Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT01478594
Status:
COMPLETED
Last Update Posted:
2015-07-08
First Post:
2011-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Combining mFOLFOX6 With Tivozanib or Bevacizumab in Patients With Metastatic Colorectal Cancer as First Line Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C553176', 'term': 'tivozanib'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical@aveooncology.com', 'phone': '1.617.588.1960', 'title': 'Medical Director', 'organization': 'AVEO'}, 'certainAgreement': {'otherDetails': "Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data or after 18 months after database lock, whichever comes first. Sponsor must receive a site's manuscript at least 30 days prior to publication for review and comment. Sponsor may delay the publication for up to 60 days to seek patent protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose through 30 days after last dose of either tivozanib or bevacizumab, until the data cut-off date of 28 February 2014. The median duration of treatment was 168.0 days in the tivozanib arm and 162.0 days in the bevacizumab arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Tivozanib + mFOLFOX6', 'description': 'Participants received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6) chemotherapy every 2 weeks on Days 1 and 15 of each cycle.', 'otherNumAtRisk': 177, 'otherNumAffected': 175, 'seriousNumAtRisk': 177, 'seriousNumAffected': 82}, {'id': 'EG001', 'title': 'Bevacizumab + mFOLFOX6', 'description': 'Participants received a dose of 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.', 'otherNumAtRisk': 87, 'otherNumAffected': 85, 'seriousNumAtRisk': 87, 'seriousNumAffected': 42}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 49}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 47}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Temperature intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 36}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 25}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 15}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'Eye 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Thrombotic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Intracardiac thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Reversible posterior leukoencephalopathy syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Monoparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bile duct stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hepatic haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Mobility decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Angiomyolipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Duodenal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Wound necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anorectal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chemotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vaginal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Investigator-assessed Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib + mFOLFOX6', 'description': 'Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Bevacizumab + mFOLFOX6', 'description': 'Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '10.1'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '12.8'}]}]}], 'analyses': [{'pValue': '0.706', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.091', 'ciLowerLimit': '0.693', 'ciUpperLimit': '1.718', 'estimateComment': 'HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \\< 1 indicates a reduction in the HR in favor of tivozanib.', 'groupDescription': "An interim futility analysis was to be performed when approximately 83 PFS events (50% of the total PFS events) were observed. The Lans DeMets beta spending function with an O'Brien-Fleming boundary was used to derive the futility boundary. If the hazard ratio (HR) for PFS was greater than 1.0581, enrollment was to be stopped. With this futility stopping rule, the adjusted study power was 78.6%.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratification factors were LDH status (\\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The time from the date of randomization until objective tumor progression or death due to any cause. Objective tumor progression was determined through radiological imaging and based on the requirements of the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1):\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions.\n\nParticipants who did not progress or had not died at the time of the analysis were censored at the date of last tumor assessment where non-progression was documented.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) Based on Independent Radiological Review (IRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib + mFOLFOX6', 'description': 'Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Bevacizumab + mFOLFOX6', 'description': 'Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'timeFrame': '3 years', 'description': 'The time from the date of randomization until the date of radiological disease progression assessed by the IRR or until death due to any cause, even in the absence of radiological progression.', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was not performed due to study closure.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib + mFOLFOX6', 'description': 'Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Bevacizumab + mFOLFOX6', 'description': 'Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Could not be estimated due to the low number of events at the time of the interim analysis', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Could not be estimated due to the low number of events at the time of the interim analysis', 'groupId': 'OG001', 'lowerLimit': '12.8', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.754', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.116', 'ciLowerLimit': '0.561', 'ciUpperLimit': '2.218', 'estimateComment': 'HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \\< 1 indicates a reduction in the HR in favor of tivozanib.