{"description":"Per protocol, some grade 3 and 4 hematologic toxicities, grade 3 elevation in serum ALT or AST, grade 3 and 4 electrolyte abnormalities, and total parenteral nutrition or intravenous fluids administered to prevent significant weight loss/malnutrition were not collected, especially if they occurred from the beginning of induction chemotherapy. The one patient in the high-risk group who did not start therapy due to early disease progression was excluded from adverse event results.","eventGroups":[{"deathsNumAffected":10,"deathsNumAtRisk":57,"description":"Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.","id":"EG000","otherNumAffected":55,"otherNumAtRisk":57,"seriousNumAffected":3,"seriousNumAtRisk":57,"title":"Low-Risk Group"},{"deathsNumAffected":58,"deathsNumAtRisk":156,"description":"Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.","id":"EG001","otherNumAffected":145,"otherNumAtRisk":156,"seriousNumAffected":7,"seriousNumAtRisk":156,"title":"Intermediate-Risk Group"},{"deathsNumAffected":49,"deathsNumAtRisk":77,"description":"Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.","id":"EG002","otherNumAffected":70,"otherNumAtRisk":76,"seriousNumAffected":5,"seriousNumAtRisk":76,"title":"High-Risk Group"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Fever of unknown origin without clinically or microbiologically documented infection (ANC \\<1.0 x 10e9/L, fever \\>=38.5 degrees C)","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":57,"numEvents":83},{"groupId":"EG001","numAffected":92,"numAtRisk":156,"numEvents":169},{"groupId":"EG002","numAffected":48,"numAtRisk":76,"numEvents":120}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system 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(3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":57,"numEvents":11},{"groupId":"EG001","numAffected":25,"numAtRisk":156,"numEvents":32},{"groupId":"EG002","numAffected":22,"numAtRisk":76,"numEvents":29}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":57,"numEvents":15},{"groupId":"EG001","numAffected":9,"numAtRisk":156,"numEvents":20},{"groupId":"EG002","numAffected":3,"numAtRisk":76,"numEvents":3}],"term":"Hemoglobin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 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Catheter-related"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":57,"numEvents":19},{"groupId":"EG001","numAffected":8,"numAtRisk":156,"numEvents":9},{"groupId":"EG002","numAffected":4,"numAtRisk":76,"numEvents":4}],"term":"Platelets"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":57,"numEvents":1},{"groupId":"EG001","numAffected":8,"numAtRisk":156,"numEvents":10},{"groupId":"EG002","numAffected":9,"numAtRisk":76,"numEvents":13}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 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cavity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":57,"numEvents":3},{"groupId":"EG001","numAffected":8,"numAtRisk":156,"numEvents":12},{"groupId":"EG002","numAffected":7,"numAtRisk":76,"numEvents":10}],"term":"Colitis, infectious (e.g., Clostridium difficile)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":57,"numEvents":0},{"groupId":"EG001","numAffected":7,"numAtRisk":156,"numEvents":9},{"groupId":"EG002","numAffected":7,"numAtRisk":76,"numEvents":7}],"term":"Infection, Skin (cellulitis)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":57,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":156,"numEvents":5},{"groupId":"EG002","numAffected":7,"numAtRisk":76,"numEvents":7}],"term":"Seizure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":57,"numEvents":5},{"groupId":"EG001","numAffected":5,"numAtRisk":156,"numEvents":6},{"groupId":"EG002","numAffected":5,"numAtRisk":76,"numEvents":5}],"term":"Infection, Blood"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":57,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":156,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":76,"numEvents":6}],"term":"Weight loss"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":57,"numEvents":1},{"groupId":"EG001","numAffected":6,"numAtRisk":156,"numEvents":6},{"groupId":"EG002","numAffected":6,"numAtRisk":76,"numEvents":6}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":57,"numEvents":1},{"groupId":"EG001","numAffected":11,"numAtRisk":156,"numEvents":12},{"groupId":"EG002","numAffected":4,"numAtRisk":76,"numEvents":5}],"term":"Mucositis/stomatitis (clinical exam), Oral cavity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":57,"numEvents":4},{"groupId":"EG001","numAffected":8,"numAtRisk":156,"numEvents":11},{"groupId":"EG002","numAffected":4,"numAtRisk":76,"numEvents":5}],"term":"Infection - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":57,"numEvents":2},{"groupId":"EG001","numAffected":8,"numAtRisk":156,"numEvents":9},{"groupId":"EG002","numAffected":5,"numAtRisk":76,"numEvents":5}],"term":"Hydrocephalus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":57,"numEvents":3},{"groupId":"EG001","numAffected":9,"numAtRisk":156,"numEvents":9},{"groupId":"EG002","numAffected":4,"numAtRisk":76,"numEvents":4}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils, Blood"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":57,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":156,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Hearing: patients with/without baseline audiogram and enrolled in a monitoring program"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":57,"numEvents":4},{"groupId":"EG001","numAffected":8,"numAtRisk":156,"numEvents":9},{"groupId":"EG002","numAffected":3,"numAtRisk":76,"numEvents":3}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":57,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":156,"numEvents":4},{"groupId":"EG002","numAffected":4,"numAtRisk":76,"numEvents":4}],"term":"Infection, Upper airway NOS"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 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defined as ANC <1.0 x 10e9/L)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":57,"numEvents":1},{"groupId":"EG001","numAffected":8,"numAtRisk":156,"numEvents":9},{"groupId":"EG002","numAffected":3,"numAtRisk":76,"numEvents":3}],"term":"ALT, SGPT (serum glutamic pyruvic transaminase)"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":57,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":156,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":76,"numEvents":0}],"term":"Hearing: patients with/without baseline audiogram and enrolled in a monitoring program"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":57,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":156,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":76,"numEvents":0}],"term":"Hemoglobin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":57,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":156,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Neutrophils/granulocytes (ANC/AGC)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 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malaise)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":57,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":156,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":76,"numEvents":0}],"term":"Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":57,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":156,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":76,"numEvents":0}],"term":"Weight loss"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":57,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":156,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":76,"numEvents":0}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":57,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":156,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":57,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":156,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":76,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":57,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":156,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":57,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":156,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":76,"numEvents":0}],"term":"Mucositis/stomatitis (clinical exam), Oral 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(3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":57,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":156,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":76,"numEvents":0}],"term":"Dyspnea (shortness of breath)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":57,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":156,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":76,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":57,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":156,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":76,"numEvents":0}],"term":"Pneumonitis/pulmonary infiltrates"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":57,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":156,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":76,"numEvents":2}],"term":"Pulmonary/Upper Respiratory - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":57,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":156,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":76,"numEvents":0}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils, Wound"}],"timeFrame":"All adverse events grades 3, 4, and 5 which occur during treatment and for 30 days after the end of treatment, and events which occur later than 30 days after the end of treatment which are felt to be at least possibly related to treatment, to the time of off study, were collected with some exceptions noted in the additional description section, up to 6 years.."}