Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-02-07 @ 12:54 AM
Study NCT ID:
NCT02141295
Status:
TERMINATED
Last Update Posted:
2020-03-25
First Post:
2014-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing the Efficacy and Safety of Vanucizumab and FOLFOX With Bevacizumab and FOLFOX in Participants With Untreated Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'C000619444', 'term': 'vanucizumab'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '1-800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).', 'description': 'n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Safety Run-In', 'description': '8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.", 'otherNumAtRisk': 93, 'deathsNumAtRisk': 93, 'otherNumAffected': 91, 'seriousNumAtRisk': 93, 'deathsNumAffected': 24, 'seriousNumAffected': 46}, {'id': 'EG002', 'title': 'Bevacizumab + mFOLFOX-6', 'description': "In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.", 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 94, 'seriousNumAtRisk': 95, 'deathsNumAffected': 27, 'seriousNumAffected': 41}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 19, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 52, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 63, 'numAffected': 43}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 33, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 36, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 52, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 107, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 133, 'numAffected': 57}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 93, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 98, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 25, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 40, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 46, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 89, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 129, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 33, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 28, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 42, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 68, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 24, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Temperature intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 16, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 25, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 45, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 67, 'numAffected': 33}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pain in extremitiy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 32, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 79, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 30, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 31, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 66, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 24, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 83, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 72, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 17, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 36, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 23, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Embolism venous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 75, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 50, 'numAffected': 27}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myocardial Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Enterovesical fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastrointestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Enterococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Splenic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastrointestinal anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Infected neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tumor obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Guillain-Barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Female genital tract fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aortic thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vasospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oesophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Obstructive nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS), Time to Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}, {'id': 'OG001', 'title': 'Bevacizumab + mFOLFOX-6', 'description': "In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}], 'classes': [{'categories': [{'measurements': [{'value': '338.0', 'groupId': 'OG000', 'lowerLimit': '312.0', 'upperLimit': '381.0'}, {'value': '309.0', 'groupId': 'OG001', 'lowerLimit': '284.0', 'upperLimit': '352.0'}]}]}], 'analyses': [{'pValue': '= 0.6753', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.39', 'pValueComment': 'log-rank', 'groupDescription': 'Kaplan-Meier methods were used to estimate median PFS for each treatment arm and the 95% CIs for median PFS were computed using the Brookmeyer and Crowley method. The stratified Cox proportional hazard was used to estimate the hazard ratio (i.e., the magnitude of the treatment effect) and the corresponding 95% confidence interval. The stratification factors are number of metastatic sites (1 vs. \\>1) and country/region (USA vs rest of the world).