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratification factors were LDH status (\\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'Overall survival (OS) is defined as the time from the date of randomization until the documented date of death. Participants still alive at the time of analysis were censored on the last day the participant was known to be alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib + mFOLFOX6', 'description': 'Participants received 1.5 m tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Bevacizumab + mFOLFOX6', 'description': 'Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000'}, {'value': '43.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.718', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratification factors were LDH status (\\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'Objective response rate is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) confirmed a minimum of four weeks apart based on RECIST 1.1 criteria.\n\nCR: Disappearance of all target and non-target lesions and no new lesions.\n\nPR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and no progression of non-target lesions and no new lesions, or, disappearance of all target lesions and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib + mFOLFOX6', 'description': 'Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Bevacizumab + mFOLFOX6', 'description': 'Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '11.3'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '10.7'}]}]}], 'analyses': [{'pValue': '0.437', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.389', 'ciLowerLimit': '0.604', 'ciUpperLimit': '3.194', 'estimateComment': 'HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \\< 1 indicates a reduction in the HR in favor of tivozanib.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratification factors were LDH status (\\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'Duration of response (DoR) is defined as the time from the date of the first documented response of CR or PR (whichever is first recorded) to documented progression or death. If a participant did not progress or had not died at the time of analysis, the duration of response was censored at the date of last tumor assessment. Duration of response is only defined for participants whose best overall response was CR or PR.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a best overall response of complete response (CR) or partial response (PR).'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure (TTF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib + mFOLFOX6', 'description': 'Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Bevacizumab + mFOLFOX6', 'description': 'Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '7.1'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '6.7'}]}]}], 'analyses': [{'pValue': '0.967', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.006', 'ciLowerLimit': '0.746', 'ciUpperLimit': '1.358', 'estimateComment': 'HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \\< 1 indicates a reduction in the HR in favor of tivozanib.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratification factors were LDH status (\\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'Time to Treatment Failure (TTF) is defined as the time from randomization to last dose date of tivozanib/bevacizumab. If a participant discontinued treatment for any reason, the participant was considered as an event. Participants remaining on treatment at the time of analysis were censored at date of last dose.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life (HRQoL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib + mFOLFOX6', 'description': 'Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Bevacizumab + mFOLFOX6', 'description': 'Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'timeFrame': '3 years', 'description': 'Time to deterioration in HRQoL measured by Colorectal cancer (CRC) subscale of the Functional Assessment of cancer Therapy Colorectal (FACT-C) scale, change in score from baseline using the European Quality of Life - 5 Dimensions (EQ-5D) and Fact Colorectal Symptom Index (FCSI) were not evaluated due to study closure.', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was not performed due to study closure.'}, {'type': 'SECONDARY', 'title': 'Safety as Assessed by Physical Examination, Vital Signs, Laboratory Assessments, 12-lead Electrocardiogram (ECGs), and Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib + mFOLFOX6', 'description': 'Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Bevacizumab + mFOLFOX6', 'description': 'Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'CTCAE Grade 3 or higher', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Any tivozanib/bevacizumab-related adverse event', 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Any mFOLFOX6-related adverse event', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}, {'title': 'Any tivozanib/bevacizumab and mFOLFOX6-related AE', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Any tivozanib/bevacizumab-related AE ≥ Grade 3', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Any mFOLFOX6-related AE ≥ Grade 3', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Any tiv/bev and mFOLFOX6-related AE ≥ Grade 3', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Any AE with an outcome of death', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any tivozanib/bevacizumab-related AE of death', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any mFOLFOX6-related AE outcome of death', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any tiv/bev & mFOLFOX6-related AE outcome of death', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any serious adverse event (SAE)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Any tivozanib/bevacizumab-related SAE', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Any mFOLFOX6-related SAE', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Any tivozanib/bevacizumab and mFOLFOX6-related SAE', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'AE leading to tiv/bev discontinuation', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'AE leading to tivozanib/bevacizumab interruption', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose through 30 days after last dose of either tivozanib or bevacizumab, until the data cut-off date of 28 February 2014. The median duration of treatment was 168.0 days in the tivozanib (tiv) arm and 162.0 days in the bevacizumab (bev) arm.', 'description': "An abnormality identified during a medical test is defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study medication or was clinically significant in the investigator's opinion.\n\nAn AE was serious if it resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required or prolonged inpatient hospitalization or other medically important event.\n\nAEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute Common Terminology Criteria for Grading Adverse Events (NCI-CTCAE) Version 4.03 per the following: 1=mild; 2= moderate; 3= severe; 4= life threatening; 5=death.\n\nTreatment-related AEs were defined as events where the relationship to study drug was marked as probably or possibly, or was missing.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consisted of all randomized participants who received at least one dose of study drug (tivozanib or bevacizumab), analyzed according to the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival Events by Lactate Dehydrogenase (LDH) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib: LDH < 1.5 ULN', 'description': 'Participants with LDH status \\< 1.5 ULN received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Tivozanib: LDH ≥ 1.5 ULN', 'description': 'Participants with LDH status ≥ 1.5 ULN received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG002', 'title': 'Bevacizumab: LDH < 1.5 ULN', 'description': 'Participants with LDH status \\< 1.5 ULN received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab : LDH ≥ 1.5 ULN', 'description': 'Participants with LDH status ≥ 1.5 ULN received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.331', 'ciLowerLimit': '0.746', 'ciUpperLimit': '2.375', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.575', 'ciLowerLimit': '0.285', 'ciUpperLimit': '1.160', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum lactate dehydrogenase status.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival Events by Serum Vascular Endothelial Growth Factor-A (VEGF-A) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib: VEGF-A < Median', 'description': 'Participants with VEGF-A levels \\< median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Tivozanib: VEGF-A ≥ Median', 'description': 'Participants with VEGF-A levels ≥ median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG002', 'title': 'Bevacizumab: VEGF-A < Median', 'description': 'Participants with VEGF-A levels \\< median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab: VEGF-A ≥ Median', 'description': 'Participants with VEGF-A levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.608', 'ciLowerLimit': '0.635', 'ciUpperLimit': '4.073', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.755', 'ciLowerLimit': '0.375', 'ciUpperLimit': '1.521', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum vascular endothelial growth factor-A (VEGF-A) level. VEGF-A protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available serum protein samples'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival Events by Serum Vascular Endothelial Growth Factor-C (VEGF-C) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib: VEGF-C < Median', 'description': 'Participants with VEGF-C levels \\< median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Tivozanib: VEGF-C ≥ Median', 'description': 'Participants with VEGF-C levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG002', 'title': 'Bevacizumab: VEGF-C < Median', 'description': 'Participants with VEGF-C levels \\< median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab: VEGF-C ≥ Median', 'description': 'Participants with VEGF-C levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.877', 'ciLowerLimit': '0.366', 'ciUpperLimit': '2.100', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.275', 'ciLowerLimit': '0.614', 'ciUpperLimit': '2.646', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum VEGF-C level. VEGF-C protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available serum protein samples'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival Events by Serum VEGF-C / VEGF-A Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib: VEGF-C/VEGF-A < Median', 'description': 'Participants with VEGF-C/VEGF-A ratio \\< median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Tivozanib: VEGF-C/VEGF-A ≥ Median', 'description': 'Participants with VEGF-C/VEGF-A ratio ≥ median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG002', 'title': 'Bevacizumab: VEGF-C/VEGF-A < Median', 'description': 'Participants with VEGF-C/VEGF-A ratio \\< median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab: VEGF-C/VEGF-A ≥ Median', 'description': 'Participants with VEGF-C/VEGF-A ratio ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.721', 'ciLowerLimit': '0.345', 'ciUpperLimit': '1.507', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.597', 'ciLowerLimit': '0.672', 'ciUpperLimit': '3.795', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum VEGF-C/VEGF-A ratio. VEGF-A and VEGF-C protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the ratio is expressed relative to the observed median.