Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT01246960
Status:
COMPLETED
Last Update Posted:
2014-10-08
First Post:
2010-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Ramucirumab in Participants With Gastric, Esophageal, and Gastroesophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000096662', 'term': 'Ramucirumab'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'otherDetails': 'Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ramucirumab and mFOLFOX6', 'description': "Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.", 'otherNumAtRisk': 82, 'otherNumAffected': 82, 'seriousNumAtRisk': 82, 'seriousNumAffected': 48}, {'id': 'EG001', 'title': 'Placebo and mFOLFOX6', 'description': "Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.", 'otherNumAtRisk': 80, 'otherNumAffected': 79, 'seriousNumAtRisk': 80, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 41, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 58, 'numAffected': 38}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 18, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 76, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 108, 'numAffected': 33}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 62, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 45, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 20, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 41, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 41, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 67, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 56, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 11, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 72, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 82, 'numAffected': 56}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 21, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 49, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 42, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 91, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 81, 'numAffected': 56}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 23, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 30, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Temperature intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 14, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 18, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 24, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 50, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 16, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 45, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 24, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 41, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 31, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 47, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 36, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 22, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 13, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 19, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 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'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Catheter site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anastomotic ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urostomy complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Polyarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Embolism venous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramucirumab and mFOLFOX6', 'description': "Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}, {'id': 'OG001', 'title': 'Placebo and mFOLFOX6', 'description': "Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '9.3'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '7.8'}]}]}], 'analyses': [{'pValue': '0.886', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.37', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to measured PD or date of death from any cause (up to Month 25.0)', 'description': 'PFS was defined using Response Evaluation Criteria in Solid Tumors \\[RECIST version (v.) 1.1\\] as the time from randomization to the first observation of progressive disease (PD) or death due to any cause, whichever came first. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 millimeters (mm); the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. If a participant did not have a baseline disease assessment, PFS time was censored at the randomization date, regardless of whether or not PD or death was observed. Participants not known to have died or have objective PD were censored at the last post-baseline radiological assessment date.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'ITT population: all randomized participants. Fourteen participants in the Ramucirumab and mFOLFOX6 treatment arm and 15 participants in the Placebo and mFOLFOX6 treatment arm were censored.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramucirumab and mFOLFOX6', 'description': "Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}, {'id': 'OG001', 'title': 'Placebo and mFOLFOX6', 'description': "Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '14.6'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '15.3'}]}]}], 'analyses': [{'pValue': '0.712', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.58', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to date of death from any cause (up to Month 28.3)', 'description': 'OS was defined as the time from randomization to death due to any cause. OS was censored at the date of the last follow-up visit for participants who were alive or lost to follow-up.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'ITT population: all randomized participants. Twenty-seven participants in the Ramucirumab and mFOLFOX6 treatment arm and 32 participants in the Placebo and mFOLFOX6 treatment arm were censored.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an Objective Response (Objective Response Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramucirumab and mFOLFOX6', 'description': "Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}, {'id': 'OG001', 'title': 'Placebo and mFOLFOX6', 'description': "Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}], 'classes': [{'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000', 'lowerLimit': '34.3', 'upperLimit': '56.5'}, {'value': '46.4', 'groupId': 'OG001', 'lowerLimit': '35.5', 'upperLimit': '57.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to measured PD (up to Month 23.0)', 'description': 'The percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR) is reported. Response was defined using RECIST, v. 1.1 criteria. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to \\<10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. The percentage of participants with objective response=(number of participants whose best overall response achieved was CR or PR/number of participants treated)\\*100.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'ITT population: all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramucirumab and mFOLFOX6', 'description': "Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}, {'id': 'OG001', 'title': 'Placebo and mFOLFOX6', 'description': "Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '8.4'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time of first response to measured PD (up to Month 23.0)', 'description': 'Duration of response was defined using RECIST v. 1.1 criteria as the time from the date criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death from any cause. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to \\<10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'Randomized participants who achieved an objective response of CR or PR. Eight participants in the Ramucirumab and mFOLFOX6 treatment arm and 8 participants in the Placebo and mFOLFOX6 treatment arm were censored.'}, {'type': 'SECONDARY', 'title': 'Time to Disease Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramucirumab and mFOLFOX6', 'description': "Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}, {'id': 'OG001', 'title': 'Placebo and mFOLFOX6', 'description': "Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '9.8'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '9.2'}]}]}], 'analyses': [{'pValue': '0.516', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.30', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to measured PD (up to Month 25.0)', 'description': 'TTP was defined using RECIST v. 1.1 as the time from study randomization to the first date of PD. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. TTP was censored at the date of last adequate tumor assessment if death was due to causes other than PD.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'populationDescription': 'ITT population: all randomized participants. Thirty-five participants in the Ramucirumab and mFOLFOX6 treatment arm and 31 participants in the Placebo and mFOLFOX6 treatment arm were censored.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramucirumab and mFOLFOX6', 'description': "Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}, {'id': 'OG001', 'title': 'Placebo and mFOLFOX6', 'description': "Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 1, 2, 4, 6, and 8', 'description': 'Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).', 'unitOfMeasure': 'participants', 'populationDescription': 'Randomized participants who received any quantity of ramucirumab or placebo, and were evaluated for the presence of anti-ramucirumab antibodies.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramucirumab and mFOLFOX6', 'description': "Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}, {'id': 'OG001', 'title': 'Placebo and mFOLFOX6', 'description': "Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}], 'classes': [{'title': 'Any Ramucirumab/Placebo-Related AE', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Any Ramucirumab/Placebo-Related SAE', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Any Ramucirumab/Placebo-Related ≥Grade 3 AE', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Any Ramucirumab/Placebo-Related Grade 5 AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any AE Leading to Treatment Discontinuation', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any AE with Outcome of Death', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through study completion (up to Month 28.3)', 'description': 'Reported are the number of participants who had ramucirumab/placebo-related: AEs, serious AEs (SAEs), AEs based on common terminology criteria for adverse events (CTCAE) ≥Grade 3, AEs = CTCAE Grade 5, as well as, AEs leading to treatment discontinuation and AEs resulting in death. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.', 'unitOfMeasure': 'participants', 'populationDescription': 'Safety population: randomized participants who received any quantity of study drug (Ramucirumab, mFOLFOX6, or placebo).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ramucirumab and mFOLFOX6', 'description': "Ramucirumab: 8 milligrams per kilogram (mg/kg) intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering modified FOLFOX6 (mFOLFOX6).\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin 85 milligrams per square meter (mg/m\\^2)\n* Leucovorin 400 mg/m\\^2\n* 5-Fluorouracil (5-FU) 400 mg/m\\^2 bolus\n* 5-FU 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}, {'id': 'FG001', 'title': 'Placebo and mFOLFOX6', 'description': "Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin 85 mg/m\\^2\n* Leucovorin 400 mg/m\\^2\n* 5-FU 400 mg/m\\^2 bolus\n* 5-FU 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'Received Any Quantity of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal (by participant or physician)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ramucirumab and mFOLFOX6', 'description': "Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."}, {'id': 'BG001', 'title': 'Placebo and mFOLFOX6', 'description': "Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.\n\nmFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).\n\n* Oxaliplatin: 85 mg/m\\^2\n* Leucovorin: 400 mg/m\\^2\n* 5-FU: 400 mg/m\\^2 bolus\n* 5-FU: 2400 mg/m\\^2 continuous given over 46-48 hours\n\nParticipants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion 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': '42', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '155', '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/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'dispFirstSubmitDate': '2014-04-25', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-03', 'studyFirstSubmitDate': '2010-11-08', 'dispFirstSubmitQcDate': '2014-04-25', 'resultsFirstSubmitDate': '2014-10-03', 'studyFirstSubmitQcDate': '2010-11-23', 'dispFirstPostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-10-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-03', 'studyFirstPostDateStruct': {'date': '2010-11-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Baseline through study completion (up to Month 28.3)', 'description': 'Reported are the number of participants who had ramucirumab/placebo-related: AEs, serious AEs (SAEs), AEs based on common terminology criteria for adverse events (CTCAE) ≥Grade 3, AEs = CTCAE Grade 5, as well as, AEs leading to treatment discontinuation and AEs resulting in death. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.'}], 'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Randomization to measured PD or date of death from any cause (up to Month 25.0)', 'description': 'PFS was defined using Response Evaluation Criteria in Solid Tumors \\[RECIST version (v.) 1.1\\] as the time from randomization to the first observation of progressive disease (PD) or death due to any cause, whichever came first. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 millimeters (mm); the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. If a participant did not have a baseline disease assessment, PFS time was censored at the randomization date, regardless of whether or not PD or death was observed. Participants not known to have died or have objective PD were censored at the last post-baseline radiological assessment date.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Randomization to date of death from any cause (up to Month 28.3)', 'description': 'OS was defined as the time from randomization to death due to any cause. OS was censored at the date of the last follow-up visit for participants who were alive or lost to follow-up.'}, {'measure': 'Percentage of Participants Achieving an Objective Response (Objective Response Rate)', 'timeFrame': 'Randomization to measured PD (up to Month 23.0)', 'description': 'The percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR) is reported. Response was defined using RECIST, v. 1.1 criteria. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to \\<10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. The percentage of participants with objective response=(number of participants whose best overall response achieved was CR or PR/number of participants treated)\\*100.'}, {'measure': 'Duration of Response', 'timeFrame': 'Time of first response to measured PD (up to Month 23.0)', 'description': 'Duration of response was defined using RECIST v. 1.1 criteria as the time from the date criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death from any cause. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to \\<10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy.'}, {'measure': 'Time to Disease Progression (TTP)', 'timeFrame': 'Randomization to measured PD (up to Month 25.0)', 'description': 'TTP was defined using RECIST v. 1.1 as the time from study randomization to the first date of PD. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. TTP was censored at the date of last adequate tumor assessment if death was due to causes other than PD.'}, {'measure': 'Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies', 'timeFrame': 'Months 1, 2, 4, 6, and 8', 'description': 'Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer', 'stomach', 'esophagus', 'gastroesophageal'], 'conditions': ['Stomach Cancer', 'Esophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '27765757', 'type': 'DERIVED', 'citation': 'Yoon HH, Bendell JC, Braiteh FS, Firdaus I, Philip PA, Cohn AL, Lewis N, Anderson DM, Arrowsmith E, Schwartz JD, Gao L, Hsu Y, Xu Y, Ferry D, Alberts SR, Wainberg ZA. Ramucirumab combined with FOLFOX as front-line therapy for advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma: a randomized, double-blind, multicenter Phase II trial. Ann Oncol. 2016 Dec;27(12):2196-2203. doi: 10.1093/annonc/mdw423. Epub 2016 Oct 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether ramucirumab when used in conjunction with chemotherapy treatment can help participants with stomach, esophagus, and gastroesophageal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologic or cytologic confirmation of adenocarcinoma of the esophagus, gastroesophageal junction (GEJ), or stomach\n* Metastatic or locally advanced, unresectable disease at time of study entry\n* Provided signed informed consent and is amenable to compliance with protocol schedules and testing\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1 at study entry\n* Adequate renal, hematological, and hepatic function\n* Measurable or non-measurable disease at the time of study entry\n* Resolution to Grade less than or equal to 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0, of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer therapy, except where otherwise mentioned in the eligibility criteria\n* Eligible participants of reproductive potential (both sexes) must agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and at least 12 weeks after the last dose of study therapy\n* Life expectancy of greater than or equal to 3 months\n* Willingness to provide blood and tissue samples for research purposes. Submission of tumor specimen is mandatory for participation in this study, if a histologic, paraffin-embedded specimen exists (either from a surgical resection or biopsy); submission of paraffin block or a minimum of 8 unstained slides is required if sufficient sample. NOTE: If insufficient additional tissue exists (that is, all tissue has been utilized for prior diagnostic purposes), participation in the study is allowable without the requirement for an additional biopsy; this situation must be discussed with the study principal investigator and/or the ImClone medical monitor or designee.\n\nExclusion Criteria:\n\n* The participant has received prior first-line systemic therapy for advanced/unresectable and/or metastatic disease (prior adjuvant or neo-adjuvant therapy is permitted)\n* Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to study entry\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the participant ineligible for entry into this study\n* The participant is receiving chronic therapy with nonsteroidal anti-inflammatory agents (NSAIDs; for example, indomethacin, ibuprofen, naproxen, or similar agents) or other antiplatelet agents (for example, clopidogrel, ticlopidine, dipyridamole, anagrelide). Aspirin use at doses up to 325 milligrams per day (mg/day) is permitted.\n* The participant has significant third-space fluid retention (for example, ascites or pleural effusion), and is not amenable for required repeated drainage\n* The participant is pregnant or breastfeeding\n* Uncontrolled intercurrent illness including, but not limited to, active or uncontrolled clinically serious infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled thromboembolic, or hemorrhagic disorder, psychiatric illness/social situations, or other co-morbid systemic illnesses, or other severe concurrent disease\n* Immunocompromised participants including participants known to be human immunodeficiency virus (HIV) positive.