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, every 8 weeks, up to approximately 29 months', 'description': 'Efficacy of vanucizumab was evaluated in terms of PFS as Investigator-Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). PFS was defined as the time between randomization and the date of first documented disease progression or death from any cause on study, whichever occurred first. Death on study was defined as death from any cause within 30 days of the last study treatment.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was based on the ITT population, which consisted of all participants who were randomized (Part II only) and received any amount of the study treatment (5 FU/folinic acid, oxaliplatin, bevacizumab, or vanucizumab) in the bevacizumab + mFOLFOX-6 and vanucizumab + mFOLFOX-6 arms. Participants in the safety-run in were not included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response (ORR) as Assessed Using RECIST v. 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Run-In', 'description': '8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.'}, {'id': 'OG001', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}, {'id': 'OG002', 'title': 'Bevacizumab + mFOLFOX-6', 'description': "In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}], 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '34.3', 'upperLimit': '90.6'}, {'value': '43.6', 'groupId': 'OG001', 'lowerLimit': '33.59', 'upperLimit': '53.64'}, {'value': '51.6', 'groupId': 'OG002', 'lowerLimit': '41.53', 'upperLimit': '61.63'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (within 28 days prior to Day 1), then every 8 weeks until progressive disease (PD), start of other anticancer therapy, withdrawal of consent, or death (up to approximately 29 months)', 'description': 'Efficacy of vanucizumab was evaluated in terms of Percentage of Participants With ORR as Investigator-Assessed Using RECIST v. 1.1. Best Overall Confirmed Response.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Objective Response, as Assessed Using RECIST v. 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}, {'id': 'OG001', 'title': 'Bevacizumab + mFOLFOX-6', 'description': "In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}], 'classes': [{'categories': [{'measurements': [{'value': '342', 'groupId': 'OG000', 'lowerLimit': '274', 'upperLimit': '510'}, {'value': '304', 'groupId': 'OG001', 'lowerLimit': '220', 'upperLimit': '366'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (within 28 days prior to Day 1), then every 8 weeks until PD, start of other anticancer therapy, withdrawal of consent, or death (up to approximately 29 months)', 'description': 'Efficacy of vanucizumab was evaluated in terms of duration of objective response as assessed using RECIST v. 1.1. This was computed using the PFS definition with death on study (deaths that occurred outside the 30 days window from the last study treatment are excluded).', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was based on the ITT population, which consisted of all participants in the bevacizumab + mFOLFOX-6 and vanucizumab + mFOLFOX-6 arms. Participants in the safety-run in were not included.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}, {'id': 'OG001', 'title': 'Bevacizumab + mFOLFOX-6', 'description': "In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}], 'classes': [{'categories': [{'measurements': [{'value': '746.0', 'comment': 'Value is not estimable due to an insufficient number of participants with the event prior to study termination.', 'groupId': 'OG000', 'lowerLimit': '687.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Value is not estimable due to an insufficient number of participants with the event prior to study termination.', 'groupId': 'OG001', 'lowerLimit': '723.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '= 0.5740', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.49', 'ciUpperLimit': '1.49', 'groupDescription': 'Kaplan-Meier methods were used to estimate median OS for each treatment arm and the 95% CIs for median OS were computed using the Brookmeyer and Crowley method. The stratified Cox proportional hazard was used to estimate the hazard ratio (i.e., the magnitude of the treatment effect) and the corresponding 95% confidence interval. The stratification factors are number of metastatic sites (1 vs. \\>1) and country/region (USA vs rest of the world).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until death from any cause (maximum up to approximately 3.5 years)', 'description': 'Efficacy of vanucizumab was evaluated in terms of OS as the time from randomization until death from any cause. 99999 = data not estimable due to the low number of deaths.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was based on the ITT population, which consisted of all participants in the bevacizumab + mFOLFOX-6 and vanucizumab + mFOLFOX-6 arms. Participants in the safety-run in were not included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Run-In', 'description': '8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.'}, {'id': 'OG001', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}, {'id': 'OG002', 'title': 'Bevacizumab + mFOLFOX-6', 'description': "In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}], 'classes': [{'title': 'Serious Adverse events', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '49.5', 'groupId': 'OG001'}, {'value': '43.2', 'groupId': 'OG002'}]}]}, {'title': 'Adverse events', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 29 months', 'description': 'Safety is evaluated in terms of percentage of participants with at least one serious adverse event and percentage of participants with at least one adverse event.