analysis population for PRO data were a subset of the FAS (ITT) population who had evaluable baseline EORTC QLQ-C30 or QLQ-PAN26 forms where evaluable meant that at least 1 sub-scale baseline score could be determined from at least 1 of the 2 forms.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg Twice Daily (bd)', 'description': 'Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Any AE of CTCAE Grade 3 or higher', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Any AE with outcome = death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE (including events with outcome = death)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'AnyAE leading to withdrawal of olaparib/placebo', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any AE leading to dose interruption', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any AE leading to dose reduction', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 years', 'description': 'To assess the safety and tolerability of olaparib maintenance monotherapy. SAE: serious adverse events CTCAE: Common Terminology Criteria for Adverse Events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set consisted of all patients who received at least one dose of study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olaparib 300 mg Twice Daily (bd)', 'description': 'Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Patient decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Eligibility criteria not fulfilled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'This study randomised patients at a total of 59 study centres in 12 countries: United States of America (13), Germany (8), France (7), Israel (7), Spain (7), United Kingdom (6), Italy (4), Belgium (2), Republic of Korea (2), Australia (1), Canada (1) and Netherlands (1).', 'preAssignmentDetails': "Screening Part 1 was only required if a patient's gBRCAm status was unknown and Screening Part 2 was for patients with known local germline BRCA (gBRCA) test. All other screening parameters were done as per the Study Schedule."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Olaparib 300 mg Twice Daily (bd)', 'description': 'Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.2', 'spread': '10.27', 'groupId': 'BG000'}, {'value': '56.4', 'spread': '9.07', 'groupId': 'BG001'}, {'value': '57.5', 'spread': '9.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', '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': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '141', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set consisted of all randomised patients analysed on an intent to treat basis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-30', 'size': 6874842, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-21T09:49', 'hasProtocol': True}, {'date': '2020-01-31', 'size': 3981358, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-07-21T09:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-18', 'studyFirstSubmitDate': '2014-06-06', 'resultsFirstSubmitDate': '2020-01-14', 'studyFirstSubmitQcDate': '2014-07-03', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-14', 'studyFirstPostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)', 'timeFrame': 'Up to 4 years', 'description': 'To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Upto 4 years', 'description': 'To determine the efficacy by assessment of OS of olaparib maintenance monotherapy compared to placebo. The OS was defined as the time from the date of randomization until death due to any cause.'}, {'measure': 'Time From Randomisation to Second Progression (PFS2)', 'timeFrame': 'Up to 4 years', 'description': 'To determine efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or death.'}, {'measure': 'Time From Randomisation to Second Subsequent Therapy or Death (TSST)', 'timeFrame': 'Up to 4 years', 'description': 'To determine the efficacy by assessment of TSST of olaparib maintenance monotherapy compared to placebo. The TSST was defined as time to second subsequent therapy or death.'}, {'measure': 'Time From Randomisation to First Subsequent Therapy or Death (TFST)', 'timeFrame': 'Up to 4 years', 'description': 'To determine the efficacy by assessment of TFST of olaparib maintenance monotherapy compared to placebo. The TFST was defined as time to first subsequent therapy or death.'