Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-31 @ 4:48 AM
Study NCT ID:
NCT01111604
Status:
COMPLETED
Last Update Posted:
2019-08-06
First Post:
2010-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Ramucirumab or Icrucumab in Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000096662', 'term': 'Ramucirumab'}, {'id': 'C000626257', 'term': 'Icrucumab'}, {'id': 'C548516', 'term': 'IMC-18F1'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Compnay'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'All randomized participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'mFOLFOX-6', 'description': 'mFOLFOX-6\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks\n\nFA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 48, 'seriousNumAtRisk': 49, 'deathsNumAffected': 37, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab\n\nRamucirumab : 8 mg/kg I.V. infusion, administered every 2 weeks\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks\n\nFA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 52, 'seriousNumAtRisk': 52, 'deathsNumAffected': 41, 'seriousNumAffected': 18}, {'id': 'EG002', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab\n\nIcrucumab: 15 mg/kg I.V. infusion, administered every 2 weeks\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks\n\nFA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 52, 'seriousNumAtRisk': 52, 'deathsNumAffected': 40, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 19, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 33, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 37, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 39, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 19, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 35, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 37, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 21, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 37, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 21, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 27, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 32, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 53, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 54, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 68, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 61, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 42, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 82, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 30, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 30, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 19, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 31, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 21, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 58, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 86, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 91, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 106, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 19, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 13, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 28, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 54, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Temperature intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 76, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 33, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 66, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 14, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 50, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 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12.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bile duct stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutropenic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Medication error', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Stent occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], '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': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'mFOLFOX-6', 'description': 'mFOLFOX-6: Oxaliplatin: 85 per meter squared (mg/m²) IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'OG001', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab\n\nRamucirumab: 8 mg/kg IV infusion Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'OG002', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab\n\nIcrucumab: 15 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV infusion Q2W\n\nFA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000', 'lowerLimit': '15.7', 'upperLimit': '24.4'}, {'value': '21.4', 'groupId': 'OG001', 'lowerLimit': '16.1', 'upperLimit': '25.0'}, {'value': '15.9', 'groupId': 'OG002', 'lowerLimit': '14.1', 'upperLimit': '16.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until Disease Progression or Death from Any Cause (Up to 95 Weeks)', 'description': 'PFS is defined as the time from baseline until the date of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever was first. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress, are lost to follow-up, or have missed two or more scheduled tumor assessments will be censored at the day of their last radiographic tumor assessment, if there are no post-baseline tumor measurements for a randomized and treated participant, the participant will be censored at the date of randomization. If death or progressive disease (PD) occurs after 2 or more missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the last visit.