Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-25 @ 7:08 PM
Study NCT ID:
NCT02282020
Status:
COMPLETED
Last Update Posted:
2022-07-26
First Post:
2014-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531550', 'term': 'olaparib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Leader', 'organization': 'AstraZeneca AB'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Includes all AEs that had a start date or a worsening (increase in CTCAE grade) after the start of treatment up until the end of the 30 day follow-up period. The 30 day follow-up period will be defined as 30 days following discontinuation of olaparib/chemotherapy treatment. Assessed from randomisation to data cut off. DCO: 16Apr2021', 'description': 'All-Cause Mortality was collected for the Full Analysis Set (FAS).\n\nSerious Adverse Events and Other Adverse Events were collected for the Safety Analysis Set (SAS), which includes patients who received at least 1 dose of the randomised study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Olaparib 300 mg bd', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.', 'otherNumAtRisk': 178, 'deathsNumAtRisk': 178, 'otherNumAffected': 173, 'seriousNumAtRisk': 178, 'deathsNumAffected': 116, 'seriousNumAffected': 46}, {'id': 'EG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine.", 'otherNumAtRisk': 76, 'deathsNumAtRisk': 88, 'otherNumAffected': 73, 'seriousNumAtRisk': 76, 'deathsNumAffected': 46, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 163, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 41, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 37, 'numAffected': 22}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 34, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 36, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 28, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 42, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 80, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 36, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 23, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 149, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 240, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 47, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 28, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 165, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 20, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 52, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 24, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 91, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 26, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 24, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 16, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 25, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 34, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 22, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 19, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 35, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 21, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 18, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 65, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 79, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nail discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Mesenteric vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Corneal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.53', 'ciLowerLimit': '1.40', 'ciUpperLimit': '4.58', 'estimateComment': 'An odds ratio \\>1 favours the olaparib arm', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \\> 12 months)'}], 'paramType': 'NUMBER', 'timeFrame': 'RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)', 'description': "To determine the efficacy of olaparib vs. physician's choice single agent chemotherapy by assessment of Objective Response Rate (ORR) using blinded independent central review (BICR)\n\nResponse Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was used by a Blinded Independent Central Review (BICR) to assess participant response to treatment\n\nORR is the number of participants with Complete Response (CR) or Partial Response (PR) in the Measurable Disease Analysis Set (MDAS). Complete response is declared when all lesions have disappeared or all lesions have disappeared and all nodal disease is \\< 10 mm each. Partial response is declared when there is a decrease in sum of diameters of target lesions ≥ 30%.", 'unitOfMeasure': 'Count of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Measurable Disease Analysis Set (MDAS) includes all participants in the Full Analysis Set (FAS) with measurable disease at baseline (as per RECIST 1.1), determined using Blinded Independent Central Review.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '14.1'}, {'value': '9.2', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '11.2'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.43', 'ciUpperLimit': '0.91', 'pValueComment': 'Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \\> 12 months).', 'estimateComment': 'A hazard ratio \\< 1 favours the olaparib arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)', 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by progression free survival (PFS) using BICR assessment according to RECIST 1.1 criteria\n\nPFS is defined as the time from randomization until the date of objective radiological disease progression according to RECIST 1.1 or death (by any cause in the absence of disease progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to disease progression (i.e., date of RECIST progression/death or censoring - date of randomization +1).", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Time From Randomisation to Second Progression (PFS2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '26.0'}, {'value': '19.6', 'groupId': 'OG001', 'lowerLimit': '16.9', 'upperLimit': '21.8'}]}]}], 'analyses': [{'pValue': '0.229', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.15', 'pValueComment': 'Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \\> 12 months).', 'estimateComment': 'A hazard ratio \\< 1 favours the olaparib arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Visits to occur every 12 weeks from the date of first progression, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)', 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by second progression (PFS2).