{"eventGroups":[{"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":"EG000","otherNumAffected":1112,"otherNumAtRisk":1126,"seriousNumAffected":226,"seriousNumAtRisk":1126,"title":"FOLFOX4"},{"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":"EG001","otherNumAffected":1127,"otherNumAtRisk":1145,"seriousNumAffected":297,"seriousNumAtRisk":1145,"title":"FOLFOX4 + 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":"EG002","otherNumAffected":1117,"otherNumAtRisk":1135,"seriousNumAffected":284,"seriousNumAtRisk":1135,"title":"XELOX+Bv"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":725,"numAtRisk":1126},{"groupId":"EG001","numAffected":761,"numAtRisk":1145},{"groupId":"EG002","numAffected":720,"numAtRisk":1135}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":620,"numAtRisk":1126},{"groupId":"EG001","numAffected":699,"numAtRisk":1145},{"groupId":"EG002","numAffected":699,"numAtRisk":1135}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":385,"numAtRisk":1126},{"groupId":"EG001","numAffected":394,"numAtRisk":1145},{"groupId":"EG002","numAffected":460,"numAtRisk":1135}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":310,"numAtRisk":1126},{"groupId":"EG001","numAffected":360,"numAtRisk":1145},{"groupId":"EG002","numAffected":246,"numAtRisk":1135}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":308,"numAtRisk":1126},{"groupId":"EG001","numAffected":324,"numAtRisk":1145},{"groupId":"EG002","numAffected":219,"numAtRisk":1135}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":220,"numAtRisk":1126},{"groupId":"EG001","numAffected":227,"numAtRisk":1145},{"groupId":"EG002","numAffected":214,"numAtRisk":1135}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":126,"numAtRisk":1126},{"groupId":"EG001","numAffected":162,"numAtRisk":1145},{"groupId":"EG002","numAffected":84,"numAtRisk":1135}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":86,"numAtRisk":1126},{"groupId":"EG001","numAffected":118,"numAtRisk":1145},{"groupId":"EG002","numAffected":113,"numAtRisk":1135}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":1126},{"groupId":"EG001","numAffected":68,"numAtRisk":1145},{"groupId":"EG002","numAffected":41,"numAtRisk":1135}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":430,"numAtRisk":1126},{"groupId":"EG001","numAffected":430,"numAtRisk":1145},{"groupId":"EG002","numAffected":436,"numAtRisk":1135}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":310,"numAtRisk":1126},{"groupId":"EG001","numAffected":328,"numAtRisk":1145},{"groupId":"EG002","numAffected":314,"numAtRisk":1135}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":252,"numAtRisk":1126},{"groupId":"EG001","numAffected":234,"numAtRisk":1145},{"groupId":"EG002","numAffected":204,"numAtRisk":1135}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":169,"numAtRisk":1126},{"groupId":"EG001","numAffected":284,"numAtRisk":1145},{"groupId":"EG002","numAffected":219,"numAtRisk":1135}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":237,"numAtRisk":1126},{"groupId":"EG001","numAffected":222,"numAtRisk":1145},{"groupId":"EG002","numAffected":152,"numAtRisk":1135}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 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(13.0)","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":1126},{"groupId":"EG001","numAffected":50,"numAtRisk":1145},{"groupId":"EG002","numAffected":59,"numAtRisk":1135}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":404,"numAtRisk":1126},{"groupId":"EG001","numAffected":425,"numAtRisk":1145},{"groupId":"EG002","numAffected":355,"numAtRisk":1135}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":241,"numAtRisk":1126},{"groupId":"EG001","numAffected":251,"numAtRisk":1145},{"groupId":"EG002","numAffected":250,"numAtRisk":1135}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":186,"numAtRisk":1126},{"groupId":"EG001","numAffected":185,"numAtRisk":1145},{"groupId":"EG002","numAffected":106,"numAtRisk":1135}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":85,"numAtRisk":1126},{"groupId":"EG001","numAffected":85,"numAtRisk":1145},{"groupId":"EG002","numAffected":57,"numAtRisk":1135}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":61,"numAtRisk":1126},{"groupId":"EG001","numAffected":61,"numAtRisk":1145},{"groupId":"EG002","numAffected":50,"numAtRisk":1135}],"term":"Temperature