{"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). The \"AE Other\" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.","eventGroups":[{"deathsNumAffected":12,"deathsNumAtRisk":18,"description":"CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8.\n\nIrinotecan Hydrochloride: Given IV\n\nLaboratory Biomarker Analysis: Optional correlative studies\n\nTemozolomide: Given PO\n\nTemsirolimus: Given IV","id":"EG000","otherNumAffected":10,"otherNumAtRisk":18,"seriousNumAffected":5,"seriousNumAtRisk":18,"title":"Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)"},{"deathsNumAffected":15,"deathsNumAtRisk":51,"description":"Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12.\n\nDinutuximab: Given IV\n\nIrinotecan Hydrochloride: Given IV\n\nLaboratory Biomarker Analysis: Optional correlative studies\n\nSargramostim: Given SC or IV\n\nTemozolomide: Given PO","id":"EG001","otherNumAffected":39,"otherNumAtRisk":51,"seriousNumAffected":18,"seriousNumAtRisk":51,"title":"Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":51}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18},{"groupId":"EG001","numAffected":8,"numAtRisk":51}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Allergic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":18},{"groupId":"EG001","numAffected":12,"numAtRisk":51}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":51}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":51}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"BACTEREMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":51}],"term":"BLOOD"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"BLOOD - STAPHYLOCOCCUS EPIDERMIDIS ISOLATED."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"BLOOD - STAPHYLOCOCCUS HOMINIS ISOLATES"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":51}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Blurred vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":51}],"term":"Capillary leak syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"CENTRAL LINE INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":51}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":8,"numAtRisk":51}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Enterocolitis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":10,"numAtRisk":51}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":51}],"term":"GGT increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":51}],"term":"GRAM-POSITIVE BACILLI FROM PORT BLOOD CULTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":51}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":51}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 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5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":6,"numAtRisk":51}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":5,"numAtRisk":51}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 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infestations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"LINE INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18},{"groupId":"EG001","numAffected":13,"numAtRisk":51}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Lymphocyte count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":51}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":18},{"groupId":"EG001","numAffected":13,"numAtRisk":51}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 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WARNERI FROM WHITE LUMEN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":51}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":51}],"term":"Urine output decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 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