{"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. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.","eventGroups":[{"deathsNumAffected":3,"deathsNumAtRisk":68,"description":"COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5.\n\nCOURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5.\n\nBrentuximab Vedotin: Given IV\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IT and IV\n\nDexamethasone: Given PO or IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nIfosfamide: Given IV\n\nMethotrexate: Given IT and IV","id":"EG000","otherNumAffected":57,"otherNumAtRisk":68,"seriousNumAffected":24,"seriousNumAtRisk":68,"title":"Arm BV (Brentuximab Vedotin, Combination Chemotherapy)"},{"deathsNumAffected":3,"deathsNumAtRisk":68,"description":"COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A.\n\nCOURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.\n\nCrizotinib: Given PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IT and IV\n\nDexamethasone: Given PO or IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nIfosfamide: Given IV\n\nMethotrexate: Given IT and IV","id":"EG001","otherNumAffected":55,"otherNumAtRisk":68,"seriousNumAffected":41,"seriousNumAtRisk":68,"title":"Arm CZ (Crizotinib, Combination Chemotherapy)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":68},{"groupId":"EG001","numAffected":27,"numAtRisk":68}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Blood and lymphatic system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":68},{"groupId":"EG001","numAffected":30,"numAtRisk":68}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Periorbital edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":2,"numAtRisk":68}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":68}],"term":"Dental caries"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":68},{"groupId":"EG001","numAffected":3,"numAtRisk":68}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":68}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Hepatobiliary disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":68}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Endocarditis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Enterocolitis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":68},{"groupId":"EG001","numAffected":5,"numAtRisk":68}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Kidney infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Otitis media"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Scrotal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":2,"numAtRisk":68}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Wound dehiscence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":68},{"groupId":"EG001","numAffected":9,"numAtRisk":68}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":68},{"groupId":"EG001","numAffected":3,"numAtRisk":68}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Creatinine 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decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Lymphocyte count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":68},{"groupId":"EG001","numAffected":32,"numAtRisk":68}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":68},{"groupId":"EG001","numAffected":26,"numAtRisk":68}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":68}],"term":"Weight 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