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Human Anti-human Antibodies (HAHAs) Against Vanucizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Run-In', 'description': '8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.'}, {'id': 'OG001', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of study (EoS, within 28 to 42 days after last dose, latest at 29 months)', 'description': 'Safety is evaluated in terms of number of participants with Human Anti-human Antibodies (HAHAs) Against Vanucizumab.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Endpoint includes only arms in which the participants received vanucizumab. n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-Time Curve (AUC) of Vanucizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Run-In', 'description': '8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.'}, {'id': 'OG001', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73600', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '63500', 'spread': '27.2', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '112000', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '82100', 'spread': '31.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycles 1 and 8 of parts 1 and 2', 'description': 'PK profile of vanucizumab was evaluated in terms of AUC', 'unitOfMeasure': 'hr*ug/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint was only reported for arms in which the participants received vanucizumab.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Vanucizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Run-In', 'description': '8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.'}, {'id': 'OG001', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '463', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '500', 'spread': '26.3', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '685', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '794', 'spread': '38.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycles 1 and 8 of parts 1 and 2', 'description': 'PK profile of vanucizumab was evaluated in terms of Cmax', 'unitOfMeasure': 'ug/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint was only reported for arms in which the participants received vanucizumab.'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Plasma Concentration (Clast) of Vanucizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '103', 'spread': '67.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '361', 'spread': '39.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycles 1 and 8 of parts 1 and 2', 'description': 'PK profile of vanucizumab was evaluated in terms of Clast', 'unitOfMeasure': 'ug/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were collected and analyzed for the reported arms only.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Cmax (Tmax) of Vanucizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Run-In', 'description': '8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.'}, {'id': 'OG001', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.79', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '7.67'}, {'value': '2.05', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '26.1'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.04', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '5.25'}, {'value': '1.58', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '4.77'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycles 1 and 8 of parts 1 and 2', 'description': 'PK profile of vanucizumab was evaluated in terms of Tmax', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint was only reported for arms in which the participants received vanucizumab.'}, {'type': 'SECONDARY', 'title': 'Plasma Terminal Half-Life (t1/2) of Vanucizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Run-In', 'description': '8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.'}, {'id': 'OG001', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}], 'classes': [{'categories': [{'measurements': [{'value': '202', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '157', 'spread': '30.3', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 8', 'description': 'PK profile of vanucizumab was evaluated in terms of t1/2, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint was only reported for arms in which the participants received vanucizumab.'}, {'type': 'SECONDARY', 'title': 'Plasma Clearance at Steady State (CLss) of Vanucizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Run-In', 'description': '8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.'}, {'id': 'OG001', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}], 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'spread': '26.7', 'groupId': 'OG000'}, {'value': '18.0', 'spread': '29.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 8', 'description': 'PK profile of vanucizumab was evaluated in terms of CLss, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.', 'unitOfMeasure': 'ml/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint was only reported for arms in which the participants received vanucizumab.