Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-05 @ 5:22 PM
Study NCT ID:
NCT02514551
Status:
COMPLETED
Last Update Posted:
2020-06-17
First Post:
2015-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer
Sponsor:
Organization:
Raw JSON
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'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up To 40 Months', 'description': 'All randomized participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': '12mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.', 'otherNumAtRisk': 123, 'deathsNumAtRisk': 123, 'otherNumAffected': 117, 'seriousNumAtRisk': 123, 'deathsNumAffected': 81, 'seriousNumAffected': 47}, {'id': 'EG001', 'title': '8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 115, 'seriousNumAtRisk': 120, 'deathsNumAffected': 76, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 72, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 77, 'numAffected': 39}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 44, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 18, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 78, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 62, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 31, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 33, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 27, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 78, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 65, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 52, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 95, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 41, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 51, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 44, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 35, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 49, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 85, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 82, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 22, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 27, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 43, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 15, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 25, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 91, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 60, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 33, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 35, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 41, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 58, 'numAffected': 32}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 18, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 20, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 34, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 16, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 38, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 22, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 30, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 29, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 46, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 19, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 43, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 36, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 28, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 44, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 46, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 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'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) in Ramucirumab 12mg/kg Arm I4T-MC-JVCZ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.42', 'groupId': 'OG000', 'lowerLimit': '4.40', 'upperLimit': '6.01'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.617', 'ciLowerLimit': '0.447', 'ciUpperLimit': '0.853', 'estimateComment': 'Unstratified cox proportional hazards model comparing Ramucirumab I4T-MC-JVCZ and I4T-IE-JVBE (NCT01170663)', 'groupDescription': 'This analysis were comparison of PFS for participants treated with ramucirumab 12 mg/kg plus paclitaxel in Study I4T-MC-JVCZ versus placebo plus paclitaxel in I4T-IE-JVBE (NCT01170663) using meta-analysis.\n\nPlacebo + 80 mg/m² Paclitaxel in I4T-IE-JVBE Number of participants: 335, Median (95% CI), months: 2.86 (2.79 to 3.02)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to Objective Progressive Disease or Death (Up To 21 Months)', 'description': 'PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment (AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in arm 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel. Number of participants censored: Ramucirumab 12 mg/kg + 80 mg/m² Paclitaxel= 25. All randomized participants (including the censored participants) were included in the analyses.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) Ramucirumab 12mg/kg Arm and 8mg/kg Arm in I4T-MC-JVCZ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.'}, {'id': 'OG001', 'title': '8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.42', 'groupId': 'OG000', 'lowerLimit': '4.40', 'upperLimit': '6.01'}, {'value': '5.16', 'groupId': 'OG001', 'lowerLimit': '3.81', 'upperLimit': '5.65'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.963', 'ciLowerLimit': '0.727', 'ciUpperLimit': '1.274', 'estimateComment': 'Unstratified cox proportional hazards model.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to Objective Progressive Disease or Death (Up To 21 Months)', 'description': 'PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment(AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Number of participants censored: Ramucirumab 12 mg/kg + Paclitaxel 80 mg/m2= 25 and 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel =23. All randomized participants (including the censored participants) were included in the analyses.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.'}, {'id': 'OG001', 'title': '8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.'