\n\nTime from randomization to PFS2 is defined as the time from the date of randomization to the earliest of the progression events subsequent to first progression or death. The date of second progression was recorded by the investigator and defined according to local standard clinical practice, and could involve objective radiological, clinical, cancer antigen-125 (CA-125) progression or death. CA-125 progression was assessed per Gynecological Cancer Intergroup (GCIG) criteria.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'groupId': 'OG000', 'lowerLimit': '30.0', 'upperLimit': '39.2'}, {'value': '32.9', 'groupId': 'OG001', 'lowerLimit': '23.5', 'upperLimit': '43.2'}]}]}], 'analyses': [{'pValue': '0.714', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.49', 'pValueComment': 'Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \\> 12 months).', 'estimateComment': 'A hazard ratio \\< 1 favours the olaparib arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Visits to occur every 12 weeks from the date of first progression, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)', 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by overall survival (OS).\n\nOverall survival is defined as the time from the date of randomisation until death due to any cause.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Time To Earliest Progression By RECIST 1.1 Or Cancer Antigen (CA) -125 Or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '13.8'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '9.4'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.41', 'ciUpperLimit': '0.85', 'pValueComment': 'Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \\> 12 months).', 'estimateComment': 'A hazard ratio \\<1 favours the olaparib arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'RECIST and CA-125 follow-up assessments performed every 8 weeks (±1week), up to 48 weeks, then every 12 weeks (±1week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)', 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time to earliest progression by RECIST 1.1 or CA-125 or death.\n\nResponse Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was used to assess participant response to treatment. CA-125 progression was assessed per Gynecological Cancer Intergroup (GCIG).", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Time From Randomization To First Subsequent Therapy Or Death (TFST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '13.5', 'upperLimit': '17.6'}, {'value': '10.9', 'groupId': 'OG001', 'lowerLimit': '9.2', 'upperLimit': '14.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.49', 'ciLowerLimit': '0.35', 'ciUpperLimit': '0.69', 'pValueComment': 'Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \\> 12 months).', 'estimateComment': 'A hazard ratio \\< 1 favours the olaparib arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': "Anti-cancer treatments initiated post discontinuation of study treatment and investigator's opinion of response and date of progression recorded, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)", 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time from randomisation to first subsequent therapy or death (TFST)\n\nTFST is defined as the time from the date of randomisation to the earlier of first subsequent chemotherapy start date or death.\n\nAnti-cancer treatments include chemotherapy and targeted agents.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Time From Randomization To Second Subsequent Therapy Or Death (TSST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'groupId': 'OG000', 'lowerLimit': '21.3', 'upperLimit': '27.8'}, {'value': '19.9', 'groupId': 'OG001', 'lowerLimit': '18.0', 'upperLimit': '24.2'}]}]}], 'analyses': [{'pValue': '0.089', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.05', 'pValueComment': 'Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \\> 12 months).', 'estimateComment': 'A hazard ratio \\< 1 favours the olaparib arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': "Anti-cancer treatments initiated post discontinuation of study treatment and investigator's opinion of response and date of progression recorded, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)", 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time from randomisation to second subsequent therapy or death (TSST)\n\nTSST was defined as the time from the date of randomisation to the earlier of second subsequent chemotherapy start date or death.\n\nAnti-cancer treatments include chemotherapy and targeted agents.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Time From Randomization To Study Treatment Discontinuation Or Death (TDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '14.6'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '6.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.29', 'pValueComment': 'Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \\> 12 months).', 'estimateComment': 'A hazard ratio \\< 1 favours the olaparib arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Patients randomised to Olaparib administer their tablets orally at a dose of 300 mg twice daily and continue Olaparib until objective disease progression. Assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)', 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time to study treatment discontinuation or death (TDT)\n\nTDT was defined as the time from randomization to the earlier of the date of study treatment discontinuation or death.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '25.7'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '15.