{"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 are excluded from reporting of adverse events.","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":18,"description":"Patients with orbital disease (including microscopic trans-scleral invasion seen on enucleation pathology), optic nerve margin (+), and/or regional nodal disease, but no other sites of metastases. Stage 2 and 3 patients will receive Induction chemotherapy and External Beam Radiation Therapy, but will not receive Consolidation therapy (High-Dose Chemotherapy with Stem Cell Rescue).","id":"EG000","otherNumAffected":13,"otherNumAtRisk":18,"seriousNumAffected":1,"seriousNumAtRisk":18,"title":"Stage 2/3 Patients"},{"deathsNumAffected":5,"deathsNumAtRisk":18,"description":"Patients with overt distant metastatic disease (such as bone, bone marrow, and/or liver) but no detectable CNS involvement. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.","id":"EG001","otherNumAffected":12,"otherNumAtRisk":18,"seriousNumAffected":2,"seriousNumAtRisk":18,"title":"Stage 4a Patients"},{"deathsNumAffected":15,"deathsNumAtRisk":19,"description":"Patients with overt CNS involvement (brain parenchyma, leptomeninges and CSF cytology). Patients with trilateral retinoblastoma will be included. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.","id":"EG002","otherNumAffected":10,"otherNumAtRisk":19,"seriousNumAffected":0,"seriousNumAtRisk":19,"title":"Stage 4b Patients"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":6,"numAtRisk":18},{"groupId":"EG002","numAffected":3,"numAtRisk":19}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Apnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Cognitive disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":19}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Enterocolitis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Esophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":18},{"groupId":"EG001","numAffected":9,"numAtRisk":18},{"groupId":"EG002","numAffected":7,"numAtRisk":19}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Gastric hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"GGT increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Hearing impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Hypermagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":19}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":18},{"groupId":"EG001","numAffected":3,"numAtRisk":18},{"groupId":"EG002","numAffected":4,"numAtRisk":19}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":19}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":3,"numAtRisk":19}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":19}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":18},{"groupId":"EG001","numAffected":6,"numAtRisk":18},{"groupId":"EG002","numAffected":4,"numAtRisk":19}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Lower gastrointestinal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":5,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18},{"groupId":"EG001","numAffected":2,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":2,"numAtRisk":19}],"term":"Nervous system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Pharyngeal mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Rectal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18},{"groupId":"EG001","numAffected":4,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":0,"numAtRisk":18},{"groupId":"EG002","numAffected":1,"numAtRisk":19}],"term":"White blood cell decreased"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18},{"groupId":"EG001","numAffected":1,"numAtRisk":18},{"groupId":"EG002","numAffected":0,"numAtRisk":19}],"term":"Sepsis"}],"timeFrame":"Up to 30 days after completion of study treatment."}