}], 'classes': [{'title': 'Cycle 1 Day 15 (Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.2', 'spread': '43', 'groupId': 'OG000'}, {'value': '21.4', 'spread': '58', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1 (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.6', 'spread': '40', 'groupId': 'OG000'}, {'value': '37.1', 'spread': '50', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 15 (Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.7', 'spread': '42', 'groupId': 'OG000'}, {'value': '43.5', 'spread': '53', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1(Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.2', 'spread': '40', 'groupId': 'OG000'}, {'value': '51.5', 'spread': '55', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 15 (Week 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.0', 'spread': '44', 'groupId': 'OG000'}, {'value': '52.9', 'spread': '56', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1 (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '101', 'spread': '55', 'groupId': 'OG000'}, {'value': '56.1', 'spread': '56', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle(C) 1 Day(D) 1: Prior to Infusion(PTI),1 to 1.5 hours(hrs) after end of Infusion(EOI); C1 D15: 3 days PTI; C2 D1: 3 days PTI; C2 D15: 3 days PTI,1 to 1.5 hrs after EOI; C3 D1 and 15: 3 days PTI; C4 D1: 3 days PTI and 1 to 1.5 hrs after EOI', 'description': 'Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination with Paclitaxel', 'unitOfMeasure': 'Microgram per milliliter (µg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.'}, {'id': 'OG001', 'title': '8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000'}, {'value': '25.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Objective Progressive Disease (Up To 21 Months)', 'description': 'ORR was defined as the percentage of participants who achieved a PR or CR per RECIST v.1.1.CR is the disappearance of all target lesions.Any pathological lymph nodes(whether target or non-target)must have reduction in short axis to\\<10mm.Tumor marker results must have normalized.PR is at least a 30% decrease in the sum of diameter of target lesions,taking as reference the baseline sum diameters.ORR is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) [Disease Control Rate (DCR)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.'}, {'id': 'OG001', 'title': '8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000'}, {'value': '75.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Objective Progressive Disease (Up To 21 Months)', 'description': 'DCR is defined as the percentage of participants who achieved CR, PR, or SD per RECIST v.1.1. CR is the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \\<10 mm.Tumor marker results must have normalized. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression. Non-Target PD is unequivocal progression of existing nontarget lesions. DCR=CR+PR+SD/total number of participants\\*100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Ramucirumab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.'}, {'id': 'OG001', 'title': '8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 Predose through Follow-up (Up To 24 Months)', 'description': 'Participants who had anti-ramucirumab antibodies at postbaseline.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and were evaluable for ramucirumab anti-drug antibody.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '12mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '12 milligram per kilogram (mg/kg) ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 milligram per square meter (mg/m²) paclitaxel administered IV on day 1, day 8 and day 15.'}, {'id': 'FG001', 'title': '8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant Never Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Completers are defined as participants who died or had progressive disease (PD) or completed treatment or did not complete treatment and were followed for survival data. Final study data will be provided after study completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '12mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.'}, {'id': 'BG001', 'title': '8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.6', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '57.9', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '58.3', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Greece', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-05-07', 'size': 1040408, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-10T16:29', 'hasProtocol': True}, {'date': '2017-11-15', 'size': 644378, 'label': 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'studyFirstPostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) in Ramucirumab 12mg/kg Arm I4T-MC-JVCZ', 'timeFrame': 'Randomization to Objective Progressive Disease or Death (Up To 21 Months)', 'description': 'PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment (AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS) Ramucirumab 12mg/kg Arm and 8mg/kg Arm in I4T-MC-JVCZ', 'timeFrame': 'Randomization to Objective Progressive Disease or Death (Up To 21 Months)', 'description': 'PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment(AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.'}, {'measure': 'Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel', 'timeFrame': 'Cycle(C) 1 Day(D) 1: Prior to Infusion(PTI),1 to 1.5 hours(hrs) after end of Infusion(EOI); C1 D15: 3 days PTI; C2 D1: 3 days PTI; C2 D15: 3 days PTI,1 to 1.5 hrs after EOI; C3 D1 and 15: 3 days PTI; C4 D1: 3 days PTI and 1 to 1.5 hrs after EOI', 'description': 'Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination with Paclitaxel'}, {'measure': 'Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])', 'timeFrame': 'Baseline to Objective Progressive Disease (Up To 21 Months)', 'description': 'ORR was defined as the percentage of participants who achieved a PR or CR per RECIST v.1.1.CR is the disappearance of all target lesions.Any pathological lymph nodes(whether target or non-target)must have reduction in short axis to\\<10mm.Tumor marker results must have normalized.PR is at least a 30% decrease in the sum of diameter of target lesions,taking as reference the baseline sum diameters.ORR is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.'}, {'measure': 'Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) [Disease Control Rate (DCR)]', 'timeFrame': 'Baseline to Objective Progressive Disease (Up To 21 Months)', 'description': 'DCR is defined as the percentage of participants who achieved CR, PR, or SD per RECIST v.1.1. CR is the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \\<10 mm.Tumor marker results must have normalized. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression. Non-Target PD is unequivocal progression of existing nontarget lesions. DCR=CR+PR+SD/total number of participants\\*100.'}, {'measure': 'Number of Participants With Anti-Ramucirumab Antibodies', 'timeFrame': 'Cycle 1 Predose through Follow-up (Up To 24 Months)', 'description': 'Participants who had anti-ramucirumab antibodies at postbaseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stomach cancer'], 'conditions': ['Gastric Adenocarcinoma', 'Gastroesophageal Junction Adenocarcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrialguide.com/EN-us/studies/cancer/jvcz', 'label': 'Click here for more information about this study: A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the efficacy of an alternative dose of ramucirumab in combination with paclitaxel in participants with second-line metastatic or locally advanced, unresectable gastric or gastroesophageal junction adenocarcinoma (GEJ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The participant has a diagnosis of gastric or GEJ adenocarcinoma.\n* The participant has disease progression during or within 4 months after last dose of first-line chemotherapy or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy.\n* The participant received combination chemotherapy, which must include a platinum and/or a fluoropyrimidine and must not include a taxane or antiangiogenic agent.\n* The disease is evaluable by imaging per Response Evaluation Criteria in Solid Tumors 1.1.\n* The participant has an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* The participant has adequate organ function:\n\n * Total bilirubin ≤1.5 × the upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN. If the liver has tumor involvement, AST and ALT \\<5 × ULN.\n * Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥50 milliliters/minute.\n * Urinary protein is \\<2+.\n * Absolute neutrophil count ≥1.5 × 10\\^9/liter (L), platelets ≥100 × 10\\^9/L, and hemoglobin ≥9 grams/deciliter (5.58 millimoles/L).\n * International normalized ratio ≤1.5 × ULN and partial thromboplastin time ≤5 seconds above ULN.\n* The participant has an estimated life expectancy of minimum 12 weeks.\n* The participant has resolution to Grade 1 or less by Common Terminology Criteria for Adverse Events Version 4.0, of all clinically significant toxic effects of previous therapy.\n* The participant, if male, is sterile or agrees to use a reliable method of birth control.\n* The participant, if female, is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control.\n* The participant, if female and of child-bearing potential, must have a negative pregnancy test.\n\nExclusion Criteria:\n\n* The participant is receiving therapy with any of the following:\n\n * Nonsteroidal anti-inflammatory agents.\n * Other anti-platelet agents; Aspirin use at doses up to 325 milligrams (mg)/day is permitted.\n* The participant received radiotherapy within 14 days prior to randomization.\n* The participant received previous chemotherapy with a cumulative dose of \\>900 mg per meter squared (mg/m\\^2) of epirubicin or \\>400 mg/m\\^2 of doxorubicin.\n* The participant has documented brain metastases or leptomeningeal disease.\n* The participant has a significant bleeding disorder or vasculitis.\n* The participant experienced any arterial thromboembolic event within 6 months.\n* The participant has symptomatic congestive heart failure or symptomatic cardiac arrhythmia.\n* The participant has uncontrolled hypertension, despite antihypertensive intervention.\n* The participant underwent major surgery within 28 days.\n* The participant has a history of gastrointestinal perforation or fistula within 6 months.\n* The participant has a history of inflammatory bowel disease or Crohn's disease requiring medical intervention within 12 months.\n* The participant has bowel obstruction or history of chronic diarrhea that is considered clinically significant.\n* The participant has either of the following:\n\n * Child-pugh B or C cirrhosis.\n* The participant has a serious illness or medical condition including:\n\n * Human immunodeficiency virus infection.\n* The participant has a concurrent active malignancy other than the following:\n\n * Nonmelanomatous skin cancer.\n * In situ carcinoma of the cervix or other noninvasive carcinoma or in situ neoplasm.\n* The participant has a serious nonhealing: (a) wound, (b) peptic ulcer, or (c) bone fracture.\n* The participant experienced any Grade 3 or 4 venous thromboembolic event that is not adequately treated."}, 'identificationModule': {'nctId': 'NCT02514551', 'briefTitle': 'A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Randomized Phase 2 Trial Evaluating Alternative Ramucirumab Doses in Combination With Paclitaxel in Second-Line Metastatic or Locally Advanced, Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma', 'orgStudyIdInfo': {'id': '15541'}, 'secondaryIdInfos': [{'id': 'I4T-MC-JVCZ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2014-005067-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '12mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '12 milligram per kilogram (mg/kg) ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 milligram per square meter (mg/m²) paclitaxel administered IV on day 1, day 8 and day 15.', 'interventionNames': ['Drug: Ramucirumab', 'Drug: Paclitaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': '8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel', 'description': '8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.', 'interventionNames': ['Drug: Ramucirumab', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'Ramucirumab', 'type': 'DRUG', 'otherNames': ['LY3009806', 'IMC-1121B', 'Cyramza'], 'description': 'Administered IV', 'armGroupLabels': ['12mg/kg Ramucirumab + 80 mg/m² Paclitaxel', '8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['12mg/kg Ramucirumab + 80 mg/m² Paclitaxel', '8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010-0269', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Scott & White Memorial Hospital & Clinic', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '98502', 'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'facility': 'Vista Oncology