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution at Steady State (Vss) of Vanucizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Run-In', 'description': '8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.'}, {'id': 'OG001', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}], 'classes': [{'categories': [{'measurements': [{'value': '4400', 'spread': '25.1', 'groupId': 'OG000'}, {'value': '4140', 'spread': '29.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 8', 'description': 'PK profile of vanucizumab was evaluated in terms of Vss, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.', 'unitOfMeasure': 'ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint was only reported for arms in which the participants received vanucizumab.'}, {'type': 'SECONDARY', 'title': 'Cmax Accumulation Ratio (AR) of Vanucizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Run-In', 'description': '8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.'}, {'id': 'OG001', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}], 'classes': [{'categories': [{'measurements': [{'value': '1.51', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '1.63', 'spread': '36.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 8', 'description': 'PK profile of vanucizumab was evaluated in terms of Cmax Ratio, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint was only reported for arms in which the participants received vanucizumab.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Safety Run-In', 'description': '8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.'}, {'id': 'FG001', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}, {'id': 'FG002', 'title': 'Bevacizumab + mFOLFOX-6', 'description': "In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '95'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'Reason not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'Participants with previously untreated metastatic colorectal cancer (mCRC) as defined by RECIST v1.1 were enrolled globally from 7 countries.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '197', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Safety Run-In', 'description': '8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.'}, {'id': 'BG001', 'title': 'Vanucizumab + mFOLFOX-6', 'description': "In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}, {'id': 'BG002', 'title': 'Bevacizumab + mFOLFOX-6', 'description': "In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.3', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '62.7', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '62.3', 'spread': '10.6', 'groupId': 'BG002'}, {'value': '62.5', 'spread': '0.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Adults (18-64 years)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}]}, {'title': 'From 65-84 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-10', 'size': 1709223, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-06T12:16', 'hasProtocol': True}, {'date': '2016-09-09', 'size': 377342, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-01-06T12:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'dispFirstSubmitDate': '2018-01-08', 'completionDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-11', 'studyFirstSubmitDate': '2014-05-15', 'dispFirstSubmitQcDate': '2018-01-08', 'resultsFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2014-05-15', 'dispFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-11', 'studyFirstPostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS), Time to Event', 'timeFrame': 'Baseline, every 8 weeks, up to approximately 29 months', 'description': 'Efficacy of vanucizumab was evaluated in terms of PFS as Investigator-Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). PFS was defined as the time between randomization and the date of first documented disease progression or death from any cause on study, whichever occurred first. Death on study was defined as death from any cause within 30 days of the last study treatment.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Objective Response (ORR) as Assessed Using RECIST v. 1.1', 'timeFrame': 'Baseline (within 28 days prior to Day 1), then every 8 weeks until progressive disease (PD), start of other anticancer therapy, withdrawal of consent, or death (up to approximately 29 months)', 'description': 'Efficacy of vanucizumab was evaluated in terms of Percentage of Participants With ORR as Investigator-Assessed Using RECIST v. 1.1. Best Overall Confirmed Response.'}, {'measure': 'Duration of Objective Response, as Assessed Using RECIST v. 1.1', 'timeFrame': 'Baseline (within 28 days prior to Day 1), then every 8 weeks until PD, start of other anticancer therapy, withdrawal of consent, or death (up to approximately 29 months)', 'description': 'Efficacy of vanucizumab was evaluated in terms of duration of objective response as assessed using RECIST v. 1.1. This was computed using the PFS definition with death on study (deaths that occurred outside the 30 days window from the last study treatment are excluded).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline until death from any cause (maximum up to approximately 3.5 years)', 'description': 'Efficacy of vanucizumab was evaluated in terms of OS as the time from randomization until death from any cause. 99999 = data not estimable due to the low number of deaths.'