{"description":"Subjects and parents completed daily study medication logs and noted any adverse events or symptoms. Site personnel reviewed study medication logs with subjects to assess for adverse events and completed an in-person neurological exam and chemistry profile at weeks 5 and 10 to assess for adverse events. Adverse events reviewed by independent DSMB.","eventGroups":[{"description":"Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).","id":"EG000","otherNumAffected":16,"otherNumAtRisk":127,"seriousNumAffected":9,"seriousNumAtRisk":127,"title":"Arm I Glutamic Acid"},{"description":"Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).","id":"EG001","otherNumAffected":5,"otherNumAtRisk":123,"seriousNumAffected":6,"seriousNumAtRisk":123,"title":"Arm II Placebo"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":127,"numEvents":10},{"groupId":"EG001","numAffected":3,"numAtRisk":123,"numEvents":3}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":127,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":123,"numEvents":6}],"term":"Pain"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":123,"numEvents":1}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":123,"numEvents":0}],"term":"Adrenal Insufficiency"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":123,"numEvents":1}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":123,"numEvents":1}],"term":"Tumor lysis syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":123,"numEvents":1}],"term":"Pancreatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":123,"numEvents":0}],"term":"Colitis, infectious (e.g., Clostridium difficile)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":123,"numEvents":2}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":123,"numEvents":0}],"term":"Infection-Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":123,"numEvents":0}],"term":"Infection with unknown ANC"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":123,"numEvents":1}],"term":"Bilirubin (hyperbilirubinemia)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":123,"numEvents":0}],"term":"Cognitive disturbance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":123,"numEvents":1}],"term":"Confusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":123,"numEvents":1}],"term":"Encephalopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":123,"numEvents":0}],"term":"Leukoencephalopathy (radiographic findings)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":127,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":123,"numEvents":3}],"term":"Seizure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":123,"numEvents":0}],"term":"Somnolence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":123,"numEvents":0}],"term":"Syncope (fainting)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":123,"numEvents":0}],"term":"Pulmonary/Upper Respiratory - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":123,"numEvents":1}],"term":"Vascular - Other"}],"timeFrame":"10 weeks"}