Viewing Study NCT00112918

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 4:40 AM

Ignite Modification Date: 2026-03-08 @ 1:20 AM

Study NCT ID: NCT00112918

Status: COMPLETED

Last Update Posted: 2013-08-27

First Post: 2005-06-02

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic 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': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffman-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse events occurring between the date of first drug intake and 28 days after last drug intake, regardless of which treatment group the patient was randomized to.', 'eventGroups': [{'id': 'EG000', 'title': 'FOLFOX4', 'description': 'Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\\^2 intravenous infusion over 2 hours concomitantly with Leucovorin as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Observation only.', 'otherNumAtRisk': 1126, 'otherNumAffected': 1112, 'seriousNumAtRisk': 1126, 'seriousNumAffected': 226}, {'id': 'EG001', 'title': 'FOLFOX4 + Bv', 'description': 'Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).', 'otherNumAtRisk': 1145, 'otherNumAffected': 1127, 'seriousNumAtRisk': 1145, 'seriousNumAffected': 297}, {'id': 'EG002', 'title': 'XELOX+Bv', 'description': 'Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m\\^2 twice daily (equivalent to a total daily dose of 2000 mg/m\\^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).', 'otherNumAtRisk': 1135, 'otherNumAffected': 1117, 'seriousNumAtRisk': 1135, 'seriousNumAffected': 284}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 725}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 761}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 720}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 620}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 699}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 699}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 385}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 394}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 460}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 310}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 360}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 246}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 308}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 324}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 219}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 220}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 227}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 214}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 126}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 162}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 84}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 118}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 113}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 430}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 430}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 436}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 310}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 328}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 314}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 252}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 234}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 204}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 169}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 284}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 219}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 237}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 222}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 152}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 106}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 128}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 117}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 79}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 50}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 59}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 404}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 425}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 355}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 241}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 251}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 250}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 186}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 185}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 106}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 85}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 57}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Temperature intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 660}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 567}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 273}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 331}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 115}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 99}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 89}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 74}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 34}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Palmar-Plantar Erythrodysaesthesia Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 