intolerance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":1126},{"groupId":"EG001","numAffected":62,"numAtRisk":1145},{"groupId":"EG002","numAffected":45,"numAtRisk":1135}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":660,"numAtRisk":1126},{"groupId":"EG001","numAffected":567,"numAtRisk":1145},{"groupId":"EG002","numAffected":273,"numAtRisk":1135}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":331,"numAtRisk":1126},{"groupId":"EG001","numAffected":115,"numAtRisk":1145},{"groupId":"EG002","numAffected":99,"numAtRisk":1135}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":116,"numAtRisk":1126},{"groupId":"EG001","numAffected":89,"numAtRisk":1145},{"groupId":"EG002","numAffected":74,"numAtRisk":1135}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":79,"numAtRisk":1126},{"groupId":"EG001","numAffected":55,"numAtRisk":1145},{"groupId":"EG002","numAffected":34,"numAtRisk":1135}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":98,"numAtRisk":1126},{"groupId":"EG001","numAffected":119,"numAtRisk":1145},{"groupId":"EG002","numAffected":435,"numAtRisk":1135}],"term":"Palmar-Plantar Erythrodysaesthesia Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":231,"numAtRisk":1126},{"groupId":"EG001","numAffected":241,"numAtRisk":1145},{"groupId":"EG002","numAffected":73,"numAtRisk":1135}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":114,"numAtRisk":1126},{"groupId":"EG001","numAffected":112,"numAtRisk":1145},{"groupId":"EG002","numAffected":110,"numAtRisk":1135}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":1126},{"groupId":"EG001","numAffected":66,"numAtRisk":1145},{"groupId":"EG002","numAffected":50,"numAtRisk":1135}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":1126},{"groupId":"EG001","numAffected":65,"numAtRisk":1145},{"groupId":"EG002","numAffected":28,"numAtRisk":1135}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":228,"numAtRisk":1126},{"groupId":"EG001","numAffected":424,"numAtRisk":1145},{"groupId":"EG002","numAffected":216,"numAtRisk":1135}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":86,"numAtRisk":1126},{"groupId":"EG001","numAffected":120,"numAtRisk":1145},{"groupId":"EG002","numAffected":41,"numAtRisk":1135}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":57,"numAtRisk":1126},{"groupId":"EG001","numAffected":74,"numAtRisk":1145},{"groupId":"EG002","numAffected":73,"numAtRisk":1135}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":1126},{"groupId":"EG001","numAffected":91,"numAtRisk":1145},{"groupId":"EG002","numAffected":74,"numAtRisk":1135}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":1126},{"groupId":"EG001","numAffected":28,"numAtRisk":1145},{"groupId":"EG002","numAffected":79,"numAtRisk":1135}],"term":"Dysaesthesia pharynx"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":1126},{"groupId":"EG001","numAffected":59,"numAtRisk":1145},{"groupId":"EG002","numAffected":33,"numAtRisk":1135}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":1126},{"groupId":"EG001","numAffected":140,"numAtRisk":1145},{"groupId":"EG002","numAffected":122,"numAtRisk":1135}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":1126},{"groupId":"EG001","numAffected":78,"numAtRisk":1145},{"groupId":"EG002","numAffected":116,"numAtRisk":1135}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":79,"numAtRisk":1126},{"groupId":"EG001","numAffected":87,"numAtRisk":1145},{"groupId":"EG002","numAffected":66,"numAtRisk":1135}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":1126},{"groupId":"EG001","numAffected":86,"numAtRisk":1145},{"groupId":"EG002","numAffected":46,"numAtRisk":1135}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 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