{"eventGroups":[{"description":"Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies","id":"EG000","otherNumAffected":13,"otherNumAtRisk":13,"seriousNumAffected":3,"seriousNumAtRisk":13,"title":"Arm I (Carboplatin and Paclitaxel)"},{"description":"Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCapecitabine: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nOxaliplatin: Given IV\n\nQuality-of-Life Assessment: Ancillary studies","id":"EG001","otherNumAffected":13,"otherNumAtRisk":13,"seriousNumAffected":4,"seriousNumAtRisk":13,"title":"Arm II (Oxaliplatin and Capecitabine)"},{"description":"Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.\n\nBevacizumab: Given IV\n\nCarboplatin: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies","id":"EG002","otherNumAffected":13,"otherNumAtRisk":13,"seriousNumAffected":2,"seriousNumAtRisk":13,"title":"Arm III (Carboplatin, Paclitaxel, Bevacizumab)"},{"description":"Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.\n\nBevacizumab: Given IV\n\nCapecitabine: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nOxaliplatin: Given IV\n\nQuality-of-Life Assessment: Ancillary studies","id":"EG003","otherNumAffected":11,"otherNumAtRisk":11,"seriousNumAffected":3,"seriousNumAtRisk":11,"title":"Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":4,"numAtRisk":13},{"groupId":"EG002","numAffected":0,"numAtRisk":13},{"groupId":"EG003","numAffected":0,"numAtRisk":11}],"term":"Laryngeal Spasm"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":13},{"groupId":"EG002","numAffected":1,"numAtRisk":13},{"groupId":"EG003","numAffected":0,"numAtRisk":11}],"term":"Low Lymphocytes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":2,"numAtRisk":13},{"groupId":"EG002","numAffected":1,"numAtRisk":13},{"groupId":"EG003","numAffected":1,"numAtRisk":11}],"term":"Low Mood"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":13},{"groupId":"EG001","numAffected":5,"numAtRisk":13},{"groupId":"EG002","numAffected":4,"numAtRisk":13},{"groupId":"EG003","numAffected":7,"numAtRisk":11}],"term":"Low Neutrophils"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":13},{"groupId":"EG001","numAffected":3,"numAtRisk":13},{"groupId":"EG002","numAffected":5,"numAtRisk":13},{"groupId":"EG003","numAffected":7,"numAtRisk":11}],"term":"Low platelets"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":13},{"groupId":"EG001","numAffected":5,"numAtRisk":13},{"groupId":"EG002","numAffected":4,"numAtRisk":13},{"groupId":"EG003","numAffected":6,"numAtRisk":11}],"term":"Low White Blood Cells"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":13},{"groupId":"EG002","numAffected":1,"numAtRisk":13},{"groupId":"EG003","numAffected":3,"numAtRisk":11}],"term":"Mucositis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":13},{"groupId":"EG001","numAffected":8,"numAtRisk":13},{"groupId":"EG002","numAffected":9,"numAtRisk":13},{"groupId":"EG003","numAffected":9,"numAtRisk":11}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13},{"groupId":"EG001","numAffected":2,"numAtRisk":13},{"groupId":"EG002","numAffected":4,"numAtRisk":13},{"groupId":"EG003","numAffected":9,"numAtRisk":11}],"term":"Oral problems"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":13},{"groupId":"EG001","numAffected":4,"numAtRisk":13},{"groupId":"EG002","numAffected":7,"numAtRisk":13},{"groupId":"EG003","numAffected":7,"numAtRisk":11}],"term":"Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":13},{"groupId":"EG001","numAffected":6,"numAtRisk":13},{"groupId":"EG002","numAffected":7,"numAtRisk":13},{"groupId":"EG003","numAffected":7,"numAtRisk":11}],"term":"Other GI Problems"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":13},{"groupId":"EG001","numAffected":6,"numAtRisk":13},{"groupId":"EG002","numAffected":7,"numAtRisk":13},{"groupId":"EG003","numAffected":7,"numAtRisk":11}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":13},{"groupId":"EG001","numAffected":11,"numAtRisk":13},{"groupId":"EG002","numAffected":8,"numAtRisk":13},{"groupId":"EG003","numAffected":10,"numAtRisk":11}],"term":"Peripheral/sensory Neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":13},{"groupId":"EG002","numAffected":0,"numAtRisk":13},{"groupId":"EG003","numAffected":0,"numAtRisk":11}],"term":"Pneumothorax"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":13},{"groupId":"EG002","numAffected":2,"numAtRisk":13},{"groupId":"EG003","numAffected":0,"numAtRisk":11}],"term":"Raised CA19-9"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":13},{"groupId":"EG002","numAffected":0,"numAtRisk":13},{"groupId":"EG003","numAffected":1,"numAtRisk":11}],"term":"Raised