}, {'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to approximately 29 months', 'description': 'Safety is evaluated in terms of percentage of participants with at least one serious adverse event and percentage of participants with at least one adverse event.'}, {'measure': 'Number of Participants With Human Anti-human Antibodies (HAHAs) Against Vanucizumab', 'timeFrame': 'End of study (EoS, within 28 to 42 days after last dose, latest at 29 months)', 'description': 'Safety is evaluated in terms of number of participants with Human Anti-human Antibodies (HAHAs) Against Vanucizumab.'}, {'measure': 'Area Under the Plasma Concentration-Time Curve (AUC) of Vanucizumab', 'timeFrame': 'Cycles 1 and 8 of parts 1 and 2', 'description': 'PK profile of vanucizumab was evaluated in terms of AUC'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Vanucizumab', 'timeFrame': 'Cycles 1 and 8 of parts 1 and 2', 'description': 'PK profile of vanucizumab was evaluated in terms of Cmax'}, {'measure': 'Minimum Observed Plasma Concentration (Clast) of Vanucizumab', 'timeFrame': 'Cycles 1 and 8 of parts 1 and 2', 'description': 'PK profile of vanucizumab was evaluated in terms of Clast'}, {'measure': 'Time to Reach Cmax (Tmax) of Vanucizumab', 'timeFrame': 'Cycles 1 and 8 of parts 1 and 2', 'description': 'PK profile of vanucizumab was evaluated in terms of Tmax'}, {'measure': 'Plasma Terminal Half-Life (t1/2) of Vanucizumab', 'timeFrame': 'Cycle 8', 'description': 'PK profile of vanucizumab was evaluated in terms of t1/2, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.'}, {'measure': 'Plasma Clearance at Steady State (CLss) of Vanucizumab', 'timeFrame': 'Cycle 8', 'description': 'PK profile of vanucizumab was evaluated in terms of CLss, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.'}, {'measure': 'Volume of Distribution at Steady State (Vss) of Vanucizumab', 'timeFrame': 'Cycle 8', 'description': 'PK profile of vanucizumab was evaluated in terms of Vss, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.'}, {'measure': 'Cmax Accumulation Ratio (AR) of Vanucizumab', 'timeFrame': 'Cycle 8', 'description': 'PK profile of vanucizumab was evaluated in terms of Cmax Ratio, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2 multicenter, randomized, parallel arms, double-blind study of vanucizumab to evaluate the efficacy and safety of vanucizumab in combination with oxaliplatin, folinic acid, and 5-fluorouracil (5-FU) (mFOLFOX-6) versus bevacizumab (Avastin) + mFOLFOX-6 in participants with previously untreated metastatic colorectal cancer (mCRC). The study consists of 2 parts: a safety run-in open-label, single-arm part (Part 1) and a randomized, parallel-arms, double-blind part (Part 2). During Part 1 at least 6 eligible participants will receive 2000 milligrams (mg) vanucizumab every 2 weeks + mFOLFOX-6 in order to confirm the dose and schedule that will be used in Part 2. In Part 2, all eligible participants will be randomized in a ratio of 1:1 to receive either mFOLFOX-6 + vanucizumab or mFOLFOX-6 + bevacizumab. Study treatment (induction and maintenance) will be given on Day 1 of each 14-day cycle. Induction therapy will consist of up to 8 cycles of mFOLFOX-6 plus either bevacizumab or vanucizumab. Maintenance therapy will consist of 5-fluorouracil and folinic acid plus either vanucizumab or bevacizumab for up to 24 months or until disease progression, unacceptable toxicity, Investigator decision or consent withdrawal, whichever occurs first.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed mCRC not amenable to potentially curative resection with at least one measurable metastatic lesion, as defined by RECIST v1.1\n* Eastern Cooperative Oncology Group (World Health Organization) performance status of 0 or 1\n* Adequate hematologic, liver, coagulation, renal, and cardiovascular function\n* Recovery from all reversible AEs of previous medical therapies to baseline or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 1, except for alopecia (any grade)\n* Negative serum pregnancy test within 7 days prior to starting study treatment in premenopausal women and women less than (\\< 2) years after the onset of menopause\n\nExclusion Criteria:\n\n* Any prior systemic therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, immunotherapy, hormonal therapy) before Day 1 of Cycle 1 for treatment of mCRC\n* Malignancies other than CRC within 5 years prior to randomization, except for those with a minimal risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ treated surgically with curative intent\n* Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior to Day 1 of Cycle 1, except palliative radiotherapy to bone lesions within 7 days prior to Day 1 of Cycle 1\n* Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to Day 1 of Cycle\n* Pregnant or lactating women\n* Symptomatic central nervous system (CNS) metastases or carcinomatous meningitis. Asymptomatic patients must be clinically stable with regard to their CNS/ meningeal metastatic involvement, have completed previous therapy (including radiation and/ or surgery) at least 4 weeks prior to study drug administration, are not receiving steroid therapy or taper, and are not receiving anti-convulsive medication for any CNS involvement\n* Active infection requiring IV antibiotics\n* Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs (NSAIDs), inhaled corticosteroids, or the equivalent of less than or equal to (\\</=) 10 mg/day prednisone\n* Sensory peripheral neuropathy