\n* Progressive disease less than or equal to 12 months of completing platinum or 5-FU treatment, including capecitabine, if given previously in the perioperative (adjuvant or neoadjuvant) setting\n* Current or recent (within 28 days prior to randomization) treatment with an investigational drug that has not received regulatory approval for any indication at the time of study entry, or participation in another interventional clinical trial. Participants participating in surveys or observational studies are eligible to participate in this study.\n* Are currently enrolled in, or discontinued within the last 28 days from, a clinical trial involving ramucirumab drug product (DP), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study\n* Received prior therapy with an antiangiogenic agent (including but not limited to bevacizumab, sunitinib, or sorafenib)\n* Major surgical procedure or significant traumatic injury less than 28 days prior to randomization, or anticipation of need for elective or planned major surgical procedure during the course of the study. Subcutaneous venous access device placement within 7 days prior to randomization\n* Clinically significant peripheral neuropathy at the time of registration\n* Known central nervous system metastases that are symptomatic or untreated\n* New York Heart Association (NYHA) classification III-IV congestive heart failure\n* Greater than normal risk of bleeding or coagulopathy in the absence of therapeutic anticoagulation; Grade 3/4 gastrointestinal bleeding within 3 months prior to registration; active bleeding (that is, within 14 days prior to first dose of study therapy); or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices)\n* Participant has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, stroke, transient ischemic attack (TIA), cerebrovascular accident, or unstable angina, less than or equal to 6 months prior to registration\n* Clinically significant vascular disease (for example, aortic aneurysm, aortic dissection) for which more than minimal intervention is being administered or planned\n* History of hypertensive crisis or hypertensive encephalopathy or current poorly-controlled hypertension despite standard medical management\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess less than 6 months prior to registration\n* Known hypersensitivity to any of the treatment components of modified FOLFOX6 (mFOLFOX6) (oxaliplatin, 5-FU, and leucovorin) or ramucirumab DP'}, 'identificationModule': {'nctId': 'NCT01246960', 'briefTitle': 'A Study of Ramucirumab in Participants With Gastric, Esophageal, and Gastroesophageal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Randomized, Placebo-Controlled, Double-Blind Phase 2 Study of mFOLFOX6 Chemotherapy Plus Ramucirumab Drug Product(IMC-1121B) Versus mFOLFOX6 Plus Placebo for Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction or Stomach', 'orgStudyIdInfo': {'id': '14057'}, 'secondaryIdInfos': [{'id': 'I4T-MC-JVBT', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ramucirumab', 'description': '* Oxaliplatin 85 milligrams per square meter (mg/m\\^2) given on Day 1 of a 2-week cycle\n* Leucovorin 400 mg/m\\^2 given on Day 1 of a 2-week cycle\n* 5-Fluorouracil (5-FU) 400 mg/m\\^2 bolus given on Day 1 of a 2-week cycle\n* 5-FU 2400 mg/m\\^2 continuously given over 46-48 hours on Day 1 of a 2-week cycle\n* Ramucirumab 8 milligrams per kilogram (mg/kg) given on Day 1 of a 2-week cycle\n\nParticipants will receive study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion is met', 'interventionNames': ['Biological: Ramucirumab', 'Drug: Oxaliplatin', 'Drug: Leucovorin', 'Drug: 5-Fluorouracil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '* Oxaliplatin 85 mg/m\\^2 given on Day 1 of a 2-week cycle\n* Leucovorin 400 mg/m\\^2 given on Day 1 of a 2-week cycle\n* 5-FU 400 mg/m\\^2 bolus given on Day 1 of a 2-week cycle\n* 5-FU 2400 mg/m\\^2 continuously given over 46-48 hours on Day 1 of a 2-week cycle\n* Placebo given on Day 1 of a 2-week cycle\n\nParticipants will receive study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion is met', 'interventionNames': ['Drug: Placebo', 'Drug: Oxaliplatin', 'Drug: Leucovorin', 'Drug: 5-Fluorouracil']}], 'interventions': [{'name': 'Ramucirumab', 'type': 'BIOLOGICAL', 'otherNames': ['LY3009806', 'IMC-1121B'], 'description': 'Administered intravenously', 'armGroupLabels': ['Ramucirumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['Placebo']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['Placebo', 'Ramucirumab']}, {'name': 'Leucovorin', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['Placebo', 'Ramucirumab']}, {'name': '5-Fluorouracil', 'type': 'DRUG', 'otherNames': ['5-FU'], 'description': 'Administered intravenously', 'armGroupLabels': ['Placebo', 'Ramucirumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91801', 'city': 'Alhambra', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.09529, 'lon': -118.12701}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '93454', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '81501', 'city': 'Grand Junction', 'state': 'Colorado', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '34223', 'city': 'Englewood', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.96201, 'lon': -82.3526}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '47802', 'city': 'Terre Haute', 'state': 'Indiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.4667, 'lon': -87.41391}}, {'zip': '51101', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '04240', 'city': 'Lewiston', 'state': 'Maine', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.10035, 'lon': -70.21478}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '01107', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '55805', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '59715', 'city': 'Bozeman', 'state': 'Montana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.67965, 'lon': -111.03856}}, {'zip': '68106', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89169', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45420', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '18512', 'city': 'Dunmore', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.4198, 'lon': -75.63241}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29210', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23230', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}, {'zip': '98273', 'city': 'Mount Vernon', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.42122, 'lon': -122.33405}}, {'zip': '98112', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}