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available serum protein samples'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival Events by Soluble Vascular Endothelial Growth Factor Receptor-2 (sVEGFR-2) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib: sVEGFR-2 < Median', 'description': 'Participants with sVEGFR-2 levels \\< median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Tivozanib: sVEGFR-2 ≥ Median', 'description': 'Participants with sVEGFR-2 levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG002', 'title': 'Bevacizumab: sVEGFR-2 < Median', 'description': 'Participants with sVEGFR-2 levels \\< median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab: sVEGFR-2 ≥ Median', 'description': 'Participants with sVEGFR-2 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.627', 'ciLowerLimit': '0.580', 'ciUpperLimit': '4.564', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.779', 'ciLowerLimit': '0.397', 'ciUpperLimit': '1.531', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum sVEGFR-2 level. sVEGFR-2 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available serum protein samples'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival Events by Soluble Vascular Endothelial Growth Factor Receptor-3 (sVEGFR-3) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib: sVEGFR-3 < Median', 'description': 'Participants with sVEGFR-3 levels \\< median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Tivozanib: sVEGFR-3 ≥ Median', 'description': 'Participants with sVEGFR-3 levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG002', 'title': 'Bevacizumab: sVEGFR-3 < Median', 'description': 'Participants with sVEGFR-3 levels \\< median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab: sVEGFR-3 ≥ Median', 'description': 'Participants with sVEGFR-3 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.946', 'ciLowerLimit': '0.636', 'ciUpperLimit': '5.956', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.806', 'ciLowerLimit': '0.422', 'ciUpperLimit': '1.538', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum sVEGFR-3 level. sVEGFR-3 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available serum protein samples'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival Events by Serum Interleukin-8 (IL-8) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib: IL-8 < Median', 'description': 'Participants with IL-8 levels \\< median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Tivozanib: IL-8 ≥ Median', 'description': 'Participants with IL-8 levels ≥ median received 1.5 m tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG002', 'title': 'Bevacizumab: IL-8 < Median', 'description': 'Participants with IL-8 levels \\< median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab: IL-8 ≥ Median', 'description': 'Participants with IL-8 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.776', 'ciLowerLimit': '0.303', 'ciUpperLimit': '1.991', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.241', 'ciLowerLimit': '0.615', 'ciUpperLimit': '2.501', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum interleukin-8 level. IL-8 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available serum protein samples'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival Events by Serum Neuropilin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib: Neuropilin < Median', 'description': 'Participants with neuropilin levels \\< median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Tivozanib: Neuropilin ≥ Median', 'description': 'Participants with neuropilin levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG002', 'title': 'Bevacizumab: Neuropilin < Median', 'description': 'Participants with neuropilin levels \\< median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and FOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab: Neuropilin ≥ Median', 'description': 'Participants with neuropilin levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.950', 'ciLowerLimit': '0.343', 'ciUpperLimit': '2.630', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.983', 'ciLowerLimit': '0.503', 'ciUpperLimit': '1.918', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum neuropilin level. Neuropilin protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available serum protein samples'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival Events by Tumor VEGF-A Ribonucleic Acid (RNA) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib: VEGF-A RNA < Median', 'description': 'Participants with VEGF-A RNA levels \\< median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Tivozanib: VEGF-A RNA ≥ Median', 'description': 'Participants with VEGF-A RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG002', 'title': 'Bevacizumab: VEGF-A RNA < Median', 'description': 'Participants with VEGF-A RNA levels \\< median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab: VEGF-A RNA ≥ Median', 'description': 'Participants with VEGF-A RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.226', 'ciLowerLimit': '0.468', 'ciUpperLimit': '3.214', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.232', 'ciLowerLimit': '0.447', 'ciUpperLimit': '3.396', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-A RNA level.