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)', 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by duration of response (DoR) by BICR using RECIST 1.1 criteria for evaluable patients.\n\nDuration of response is the time from the first documentation of complete response (CR) or partial response (PR) until the date of progression or death, or the last evaluable RECIST assessment for participants that do not progress or progress after 2 missed assessments. Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was used to assess participant response to treatment.", 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Measurable Disease Analysis Set (MDAS) includes all participants in the Full Analysis Set (FAS) with measurable disease at baseline (as per RECIST 1.1), determined using Blinded Independent Central Review.'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '3.9'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '3.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)', 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time to response (TTR) by BICR using RECIST 1.1 criteria for evaluable patients.\n\nTTR was defined as the time from randomization until the date of first documented response by Blinded independent central review (BICR) assessment.", 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Measurable Disease Analysis Set (MDAS) includes all participants in the Full Analysis Set (FAS) with measurable disease at baseline (as per RECIST 1.1), determined using Blinded Independent Central Review.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline In Trial Outcome Index (TOI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Selected Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '9.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.108', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '5.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes factors for patient, treatment, visit, treatment by visit interaction, baseline TOI score and baseline TOI score by visit interaction.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) to Week 48 (±1 week). DCO: 10Oct2018', 'description': "To compare the efficacy of single agent olaparib versus physician's choice single agent chemotherapy on the Health-related Quality of Life (HRQoL) as measured by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)\n\nThe TOI score was derived from the sum of the scores of the 25 items included in the physical well-being (7 items), functional well-being (7 items), and additional concerns ovarian cancer subscale (11 items) of the FACT-O questionnaire Version 4. TOI score ranges from 0 to 100, a higher score indicates a higher HRQoL. A negative change in score from baseline indicated a worsening in symptoms.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Show an Improvement in TOI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.092', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.24', 'ciLowerLimit': '0.88', 'ciUpperLimit': '6.86', 'pValueComment': 'Estimated from an unadjusted logistic regression model', 'estimateComment': 'An odds ratio \\> 1 favours the olaparib arm', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) to Week 48 (±1 week). DCO: 10Oct2018', 'description': "To compare the efficacy of single agent olaparib versus physician's choice single agent chemotherapy on the Health-related Quality of Life (HRQoL) as measured by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)\n\nThe TOI score was derived from the sum of the scores of the 25 items included in the physical well-being (7 items), functional well-being (7 items), and additional concerns ovarian cancer subscale (11 items) of the FACT-O questionnaire Version 4. TOI score ranges from 0 to 100, a higher score indicates a higher health-related quality of life (HRQoL). A change in at least 10 points was considered clinically relevant.", 'unitOfMeasure': 'Count of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) in Breast Cancer Susceptibility (BRCA) Gene Population by Blinded Independent Central Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.40', 'ciLowerLimit': '1.32', 'ciUpperLimit': '4.39', 'pValueComment': 'Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \\> 12 months).', 'estimateComment': 'An odds ratio \\> 1 favours the olaparib arm', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)', 'description': 'BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).\n\nThe number of participants with complete or partial response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. Partial response is declared when there is a decrease in sum of target disease ≥ 30%. Complete response is declared when all lesions have disappeared or all lesions have disappeared and all nodal disease is \\< 10 mm each.', 'unitOfMeasure': 'Count of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Measurable Disease Analysis Set (MDAS) includes all participants in the Full Analysis Set (FAS) with measurable disease at baseline (as per RECIST 1.1), determined using Blinded Independent Central Review.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Disease Progression or Death in BRCA Gene Population by Blinded Independent Central Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.91', 'pValueComment': 'Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \\> 12 months).', 'estimateComment': 'A hazard ratio \\< 1 favours the olaparib arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)', 'description': 'BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).