}, {'measure': 'Time From Randomisation to Study Treatment Discontinuation or Death (TDT)', 'timeFrame': 'Up to 4 years', 'description': 'To determine the efficacy by assessment of TDT compared to placebo. compared to placebo. The TDT was defined as time to study treatment discontinuation or death.'}, {'measure': 'Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1', 'timeFrame': 'Up to 4 years', 'description': 'To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. The ORR is defined as the number of with a BoR of CR and PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline.'}, {'measure': 'Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1', 'timeFrame': 'At 16 weeks', 'description': 'Efficacy by assessment of disease control rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo.'}, {'measure': 'Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire', 'timeFrame': 'From baseline up to 6 months', 'description': 'To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100.\n\nA higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful.\n\nbd twice daily.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 4 years', 'description': 'To assess the safety and tolerability of olaparib maintenance monotherapy. SAE: serious adverse events CTCAE: Common Terminology Criteria for Adverse Events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['BRCA, metastatic adenocarcinoma pancreas, maintenance olaparib monotherapy, first line platinum chemotherapy, pancreatic cancer, PARP inhibitor'], 'conditions': ['Germline BRCA1/2 Mutations and', 'Metastatic Adenocarcinoma of the Pancreas']}, 'referencesModule': {'references': [{'pmid': '31157963', 'type': 'BACKGROUND', 'citation': "Golan T, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algul H, O'Reilly EM, McGuinness D, Cui KY, Schlienger K, Locker GY, Kindler HL. Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer. N Engl J Med. 2019 Jul 25;381(4):317-327. doi: 10.1056/NEJMoa1903387. Epub 2019 Jun 2."}, {'pmid': '35834777', 'type': 'DERIVED', 'citation': "Kindler HL, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algul H, O'Reilly EM, Bordia S, McGuinness D, Cui K, Locker GY, Golan T. Overall Survival Results From the POLO Trial: A Phase III Study of Active Maintenance Olaparib Versus Placebo for Germline BRCA-Mutated Metastatic Pancreatic Cancer. J Clin Oncol. 2022 Dec 1;40(34):3929-3939. doi: 10.1200/JCO.21.01604. Epub 2022 Jul 14."}, {'pmid': '35596182', 'type': 'DERIVED', 'citation': 'Amin S, Joo S, Nolte S, Yoo HK, Patel N, Byrnes HF, Costa-Cabral S, Johnson CD. Health-related quality of life scores of metastatic pancreatic cancer patients responsive to first line chemotherapy compared to newly derived EORTC QLQ-C30 reference values. BMC Cancer. 2022 May 20;22(1):563. doi: 10.1186/s12885-022-09661-7.'}, {'pmid': '33959007', 'type': 'DERIVED', 'citation': 'Li N, Zheng H, Huang Y, Zheng B, Cai H, Liu M. Cost-Effectiveness Analysis of Olaparib Maintenance Treatment for Germline BRCA-Mutated Metastatic Pancreatic Cancer. Front Pharmacol. 2021 Apr 20;12:632818. doi: 10.3389/fphar.2021.632818. eCollection 2021.'}, {'pmid': '33364840', 'type': 'DERIVED', 'citation': 'Zhan M, Zheng H, Yang Y, He Z, Xu T, Li Q. Cost-Effectiveness Analysis of Maintenance Olaparib in Patients with Metastatic Pancreatic Cancer and a Germline BRCA1/2 Mutation Based on the POLO Trial. Cancer Manag Res. 2020 Dec 16;12:12919-12926. doi: 10.2147/CMAR.S283169. eCollection 2020.'}, {'pmid': '32073954', 'type': 'DERIVED', 'citation': 'Golan T, Kindler HL, Park JO, Reni M, Macarulla T, Hammel P, Van Cutsem E, Arnold D, Hochhauser D, McGuinness D, Locker GY, Goranova T, Schatz P, Liu YZ, Hall MJ. Geographic and Ethnic Heterogeneity of Germline BRCA1 or BRCA2 Mutation Prevalence Among Patients With Metastatic Pancreatic Cancer Screened for Entry Into the POLO Trial. J Clin Oncol. 2020 May 1;38(13):1442-1454. doi: 10.1200/JCO.19.01890. Epub 2020 Feb 19.'}, {'pmid': '31562758', 'type': 'DERIVED', 'citation': "Hammel P, Kindler HL, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algul H, O'Reilly EM, McGuinness D, Cui KY, Joo S, Yoo HK, Patel N, Golan T; POLO Investigators. Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib. Ann Oncol. 2019 Dec 1;30(12):1959-1968. doi: 10.1093/annonc/mdz406."