{"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":51,"deathsNumAtRisk":308,"description":"INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11.\n\nCONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9.","id":"EG000","otherNumAffected":105,"otherNumAtRisk":308,"seriousNumAffected":8,"seriousNumAtRisk":308,"title":"Arm A (Combination Chemotherapy)"},{"deathsNumAffected":42,"deathsNumAtRisk":318,"description":"INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11.\n\nCONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19.","id":"EG001","otherNumAffected":91,"otherNumAtRisk":318,"seriousNumAffected":11,"seriousNumAtRisk":318,"title":"Arm B (Combination Chemotherapy, Topotecan Hydrochloride)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":308,"numEvents":16},{"groupId":"EG001","numAffected":16,"numAtRisk":318,"numEvents":16}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Blood and lymphatic system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Bone marrow hypocellular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":308,"numEvents":28},{"groupId":"EG001","numAffected":25,"numAtRisk":318,"numEvents":25}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":308,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Left ventricular systolic dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":308,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Anal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Cecal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":308,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":308,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Rectal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":308,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General 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infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Bone infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":308,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Endocarditis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":308,"numEvents":15},{"groupId":"EG001","numAffected":6,"numAtRisk":318,"numEvents":6}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Mucosal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Otitis media"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Pelvic infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Pleural infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and 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complications","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":308,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Intraoperative neurological injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":308,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Radiation recall reaction (dermatologic)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":2}],"term":"Wound complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":308,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":318,"numEvents":2}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":318,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":308,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":318,"numEvents":1}],"term":"Blood bilirubin 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