\n\nProgressive disease was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'Count of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Second Progression or Death (PFS2) in BRCA Gene Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.213', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.14', 'pValueComment': 'Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \\> 12 months).', 'estimateComment': 'A hazard ratio \\< 1 favours the olaparib arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Visits to occur every 12 weeks from the date of first progression, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)', 'description': 'BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).', 'unitOfMeasure': 'Count of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) in BRCA Gene Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.699', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.51', 'pValueComment': 'Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \\> 12 months).', 'estimateComment': 'A hazard ratio \\< 1 favours the olaparib arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Visits to occur every 12 weeks from the date of first progression, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)', 'description': 'BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).\n\nOS in BRCA gene population was measured by the number of participants who died due to any cause.', 'unitOfMeasure': 'Count of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Treatment or Died in BRCA Gene Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '0.12', 'ciUpperLimit': '0.27', 'pValueComment': 'Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \\> 12 months).', 'estimateComment': 'A hazard ratio \\< 1 favours the olaparib arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Patients randomised to Olaparib administer their tablets orally at a dose of 300 mg twice daily and continue Olaparib until objective disease progression. Assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)', 'description': 'BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).', 'unitOfMeasure': 'Count of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Subsequent Chemotherapy or Died in BRCA Gene Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Selected Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '0.33', 'ciUpperLimit': '0.66', 'pValueComment': 'Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \\> 12 months).', 'estimateComment': 'A hazard ratio \\< 1 favours the olaparib arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': "Anti-cancer treatments initiated post discontinuation of study treatment and investigator's opinion of response and date of progression recorded, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)", 'description': 'BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).\n\nAnti-cancer treatments include chemotherapy and targeted agents.', 'unitOfMeasure': 'Count of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Second Subsequent Chemotherapy or Died in BRCA Gene Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.01', 'pValueComment': 'Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \\> 12 months).', 'estimateComment': 'A hazard ratio \\< 1 favours the olaparib arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': "Anti-cancer treatments initiated post discontinuation of study treatment and investigator's opinion of response and date of progression recorded, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)", 'description': 'BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).\n\nAnti-cancer treatments include chemotherapy and targeted agents.', 'unitOfMeasure': 'Count of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Plasma Concentration of Olaparib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}], 'classes': [{'title': 'Day 1, 1 hour post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.76', 'spread': '112.93', 'groupId': 'OG000'}]}]}, {'title': 'Day 29, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.78', 'spread': '100.54', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, 1 hour post-dose and Day 29 pre-dose. DCO: 10Oct2018', 'description': 'Summary of plasma concentrations (ug/mL) of olaparib', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) analysis set includes all participants who received an olaparib dose and provided evaluable plasma concentration data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experience at Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olaparib 300 mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'classes': [{'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Safety Follow-up 30 days after last dose of IP, assessed from the date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)', 'description': 'An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.', 'unitOfMeasure': 'Count of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set includes all participants who received at least 1 dose of randomized study treatment, olaparib or chemotherapy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olaparib 300mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'FG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'comment': 'Ongoing study treatment at time of analysis DCO: 16 April 2021', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '88'}]}], 'dropWithdraws': [{'type': 'Objective Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Severe Non-compliance to Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Developed Discontinuation Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrew Consent Prior to Dosing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'A total of 678 patients were screened (gave informed consent) at 94 centres in 13 countries. Of the 678 patients screened, 266 patients were randomised from 78 sites in 13 countries worldwide.\n\nA wash-out period of up to 5 weeks was required for participants who have previously taken potent inhibitors or CYP3A4/5 inducers.', 'preAssignmentDetails': 'Participants were randomized in a 2:1 ratio between olaparib and single agent chemotherapy. Of the 266 patients randomised, 178 patients were in the olaparib arm and 88 in the chemotherapy arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Olaparib 300mg BID', 'description': 'Participants received olaparib twice daily as a 300 mg tablet.'