119}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 435}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 231}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 241}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 73}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 112}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 110}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 66}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 50}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 28}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 228}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 424}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 216}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 120}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 41}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 73}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 91}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 74}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dysaesthesia pharynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 79}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 33}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 140}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 122}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 116}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 87}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 66}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 86}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 46}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 56}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 196}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 472}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 468}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 268}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 324}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 295}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 135}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 132}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 91}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 61}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nephrogenic diabetes insipidus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Intervertebral disc protusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Musculoskeletal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood glucose fluctuation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Palmar-Plantar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Retinal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Benign lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Female genital tract fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pregnancy of partner', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Central venous catheter removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1135, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease-free Survival in Stage III Cancer Patients - Time to Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '955', 'groupId': 'OG000'}, {'value': '960', 'groupId': 'OG001'}, {'value': '952', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX4', 'description': 'Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\\^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Observation only.'}, {'id': 'OG001', 'title': 'FOLFOX4 + Bv', 'description': 'Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).'}, {'id': 'OG002', 'title': 'XELOX+Bv', 'description': 'Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m\\^2 twice daily (equivalent to a total daily dose of 2000 mg/m\\^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median time to event and 95% confidence intervals could not be estimated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median time to event and 95% confidence intervals could not be estimated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median time to event and 95% confidence intervals could not be estimated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.2024', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Adjustments for multiplicity was done using a closed test procedure which tests for differences between all three treatment groups at the 5% alpha level first. Only in case of a significant result, the pair-wise comparison between the control arm and each of the bevacizumab arm will be tested, again at the 5% alpha level.', 'statisticalMethod': 'Closed test procedure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).', 'description': 'Disease-free survival (DFS) was defined as the time from the date of randomization to the time of a recurrence, a new occurrence of colorectal cancer or death due to any cause, whichever occurred first. Patients without an event were censored at the last date the patient was known to be disease-free. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Patients with no tumor assessments after baseline but still alive at the time of the clinical cut-off were censored at day 1.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease.'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Stage III Cancer Patients - Time to Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '955', 'groupId': 'OG000'}, {'value': '960', 'groupId': 'OG001'}, {'value': '952', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX4', 'description': 'Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\\^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Observation only.'