greater than or equal to (\\>/=) Grade 2\n* Significant cardiovascular or cerebrovascular disease within 6 months prior to Day 1 of Cycle 1\n* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation\n* Current use of anticoagulants at therapeutic doses within 7 days prior to study drug administration. Prophylactic use of unfractioned heparin or low molecular weight heparin is permitted\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to Day 1 of Cycle 1\n* History of intra-abdominal inflammatory process within 6 months prior to Day 1 of Cycle 1 including but not limited to peptic ulcer disease, diverticulitis, or colitis\n* Colonic prosthesis (stent) implant in place\n* History of abdominal or tracheo-oesophageal fistula or gastrointestinal (GI) perforation or intra abdominal abscess within 6 months prior to Day 1 of Cycle 1\n* History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or a requirement for routine parenteral hydration, parenteral nutrition, or tube feeding within 6 months prior to Day 1 of Cycle 1\n* Chronic daily treatment with NSAID (occasional use for the symptomatic relief of medical conditions, for example headache or fever is allowed)\n* Chronic daily treatment with corticosteroids (dose \\> 10 mg/day methylprednisolone equivalent) excluding inhaled steroids\n* Evidence of abdominal free air not explained by paracentesis or recent surgical procedure\n* Metastatic disease that involve major airways or blood vessels, or centrally located mediastinal tumor masses (\\< 30 millimeter from the carina) of large volume\n* History of bronchopulmonary hemorrhage NCI CTCAE \\>/= Grade 2 within 2 months prior to randomization\n* Severe, nonhealing or open wound, active ulcer, or untreated bone fracture\n* Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5-FU toxicity\n* Any other condition, diseases, metabolic dysfunction, active or uncontrolled infections/inflammation, physical examination finding, mental status or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates participation in the clinical study due to safety concerns, compliance with clinical study procedures or that may affect the interpretation of the results'}, 'identificationModule': {'nctId': 'NCT02141295', 'acronym': 'McCAVE', 'briefTitle': 'A Study Comparing the Efficacy and Safety of Vanucizumab and FOLFOX With Bevacizumab and FOLFOX in Participants With Untreated Metastatic Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase II, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of RO5520985 (Vanucizumab) Plus FOLFOX Versus Bevacizumab Plus FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'BP29262'}, 'secondaryIdInfos': [{'id': '2013-005108-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 (Induction): Vanucizumab + mFOLFOX-6', 'description': 'Participants will receive vanucizumab at a dose of 2000 milligram (mg) as intravenous (IV) infusion; oxaliplatin at a dose of 85 mg per meter-squared (mg/m\\^2) as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months).', 'interventionNames': ['Drug: 5-FU', 'Drug: Folinic acid', 'Drug: Oxaliplatin', 'Drug: Vanucizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 (Maintenance): Vanucizumab + 5-FU + Folinic acid', 'description': "Participants will receive vanucizumab at a dose confirmed during induction as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.", 'interventionNames': ['Drug: 5-FU', 'Drug: Folinic acid', 'Drug: Vanucizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2 (Induction): Bevacizumab + mFOLFOX-6', 'description': 'Participants will receive bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months).', 'interventionNames': ['Drug: 5-FU', 'Drug: Bevacizumab', 'Drug: Folinic acid', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 (Induction): Vanucizumab + mFOLFOX-6', 'description': 'Participants will receive vanucizumab at a dose confirmed during part 1 as IV infusion; oxaliplatin at a dose of 85 mg/m\\^2 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months).', 'interventionNames': ['Drug: 5-FU', 'Drug: Folinic acid', 'Drug: Oxaliplatin', 'Drug: Vanucizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2 (Maintenance): Bevacizumab + 5-FU + Folinic acid', 'description': "Participants will receive bevacizumab at a dose of 5 mg/kg as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.", 'interventionNames': ['Drug: 5-FU', 'Drug: Bevacizumab', 'Drug: Folinic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 (Maintenance): Vanucizumab + 5-FU + Folinic acid', 'description': "Participants will receive vanucizumab at a dose confirmed during part 1 as IV infusion; folinic acid at a dose of 400 mg/m\\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\\^2 as starting IV bolus followed by 2400 mg/m\\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.", 'interventionNames': ['Drug: 5-FU', 'Drug: Folinic acid', 'Drug: Vanucizumab']}], 'interventions': [{'name': '5-FU', 'type': 'DRUG', 'description': '5-FU will be administered according to dose and schedule described in respective arm.', 'armGroupLabels': ['Part 1 (Induction): Vanucizumab + mFOLFOX-6', 'Part 1 (Maintenance): Vanucizumab + 5-FU + Folinic acid', 'Part 2 (Induction): Bevacizumab + mFOLFOX-6', 'Part 2 (Induction): Vanucizumab + mFOLFOX-6', 'Part 2 (Maintenance): Bevacizumab + 5-FU + Folinic acid', 'Part 2 (Maintenance): Vanucizumab + 5-FU + Folinic acid']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Bevacizumab