Inc. PS', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', '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': 50.85045, 'lon': 4.34878}}, {'zip': '8500', 'city': 'Kortrijk', 'country': 'Belgium', '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': 50.82803, 'lon': 3.26487}}, {'zip': '5000', 'city': 'Namur', 'country': 'Belgium', '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': 50.4669, 'lon': 4.86746}}, {'zip': 'T2N 4N2', 'city': 'Calgary', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'L1G 2B9', 'city': 'Oshawa', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': '656 53', 'city': 'Brno', 'country': 'Czechia', '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': 49.19522, 'lon': 16.60796}}, {'zip': '741 01', 'city': 'Nový Jičín', 'country': 'Czechia', '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': 49.59438, 'lon': 18.01028}}, {'zip': '140 59', 'city': 'Prague', 'country': 'Czechia', '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': 50.08804, 'lon': 14.42076}}, {'zip': '150 06', 'city': 'Prague', 'country': 'Czechia', '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': 50.08804, 'lon': 14.42076}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', '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': 52.52437, 'lon': 13.41053}}, {'zip': '60488', 'city': 'Frankfurt am Main', 'country': 'Germany', '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': 50.11552, 'lon': 8.68417}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', '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': 53.55073, 'lon': 9.99302}}, {'zip': '88212', 'city': 'Ravensburg', 'country': 'Germany', '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': 47.78198, 'lon': 9.61062}}, {'zip': '18537', 'city': 'Athens', 'country': 'Greece', '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': 37.98376, 'lon': 23.72784}}, {'zip': '12462', 'city': 'Haidari', 'country': 'Greece', '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.'}, {'zip': '71110', 'city': 'Heraklion', 'country': 'Greece', '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': 35.32787, 'lon': 25.14341}}, {'zip': '56403', 'city': 'N. Efkarpia', 'country': 'Greece', '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.'}, {'zip': '26504', 'city': 'Pátrai', 'country': 'Greece', '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': 38.2462, 'lon': 21.73508}}, {'zip': '09042', 'city': 'Cagliari', 'country': 'Italy', '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': 39.23054, 'lon': 9.11917}}, {'zip': '26100', 'city': 'Cremona', 'country': 'Italy', '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': 45.13325, 'lon': 10.02129}}, {'zip': '48018', 'city': 'Faenza', 'country': 'Italy', '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': 44.29007, 'lon': 11.87948}}, {'zip': '20089', 'city': 'Milan', 'country': 'Italy', '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': 42.78235, 'lon': 12.59836}}, {'zip': '42100', 'city': 'Reggio Emilia', 'country': 'Italy', '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': 44.69825, 'lon': 10.63125}}, {'zip': '71013', 'city': 'San Giovanni Rotondo', 'country': 'Italy', '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': 41.70643, 'lon': 15.7277}}, {'zip': '08208', 'city': 'Barcelona', 'country': 'Spain', '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': 41.38879, 'lon': 2.15899}}, {'zip': '17007', 'city': 'Barcelona', 'country': 'Spain', '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': 41.38879, 'lon': 2.15899}}, {'zip': '17007', 'city': 'Girona', 'country': 'Spain', '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': 41.98311, 'lon': 2.82493}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', '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': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', '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': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', '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': 36.72016, 'lon': -4.42034}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', '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': 43.46589, 'lon': -3.80493}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', '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': 37.38283, 'lon': -5.97317}}, {'zip': '46014', 'city': 'Valencia', 'country': 'Spain', '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': 39.47391, 'lon': -0.37966}}, {'zip': '413 56', 'city': 'Gothenburg', 'country': 'Sweden', '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': 57.70716, 'lon': 11.96679}}, {'zip': '58185', 'city': 'Linköping', 'country': 'Sweden', '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': 58.41086, 'lon': 15.62157}}, {'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', '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': 39.91987, 'lon': 32.85427}}, {'zip': '22770', 'city': 'Edirne', 'country': 'Turkey (Türkiye)', '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': 41.67719, 'lon': 26.55597}}, {'zip': '34098', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', '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': 41.01384, 'lon': 28.94966}}, {'zip': '38039', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', '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': 38.73222, 'lon': 35.48528}}, {'zip': '44280', 'city': 'Malatya', 'country': 'Turkey (Türkiye)', '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': 38.35018, 'lon': 38.31667}}, {'zip': '49102', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', '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': 48.46664, 'lon': 35.04066}}, {'zip': '04107', 'city': 'Kyiv', 'country': 'Ukraine', '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': 50.45466, 'lon': 30.5238}}, {'zip': '63000', 'city': 'Lutsk', 'country': 'Ukraine', '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': 50.75784, 'lon': 25.35024}}, {'zip': '40005', 'city': 'Sumy', 'country': 'Ukraine', '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': 50.91741, 'lon': 34.79906}}, {'zip': '21029', 'city': 'Vinnitsa', 'country': 'Ukraine', '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': 49.84639, 'lon': 37.71861}}], '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'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}