{"description":"Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.","eventGroups":[{"deathsNumAffected":17,"deathsNumAtRisk":51,"description":"HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out.\n\nHIPEC\n\nMitomycin C","id":"EG000","otherNumAffected":50,"otherNumAtRisk":51,"seriousNumAffected":34,"seriousNumAtRisk":51,"title":"HIPEC + Mitomycin C"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: AST Increase","organSystem":"Investigations","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":51}],"term":"Aspartate Aminotransferase (AST) Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: ALT Increase","organSystem":"Investigations","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":51}],"term":"Alanine Aminotransferase (ALT) Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":51}],"term":"Hyperglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":51}],"term":"Hypocalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":51}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":51}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: Neutropenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":51}],"term":"Febrile Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: Hemoglobin Decrease","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":51}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":51}],"term":"Hypoalbuminemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Lymphocyte Decrease","organSystem":"Investigations","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":51}],"term":"Lymphocyte Count Decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: White Blood Cell Count Decrease","organSystem":"Investigations","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":51}],"term":"White Blood Cell Decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: Blood Bilirubin","organSystem":"Investigations","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":51}],"term":"Blood Bilirubin Increased"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51}],"term":"Acute Kidney Injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"AEs as identified by CTCAE Version 4.0 were coded to their appropriate System Organ Class (SOC)","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Abdominal Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"AEs as identified by CTCAE Version 4.0 were coded to their appropriate System Organ Class (SOC)","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Febrile Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: AST Increase","organSystem":"Investigations","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":51}],"term":"Aspartate Aminotransferase (AST) Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: ALT Increase","organSystem":"Investigations","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":51}],"term":"Alanine Aminotransferase (ALT) Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51}],"term":"Creatinine Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51}],"term":"Chronic Kidney Disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: Hemoglobin Decreased","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":51}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51}],"term":"Hypoalbuminemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":51}],"term":"Hypocalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51}],"term":"Hyperglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51}],"term":"Hypophosphatemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: Lymphocyte Decreased","organSystem":"Investigations","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":51}],"term":"Lymphocyte Count Decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Intra-abdominal Hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Platelet Count Decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: White Blood Cell Count Decreased","organSystem":"Investigations","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":51}],"term":"White Blood Cell Decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51}],"term":"White Blood Cell Count Increased"}],"timeFrame":"Assessed throughout enrollment following the initiation of study treatment, up to 5 years"}