}, {'id': 'BG001', 'title': 'Single Agent Chemotherapy', 'description': "Participants received physician's choice of chemotherapy, out of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.5', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '60.4', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '59.2', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '178', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}]}, {'title': 'Black Or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'American Indian Or Alaska Native', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': "Baseline characteristics are displayed for all participants who started the study. This includes the 12 participants who did not receive treatment in the 'Single Agent Chemotherapy' arm."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-20', 'size': 1051376, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-03T04:57', 'hasProtocol': True}, {'date': '2018-10-30', 'size': 17849750, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-03T04:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 266}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03079687', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-25', 'studyFirstSubmitDate': '2014-10-20', 'resultsFirstSubmitDate': '2019-10-03', 'studyFirstSubmitQcDate': '2014-10-31', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-27', 'studyFirstPostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)', 'description': "To determine the efficacy of olaparib vs. physician's choice single agent chemotherapy by assessment of Objective Response Rate (ORR) using blinded independent central review (BICR)\n\nResponse Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was used by a Blinded Independent Central Review (BICR) to assess participant response to treatment\n\nORR is the number of participants with Complete Response (CR) or Partial Response (PR) in the Measurable Disease Analysis Set (MDAS). Complete response is declared when all lesions have disappeared or all lesions have disappeared and all nodal disease is \\< 10 mm each. Partial response is declared when there is a decrease in sum of diameters of target lesions ≥ 30%."}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)', 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by progression free survival (PFS) using BICR assessment according to RECIST 1.1 criteria\n\nPFS is defined as the time from randomization until the date of objective radiological disease progression according to RECIST 1.1 or death (by any cause in the absence of disease progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to disease progression (i.e., date of RECIST progression/death or censoring - date of randomization +1)."}, {'measure': 'Time From Randomisation to Second Progression (PFS2)', 'timeFrame': 'Visits to occur every 12 weeks from the date of first progression, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)', 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by second progression (PFS2).\n\nTime from randomization to PFS2 is defined as the time from the date of randomization to the earliest of the progression events subsequent to first progression or death. The date of second progression was recorded by the investigator and defined according to local standard clinical practice, and could involve objective radiological, clinical, cancer antigen-125 (CA-125) progression or death. CA-125 progression was assessed per Gynecological Cancer Intergroup (GCIG) criteria."}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Visits to occur every 12 weeks from the date of first progression, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)', 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by overall survival (OS).\n\nOverall survival is defined as the time from the date of randomisation until death due to any cause."}, {'measure': 'Time To Earliest Progression By RECIST 1.1 Or Cancer Antigen (CA) -125 Or Death', 'timeFrame': 'RECIST and CA-125 follow-up assessments performed every 8 weeks (±1week), up to 48 weeks, then every 12 weeks (±1week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)', 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time to earliest progression by RECIST 1.1 or CA-125 or death.\n\nResponse Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was used to assess participant response to treatment. CA-125 progression was assessed per Gynecological Cancer Intergroup (GCIG)."}, {'measure': 'Time From Randomization To First Subsequent Therapy Or Death (TFST)', 'timeFrame': "Anti-cancer treatments initiated post discontinuation of study treatment and investigator's opinion of response and date of progression recorded, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)", 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time from randomisation to first subsequent therapy or death (TFST)\n\nTFST is defined as the time from the date of randomisation to the earlier of first subsequent chemotherapy start date or death.\n\nAnti-cancer treatments include chemotherapy and targeted agents."}, {'measure': 'Time From Randomization To Second Subsequent Therapy Or Death (TSST)', 'timeFrame': "Anti-cancer treatments initiated post discontinuation of study treatment and investigator's opinion of response and date of progression recorded, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)", 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time from randomisation to second subsequent therapy or death (TSST)\n\nTSST was defined as the time from the date of randomisation to the earlier of second subsequent chemotherapy start date or death.\n\nAnti-cancer treatments include chemotherapy and targeted agents."}, {'measure': 'Time From Randomization To Study Treatment Discontinuation Or Death (TDT)', 'timeFrame': 'Patients randomised to Olaparib administer their tablets orally at a dose of 300 mg twice daily and continue Olaparib until objective disease progression. Assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)', 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time to study treatment discontinuation or death (TDT)\n\nTDT was defined as the time from randomization to the earlier of the date of study treatment discontinuation or death."