\n\nRNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available tumor biopsy RNA samples'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival Events by Tumor VEGF-C RNA Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib: VEGF-C RNA < Median', 'description': 'Participants with VEGF-C RNA levels \\< median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Tivozanib: VEGF-C RNA ≥ Median', 'description': 'Participants with VEGF-C RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG002', 'title': 'Bevacizumab: VEGF-C RNA < Median', 'description': 'Participants with VEGF-C RNA levels \\< median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab: VEGF-A RNA ≥ Median', 'description': 'Participants with VEGF-C RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.803', 'ciLowerLimit': '0.307', 'ciUpperLimit': '2.100', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.505', 'ciLowerLimit': '0.585', 'ciUpperLimit': '3.873', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-C RNA level.\n\nRNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available tumor biopsy RNA samples'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival Events by Tumor VEGF-C / VEGF-A RNA Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib: VEGF-C/VEGF-A RNA < Median', 'description': 'Participants with VEGF-C/VEGF-A RNA ratio \\< median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Tivozanib: VEGF-C/VEGF-A RNA ≥ Median', 'description': 'Participants with VEGF-C/VEGF-A RNA ratio ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG002', 'title': 'Bevacizumab: VEGF-C/VEGF-A RNA < Median', 'description': 'Participants with VEGF-C/VEGF-A RNA ratio \\< median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab: VEGF-C/VEGF-A RNA ≥ Median', 'description': 'Participants with VEGF-C/VEGF-A RNA ratio ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.921', 'ciLowerLimit': '0.356', 'ciUpperLimit': '2.385', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.220', 'ciLowerLimit': '0.462', 'ciUpperLimit': '3.220', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-C/VEGF-A RNA ratio.\n\nRNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available tumor biopsy RNA samples'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival Events by Tumor VEGF-D RNA Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib: VEGF-D RNA < Median', 'description': 'Participants with VEGF-D RNA levels \\< median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Tivozanib: VEGF-D RNA ≥ Median', 'description': 'Participants with VEGF-D RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG002', 'title': 'Bevacizumab: VEGF-D RNA < Median', 'description': 'Participants with VEGF-D RNA levels \\< median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab: VEGF-D RNA ≥ Median', 'description': 'Participants with VEGF-D RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.915', 'ciLowerLimit': '0.334', 'ciUpperLimit': '2.512', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.384', 'ciLowerLimit': '0.554', 'ciUpperLimit': '3.455', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-D RNA level.\n\nRNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available tumor biopsy RNA samples'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival Events by Tumor Placental Growth Factor (PIGF) RNA Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tivozanib: PIGF RNA < Median', 'description': 'Participants with PIGF RNA levels \\< median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG001', 'title': 'Tivozanib: PIGF RNA ≥ Median', 'description': 'Participants with PIGF RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG002', 'title': 'Bevacizumab: PIGF RNA < Median', 'description': 'Participants with PIGF RNA levels \\< median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab: PIGF RNA ≥ Median', 'description': 'Participants with PIGF RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.538', 'ciLowerLimit': '0.548', 'ciUpperLimit': '4.320', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.744', 'ciLowerLimit': '0.299', 'ciUpperLimit': '1.850', 'estimateComment': 'The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor PIGF RNA level.\n\nRNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available tumor biopsy RNA samples'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tivozanib + mFOLFOX6', 'description': 'Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each 28-day cycle for 21 days followed by 7 days off treatment. Participants also received modified FOLFOX6 (mFOLFOX6) chemotherapy consisting of oxaliplatin, 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 bolus then 2400 mg/m\\^2 every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'FG001', 'title': 'Bevacizumab + mFOLFOX6', 'description': 'Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants still on study as of 28 February 2014', 'groupId': 'FG000', 'numSubjects': '112'}, {'comment': 'Participants still on study as of 28 February 2014', 'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Randomized but Never Received Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Study Closed by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Participants were at least 18 years of age with Stage IV metastatic colorectal cancer (mCRC) and measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Version 1.1).', 'preAssignmentDetails': 'Participants were randomized in a 2:1 ratio (tivozanib to bevacizumab) and stratified by lactate dehydrogenase (LDH) status (\\< 1.5 x the upper limit of normal \\[ULN\\] or \\> 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or \\> 2).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tivozanib + mFOLFOX6', 'description': 'Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'BG001', 'title': 'Bevacizumab + mFOLFOX6', 'description': 'Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'spread': '9.58', 'groupId': 'BG000'}, {'value': '62.6', 'spread': '11.17', 'groupId': 'BG001'}, {'value': '62.2', 'spread': '10.