}, {'id': 'OG001', 'title': 'FOLFOX4 + Bv', 'description': 'Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).'}, {'id': 'OG002', 'title': 'XELOX+Bv', 'description': 'Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m\\^2 twice daily (equivalent to a total daily dose of 2000 mg/m\\^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median time to event and 95% confidence intervals could not be estimated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median time to event and 95% confidence intervals could not be estimated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median time to event and 95% confidence intervals could not be estimated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).', 'description': 'Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the analysis were censored at the date they were last known to be alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT patients with Stage III disease.'}, {'type': 'PRIMARY', 'title': 'Disease-free Survival in Stage III Cancer Patients - Number of Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '955', 'groupId': 'OG000'}, {'value': '960', 'groupId': 'OG001'}, {'value': '952', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX4', 'description': 'Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\\^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Observation only.'}, {'id': 'OG001', 'title': 'FOLFOX4 + Bv', 'description': 'Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).'}, {'id': 'OG002', 'title': 'XELOX+Bv', 'description': 'Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m\\^2 twice daily (equivalent to a total daily dose of 2000 mg/m\\^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).'}], 'classes': [{'title': 'Patients with a DFS event', 'categories': [{'measurements': [{'value': '237', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}, {'value': '253', 'groupId': 'OG002'}]}]}, {'title': 'Recurrence', 'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}]}]}, {'title': 'New Occurrence', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Patients without events', 'categories': [{'measurements': [{'value': '718', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}, {'value': '699', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).', 'description': 'A disease-free survival (DFS) event was composed of a recurrence, a new occurrence of colorectal cancer or death due to any cause. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Triggering events for DFS are reported; a patient can have both recurrence and a new occurrence of colon cancer.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease.'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Stage III Cancer Patients - Number of Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '955', 'groupId': 'OG000'}, {'value': '960', 'groupId': 'OG001'}, {'value': '952', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX4', 'description': 'Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\\^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Observation only.'}, {'id': 'OG001', 'title': 'FOLFOX4 + Bv', 'description': 'Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).'}, {'id': 'OG002', 'title': 'XELOX+Bv', 'description': 'Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m\\^2 twice daily (equivalent to a total daily dose of 2000 mg/m\\^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).'}], 'classes': [{'title': 'Patients with events', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}]}, {'title': 'Patients without events', 'categories': [{'measurements': [{'value': '840', 'groupId': 'OG000'}, {'value': '809', 'groupId': 'OG001'}, {'value': '807', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).', 'description': 'An overall survival event was death due to any cause.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT patients with Stage III disease.'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '955', 'groupId': 'OG000'}, {'value': '960', 'groupId': 'OG001'}, {'value': '952', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX4', 'description': 'Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\\^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Observation only.'}, {'id': 'OG001', 'title': 'FOLFOX4 + Bv', 'description': 'Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).'}, {'id': 'OG002', 'title': 'XELOX+Bv', 'description': 'Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m\\^2 twice daily (equivalent to a total daily dose of 2000 mg/m\\^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median time to event and 95% confidence intervals could not be estimated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median time to event and 95% confidence intervals could not be estimated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median time to event and 95% confidence intervals could not be estimated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).', 'description': 'Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the clinical cut-off date (30 June 2012) were censored at the date they were last known to be alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT patients with Stage III disease.'