}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)', 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by duration of response (DoR) by BICR using RECIST 1.1 criteria for evaluable patients.\n\nDuration of response is the time from the first documentation of complete response (CR) or partial response (PR) until the date of progression or death, or the last evaluable RECIST assessment for participants that do not progress or progress after 2 missed assessments. Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was used to assess participant response to treatment."}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)', 'description': "To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time to response (TTR) by BICR using RECIST 1.1 criteria for evaluable patients.\n\nTTR was defined as the time from randomization until the date of first documented response by Blinded independent central review (BICR) assessment."}, {'measure': 'Mean Change From Baseline In Trial Outcome Index (TOI) Score', 'timeFrame': 'Baseline (Day 1) to Week 48 (±1 week). DCO: 10Oct2018', 'description': "To compare the efficacy of single agent olaparib versus physician's choice single agent chemotherapy on the Health-related Quality of Life (HRQoL) as measured by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)\n\nThe TOI score was derived from the sum of the scores of the 25 items included in the physical well-being (7 items), functional well-being (7 items), and additional concerns ovarian cancer subscale (11 items) of the FACT-O questionnaire Version 4. TOI score ranges from 0 to 100, a higher score indicates a higher HRQoL. A negative change in score from baseline indicated a worsening in symptoms."}, {'measure': 'Number of Participants Who Show an Improvement in TOI Score', 'timeFrame': 'Baseline (Day 1) to Week 48 (±1 week). DCO: 10Oct2018', 'description': "To compare the efficacy of single agent olaparib versus physician's choice single agent chemotherapy on the Health-related Quality of Life (HRQoL) as measured by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)\n\nThe TOI score was derived from the sum of the scores of the 25 items included in the physical well-being (7 items), functional well-being (7 items), and additional concerns ovarian cancer subscale (11 items) of the FACT-O questionnaire Version 4. TOI score ranges from 0 to 100, a higher score indicates a higher health-related quality of life (HRQoL). A change in at least 10 points was considered clinically relevant."}, {'measure': 'Objective Response Rate (ORR) in Breast Cancer Susceptibility (BRCA) Gene Population by Blinded Independent Central Review (BICR)', 'timeFrame': 'RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)', 'description': 'BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).\n\nThe number of participants with complete or partial response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. Partial response is declared when there is a decrease in sum of target disease ≥ 30%. Complete response is declared when all lesions have disappeared or all lesions have disappeared and all nodal disease is \\< 10 mm each.'}, {'measure': 'Number of Participants Who Experienced Disease Progression or Death in BRCA Gene Population by Blinded Independent Central Review (BICR)', 'timeFrame': 'RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)', 'description': 'BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).\n\nProgressive disease was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Number of Participants Who Experienced Second Progression or Death (PFS2) in BRCA Gene Population', 'timeFrame': 'Visits to occur every 12 weeks from the date of first progression, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)', 'description': 'BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).'}, {'measure': 'Overall Survival (OS) in BRCA Gene Population', 'timeFrame': 'Visits to occur every 12 weeks from the date of first progression, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)', 'description': 'BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).\n\nOS in BRCA gene population was measured by the number of participants who died due to any cause.'}, {'measure': 'Number of Participants Who Discontinued Study Treatment or Died in BRCA Gene Population', 'timeFrame': 'Patients randomised to Olaparib administer their tablets orally at a dose of 300 mg twice daily and continue Olaparib until objective disease progression. Assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)', 'description': 'BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).'}, {'measure': 'Number of Participants Who Received Subsequent Chemotherapy or Died in BRCA Gene Population', 'timeFrame': "Anti-cancer treatments initiated post discontinuation of study treatment and investigator's opinion of response and date of progression recorded, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)", 'description': 'BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).\n\nAnti-cancer treatments include chemotherapy and targeted agents.'}, {'measure': 'Number of Participants Who Received Second Subsequent Chemotherapy or Died in BRCA Gene Population', 'timeFrame': "Anti-cancer treatments initiated post discontinuation of study treatment and investigator's opinion of response and date of progression recorded, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)", 'description': 'BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).\n\nAnti-cancer treatments include chemotherapy and targeted agents.'