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) performance status', 'classes': [{'title': 'ECOG Performance Status 0', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}]}, {'title': 'ECOG Performance Status 1', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}, {'title': 'ECOG Performance Status 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'ECOG Performance Status 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'ECOG Performance Status 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'ECOG criteria: 0: Fully active. 1: Ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of all self-care. 3: Capable of limited self-care, confined to bed or chair more than 50% of waking hours. 4: Completely disabled, no self-care, totally confined to bed or chair. 5: Dead.', 'unitOfMeasure': 'participants'}, {'title': 'Lactate dehydrogenase (LDH) Status', 'classes': [{'title': '< 1.5 Upper Limit of Normal', 'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}]}, {'title': '≥ 1.5 Upper Limit of Normal', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The upper limit of normal (ULN) from the site was used.', 'unitOfMeasure': 'participants'}, {'title': 'Origin of Cancer', 'classes': [{'title': 'Rectal', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Colon', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of metastatic sites/organs', 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': '≥ 4', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Kirsten rat sarcoma (KRAS) Mutation Status', 'classes': [{'title': 'Wild-type', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'Mutant', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time Since Initial Diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '9.41', 'spread': '20.473', 'groupId': 'BG000'}, {'value': '10.88', 'spread': '21.055', 'groupId': 'BG001'}, {'value': '9.90', 'spread': '20.640', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of metastatic sites at screening', 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '1.02', 'groupId': 'BG000'}, {'value': '2.0', 'spread': '0.85', 'groupId': 'BG001'}, {'value': '2.0', 'spread': '0.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'metastatic sites', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 265}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-09', 'studyFirstSubmitDate': '2011-11-21', 'resultsFirstSubmitDate': '2015-02-19', 'studyFirstSubmitQcDate': '2011-11-21', 'lastUpdatePostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-02', 'studyFirstPostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator-assessed Progression-Free Survival (PFS)', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The time from the date of randomization until objective tumor progression or death due to any cause. Objective tumor progression was determined through radiological imaging and based on the requirements of the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1):\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions.\n\nParticipants who did not progress or had not died at the time of the analysis were censored at the date of last tumor assessment where non-progression was documented.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) Based on Independent Radiological Review (IRR)', 'timeFrame': '3 years', 'description': 'The time from the date of randomization until the date of radiological disease progression assessed by the IRR or until death due to any cause, even in the absence of radiological progression.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'Overall survival (OS) is defined as the time from the date of randomization until the documented date of death. Participants still alive at the time of analysis were censored on the last day the participant was known to be alive.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'Objective response rate is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) confirmed a minimum of four weeks apart based on RECIST 1.1 criteria.\n\nCR: Disappearance of all target and non-target lesions and no new lesions.\n\nPR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and no progression of non-target lesions and no new lesions, or, disappearance of all target lesions and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions.'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'Duration of response (DoR) is defined as the time from the date of the first documented response of CR or PR (whichever is first recorded) to documented progression or death. If a participant did not progress or had not died at the time of analysis, the duration of response was censored at the date of last tumor assessment. Duration of response is only defined for participants whose best overall response was CR or PR.'}, {'measure': 'Time to Treatment Failure (TTF)', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'Time to Treatment Failure (TTF) is defined as the time from randomization to last dose date of tivozanib/bevacizumab. If a participant discontinued treatment for any reason, the participant was considered as an event. Participants remaining on treatment at the time of analysis were censored at date of last dose.'}, {'measure': 'Health Related Quality of Life (HRQoL)', 'timeFrame': '3 years', 'description': 'Time to deterioration in HRQoL measured by Colorectal cancer (CRC) subscale of the Functional Assessment of cancer Therapy Colorectal (FACT-C) scale, change in score from baseline using the European Quality of Life - 5 Dimensions (EQ-5D) and Fact Colorectal Symptom Index (FCSI) were not evaluated due to study closure.'}, {'measure': 'Safety as Assessed by Physical Examination, Vital Signs, Laboratory Assessments, 12-lead Electrocardiogram (ECGs), and Adverse Events (AEs)', 'timeFrame': 'From first dose through 30 days after last dose of either tivozanib or bevacizumab, until the data cut-off date of 28 February 2014. The median duration of treatment was 168.0 days in the tivozanib (tiv) arm and 162.0 days in the bevacizumab (bev) arm.', 'description': "An abnormality identified during a medical test is defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study medication or was clinically significant in the investigator's opinion.