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Stage III Cancer Patients - Number of Events: Final Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '955', 'groupId': 'OG000'}, {'value': '960', 'groupId': 'OG001'}, {'value': '952', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX4', 'description': 'Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\\^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Observation only.'}, {'id': 'OG001', 'title': 'FOLFOX4 + Bv', 'description': 'Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).'}, {'id': 'OG002', 'title': 'XELOX+Bv', 'description': 'Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m\\^2 twice daily (equivalent to a total daily dose of 2000 mg/m\\^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).'}], 'classes': [{'title': 'Patients with events', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}]}, {'title': 'Patients without events', 'categories': [{'measurements': [{'value': '794', 'groupId': 'OG000'}, {'value': '758', 'groupId': 'OG001'}, {'value': '770', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).', 'description': 'An overall survival event was death due to any cause.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT patients with Stage III disease.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FOLFOX4', 'description': 'Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\\^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Observation only.'}, {'id': 'FG001', 'title': 'FOLFOX4 + Bv', 'description': 'Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).'}, {'id': 'FG002', 'title': 'XELOX+Bv', 'description': 'Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m\\^2 twice daily (equivalent to a total daily dose of 2000 mg/m\\^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1151'}, {'groupId': 'FG001', 'numSubjects': '1155'}, {'groupId': 'FG002', 'numSubjects': '1145'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1126'}, {'comment': 'Includes two patients from FOLFOX4 who received Bv and were assigned to FOLFOX4+Bv safety analysis', 'groupId': 'FG001', 'numSubjects': '1145'}, {'groupId': 'FG002', 'numSubjects': '1135'}]}, {'type': 'Stage III Disease Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '955'}, {'groupId': 'FG001', 'numSubjects': '960'}, {'groupId': 'FG002', 'numSubjects': '952'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Represents patients alive in follow-up at the time of final data cut-off (30 June 2012)', 'groupId': 'FG000', 'numSubjects': '854'}, {'comment': 'Represents patients alive in follow-up at the time of final data cut-off (30 June 2012)', 'groupId': 'FG001', 'numSubjects': '810'}, {'comment': 'Represents patients alive in follow-up at the time of final data cut-off (30 June 2012)', 'groupId': 'FG002', 'numSubjects': '846'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '297'}, {'groupId': 'FG001', 'numSubjects': '345'}, {'groupId': 'FG002', 'numSubjects': '299'}]}]}], 'preAssignmentDetails': 'Randomization was stratified according to geographic region and disease stage (high-risk stage II or stage III N1 or stage III N2). The primary analysis population consisted of patients with Stage III disease.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '955', 'groupId': 'BG000'}, {'value': '960', 'groupId': 'BG001'}, {'value': '952', 'groupId': 'BG002'}, {'value': '2867', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'FOLFOX4', 'description': 'Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\\^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Observation only.'}, {'id': 'BG001', 'title': 'FOLFOX4 + Bv', 'description': 'Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).'}, {'id': 'BG002', 'title': 'XELOX+Bv', 'description': 'Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m\\^2 twice daily (equivalent to a total daily dose of 2000 mg/m\\^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<40', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '219', 'groupId': 'BG003'}]}]}, {'title': '40-65', 'categories': [{'measurements': [{'value': '603', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '588', 'groupId': 'BG002'}, {'value': '1816', 'groupId': 'BG003'}]}]}, {'title': '>=65', 'categories': [{'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG002'}, {'value': '832', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '425', 'groupId': 'BG000'}, {'value': '473', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}, {'value': '1330', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '530', 'groupId': 'BG000'}, {'value': '487', 'groupId': 'BG001'}, {'value': '520', 'groupId': 'BG002'}, {'value': '1537', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '377', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '791', 'groupId': 'BG000'}, {'value': '813', 'groupId': 'BG001'}, {'value': '795', 'groupId': 'BG002'}, {'value': '2399', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline Measures are based on the Intent-to-Treat - Stage III Disease Patient Population.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3451}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-19', 'studyFirstSubmitDate': '2005-06-02', 'resultsFirstSubmitDate': '2012-06-01', 'studyFirstSubmitQcDate': '2005-06-02', 'lastUpdatePostDateStruct': {'date': '2013-08-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-06', 'studyFirstPostDateStruct': {'date': '2005-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free Survival in Stage III Cancer Patients - Time to Event', 'timeFrame': 'From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).', 'description': 'Disease-free survival (DFS) was defined as the time from the date of randomization to the time of a recurrence, a new occurrence of colorectal cancer or death due to any cause, whichever occurred first. Patients without an event were censored at the last date the patient was known to be disease-free. