{"description":"SAEs were grade 3+ unexpected, treatment-related events deemed notable by the study chair. Accessible adverse event data represents a count of events by toxicity type rather than worst-grade by toxicity type and therefore cannot be reported in the established framework (Affected/At Risk). See secondary outcomes for events by system organ class.","eventGroups":[{"description":"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen \\[vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)\\] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine,and hydrocortisone, coinciding with a cycle of CT.\n\nRadiation Therapy: Pts w/ M0 dz OR M+ dz aged \\<3y received focal RT (3D conformal or intensity-modulated delivery). Pts \\>3y w/ M+ dz rcvd craniospinal irradiation.\n\nContinuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.","id":"EG000","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":4,"seriousNumAtRisk":20,"title":"Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)"}],"frequencyThreshold":"0","seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Patient died of pneumococcal sepsis","organSystem":"Infections and infestations","sourceVocabulary":"CTCAEv2","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAEv2","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20,"numEvents":2}],"term":"Radiation recall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAEv2","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"Transverse Myeolitis"}],"timeFrame":"Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy."}