will be administered according to dose and schedule described in respective arm.', 'armGroupLabels': ['Part 2 (Induction): Bevacizumab + mFOLFOX-6', 'Part 2 (Maintenance): Bevacizumab + 5-FU + Folinic acid']}, {'name': 'Folinic acid', 'type': 'DRUG', 'description': 'Folinic acid will be administered according to dose and schedule described in respective arm.', 'armGroupLabels': ['Part 1 (Induction): Vanucizumab + mFOLFOX-6', 'Part 1 (Maintenance): Vanucizumab + 5-FU + Folinic acid', 'Part 2 (Induction): Bevacizumab + mFOLFOX-6', 'Part 2 (Induction): Vanucizumab + mFOLFOX-6', 'Part 2 (Maintenance): Bevacizumab + 5-FU + Folinic acid', 'Part 2 (Maintenance): Vanucizumab + 5-FU + Folinic acid']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Oxaliplatin will be administered according to dose and schedule described in respective arm.', 'armGroupLabels': ['Part 1 (Induction): Vanucizumab + mFOLFOX-6', 'Part 2 (Induction): Bevacizumab + mFOLFOX-6', 'Part 2 (Induction): Vanucizumab + mFOLFOX-6']}, {'name': 'Vanucizumab', 'type': 'DRUG', 'otherNames': ['RO5520985'], 'description': 'Vanucizumab will be administered according to dose and schedule described in respective arm.', 'armGroupLabels': ['Part 1 (Induction): Vanucizumab + mFOLFOX-6', 'Part 1 (Maintenance): Vanucizumab + 5-FU + Folinic acid', 'Part 2 (Induction): Vanucizumab + mFOLFOX-6', 'Part 2 (Maintenance): Vanucizumab + 5-FU + Folinic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Oncology', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Clinical Research Ctr', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92008', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'California Cancer Associates for Research & Excellence, Inc.', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Fresno cCare', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92093-5354', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91343', 'city': 'Sepulveda', 'state': 'California', 'country': 'United States', 'facility': 'Va Greater Los Angeles Healthcare System', 'geoPoint': {'lat': 34.16167, 'lon': -118.28285}}, {'zip': '33916', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'SCRI Florida Cancer Specialists South', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Ocala Oncology Center', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Oncology Hematology Care Inc', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Inst.', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Ctr for Cancer and Blood Disorders', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Therapy & Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84403', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'Northern Utah Associates', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'zip': '2298', 'city': 'Waratah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Calvary Mater Newcastle', 'geoPoint': {'lat': -32.90667, 'lon': 151.72647}}, {'zip': '5011', 'city': 'Woodville', 'state': 'South Australia', 'country': 'Australia', 'facility': 'The Queen Elizabeth Hospital', 'geoPoint': {'lat': -34.877, 'lon': 138.54291}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Medical Centre-Moorabbin Campus', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Salzburger Landeskliniken LKH', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '4400', 'city': 'Steyr', 'country': 'Austria', 'facility': 'Oö. Gesundheits- und Spitals-AG/LKH Steyr', 'geoPoint': {'lat': 48.04274, 'lon': 14.42127}}, {'zip': '2820', 'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Imeldaziekenhuis', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '49055', 'city': 'Angers', 'country': 'France', 'facility': 'Centre Paul Papin', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '44115', 'city': 'Saint-Herblain', 'country': 'France', 'facility': "Institut De Cancerologie De L'Ouest; Medical Oncology", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Hospital Universitario Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '14004', 'city': 'Córdoba', 'state': 'Cordoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofia; Servicio de Oncologia', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar; Servicio de Oncologia', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Univ Vall d'Hebron; Servicio de Oncologia", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08908', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Institut Catala d Oncologia Hospital Duran i Reynals', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañon; Servicio de Oncologia', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Clínico San Carlos; Servicio de Oncologia', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'HM Sanchinarro - CIOCC; Servicio de Oncologia', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary; Medical Oncology Dept', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Guys and St Thomas NHS Foundation Trust, Guys Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'ME16 9QQ', 'city': 'Maidstone', 'country': 'United Kingdom', 'facility': 'Maidstone Hospital', 'geoPoint': {'lat': 51.26667, 'lon': 0.51667}}, {'zip': 'RM7 0AG', 'city': 'Romford', 'country': 'United Kingdom', 'facility': "Queen's Hospital; Oncology", 'geoPoint': {'lat': 51.57515, 'lon': 0.18582}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'country': 'United Kingdom', 'facility': 'The Royal Marsden Hospital', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}