\n\nAn AE was serious if it resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required or prolonged inpatient hospitalization or other medically important event.\n\nAEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute Common Terminology Criteria for Grading Adverse Events (NCI-CTCAE) Version 4.03 per the following: 1=mild; 2= moderate; 3= severe; 4= life threatening; 5=death.\n\nTreatment-related AEs were defined as events where the relationship to study drug was marked as probably or possibly, or was missing."}, {'measure': 'Progression-free Survival Events by Lactate Dehydrogenase (LDH) Level', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum lactate dehydrogenase status.'}, {'measure': 'Progression-free Survival Events by Serum Vascular Endothelial Growth Factor-A (VEGF-A) Level', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum vascular endothelial growth factor-A (VEGF-A) level. VEGF-A protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.'}, {'measure': 'Progression-free Survival Events by Serum Vascular Endothelial Growth Factor-C (VEGF-C) Level', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum VEGF-C level. VEGF-C protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.'}, {'measure': 'Progression-free Survival Events by Serum VEGF-C / VEGF-A Ratio', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum VEGF-C/VEGF-A ratio. VEGF-A and VEGF-C protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the ratio is expressed relative to the observed median.'}, {'measure': 'Progression-Free Survival Events by Soluble Vascular Endothelial Growth Factor Receptor-2 (sVEGFR-2) Level', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum sVEGFR-2 level. sVEGFR-2 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.'}, {'measure': 'Progression-Free Survival Events by Soluble Vascular Endothelial Growth Factor Receptor-3 (sVEGFR-3) Level', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum sVEGFR-3 level. sVEGFR-3 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.'}, {'measure': 'Progression-Free Survival Events by Serum Interleukin-8 (IL-8) Level', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum interleukin-8 level. IL-8 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.'}, {'measure': 'Progression-Free Survival Events by Serum Neuropilin Level', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum neuropilin level. Neuropilin protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.'}, {'measure': 'Progression-Free Survival Events by Tumor VEGF-A Ribonucleic Acid (RNA) Level', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-A RNA level.\n\nRNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level.'}, {'measure': 'Progression-Free Survival Events by Tumor VEGF-C RNA Level', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-C RNA level.\n\nRNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level.'}, {'measure': 'Progression-Free Survival Events by Tumor VEGF-C / VEGF-A RNA Ratio', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-C/VEGF-A RNA ratio.\n\nRNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level.'}, {'measure': 'Progression-Free Survival Events by Tumor VEGF-D RNA Level', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-D RNA level.\n\nRNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level.'}, {'measure': 'Progression-Free Survival Events by Tumor Placental Growth Factor (PIGF) RNA Level', 'timeFrame': 'From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.', 'description': 'The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor PIGF RNA level.\n\nRNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metastatic colorectal cancer', 'Avastin', 'bevacizumab', 'tivozanib', 'mFOLFOX6', 'BATON-CRC', 'AV951', 'ASP4130'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the progression free survival (PFS), overall survival (OS), objective response rate (ORR), time to treatment failure (TTF), duration of response (DoR), quality of life, safety and tolerability of tivozanib in combination with mFOLFOX6 and bevacizumab in combination with mFOLFOX6.', 'detailedDescription': 'Imaging scans (computed tomography \\[CT\\]/magnetic resonance imaging \\[MRI\\]) to assess disease progression were to be completed within 28 days prior to first study drug administration, approximately every 8 weeks for the first 18 months and then approximately every 12 weeks until the patient showed progressive disease (PD) per the investigator, withdrew consent, was lost to follow-up or died. Per the original protocol, all patients were to be contacted by the study site every 12 weeks for survival following the end-of-treatment visit until death or for no more than 3 years after the end-of-treatment visit.\n\nThe interim futility analysis was conducted in December 2013, based on a pre-specified analysis cutoff date of 13 September 2013. The study was brought to a close as specified in the protocol due to the results of the interim futility analysis and only those participants who were deriving benefit (per the treating physician) from their current treatment remained on study until one of the discontinuation criteria was met.\n\nGiven the early closure of the study, no updated or additional efficacy analyses were performed after the interim analysis. A biomarker analysis was conducted in January 2014, based on the data from the cutoff date of 13 September 2013. The safety analysis was updated with a new cutoff date of 28 February 2014.