Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-02-27 @ 8:06 AM
Study NCT ID:
NCT01924533
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2013-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531550', 'term': 'olaparib'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gershon.locker@astrazeneca.com', 'title': 'Gershon Locker Global Clinical Lead (GCL)', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': "At least 60 days prior to submission of any material for publication or presentation, Institution and Principal Investigator (PI) shall jointly provide AstraZeneca with such material for review. If requested in writing by AstraZeneca, Institution and PI shall withhold material from submission for publication or presentation for an additional 90 days from the date of AstraZeneca's request to allow for the filing patent application or preserve its proprietary rights in the information.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.', 'eventGroups': [{'id': 'EG000', 'title': 'Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2', 'description': 'Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\\^2', 'otherNumAtRisk': 262, 'deathsNumAtRisk': 263, 'otherNumAffected': 257, 'seriousNumAtRisk': 262, 'deathsNumAffected': 181, 'seriousNumAffected': 92}, {'id': 'EG001', 'title': 'Placebo Tablets bd + Paclitaxel 80 mg/m^2', 'description': 'Placebo tablets bd + Paclitaxel 80 mg/m\\^2', 'otherNumAtRisk': 259, 'deathsNumAtRisk': 262, 'otherNumAffected': 253, 'seriousNumAtRisk': 259, 'deathsNumAffected': 200, 'seriousNumAffected': 65}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 26, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 156, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 101, 'numAffected': 62}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 232, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 177, 'numAffected': 57}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 373, 'numAffected': 122}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 300, 'numAffected': 108}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 33, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 52, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 63, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 102, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 65, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 121, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 93, 'numAffected': 63}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 32, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 67, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 70, 'numAffected': 43}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 50, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 51, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 70, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 71, 'numAffected': 52}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 41, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 23, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 45, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 59, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 16, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 31, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 40, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 22, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 35, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 37, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 188, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 80, 'numAffected': 38}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 28, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 18, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 165, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 116, 'numAffected': 48}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 127, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 97, 'numAffected': 69}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 22, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 51, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 65, 'numAffected': 35}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 41, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 45, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 45, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 30, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 36, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 29, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 27, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 112, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 117, 'numAffected': 116}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 44, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 29, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bone marrow disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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participants who were eligible and assigiend to each treatment group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2', 'description': 'Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\\^2'}, {'id': 'BG001', 'title': 'Placebo Tablets bd + Paclitaxel 80 mg/m^2', 'description': 'Placebo tablets bd + Paclitaxel 80 mg/m\\^2'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57.1', 'spread': '11.90', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '79'}, {'value': '57.3', 'spread': '11.14', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '83'}, {'value': '57.2', 'spread': '11.52', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '83'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57.0', 'spread': '12.08', 'groupId': 'BG000'}, {'value': '60.9', 'spread': '9.90', 'groupId': 'BG001'}, {'value': '58.9', 'spread': '11.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'ATM Negative Population', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.'}, {'title': 'Age, Customized', 'classes': [{'title': '>=18 - <50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}, {'title': '>=50 - <65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}]}, {'title': '>=65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Customized', 'classes': [{'title': '>=18 - <50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': '>=50 - <65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': '>=65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ATM Negative Population', 'unitOfMeasure': 'Participants', 'populationDescription': 'The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Not Hispanic Or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Not Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ATM Negative Population', 'unitOfMeasure': 'Participants', 'populationDescription': 'The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ATM Negative Population', 'unitOfMeasure': 'Participants', 'populationDescription': 'The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.'