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Patients with no tumor assessments after baseline but still alive at the time of the clinical cut-off were censored at day 1.'}, {'measure': 'Disease-free Survival in Stage III Cancer Patients - Number of Events', 'timeFrame': 'From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).', 'description': 'A disease-free survival (DFS) event was composed of a recurrence, a new occurrence of colorectal cancer or death due to any cause. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Triggering events for DFS are reported; a patient can have both recurrence and a new occurrence of colon cancer.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival in Stage III Cancer Patients - Time to Event', 'timeFrame': 'From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).', 'description': 'Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the analysis were censored at the date they were last known to be alive.'}, {'measure': 'Overall Survival in Stage III Cancer Patients - Number of Events', 'timeFrame': 'From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).', 'description': 'An overall survival event was death due to any cause.'}, {'measure': 'Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis', 'timeFrame': 'From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).', 'description': 'Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the clinical cut-off date (30 June 2012) were censored at the date they were last known to be alive.'}, {'measure': 'Overall Survival in Stage III Cancer Patients - Number of Events: Final Analysis', 'timeFrame': 'From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).', 'description': 'An overall survival event was death due to any cause.'}]}, 'conditionsModule': {'keywords': ['stage II colon cancer', 'stage III colon cancer'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '36306483', 'type': 'DERIVED', 'citation': 'Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.'}, {'pmid': '33356421', 'type': 'DERIVED', 'citation': "Cohen R, Taieb J, Fiskum J, Yothers G, Goldberg R, Yoshino T, Alberts S, Allegra C, de Gramont A, Seitz JF, O'Connell M, Haller D, Wolmark N, Erlichman C, Zaniboni A, Lonardi S, Kerr R, Grothey A, Sinicrope FA, Andre T, Shi Q. Microsatellite Instability in Patients With Stage III Colon Cancer Receiving Fluoropyrimidine With or Without Oxaliplatin: An ACCENT Pooled Analysis of 12 Adjuvant Trials. J Clin Oncol. 2021 Feb 20;39(6):642-651. doi: 10.1200/JCO.20.01600. Epub 2020 Dec 23."}, {'pmid': '33074326', 'type': 'DERIVED', 'citation': 'Chibaudel B, Henriques J, Rakez M, Brenner B, Kim TW, Martinez-Villacampa M, Gallego-Plazas J, Cervantes A, Shim K, Jonker D, Guerin-Meyer V, Mineur L, Banzi C, Dewdney A, Dejthevaporn T, Bloemendal HJ, Roth A, Moehler M, Aranda E, Van Cutsem E, Tabernero J, Schmoll HJ, Hoff PM, Andre T, de Gramont A. Association of Bevacizumab Plus Oxaliplatin-Based Chemotherapy With Disease-Free Survival and Overall Survival in Patients With Stage II Colon Cancer: A Secondary Analysis of the AVANT Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020425. doi: 10.1001/jamanetworkopen.2020.20425.'}, {'pmid': '32085892', 'type': 'DERIVED', 'citation': 'Salem ME, Yin J, Goldberg RM, Pederson LD, Wolmark N, Alberts SR, Taieb J, Marshall JL, Lonardi S, Yoshino T, Kerr RS, Yothers G, Grothey A, Andre T, De Gramont A, Shi Q. Evaluation of the change of outcomes over a 10-year period in patients with stage III colon cancer: pooled analysis of 6501 patients treated with fluorouracil, leucovorin, and oxaliplatin in the ACCENT database. Ann Oncol. 2020 Apr;31(4):480-486. doi: 10.1016/j.annonc.2019.12.007. Epub 2020 Jan 16.'}, {'pmid': '31959341', 'type': 'DERIVED', 'citation': 'Andre T, Vernerey D, Im SA, Bodoky G, Buzzoni R, Reingold S, Rivera F, McKendrick J, Scheithauer W, Ravit G, Fountzilas G, Yong WP, Isaacs R, Osterlund P, Liang JT, Creemers GJ, Rakez M, Van Cutsem E, Cunningham D, Tabernero J, de Gramont A. Bevacizumab as adjuvant treatment of colon cancer: updated results from the S-AVANT phase III study by the GERCOR Group. Ann Oncol. 2020 Feb;31(2):246-256. doi: 10.1016/j.annonc.2019.12.006. Epub 2019 Dec 18.'}, {'pmid': '31268130', 'type': 'DERIVED', 'citation': 'Taieb J, Shi Q, Pederson L, Alberts S, Wolmark N, Van Cutsem E, de Gramont A, Kerr R, Grothey A, Lonardi S, Yoshino T, Yothers G, Sinicrope FA, Zaanan A, Andre T. Prognosis of microsatellite instability and/or mismatch repair deficiency stage III colon cancer patients after disease recurrence following adjuvant treatment: results of an ACCENT pooled analysis of seven studies. Ann Oncol. 2019 Sep 1;30(9):1466-1471. doi: 10.1093/annonc/mdz208.'}, {'pmid': '23168362', 'type': 'DERIVED', 'citation': 'de Gramont A, Van Cutsem E, Schmoll HJ, Tabernero J, Clarke S, Moore MJ, Cunningham D, Cartwright TH, Hecht JR, Rivera F, Im SA, Bodoky G, Salazar R, Maindrault-Goebel F, Shacham-Shmueli E, Bajetta E, Makrutzki M, Shang A, Andre T, Hoff PM. Bevacizumab plus oxaliplatin-based chemotherapy as adjuvant treatment for colon cancer (AVANT): a phase 3 randomised controlled trial. Lancet Oncol. 