Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-03 @ 8:31 AM
Study NCT ID:
NCT02322593
Status:
COMPLETED
Last Update Posted:
2021-12-20
First Post:
2014-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'C000711476', 'term': 'S-1 plus cisplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'toiawase@taiho.co.jp', 'title': 'Taiho Pharmaceutical Co., Ltd.', 'organization': 'Clinical Trial Registration Contact'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the time a patient signed informed consent until 30 day safety follow-up visit or initiation of new anticancer treatment, whichever was earlier, an average assessed up to 42 months.', 'description': 'An adverse event (AE) is any untoward medical condition that occurs in a patient while participating in a clinical study and does not necessarily have a causal relationship with the use of the product. Treatment emergent adverse events are AEs that occur from the initiation of any study medication administration, and do not necessarily have a causal relationship to the use of the study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'TAS-118/Oxaliplatin', 'description': 'TAS-118 plus Oxaliplatin\n\nL-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.', 'otherNumAtRisk': 352, 'deathsNumAtRisk': 352, 'otherNumAffected': 344, 'seriousNumAtRisk': 352, 'deathsNumAffected': 22, 'seriousNumAffected': 155}, {'id': 'EG001', 'title': 'S-1/Cisplatin', 'description': 'S-1 plus Cisplatin\n\nCDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.', 'otherNumAtRisk': 348, 'deathsNumAtRisk': 348, 'otherNumAffected': 328, 'seriousNumAtRisk': 348, 'deathsNumAffected': 8, 'seriousNumAffected': 159}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 96}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 53}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 37}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 90}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 189}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 134}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 200}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 186}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 148}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 88}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 106}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 76}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 33}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 115}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 76}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 41}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 76}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 25}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 234}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 216}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 82}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 242}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 54}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 62}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 50}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Pigmentation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Vascular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Prinzmetal angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Rhegmatogenous retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Gastric perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Gastrointestinal necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Gastrointestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Obstruction gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 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'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 32}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Malignant ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Metastases to meninges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Tumour associated fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Metastatic gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Embolic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Renal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Adnexal torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Dermatomyositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}, {'term': 'Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (ver. 21.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAS-118/Oxaliplatin', 'description': 'TAS-118 plus Oxaliplatin\n\nL-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.'}, {'id': 'OG001', 'title': 'S-1/Cisplatin', 'description': 'S-1 plus Cisplatin\n\nCDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '18.3'}, {'value': '15.1', 'groupId': 'OG001', 'lowerLimit': '13.6', 'upperLimit': '16.4'}]}]}], 'analyses': [{'pValue': '0.039', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.69', 'ciUpperLimit': '0.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.091', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'A survival follow-up was required every 12 weeks from the date of randomization to the date of death from any cause, whichever came first, assessed up to 38 months.', 'description': 'The primary endpoint was OS, which was defined as the time from the date of randomization to the date of death from any cause. Surviving patients were censored at the cutoff date or last contact date if lost to follow-up, or upon withdrawal of consent.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)：Patients in AT population who have advanced gastric cancer at randomization.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAS-118/Oxaliplatin', 'description': 'TAS-118 plus Oxaliplatin\n\nL-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.'}, {'id': 'OG001', 'title': 'S-1/Cisplatin', 'description': 'S-1 plus Cisplatin\n\nCDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '8.3'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '6.9'}]}]}], 'analyses': [{'pValue': '0.0045', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.086', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'A radiographic imaging examination using CT or MRI was repeated every 6 weeks. Tumor assessments were performed from the date of randomization to the date of disease progression or death from any cause, whichever came first.', 'description': 'PFS was defined as the time from the date of randomization to the date of disease progression (assessed by each investigator) or death from any cause, whichever came first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAS-118/Oxaliplatin', 'description': 'TAS-118 plus Oxaliplatin\n\nL-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.'}, {'id': 'OG001', 'title': 'S-1/Cisplatin', 'description': 'S-1 plus Cisplatin\n\nCDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '6.7'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '6.2'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.70', 'ciUpperLimit': '0.96', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.078', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to the date of the last administration of the study drug.', 'description': 'TTF was defined as the time from the date of randomization to the date of the last administration of the study drug. Patients on study treatment were censored at the date of the last administration or the cutoff date, whichever came earlier.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAS-118/Oxaliplatin', 'description': 'TAS-118 plus Oxaliplatin\n\nL-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.'