}, {'measure': 'Geometric Mean Plasma Concentration of Olaparib', 'timeFrame': 'Day 1, 1 hour post-dose and Day 29 pre-dose. DCO: 10Oct2018', 'description': 'Summary of plasma concentrations (ug/mL) of olaparib'}, {'measure': 'Number of Participants Who Experience at Least One Adverse Event (AE)', 'timeFrame': 'Safety Follow-up 30 days after last dose of IP, assessed from the date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)', 'description': 'An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['BRCA, ovarian, platinum, chemotherapy,'], 'conditions': ['Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity']}, 'referencesModule': {'references': [{'pmid': '39668137', 'type': 'DERIVED', 'citation': 'Scambia G, Villalobos Valencia R, Colombo N, Cibula D, Leath CA 3rd, Bidzinski M, Kim JW, Nam JH, Madry R, Hernandez C, Mora PAR, Ryu SY, Ah-See ML, Lowe ES, Lukashchuk N, Carter D, Penson RT. Olaparib as Treatment Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer: Phase III SOLO3 Study Final Overall Survival Results. J Clin Oncol. 2025 Apr 20;43(12):1408-1416. doi: 10.1200/JCO.24.00933. Epub 2024 Dec 12.'}, {'pmid': '32530768', 'type': 'DERIVED', 'citation': 'Paulino E, Melo AC. SOLO 3 Trial: How Do the Results Fit in With Current Evidence? J Clin Oncol. 2020 Aug 10;38(23):2697-2698. doi: 10.1200/JCO.20.00576. Epub 2020 Jun 12. No abstract available.'}, {'pmid': '32530766', 'type': 'DERIVED', 'citation': 'Penson RT, Lowe ES. Reply to E. Paulino et al. J Clin Oncol. 2020 Aug 10;38(23):2698. doi: 10.1200/JCO.20.01235. Epub 2020 Jun 12. No abstract available.'}, {'pmid': '32073956', 'type': 'DERIVED', 'citation': 'Penson RT, Valencia RV, Cibula D, Colombo N, Leath CA 3rd, Bidzinski M, Kim JW, Nam JH, Madry R, Hernandez C, Mora PAR, Ryu SY, Milenkova T, Lowe ES, Barker L, Scambia G. Olaparib Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3): A Randomized Phase III Trial. J Clin Oncol. 2020 Apr 10;38(11):1164-1174. doi: 10.1200/JCO.19.02745. Epub 2020 Feb 19.'}], 'seeAlsoLinks': [{'url': 'http://emergingmed.com/networks/AstraZeneca', 'label': 'AstraZeneca Cancer Study Locator Service Phone 677 400 4656 Email astrazeneca@emergingmed.com'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D0816C00010&attachmentIdentifier=041c3c95-2c81-475b-ae11-1769903a7112&fileName=20190614_SOLO-3_d0816c00010_Protocol_Amendment-v4_20Dec17_Final_Redacted_(1).pdf&versionIdentifier=', 'label': 'Related Info'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D0816C00010&attachmentIdentifier=4ef96d32-3bc9-474b-8bcf-0c6fd80190aa&fileName=20190614_AZ_SOLO-3_Statistical_Analysis_Plan_v4_30-Oct-2018_Final_Redacted_(1).pdf&versionIdentifier=', 'label': 'Related Info'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D0816C00010&attachmentIdentifier=0e755241-5571-4243-b9f4-92b1001d85b3&fileName=d0816c00010-add2-CSRsynopsis-redacted.pdf&versionIdentifier=', 'label': 'CSR Synopsis addendum'}]}, 'descriptionModule': {'briefSummary': "Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA) mutated ovarian cancer who have progressed at least 6 months after the last platinum based chemotherapy. Patient should have received at least 2 prior lines of platinum based chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets.", 'detailedDescription': "This open label, randomised, controlled, multi-centre study will assess the efficacy and safety of single agent olaparib vs. standard of care, based on physician's choice of single agent chemotherapy ( i.e paclitaxel, or topotecan, or pegylated liposomal doxorubicin, or gemcitabine) in platinum sensitive or partially platinum sensitive relapsed ovarian cancer patients who carry germline deleterious or suspected deleterious BRCA mutation and who have received at least 2 prior lines of platinum based chemotherapy. Patients are eligible to undergo BRCA testing even if they have not yet had recurrence or progression of disease \\>6 months (\\>/=183 days) after completion of their last platinum therapy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must be ≥ 18 years of age\n* Patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer. Patients are eligible to undergo BRCA testing even if they have not yet had recurrence or progression of disease \\>6 months (\\>/=183 days) after completion of their last platinum therapy.\n* Documented germline mutation in Breast Cancer susceptibility genes: BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)\n* At least one lesion that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment.\n* Patients must have received at least 2 prior platinum based lines of chemotherapy - Patients must be partially platinum sensitive or platinum sensitive\n* Patients must be suitable to start treatment with single agent chemotherapy based on physician's choice\n* Patients must have normal organ and bone marrow function measured within 28 days of randomisation,\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Patients must have a life expectancy ≥ 16 weeks\n* Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.\n\nExclusion Criteria:\n\n* BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental\n* Exposure to any investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation\n* Any previous treatment with a Polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor, including olaparib.\n* Patients who have platinum resistant or refractory disease\n* Patients receiving any systemic chemotherapy within 3 weeks prior to first dose of study treatment\n* Previous single agent exposure to the selected chemotherapy regimen for randomisation. - Prior malignancy in the last 5 years, unless curatively treated and recurrence free (few exceptions apply)."}, 'identificationModule': {'nctId': 'NCT02282020', 'acronym': 'SOLO3', 'briefTitle': 'Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': "A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physician's Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients Carrying Germline BRCA1/2 Mutations.", 'orgStudyIdInfo': {'id': 'D0816C00010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1/OLAPARIB', 'description': 'olaparib 300mg oral tablets; twice daily', 'interventionNames': ['Drug: OLAPARIB']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2/CHEMOTHERAPY', 'description': "Physician's choice single agent chemotherapy", 'interventionNames': ['Drug: Single agent chemotherapy']}], 'interventions': [{'name': 'OLAPARIB', 'type': 'DRUG', 'description': '300 mg olaparib tablets taken orally twice daily. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria.', 'armGroupLabels': ['1/OLAPARIB']}, {'name': 'Single agent chemotherapy', 'type': 'DRUG', 'description': "Treatment of relapsed disease with single agent chemotherapy based on physician's choice of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria", 'armGroupLabels': ['2/CHEMOTHERAPY']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80120', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '30905', 'city': 'Fort Gordon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.42097, 'lon': -82.16206}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97477', 'city': 'Springfield', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.04624, 'lon': -123.02203}}, {'zip': '19001', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76022', 'city': 'Bedford', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.84402, 'lon': -97.14307}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'B1884BBF', 'city': 'Berazategui', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -34.76531, 'lon': -58.21278}}, {'zip': 'C1280AEB', 'city': 'CABA', 'country': 'Argentina', 'facility': 'Research Site'}, {'zip': 'C1180AAX', 'city': 'Ciudad de Buenos Aires', 'country': 'Argentina', 'facility': 'Research Site'}, {'zip': '5000', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'B1897GPD', 'city': 'La Plata', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': 'T4000IAK', 'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '98700-000', 'city': 'Ijuí', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -28.38778, 'lon': -53.91472}}, {'zip': '99010 260', 'city': 'Passo Fundo', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}, {'zip': '90035-003', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90610-000', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '22793-080', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '15090-000', 'city': 'São José do Rio Preto', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'zip': '01246-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '01317-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1X6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '500 05', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '708 52', 'city': 'Ostrava-Poruba', 'country': 'Czechia', 'facility': 'Research Site'}, {'zip': '128 08', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '762 75', 'city': 'Zlín', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}, {'zip': '1088', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1115', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1122', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '9024', 'city': 'Győr', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'zip': '3526', 'city': 'Miskolc', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'zip': '18101', 'city': 'Afula', 'country': 'Israel', 'facility': 'Research Site', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Research Site', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '58100', 'city': 'Holon', 'country': 'Israel', 'facility': 'Research Site', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}, {'zip': '9103102', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Research Site', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Research Site', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '4941492', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Research Site', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Research Site', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '7661041', 'city': 'Rehovot', 'country': 'Israel', 'facility': 'Research Site', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Research Site', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Research Site', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': '70300', 'city': 'Ẕerifin', 'country': 'Israel', 'facility': 'Research Site', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}, {'zip': '47014', 'city': 'Meldola', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '98158', 'city': 'Messina', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '00144', 'city': 'Roma', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '07760', 'city': 'México', 'country': 'Mexico', 'facility': 'Research Site', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': '6760', 'city': 'México', 'country': 'Mexico', 'facility': 'Research Site', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': '68000', 'city': 'Oaxaca City', 'country': 'Mexico', 'facility': 'Research Site', 'geoPoint': {'lat': 17.06025, 'lon': -96.72544}}, {'zip': '80-219', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '72-003', 'city': 'Grzepnica', 'country': 'Poland', 'facility': 'Research Site'}, {'zip': '93-513', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-090', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '10-561', 'city': 'Olsztyn', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'zip': '60-569', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '10408', 'city': 'Goyang-si', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06273', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '139-706', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '17007', 'city': 'Girona', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '18014', 'city': 'Granada', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Richard T Penson, Associate Prof. of Medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard Medical School (HMS and HSDM)'}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.\n\nAll request will be evaluated as per the AZ disclosure commitment:\n\nhttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Myriad Genetic Laboratories, Inc.', 'class': 'INDUSTRY'}, {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}