{"description":"Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the \"AE Other\" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":8,"description":"Patients undergo surgery and then receive no further treatment.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTherapeutic Conventional Surgery: Undergo surgery","id":"EG000","otherNumAffected":0,"otherNumAtRisk":8,"seriousNumAffected":0,"seriousNumAtRisk":8,"title":"Very Low-risk Group"},{"deathsNumAffected":3,"deathsNumAtRisk":49,"description":"Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, and vincristine sulfate IV over 1 minute on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.\n\nCisplatin: Given IV\n\nFluorouracil: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTherapeutic Conventional Surgery: Undergo surgery\n\nVincristine Sulfate: Given IV","id":"EG001","otherNumAffected":24,"otherNumAtRisk":49,"seriousNumAffected":0,"seriousNumAtRisk":49,"title":"Low-risk Group (Regimen T)"},{"deathsNumAffected":7,"deathsNumAtRisk":102,"description":"Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012)\n\nCisplatin: Given IV\n\nDexrazoxane: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nFluorouracil: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLiver Transplantation: Undergo liver transplant\n\nTherapeutic Conventional Surgery: Undergo surgery\n\nVincristine Sulfate: Given IV","id":"EG002","otherNumAffected":91,"otherNumAtRisk":102,"seriousNumAffected":3,"seriousNumAtRisk":102,"title":"Intermediate-risk Group (Regimen F)"},{"deathsNumAffected":11,"deathsNumAtRisk":31,"description":"(regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity.\n\nCisplatin: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nFluorouracil: Given IV\n\nIrinotecan Hydrochloride: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTherapeutic Conventional Surgery: Undergo surgery\n\nVincristine Sulfate: Given IV","id":"EG003","otherNumAffected":27,"otherNumAtRisk":31,"seriousNumAffected":2,"seriousNumAtRisk":31,"title":"High-risk Group (Regimen W)"},{"deathsNumAffected":13,"deathsNumAtRisk":36,"description":"Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6.\n\nCisplatin: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nFluorouracil: Given IV\n\nIrinotecan Hydrochloride: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLiver Transplantation: Undergo liver transplant\n\nTemsirolimus: Given IV\n\nTherapeutic Conventional Surgery: Undergo surgery\n\nVincristine Sulfate: Given IV","id":"EG004","otherNumAffected":32,"otherNumAtRisk":36,"seriousNumAffected":1,"seriousNumAtRisk":36,"title":"High-risk Group (Regimen H)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":1,"numAtRisk":102},{"groupId":"EG003","numAffected":1,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":1,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Abdominal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":7,"numAtRisk":102},{"groupId":"EG003","numAffected":3,"numAtRisk":31},{"groupId":"EG004","numAffected":5,"numAtRisk":36}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":0,"numAtRisk":102},{"groupId":"EG003","numAffected":1,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Abducens nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":4,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":1,"numAtRisk":36}],"term":"Acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":2,"numAtRisk":102},{"groupId":"EG003","numAffected":3,"numAtRisk":31},{"groupId":"EG004","numAffected":1,"numAtRisk":36}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":5,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":3,"numAtRisk":102},{"groupId":"EG003","numAffected":1,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":1,"numAtRisk":49},{"groupId":"EG002","numAffected":21,"numAtRisk":102},{"groupId":"EG003","numAffected":7,"numAtRisk":31},{"groupId":"EG004","numAffected":6,"numAtRisk":36}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":1,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":1,"numAtRisk":36}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":1,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":2,"numAtRisk":36}],"term":"Alkalosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system 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disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":0,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":2,"numAtRisk":36}],"term":"Anaphylaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":1,"numAtRisk":49},{"groupId":"EG002","numAffected":2,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":1,"numAtRisk":36}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":1,"numAtRisk":49},{"groupId":"EG002","numAffected":19,"numAtRisk":102},{"groupId":"EG003","numAffected":9,"numAtRisk":31},{"groupId":"EG004","numAffected":11,"numAtRisk":36}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":1,"numAtRisk":49},{"groupId":"EG002","numAffected":0,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Apnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":1,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":1,"numAtRisk":49},{"groupId":"EG002","numAffected":26,"numAtRisk":102},{"groupId":"EG003","numAffected":7,"numAtRisk":31},{"groupId":"EG004","numAffected":16,"numAtRisk":36}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":2,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Atelectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":1,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":1,"numAtRisk":102},{"groupId":"EG003","numAffected":1,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Biliary anastomotic leak"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":1,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Biliary fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":1,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Biliary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":2,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Bladder infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":7,"numAtRisk":102},{"groupId":"EG003","numAffected":2,"numAtRisk":31},{"groupId":"EG004","numAffected":5,"numAtRisk":36}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":1,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":1,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Bronchospasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":1,"numAtRisk":102},{"groupId":"EG003","numAffected":1,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":1,"numAtRisk":49},{"groupId":"EG002","numAffected":5,"numAtRisk":102},{"groupId":"EG003","numAffected":1,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":0,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":1,"numAtRisk":36}],"term":"Cholesterol high"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":3,"numAtRisk":102},{"groupId":"EG003","numAffected":0,"numAtRisk":31},{"groupId":"EG004","numAffected":1,"numAtRisk":36}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":49},{"groupId":"EG002","numAffected":0,"numAtRisk":102},{"groupId":"EG003","numAffected":1,"numAtRisk":31},{"groupId":"EG004","numAffected":0,"numAtRisk":36}],"term":"Colonic hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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