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diagnosis of metastatic colorectal cancer\n* One measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* No prior systemic chemotherapy for advanced colorectal cancer; no fluorouracil containing adjuvant therapy in previous 6 months\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n\nExclusion Criteria:\n\n* Any prior Vascular Endothelial Growth Factor (VEGF)-directed therapy or any other agent or investigational agent targeting the VEGF pathway\n* Primary Central Nervous System (CNS) malignancies or CNS metastases\n* Hematologic abnormalities:\n\n * Hemoglobin \\< 9.0 g/dL,\n * Absolute neutrophil count (ANC) \\< 2000 per mm\\^3,\n * Platelet count \\< 100,000 per mm\\^3,\n * Prothrombin (PT) or Partial Thromboplastin Time (PTT) \\> 1.5 X Upper Limit of Normal (ULN)\n* Serum chemistry abnormalities:\n\n * Total bilirubin \\> 1.5 X ULN,\n * Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) \\> 2.5 X ULN,\n * Alkaline phosphatase \\> 2.5 X ULN,\n * Serum albumin \\< 2.0 g/dL,\n * Creatinine \\> 1.5 X ULN,\n * Proteinuria \\> 2+ by urine dipstick\n* Significant cardiovascular disease\n* Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug\n* Non-healing wound, bone fracture, or skin ulcer\n* Inadequate recovery from any prior surgical procedure or major surgical procedure within 8 weeks prior to administration, or anticipation of major surgical procedure during the course of the study\n* History of significant gastrointestinal (GI) toxicity, diarrhea, or stomatitis within the last 6 weeks\n* An active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal condition with increased risk of perforation\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug\n* Serious/active infection or infection requiring antibiotics\n* Significant bleeding disorders within 6 months prior to administration of first dose of study drug\n* Active second primary malignancy, other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer and ductal or lobular carcinoma in situ of the breast. Subject is not considered to have a currently active malignancy if they have completed anti-cancer therapy and have been disease free for \\> 5 years\n* History of allergic reactions, or intolerance, attributed to compounds of similar chemical or biologic composition to 5-fluorouracil, history of Grade 3 hypersensitivity to oxaliplatin, history of allergic reaction to folic acid\n* Female subject is pregnant or lactating\n* Known history of genetic or acquired immune suppression disease including Human Immunodeficiency Virus (HIV); subjects on immune suppressive therapy for organ transplant\n* Inability to swallow pills, malabsorption syndrome or gastrointestinal disease, major resection of the stomach or small bowel, or gastric bypass\n* Uncontrolled neuro-psychiatric disorder or altered mental status\n* Peripheral neuropathy ≥ Grade 2\n* Participating in another interventional protocol'}, 'identificationModule': {'nctId': 'NCT01478594', 'briefTitle': 'A Study Combining mFOLFOX6 With Tivozanib or Bevacizumab in Patients With Metastatic Colorectal Cancer as First Line Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'AVEO Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination With mFOLFOX6 to Bevacizumab in Combination With mFOLFOX6, In Stage IV Metastatic Colorectal Cancer (mCRC) Subjects', 'orgStudyIdInfo': {'id': '4130-CL-0201'}, 'secondaryIdInfos': [{'id': '2011-003502-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tivozanib + mFOLFOX6', 'description': 'Participants received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received modified FOLFOX6 (mFOLFOX6) chemotherapy every 2 weeks on Days 1 and 15 of each cycle.', 'interventionNames': ['Drug: Tivozanib', 'Drug: mFOLFOX6']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bevacizumab + mFOLFOX6', 'description': 'Participants received a dose of 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.', 'interventionNames': ['Drug: Bevacizumab', 'Drug: mFOLFOX6']}], 'interventions': [{'name': 'Tivozanib', 'type': 'DRUG', 'otherNames': ['AV951', 'ASP4130'], 'description': 'Capsules for oral administration', 'armGroupLabels': ['Tivozanib + mFOLFOX6']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Solution for intravenous infusion', 'armGroupLabels': ['Bevacizumab + mFOLFOX6']}, {'name': 'mFOLFOX6', 'type': 'DRUG', 'description': 'mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m\\^2 administered as an intravenous bolus over 2 hours on Days 1 and 15, leucovorin calcium 400 mg/m\\^2 administered as an intravenous bolus over 2 hours on Days 1 and 15, fluorouracil 400 mg/m\\^2 administered as an intravenous bolus over 5 to 15 minutes on Days 1 and 15, then 2400 mg/m\\^2 continuous intravenous infusion over 46 hours on Days 1 to 3 and 15 to 17.', 'armGroupLabels': ['Bevacizumab + mFOLFOX6', 'Tivozanib + mFOLFOX6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Research Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arizona', 'country': 'United States', 'facility': 'Genesis Cancer Center'}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Clinical Research Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego-Morris Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine Medical Center, Division of Hematology/Oncology', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Desert Hematology Oncology Medical Group, Inc.', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '80033', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'Mountain Blue Cancer Care Center', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida, Davis Cancer Center (VA)', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic Florida', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': "Queen's Medical Center", 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96813', 'city': 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