2012 Dec;13(12):1225-33. doi: 10.1016/S1470-2045(12)70509-0. Epub 2012 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab (Bv) may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer in adjuvant setting.\n\nPURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens with or without bevacizumab to compare how well they work in treating patients who have undergone surgery for high risk stage II or stage III colon cancer.', 'detailedDescription': 'This was an open-label Phase III, multicenter, multinational, randomized, 3-arm study designed to evaluate the efficacy and safety of bevacizumab in combination with either intermittent fluorouracil/leucovorin with oxaliplatin (FOLFOX4) or capecitabine plus oxaliplatin (XELOX) versus FOLFOX4 regimen alone, as adjuvant chemotherapy in colon carcinoma.\n\nThe treatment phase consisted of two parts of 24 weeks for a total of 48 weeks. The first part (weeks 1 to 24) consisted of treatment with either FOLFOX4, FOLFOX4 in combination with bevacizumab, or XELOX in combination with bevacizumab. The second part (weeks 25 to 48) consisted of single-agent bevacizumab for patients randomized to either bevacizumab-containing arm, but was only an observation period for patients assigned to the FOLFOX4-alone arm.\n\nPatients were to be followed for recurrence/new occurrence of colorectal cancer and survival. Patients who experienced a confirmed recurrence, occurrence of a new colorectal cancer during therapy, or experienced unacceptable toxicity were to be taken off study treatment but remain in study follow-up. Patients that came off therapy due to a confirmed recurrence/appearance of new colorectal cancer, were to be followed for survival until the end of the study follow-up period. The primary analysis was performed 36 months after the last patient has been randomized. After the primary analysis, patients continue to be followed for survival for at least a further 2 years ie, until all patients have been followed-up for at least 5 years following randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Signed written informed consent obtained prior to any study specific screening procedures.\n2. Patient willing and able to comply with the protocol.\n3. Age ≥ 18 years-of-age.\n4. Histologically confirmed colon carcinoma, American Joint Cancer Committee/Union Internationale Contre le Cancer (AJCC/UICC) Stage II or Stage III defined as a tumor location ≥ 15 cm from the anal verge by endoscopy or above the peritoneal reflection at surgery. The patient was not to be a candidate for (neo) adjuvant radiotherapy. Note: Stage II patients were to be considered as high-risk patients fulfilling one of the following criteria:\n\n * T4 tumours,\n * Patients presenting with bowel obstruction or perforation,\n * Histological signs of vascular invasion (i.e. blood and lymphatic vessels) or perineural invasion,\n * Patients aged less than 50 years,\n * Patients with sub-optimal surgery (less than 12 nodes analyzed).\n5. Curative surgery not less than 4 and not more than 8 weeks prior to randomization.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n7. Life expectancy of ≥ 5 years.\n\nExclusion Criteria\n\n1. Macroscopic or microscopic evidence of remaining tumour. Patients should never have had any evidence of metastatic disease (including presence of tumour cells in the ascites). The isolated finding of cytokeratin positive cells in bone marrow is not considered evidence of metastatic disease for purposes of this study.\n2. Carcinoembryonic antigen \\> 1.5 x upper limit of normal (ULN) after surgery (during screening period).\n3. For patients with colostomy, unwilling to delay revision until at least 28 days after treatment completion.\n4. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, not fully healed wounds, or anticipation of the need for major surgical procedure during the course of the study. Any central venous access device (CVAD) for chemotherapy administration must be inserted at least 2 days prior to treatment start.\n5. Previous anti-angiogenic treatment for any malignancy; cytotoxic chemotherapy, radiotherapy or immunotherapy for colon cancer.\n6. Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix).\n7. Females with a positive or no pregnancy test (within 7 days before treatment start) unless childbearing potential can be otherwise excluded (postmenopausal i.e. amenorrheic for at least 2 years, hysterectomy or oophorectomy).\n8. Lactating women.\n9. Fertile women (\\< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.\n10. History or evidence upon physical examination of central nervous disease (CNS) disease (eg, primary brain tumour, seizure not controlled with standard medical therapy, any brain metastases).\n11. History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake.\n12. Clinically significant (ie, active) cardiovascular disease. This includes, but is not limited to, the following examples: cerebrovascular accidents (≤ 6 months prior to randomization), myocardial infarction (≤ 1 year prior to randomization), uncontrolled hypertension (\\>150/100 mmHg) while receiving chronic medication, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, clinically significant electrocardiogram (ECG) findings (e.g. QTc ≥ 440 msecs \\[male\\] 460 msecs \\[female\\] or ≥ 2º atrioventricular block, etc.).