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treatment (mITT) population includes all the randomized participants who received at least one dose study drug. In mFOLFOX-6, mFOLFOX-6+Ramucirumab and mFOLFOX-6 + Icrucumab, there were 13, 9 and 11 censored participants, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'mFOLFOX-6', 'description': 'mFOLFOX-6\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'OG001', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab\n\nRamucirumab: 8 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'OG002', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab\n\nIcrucumab: 15 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion Q2W'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '5.94', 'upperLimit': '27.24'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '0.47', 'upperLimit': '13.21'}, {'value': '3.8', 'groupId': 'OG002', 'lowerLimit': '0.47', 'upperLimit': '13.21'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until Disease Progression (Up to 95 Weeks)', 'description': 'The ORR is the percentage of participants with Complete Response (CR, the disappearance of target lesions and any pathological lymph nodes \\[target or non-target\\] taking as reference the baseline sum of diameters in response to treatment) or Partial Response (PR, at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters in response to treatment) according to RECIST v1.1 from the start of the treatment until disease progression.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all the randomized participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'mFOLFOX-6', 'description': 'mFOLFOX-6\n\nmFOLFOX-6: Oxaliplatin: 85 per meter squared (mg/m²) IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'OG001', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab Ramucirumab: 8 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'OG002', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab\n\nIcrucumab: 15 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}], 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000', 'lowerLimit': '36.1', 'upperLimit': '68.4'}, {'value': '41.7', 'groupId': 'OG001', 'lowerLimit': '28.4', 'upperLimit': '60.3'}, {'value': '42.0', 'groupId': 'OG002', 'lowerLimit': '32.0', 'upperLimit': '50.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline Until Death from Any Cause (Up to 163 Weeks)', 'description': 'Overall survival is defined as the time from baseline to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all the randomized participants who received at least one dose of study drug. In mFOLFOX-6, mFOLFOX-6 + Ramucirumab, and mFOLFOX-6 + Icrucumab there were 12, 11, and 12 censored participants, respectively.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'mFOLFOX-6', 'description': 'mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W(or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV infusion Q2W'}, {'id': 'OG001', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab\n\nIMC-1121B: 8 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'OG002', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab\n\nIMC-18F1: 15 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}], 'classes': [{'categories': [{'measurements': [{'value': '35.6', 'comment': 'NA= data not evaluable by Kaplan-Meier method due to sample size of participants', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'N of 2 participants were censored therefore no evaluable data was collected.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'N of 1 participant was censored therefore only individual data is presented, 8.1 weeks.', 'groupId': 'OG002', 'lowerLimit': '8.1', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Criteria First Met for CR or PR until Disease Progression or Death from Any Cause (Up to 95 Weeks)', 'description': 'DoR was measured from the time measurement criteria are first met for Complete Response or Partial Response or until the first date that the criteria for disease progression or death from any cause. whichever is first recorded. As defined according to RECIST v1.1, CR is the disappearance of all non-nodal target lesions, and PR is the short axes of any target lymph nodes reduced to \\< 10 mm and at least a 30% decrease in the sum of the diameters of target lesions including the short axes of any target lymph nodes.)', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all the randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline DoR data. 2 participants were censored in mFOLFOX-6 arm, 2 in mFOLFOX-6 + Ramucirumab arm and 1 in mFOLFOX-6 + Icrucumab.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab\n\nIMC-1121B: 8 mg/kg IV Q2W mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'OG001', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab\n\nIMC-18F1: 15 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and Coefficient of Variation were not calculated because number of participants was \\<3.\n\nValues equal 12.900/54.5000 (min/max)', 'groupId': 'OG000'}, {'value': '201', 'spread': '88', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 5, 1 Hour Post End of Infusion', 'description': 'Maximum concentration (1 hour post end of infusion, Cmax) is the concentration measured in serum.', 'unitOfMeasure': 'microgram/milliliter (µg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants assigned to the mFOLFOX-6 + Ramucirumab or mFOLFOX-6 + Icrucumab who received at least one dose of study drug and had evaluable ramucirumab or icrucumab PK data to calculate Cmax.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Trough Serum Concentrations (Ctrough) at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab\n\nRamucirumab: 8 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'OG001', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab\n\nIcrucumab: 15 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}], 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'spread': '123', 'groupId': 'OG000'}, {'value': '146', 'spread': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 5, Prior to Infusion', 'description': 'Trough (prior to infusion, Ctrough) concentrations measured in serum.