Blood counts"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":13},{"groupId":"EG001","numAffected":2,"numAtRisk":13},{"groupId":"EG002","numAffected":3,"numAtRisk":13},{"groupId":"EG003","numAffected":4,"numAtRisk":11}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":2,"numAtRisk":13},{"groupId":"EG002","numAffected":1,"numAtRisk":13},{"groupId":"EG003","numAffected":0,"numAtRisk":11}],"term":"Stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13},{"groupId":"EG001","numAffected":2,"numAtRisk":13},{"groupId":"EG002","numAffected":1,"numAtRisk":13},{"groupId":"EG003","numAffected":2,"numAtRisk":11}],"term":"Taste Alteration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":13},{"groupId":"EG002","numAffected":1,"numAtRisk":13},{"groupId":"EG003","numAffected":2,"numAtRisk":11}],"term":"Urinary Problems"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":13},{"groupId":"EG002","numAffected":1,"numAtRisk":13},{"groupId":"EG003","numAffected":2,"numAtRisk":11}],"term":"Vaginal Bleeding"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":13},{"groupId":"EG002","numAffected":1,"numAtRisk":13},{"groupId":"EG003","numAffected":2,"numAtRisk":11}],"term":"Weight Gain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13},{"groupId":"EG001","numAffected":3,"numAtRisk":13},{"groupId":"EG002","numAffected":4,"numAtRisk":13},{"groupId":"EG003","numAffected":5,"numAtRisk":11}],"term":"Weight Loss"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":13},{"groupId":"EG002","numAffected":1,"numAtRisk":13},{"groupId":"EG003","numAffected":0,"numAtRisk":11}],"term":"Allergic reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":13},{"groupId":"EG002","numAffected":0,"numAtRisk":13},{"groupId":"EG003","numAffected":1,"numAtRisk":11}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":13},{"groupId":"EG002","numAffected":0,"numAtRisk":13},{"groupId":"EG003","numAffected":1,"numAtRisk":11}],"term":"Bleeding"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":13},{"groupId":"EG002","numAffected":0,"numAtRisk":13},{"groupId":"EG003","numAffected":1,"numAtRisk":11}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":13},{"groupId":"EG002","numAffected":0,"numAtRisk":13},{"groupId":"EG003","numAffected":1,"numAtRisk":11}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":13},{"groupId":"EG002","numAffected":0,"numAtRisk":13},{"groupId":"EG003","numAffected":0,"numAtRisk":11}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":13},{"groupId":"EG002","numAffected":1,"numAtRisk":13},{"groupId":"EG003","numAffected":0,"numAtRisk":11}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":13},{"groupId":"EG002","numAffected":0,"numAtRisk":13},{"groupId":"EG003","numAffected":0,"numAtRisk":11}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":13},{"groupId":"EG002","numAffected":0,"numAtRisk":13},{"groupId":"EG003","numAffected":1,"numAtRisk":11}],"term":"GI perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":13},{"groupId":"EG002","numAffected":1,"numAtRisk":13},{"groupId":"EG003","numAffected":0,"numAtRisk":11}],"term":"Hypomagnesemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":13},{"groupId":"EG002","numAffected":1,"numAtRisk":13},{"groupId":"EG003","numAffected":0,"numAtRisk":11}],"term":"Low Neutrophils"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":13},{"groupId":"EG002","numAffected":0,"numAtRisk":13},{"groupId":"EG003","numAffected":0,"numAtRisk":11}],"term":"Low Platelets"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":13},{"groupId":"EG002","numAffected":0,"numAtRisk":13},{"groupId":"EG003","numAffected":2,"numAtRisk":11}],"term":"Nausea/Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":13},{"groupId":"EG002","numAffected":0,"numAtRisk":13},{"groupId":"EG003","numAffected":1,"numAtRisk":11}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":13},{"groupId":"EG002","numAffected":0,"numAtRisk":13},{"groupId":"EG003","numAffected":0,"numAtRisk":11}],"term":"Peripheral/sensory neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":13},{"groupId":"EG002","numAffected":0,"numAtRisk":13},{"groupId":"EG003","numAffected":1,"numAtRisk":11}],"term":"Pneumothorax"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":13},{"groupId":"EG002","numAffected":1,"numAtRisk":13},{"groupId":"EG003","numAffected":0,"numAtRisk":11}],"term":"Thromboembolic Event"}],"timeFrame":"Study treatment and up to 5 years after treatment discontinuation"}