}, {'pmid': '29223478', 'type': 'DERIVED', 'citation': "Lowery MA, Kelsen DP, Capanu M, Smith SC, Lee JW, Stadler ZK, Moore MJ, Kindler HL, Golan T, Segal A, Maynard H, Hollywood E, Moynahan M, Salo-Mullen EE, Do RKG, Chen AP, Yu KH, Tang LH, O'Reilly EM. Phase II trial of veliparib in patients with previously treated BRCA-mutated pancreas ductal adenocarcinoma. Eur J Cancer. 2018 Jan;89:19-26. doi: 10.1016/j.ejca.2017.11.004. Epub 2017 Dec 8."}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D081FC00001&attachmentIdentifier=9095e288-3d26-4c56-87dd-5dedc61f25c2&fileName=POLO_Revised_CSP_2-24Jul2019_Redacted.pdf&versionIdentifier=', 'label': 'Related Info'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D081FC00001&attachmentIdentifier=42f897a4-b682-4a0f-b2b0-cecf3f143423&fileName=D081FC00001_Redacted_SAP.pdf&versionIdentifier=', 'label': 'Redacted\\_SAP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D081FC00001&attachmentIdentifier=adf11419-4145-42dc-bd0c-e36699d77c73&fileName=D081FC00001_CSR_SynopsisRedacted.pdf&versionIdentifier=', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy', 'detailedDescription': "Approximately 145 patients will be randomised using an Interactive Voice Response System /Interactive Web Response System (IVR/IWR system) in a 3:2 ratio (Olaparib:placebo) to the treatments as specified below:\n\n* Olaparib tablets p.o. 300 mg twice daily\n* Matching placebo tablets p.o. twice daily Eligible patients will be those patients with pancreas cancer previously treated for metastatic disease who have not progressed following completion of at least 16 weeks (can be more) of first line platinum-based chemotherapy. All patients must have a known deleterious or suspected deleterious germline BRCA mutation to be randomised; this may have been determined prior to enrolment into the study or may be assessed as part of the enrolment procedure for the study (via centrally provided MyriadIntegrated BRAC.\n\nPatients will be randomised within 6 weeks after their last dose of chemotherapy (last dose is the day of the last infusion) and treatment started as soon as possible but no less than 4 and no more than 8 weeks of the last chemotherapy dose. At the time of starting protocol treatment, all previous chemotherapy treatment should be discontinued.\n\nFollowing randomisation, patients will attend clinic visits weekly for the first 4 weeks of treatment (Days 8, 15, 22 and 29). Patients will then attend clinic visits every 4 weeks whilst on study treatment. Patients should continue to receive study treatment until objective radiological disease progression as per RECIST as assessed by the investigator and as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria.\n\nOnce a patient has progressed the patient will be followed for second progression (PFS2) every 8 weeks and then survival until the final analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria\n\n* Histologically or cytologically confirmed pancreas adenocarcinoma receiving initial chemotherapy for metastatic disease and without evidence of disease progression on treatment\n* Patients with measurable disease and/or non-measurable or no evidence of disease assessed at baseline by CT (or MRI where CT is contraindicated) will be entered in this study.\n* Documented mutation in gBRCA1 or gBRCA2 that is predicted to be deleterious or suspected deleterious\n* Patients are on treatment with a first line platinum-based (cisplatin, carboplatin or oxaliplatin) regimen for metastatic pancreas cancer, have received a minimum of 16 weeks of continuous platinum treatment and have no evidence of progression based on investigator\'s opinion.\n* Patients who have received platinum as potentially curative treatment for a prior cancer (eg ovarian cancer) or as adjuvant/neoadjuvant treatment for pancreas cancer are eligible provided at least 12 months have elapsed between the last dose of platinum-based treatment and initiation of the platinum-based chemotherapy for metastatic pancreas cancer.\n\nMajor Exclusion Criteria:\n\n* gBRCA1 and/or gBRCA2 mutations that are considered to be non detrimental (eg, "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favour polymorphism" or "benign polymorphism" 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