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants assigned to the mFOLFOX-6 + Ramucirumab or mFOLFOX-6 + Icrucumab who received at least one dose of study drug and had evaluable Ramucirumab or Icrucumab PK data to calculate Ctrough.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab\n\nRamucirumab: 8 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'OG001', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab\n\nIcrucumab: 15 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}], 'timeFrame': 'Day 8 (cycles 1 and 5)', 'description': 'Maximum concentration (Cmax) is the maximum peak concentration measured in blood plasma after drug infusion.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. Outcome Measure (OM) entered incorrectly and no data collected to report.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab\n\nRamucirumab: 8 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'OG001', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab\n\nIcrucumab: 15 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}], 'timeFrame': 'Day 15 (Cycles 1 and 5)', 'description': 'Cmax is the maximum peak concentration measured in blood plasma after drug infusion.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. OM entered incorrectly and no data collected to report.'}, {'type': 'SECONDARY', 'title': 'Minimum Concentration (Cmin) at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab\n\nRamucirumab: 8 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'OG001', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab\n\nIcrucumab: 15 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}], 'timeFrame': 'Day 1 (cycles 1, 5, 9, and 13)', 'description': 'Cmin is the minimum peak concentration measured in blood plasma after drug infusion.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. OM entered incorrectly and no data collected to report.'}, {'type': 'SECONDARY', 'title': 'Minimum Concentration (Cmin) at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab\n\nRamucirumab: 8 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'OG001', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab\n\nIcrucumab: 15 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}], 'timeFrame': 'Day 4 (cycles 1 and 5)', 'description': 'Cmin is the minimum peak concentration measured in blood plasma after drug infusion.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. OM entered incorrectly and no data collected to report.'}, {'type': 'SECONDARY', 'title': 'Minimum Concentration (Cmin) at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab\n\nRamucirumab: 8 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'OG001', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab\n\nIcrucumab: 15 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}], 'timeFrame': 'Day 8 (cycles 1 and 5)', 'description': 'Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. OM entered incorrectly and no data collected to report.'}, {'type': 'SECONDARY', 'title': 'Minimum Concentration (Cmin) at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab\n\nRamucirumab: 8 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'OG001', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab\n\nIcrucumab: 15 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}], 'timeFrame': 'Day 15 (cycles 1 and 5)', 'description': 'Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. OM entered incorrectly and no data collected to report.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serum Ramucirumab Antibody Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab\n\nRamucirumab: 8 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '31 Weeks', 'description': 'A sample will be considered positive for anti-Ramucirumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-Ramucirumab antibody level seen in healthy untreated individuals.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in mFOLFOX-6 +Ramucirumab who received at least one dose of study drug and had at least 1 post treatment assessment.'}, {'type': 'SECONDARY', 'title': 'Serum Anti-Icrucumab Antibody Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab\n\nIcrucumab: 15 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion Q2W'}], 'timeFrame': '31 Weeks', 'description': 'A sample will be considered positive for anti-icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-icrucumab antibody level seen in healthy untreated individuals.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. No data collected to report.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'mFOLFOX-6', 'description': 'mFOLFOX-6\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks\n\nFA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks'}, {'id': 'OG001', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab\n\nIMC-1121B: 8 mg/kg I.V. infusion, administered every 2 weeks\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks\n\nFA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks'}, {'id': 'OG002', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab Icrucumab: 15 mg/kg I.V. infusion, administered every 2 weeks mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Any Grade ≥3 AE', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Any AE leading to discontinuation (any drug)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 165 weeks', 'description': 'A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes all the randomized participants who received at least one dose study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'mFOLFOX-6', 'description': 'mFOLFOX-6: Oxaliplatin: 85 milligram/meter squared, intravenous (mg/m², IV) infusion every 2 weeks (Q2W)\n\nFolinic acid (FA): 400 mg/m² IV infusion Q2W (or Levo-folinic acid \\[LFA\\]: 200 mg/m² Q2 weeks if FA is unavailable).