\n\n Patients who suffer from serious cardiac arrhythmia requiring medication can enter the study only if they are considered to be in a stable condition regarding both the arrhythmia and their medication. Patients with pacemakers are allowed to enter the study only if they are considered as being in a stable condition. In case of doubt, the investigator should obtain a consultation with a local cardiologist.\n13. Lack of physical integrity of the upper gastro-intestinal tract, malabsorption syndrome, or inability to take oral medication.\n14. Interstitial pneumonia or extensive symptomatic fibrosis of the lungs.\n15. Known peripheral neuropathy ≥ Common terminology criteria for adverse events (CTCAE) version 3.0 Grade 1. Absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible.\n16. Organ allografts requiring immunosuppressive therapy.\n17. Serious, non-healing wound, ulcer, or bone fracture.\n18. Evidence of bleeding diathesis or coagulopathy.\n19. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes.\n20. Chronic, daily treatment with high-dose aspirin (\\> 325 mg/day) or clopidogrel (\\> 75 mg/day).\n21. Chronic treatment with corticosteroids (dose of ≥ 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).\n22. Serious intercurrent infections (uncontrolled or requiring treatment).\n23. Known dihydropyrimidine dehydrogenase deficiency.\n24. Current or recent (within the 28 days prior to randomization) treatment with another investigational drug or participation in another investigational study.\n25. Patients with known allergy to Chinese hamster ovary cell proteins or other recombinant human or humanized antibodies or to any excipients of bevacizumab formulation, platinum compounds or to any other components of the study drugs.\n26. History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications.\n27. Presence of proteinuria at baseline as defined by:\n\n \\- Patients with \\> 1 g of protein/24 hour by a 24-hour urine collection.\n28. Any laboratory values at baseline are as follows:\n\nHaematology:\n\n* Absolute neutrophil count (ANC) \\< 1.5 x 109/L\n* Platelet count \\< 100 x 10\\^9/L\n* Haemoglobin \\< 9 g/dL (may be transfused to maintain or exceed this level)\n* International normalized ratio (INR) \\> 1.5\n* Activated partial prothrombin time (APTT) ≥ 1.5 x ULN\n\nBiochemistry:\n\n* Total bilirubin \\> 1.5 x ULN\n* aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) \\> 2.5 x ULN\n* Alkaline phosphatase (ALP) \\> 2.5 x ULN\n* Serum creatinine \\> 1.5 x ULN or creatinine clearance ≤ 50 mL/min (e.g. Cockcroft-Gault formula).'}, 'identificationModule': {'nctId': 'NCT00112918', 'briefTitle': 'Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Three Arm Multinational Phase III Study to Investigate Bevacizumab (q3w or q2w) in Combination With Either Intermittent Capecitabine Plus Oxaliplatin (XELOX) (q3w) or Fluorouracil/Leucovorin With Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 Regimen Alone as Adjuvant Chemotherapy in Colon Carcinoma: The AVANT Study', 'orgStudyIdInfo': {'id': 'CDR0000427299'}, 'secondaryIdInfos': [{'id': 'P30CA016042', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016042', 'type': 'NIH'}, {'id': 'UCLA-0412086-01'}, {'id': 'ROCHE-BO17920A'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FOLFOX4', 'description': 'Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\\^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Observation only.', 'interventionNames': ['Drug: 5-Fluorouracil (5-FU)', 'Drug: Leucovorin calcium', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'FOLFOX4 + Bv', 'description': 'Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\\^2 bolus injection, and then as a 600 mg/m\\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\\^2 (alone), followed by 5-FU 400 mg/m\\^2 bolus injection, and 5-FU 600 mg/m\\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).', 'interventionNames': ['Biological: Bevacizumab', 'Drug: 5-Fluorouracil (5-FU)', 'Drug: Leucovorin calcium', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'XELOX+Bv', 'description': 'Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m\\^2 twice daily (equivalent to a total daily dose of 2000 mg/m\\^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).\n\nWeeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).', 'interventionNames': ['Biological: Bevacizumab', 'Drug: Capecitabine', 'Drug: Oxaliplatin']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'BIOLOGICAL', 'description': 'Administered as an intravenous infusion over 30 - 90 minutes.', 'armGroupLabels': ['FOLFOX4 + Bv', 'XELOX+Bv']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda®'], 'description': 'Film-coated tablets', 'armGroupLabels': ['XELOX+Bv']}, {'name': '5-Fluorouracil (5-FU)', 'type': 'DRUG', 'description': 'Administered as either a bolus injection or continuous intravenous infusion over 22 hours.', 'armGroupLabels': ['FOLFOX4', 'FOLFOX4 + Bv']}, {'name': 'Leucovorin calcium', 'type': 'DRUG', 'description': 'Administered as a 200 mg/m\\^2 infusion over 2 hours.', 'armGroupLabels': ['FOLFOX4', 'FOLFOX4 + Bv']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Administered as an intravenous infusion over 2 hours.', 'armGroupLabels': ['FOLFOX4', 'FOLFOX4 + Bv', 'XELOX+Bv']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Joel Randolph Hecht, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}