}, {'id': 'OG001', 'title': 'S-1/Cisplatin', 'description': 'S-1 plus Cisplatin\n\nCDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months.', 'description': 'ORR was defined as the proportion of patients with the best unconfirmed overall response of complete response (CR) or partial response (PR) in patients with measurable lesions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Tumor Response (TR) Evaluable Population： Patients in FAS population presenting measurable lesions (at least one target lesion), evaluated for tumor responses at least once during treatment with the study drug.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAS-118/Oxaliplatin', 'description': 'TAS-118 plus Oxaliplatin\n\nL-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.'}, {'id': 'OG001', 'title': 'S-1/Cisplatin', 'description': 'S-1 plus Cisplatin\n\nCDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '197', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.092', 'groupIds': ['OG000'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months.', 'description': 'DCR was defined as the proportion of patients with CR, PR, or stable disease in patients with measurable lesions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TR Evaluable Population：'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAS-118/Oxaliplatin', 'description': 'TAS-118 plus Oxaliplatin\n\nL-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.'}, {'id': 'FG001', 'title': 'S-1/Cisplatin', 'description': 'S-1 plus Cisplatin\n\nCDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '356'}, {'groupId': 'FG001', 'numSubjects': '355'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '356'}, {'groupId': 'FG001', 'numSubjects': '355'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'BG000'}, {'value': '334', 'groupId': 'BG001'}, {'value': '681', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TAS-118/Oxaliplatin', 'description': 'TAS-118 plus Oxaliplatin\n\nL-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.'}, {'id': 'BG001', 'title': 'S-1/Cisplatin', 'description': 'S-1 plus Cisplatin\n\nCDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '395', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '79'}, {'value': '62.0', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '80'}, {'value': '62.0', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '469', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '347', 'groupId': 'BG000'}, {'value': '334', 'groupId': 'BG001'}, {'value': '681', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '347', 'groupId': 'BG000'}, {'value': '334', 'groupId': 'BG001'}, {'value': '681', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Full Analysis Set (FAS)：Patients in AT population who have advanced gastric cancer at randomization.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-07', 'size': 1594659, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-24T04:03', 'hasProtocol': True}, {'date': '2019-02-04', 'size': 820163, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-24T04:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 711}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-10', 'studyFirstSubmitDate': '2014-12-12', 'resultsFirstSubmitDate': '2021-08-24', 'studyFirstSubmitQcDate': '2014-12-17', 'lastUpdatePostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-10', 'studyFirstPostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'A survival follow-up was required every 12 weeks from the date of randomization to the date of death from any cause, whichever came first, assessed up to 38 months.', 'description': 'The primary endpoint was OS, which was defined as the time from the date of randomization to the date of death from any cause. Surviving patients were censored at the cutoff date or last contact date if lost to follow-up, or upon withdrawal of consent.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': 'A radiographic imaging examination using CT or MRI was repeated every 6 weeks. Tumor assessments were performed from the date of randomization to the date of disease progression or death from any cause, whichever came first.', 'description': 'PFS was defined as the time from the date of randomization to the date of disease progression (assessed by each investigator) or death from any cause, whichever came first.'}, {'measure': 'Time to Treatment Failure', 'timeFrame': 'From the date of randomization to the date of the last administration of the study drug.', 'description': 'TTF was defined as the time from the date of randomization to the date of the last administration of the study drug. Patients on study treatment were censored at the date of the last administration or the cutoff date, whichever came earlier.'}, {'measure': 'Overall Response Rate', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months.', 'description': 'ORR was defined as the proportion of patients with the best unconfirmed overall response of complete response (CR) or partial response (PR) in patients with measurable lesions'}, {'measure': 'Disease Control Rate', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months.', 'description': 'DCR was defined as the proportion of patients with CR, PR, or stable disease in patients with measurable lesions.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gastric Cancer', 'Gastrointestinal Diseases', 'Gastrointestinal Neoplasms', 'First Line Treatment', 'Antineoplastic Agents'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '32682457', 'type': 'DERIVED', 'citation': 'Kang YK, Chin K, Chung HC, Kadowaki S, Oh SC, Nakayama N, Lee KW, Hara H, Chung IJ, Tsuda M, Park SH, Hosaka H, Hironaka S, Miyata Y, Ryu MH, Baba H, Hyodo I, Bang YJ, Boku N. S-1 plus leucovorin and oxaliplatin versus S-1 plus cisplatin as first-line therapy in patients with advanced gastric cancer (SOLAR): a randomised, open-label, phase 3 trial. Lancet Oncol. 2020 Aug;21(8):1045-1056. doi: 10.1016/S1470-2045(20)30315-6. Epub 2020 Jul 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to evaluate the efficacy of TAS-118 plus Oxaliplatin compared with S-1 plus Cisplatin in overall survival in patients with advanced gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Patients who are diagnosed as gastric cancer.\n* No prior treatment for gastric cancer.\n* Negative or unknown for HER2 testing.\n* ECOG performance status of 0 or 1.\n\nKey Exclusion Criteria:\n\n* Unmanageable diarrhea.\n* Current peripheral sensory neuropathy or paresthesia.\n* Pregnant or lactating female.'}, 'identificationModule': {'nctId': 'NCT02322593', 'acronym': 'SOLAR', 'briefTitle': 'Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiho Pharmaceutical Co., Ltd.'}, 'officialTitle': 'An Open-label Randomized Multi-center Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': '10056040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAS-118/Oxaliplatin', 'description': 'TAS-118 plus Oxaliplatin', 'interventionNames': ['Drug: TAS-118 plus Oxaliplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'S-1/Cisplatin', 'description': 'S-1 plus Cisplatin', 'interventionNames': ['Drug: S-1 plus Cisplatin']}], 'interventions': [{'name': 'TAS-118 plus Oxaliplatin', 'type': 'DRUG', 'armGroupLabels': ['TAS-118/Oxaliplatin']}, {'name': 'S-1 plus Cisplatin', 'type': 'DRUG', 'armGroupLabels': ['S-1/Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '305-8576', 'city': 'Ibaraki', 'country': 'Japan', 'facility': 'Taiho Pharmaceutical Co., Ltd selected site', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'zip': '860-8556', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Taiho Pharmaceutical Co., Ltd selected site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '104-0045', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Taiho Pharmaceutical Co., Ltd selected site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Taiho Pharmaceutical Co., Ltd selected site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Taiho Pharmaceutical Co., Ltd selected site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Taiho Pharmaceutical Co., Ltd selected site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Yakult Honsha Co., LTD', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}