\n\nFluorouracil (5FU): 400 mg/m² bolus + 2400 mg/m² IV infusion Q2W'}, {'id': 'FG001', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab\n\nRamucirumab: 8 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2 weeks if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV infusion Q2W'}, {'id': 'FG002', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab\n\nIcrucumab: 15 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m2 Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Met Exclusion Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Completers were defined as participants who had failure event (progressive disease, death), or were off treatment and censored due to study completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'mFOLFOX-6', 'description': 'mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'BG001', 'title': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab\n\nRamucirumab: 8 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'BG002', 'title': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab\n\nIcrucumab: 15 mg/kg IV Q2W\n\nmFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m2 Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.8', 'spread': '9.23', 'groupId': 'BG000'}, {'value': '59.9', 'spread': '10.95', 'groupId': 'BG001'}, {'value': '58.2', 'spread': '10.15', 'groupId': 'BG002'}, {'value': '59.6', 'spread': '10.14', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'dispFirstSubmitDate': '2010-08-30', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-15', 'studyFirstSubmitDate': '2010-04-08', 'dispFirstSubmitQcDate': '2010-08-30', 'resultsFirstSubmitDate': '2019-06-13', 'studyFirstSubmitQcDate': '2010-04-26', 'dispFirstPostDateStruct': {'date': '2010-09-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-15', 'studyFirstPostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Baseline until Disease Progression or Death from Any Cause (Up to 95 Weeks)', 'description': 'PFS is defined as the time from baseline until the date of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever was first. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress, are lost to follow-up, or have missed two or more scheduled tumor assessments will be censored at the day of their last radiographic tumor assessment, if there are no post-baseline tumor measurements for a randomized and treated participant, the participant will be censored at the date of randomization. If death or progressive disease (PD) occurs after 2 or more missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the last visit.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])', 'timeFrame': 'Baseline until Disease Progression (Up to 95 Weeks)', 'description': 'The ORR is the percentage of participants with Complete Response (CR, the disappearance of target lesions and any pathological lymph nodes \\[target or non-target\\] taking as reference the baseline sum of diameters in response to treatment) or Partial Response (PR, at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters in response to treatment) according to RECIST v1.1 from the start of the treatment until disease progression.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline Until Death from Any Cause (Up to 163 Weeks)', 'description': 'Overall survival is defined as the time from baseline to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive.'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Criteria First Met for CR or PR until Disease Progression or Death from Any Cause (Up to 95 Weeks)', 'description': 'DoR was measured from the time measurement criteria are first met for Complete Response or Partial Response or until the first date that the criteria for disease progression or death from any cause. whichever is first recorded. As defined according to RECIST v1.1, CR is the disappearance of all non-nodal target lesions, and PR is the short axes of any target lymph nodes reduced to \\< 10 mm and at least a 30% decrease in the sum of the diameters of target lesions including the short axes of any target lymph nodes.)'}, {'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) at Cycle 5', 'timeFrame': 'Cycle 5, 1 Hour Post End of Infusion', 'description': 'Maximum concentration (1 hour post end of infusion, Cmax) is the concentration measured in serum.'}, {'measure': 'Pharmacokinetics (PK): Trough Serum Concentrations (Ctrough) at Cycle 5', 'timeFrame': 'Cycle 5, Prior to Infusion', 'description': 'Trough (prior to infusion, Ctrough) concentrations measured in serum.'}, {'measure': 'Maximum Concentration (Cmax) at Day 8', 'timeFrame': 'Day 8 (cycles 1 and 5)', 'description': 'Maximum concentration (Cmax) is the maximum peak concentration measured in blood plasma after drug infusion.'}, {'measure': 'Maximum Concentration (Cmax) at Day 15', 'timeFrame': 'Day 15 (Cycles 1 and 5)', 'description': 'Cmax is the maximum peak concentration measured in blood plasma after drug infusion.'}, {'measure': 'Minimum Concentration (Cmin) at Day 1', 'timeFrame': 'Day 1 (cycles 1, 5, 9, and 13)', 'description': 'Cmin is the minimum peak concentration measured in blood plasma after drug infusion.'}, {'measure': 'Minimum Concentration (Cmin) at Day 4', 'timeFrame': 'Day 4 (cycles 1 and 5)', 'description': 'Cmin is the minimum peak concentration measured in blood plasma after drug infusion.'}, {'measure': 'Minimum Concentration (Cmin) at Day 8', 'timeFrame': 'Day 8 (cycles 1 and 5)', 'description': 'Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.'}, {'measure': 'Minimum Concentration (Cmin) at Day 15', 'timeFrame': 'Day 15 (cycles 1 and 5)', 'description': 'Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.'}, {'measure': 'Number of Participants With Serum Ramucirumab Antibody Assessment', 'timeFrame': '31 Weeks', 'description': 'A sample will be considered positive for anti-Ramucirumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-Ramucirumab antibody level seen in healthy untreated individuals.'