{"description":"All patients received treatment at Step 2 and had adverse event data were included in the analysis of adverse events. Patients who underwent observation in Arm C did not receive any treatment, so no adverse event data were collected for these patients.\n\nAll patients registered/randomized at Step 2 were included in the analysis of all-cause mortality.","eventGroups":[{"deathsNumAffected":73,"deathsNumAtRisk":460,"description":"Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.","id":"EG000","otherNumAffected":399,"otherNumAtRisk":428,"seriousNumAffected":308,"seriousNumAtRisk":428,"title":"Arm A (5-FU, Leucovorin, Oxaliplatin)"},{"deathsNumAffected":69,"deathsNumAtRisk":458,"description":"Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity.","id":"EG001","otherNumAffected":388,"otherNumAtRisk":410,"seriousNumAffected":292,"seriousNumAtRisk":410,"title":"Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)"},{"deathsNumAffected":145,"deathsNumAtRisk":1013,"description":"Patients undergo observation","id":"EG002","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Arm C (Observation)"},{"deathsNumAffected":61,"deathsNumAtRisk":500,"description":"Patients whose risk assessment information was unavailable or who did not registered to Step 2 are included in this group.","id":"EG003","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"No Randomization/Registration at Step 2"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":235,"numAtRisk":428},{"groupId":"EG001","numAffected":205,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":222,"numAtRisk":428},{"groupId":"EG001","numAffected":174,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Leukocytes decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":184,"numAtRisk":428},{"groupId":"EG001","numAffected":156,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Neutrophils decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 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disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":62,"numAtRisk":428},{"groupId":"EG001","numAffected":56,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Hand-foot reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":116,"numAtRisk":428},{"groupId":"EG001","numAffected":125,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":85,"numAtRisk":428},{"groupId":"EG001","numAffected":90,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":428},{"groupId":"EG001","numAffected":35,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":216,"numAtRisk":428},{"groupId":"EG001","numAffected":213,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Diarrhea w/o prior colostomy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":428},{"groupId":"EG001","numAffected":33,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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4.0","stats":[{"groupId":"EG000","numAffected":240,"numAtRisk":428},{"groupId":"EG001","numAffected":233,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":67,"numAtRisk":428},{"groupId":"EG001","numAffected":62,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Taste disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":88,"numAtRisk":428},{"groupId":"EG001","numAffected":104,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":428},{"groupId":"EG001","numAffected":27,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Rectum, hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":428},{"groupId":"EG001","numAffected":107,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Nose, hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":428},{"groupId":"EG001","numAffected":29,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":57,"numAtRisk":428},{"groupId":"EG001","numAffected":32,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":68,"numAtRisk":428},{"groupId":"EG001","numAffected":48,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":88,"numAtRisk":428},{"groupId":"EG001","numAffected":62,"numAtRisk":410},{"groupId":"EG002","numAtRisk":0},{"groupId":"EG003","numAtRisk":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 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