}, {'title': 'ATM Status', 'classes': [{'title': 'Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}, {'title': 'Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Gastrectomy Status', 'classes': [{'title': 'Full', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}, {'title': 'None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}]}, {'title': 'Partial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gastrectomy Status', 'classes': [{'title': 'Full', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Partial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ATM Negative Population', 'unitOfMeasure': 'Participants', 'populationDescription': 'The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 525}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2013-08-14', 'resultsFirstSubmitDate': '2017-02-27', 'studyFirstSubmitQcDate': '2013-08-14', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-05', 'studyFirstPostDateStruct': {'date': '2013-08-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years', 'description': 'Time from the date of randomization until death due to any cause'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years', 'description': 'Time from randomization until the date of objective radiological disease progression according to RECIST (v1.1) or death by any cause in the absence of progression. Objective progression is defined as at least a 20% increase in the sum of the diameters of the target lesions (compared to previous minimum sum) or an overall non-target lesion assessment of progression or a new lesion.'}, {'measure': 'Number of Patients With Objective Response.', 'timeFrame': 'Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years', 'description': 'Number of patients with objective response. Per RECIST 1.1, complete response (CR) is disappearance of all target lesions since baseline; partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Overall Response = CR + PR.'}, {'measure': 'Number of Patients Objective Response', 'timeFrame': 'Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years', 'description': 'Number of patients with objective response. Per RECIST 1.1, complete response (CR) is disappearance of all target lesions since baseline; partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Overall Response = CR + PR.'}, {'measure': 'Number of Patients With Deterioration of Health Related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Questionnaire Core 30 Item Module (QLQ-C30) Global HRQoL Scale', 'timeFrame': 'Pre-treatment , Day 29 and then every 4 weeks until discontinuation, assessed up to 3 years', 'description': 'Number of patients with a clinically important deterioration in the global HRQoL score or death by any cause in the absence of a clincially meaningful symptom deterioration'}, {'measure': 'Time to Response', 'timeFrame': 'Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years', 'description': 'Time from randomization to the first onset of a confirmed objective tumour response'}, {'measure': 'Duration of Response', 'timeFrame': 'Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years', 'description': 'Time from the first documentation of CR/PR until the date of progression, or the last evaluable RECIST assessment for patients taht do not progress or progress after two or more missed visits'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '29103871', 'type': 'DERIVED', 'citation': 'Bang YJ, Xu RH, Chin K, Lee KW, Park SH, Rha SY, Shen L, Qin S, Xu N, Im SA, Locker G, Rowe P, Shi X, Hodgson D, Liu YZ, Boku N. Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1637-1651. doi: 10.1016/S1470-2045(17)30682-4. Epub 2017 Nov 2.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1856&filename=GOLD%20Study%20protocol-redacted.pdf', 'label': 'Study protocol-redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D081BC00004&attachmentIdentifier=65ef6d55-2b26-4d0d-a8d4-d96af57903de&fileName=d081bc00004-study-synopsis_Redacted.pdf&versionIdentifier=', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'This study is a phase III, multi-centre study of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy. Patients will be from China, Japan , Korea and Taiwan.', 'detailedDescription': 'A randomized, double-blinded, multicentre phase III study to access the efficacy and safety of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in Asian patients with advanced gastric cancer (including gastro-oesophageal junction) who have progressed following first line therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Advanced gastric cancer (including GEJ) that has progressed following first-line therapy.\n* Patients must be ≥18 years of age. Age ≥20 if Japanese\n* Provision of tumour sample (from either a resection or biopsy).\n* At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline and following up visits.\n\nExclusion Criteria:\n\n* More than one prior chemotherapy regimen (except for adjuvant/neoadjuvant chemotherapy with more than 6 month wash out period) for the treatment of gastric cancer in the advanced setting.\n* Any previous treatment with a Polyadenosine 5'-diphosphoribose \\[poly-(ADP-ribose)\\] polymerisation (PARP) inhibitor, including olaparib.\n* Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥5 years.\n* Human Epidermalgrowth Factor Receptor-2 (HER2) positive patients."}, 'identificationModule': {'nctId': 'NCT01924533', 'briefTitle': 'Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Double-blinded, Placebo Controlled, Multicentre Phase III Study to Assess the Efficacy and Safety of Olaparib (AZD2281) in Combination With Paclitaxel, Compared to Placebo in Combination With Paclitaxel, in Asian Patients With Advanced Gastric Cancer (Including the Gastro-oesophageal Junction) Who Have Progressed Following First Line Therapy', 'orgStudyIdInfo': {'id': 'D081BC00004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olaparib+ paclitaxel', 'description': 'olaparib + paclitaxel', 'interventionNames': ['Drug: Olaparib', 'Drug: Paclitaxel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo+paclitaxel', 'description': 'placebo+ paclitaxel', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Placebo']}], 'interventions': [{'name': 'Olaparib', 'type': 'DRUG', 'description': 'Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy olaparib dose will be 300mg twice daily.', 'armGroupLabels': ['Olaparib+ paclitaxel']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule.', 'armGroupLabels': ['Olaparib+ paclitaxel', 'Placebo+paclitaxel']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy placebo dose will be 300mg twice daily.', 'armGroupLabels': ['Placebo+paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100071', 'city': 'Beijing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100142', 'city': 'Beijing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '233060', 'city': 'Bengbu', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'zip': '130000', 'city': 'Changchun', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '410005', 'city': 'Changsha', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410011', 'city': 'Changsha', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410013', 'city': 'Changsha', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '610041', 'city': 'Chengdu', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610083', 'city': 'Chengdu', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '350014', 'city': 'Fuzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510060', 'city': 'Guangzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '310003', 'city': 'Hangzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310016', 'city': 'Hangzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310022', 'city': 'Hangzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '150081', 'city': 'Harbin', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '330006', 'city': 'Nanchang', 'country': 'China', 'facility': 'Research 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