}, {'measure': 'Serum Anti-Icrucumab Antibody Assessment', 'timeFrame': '31 Weeks', 'description': 'A sample will be considered positive for anti-icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-icrucumab antibody level seen in healthy untreated individuals.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Baseline up to 165 weeks', 'description': 'A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colonic Neoplasms', 'Rectal Neoplasms', 'Adenocarcinoma', 'Antibodies, Monoclonal'], 'conditions': ['Colon Cancer', 'Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '27733377', 'type': 'DERIVED', 'citation': 'Moore M, Gill S, Asmis T, Berry S, Burkes R, Zbuk K, Alcindor T, Jeyakumar A, Chan T, Rao S, Spratlin J, Tang PA, Rothenstein J, Chan E, Bendell J, Kudrik F, Kauh J, Tang S, Gao L, Kambhampati SR, Nasroulah F, Yang L, Ramdas N, Binder P, Strevel E. Randomized phase II study of modified FOLFOX-6 in combination with ramucirumab or icrucumab as second-line therapy in patients with metastatic colorectal cancer after disease progression on first-line irinotecan-based therapy. Ann Oncol. 2016 Dec;27(12):2216-2224. doi: 10.1093/annonc/mdw412. Epub 2016 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.', 'detailedDescription': 'The purpose of this study is to evaluate the progression-free survival (PFS) in participants with metastatic colorectal cancer when treated with 1 of 3 modified FOLFOX-6 (folinic acid \\[FA\\] + fluorouracil \\[5-FU\\] + oxaliplatin \\[mFOLFOX-6\\])-based regimens, as second-line therapy.\n\nDuring 2010, there has been an identified shortage of injectable folinic acid (FA) in the United States. Levo-folinic acid (LFA) will be allowed as a substitute for FA in the mFOLFOX-6 chemotherapy regimen in circumstances in which FA is not available, to facilitate continuity of participant care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Disease progression on an irinotecan-based first-line chemotherapy regimen (ie FOLFIRI or CAPIRI \\[capecitabine + irinotecan\\], with or without bevacizumab)\n* Age ≥ 18 years\n* Life expectancy of ≥ 6 months\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 at study entry\n* Agrees to adequate contraception during the study period and for 12 weeks after the last dose of study medication\n* Provided signed informed consent\n\nExclusion Criteria:\n\n* Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable or metastatic Colorectal Cancer (CRC) (Prior oxaliplatin-based adjuvant chemotherapy is allowed if the last dose of oxaliplatin was administered \\> 12 months prior to randomization)\n* Has documented and/or symptomatic brain or leptomeningeal metastases\n* Has an ongoing or active infection, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders\n* On chronic non-topical corticosteroid treatment. A participant discontinuing such treatment \\> 3 months prior to randomization is eligible\n* Has uncontrolled or poorly controlled hypertension on a standard regimen of antihypertensive therapy\n* Has a concurrent active malignancy. A participant with previous history of malignancy is eligible, provided that he/she has been disease free for \\> 3 years\n* If female, is pregnant (confirmed by serum beta human chorionic gonadotropin \\[βHCG\\] test) or lactating\n* Has received a prior autologous or allogeneic organ or tissue transplantation\n* Has undergone major surgery within 28 days prior to randomization\n* Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization\n* Has an elective or planned major surgery to be performed during the course of the trial\n* Has a history of inflammatory bowel disease requiring pharmacological and/or surgical intervention in the 12 months prior to randomization'}, 'identificationModule': {'nctId': 'NCT01111604', 'briefTitle': 'A Study of Ramucirumab or Icrucumab in Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of 5 FU/FA and Oxaliplatin (Modified FOLFOX 6) in Combination With Ramucirumab or IMC-18F1 or Without Investigational Therapy as Second Line Therapy in Patients With Metastatic Colorectal Cancer Following Disease Progression on First Line Irinotecan-based Therapy', 'orgStudyIdInfo': {'id': '13942'}, 'secondaryIdInfos': [{'id': 'CP20-0801', 'type': 'OTHER', 'domain': 'ImClone Systems'}, {'id': 'I4Y-IE-JCDB', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'mFOLFOX-6', 'description': 'mFOLFOX-6', 'interventionNames': ['Drug: mFOLFOX-6']}, {'type': 'EXPERIMENTAL', 'label': 'mFOLFOX-6 + Ramucirumab', 'description': 'mFOLFOX-6 + Ramucirumab', 'interventionNames': ['Biological: Ramucirumab', 'Drug: mFOLFOX-6']}, {'type': 'EXPERIMENTAL', 'label': 'mFOLFOX-6 + Icrucumab', 'description': 'mFOLFOX-6 + Icrucumab', 'interventionNames': ['Biological: Icrucumab', 'Drug: mFOLFOX-6']}], 'interventions': [{'name': 'Ramucirumab', 'type': 'BIOLOGICAL', 'otherNames': ['IMC-1121B', 'LY3009806'], 'description': '8 mg/kg IV Q2W', 'armGroupLabels': ['mFOLFOX-6 + Ramucirumab']}, {'name': 'Icrucumab', 'type': 'BIOLOGICAL', 'otherNames': ['IMC-18F1', 'LY3012212'], 'description': '15 mg/kg IV Q2W', 'armGroupLabels': ['mFOLFOX-6 + Icrucumab']}, {'name': 'mFOLFOX-6', 'type': 'DRUG', 'description': 'Oxaliplatin: 85 milligram per square meter (mg/m²) IV every 2 weeks (Q2W)\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W', 'armGroupLabels': ['mFOLFOX-6', 'mFOLFOX-6 + Icrucumab', 'mFOLFOX-6 + Ramucirumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '29210', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V1Y 5L3', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V3V 1Z2', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L5M 2N1', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L1G 2B9', 'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N8W 2X3', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'H2W 156', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], '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'}}}}