{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"28.2","upperLimit":"54.8","value":"41.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"53"}],"units":"Participants"}],"description":"Percentage of patients who are responders to therapy with dinutuximab will be tabulated, including a 95% confidence interval on the response rate. Responders are defined as patients who achieve a best overall response of complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Neuroblastoma Response Criteria (INRC). Per INRC: CR= Disappearance of all target lesions. No evidence of tumor at any site; VGPR= \\>90% decrease of disease measurement for CT/MRI target lesions. All pre-existing bone lesions with CR by MIBG; MIBG scan can be stable disease (SD) or CR in soft tissue lesions corresponding to lesions on CT/MRI. CR in bone marrow. No new sites of tumor; PR= ≥30% decrease in disease measurement for CT/MRI target lesions. Bone marrow with CR. MIBG with either PR/CR in bone lesions; MIBG may be SD or CR in soft tissue lesions corresponding to lesions on CT/MRI. Homovanillic acid (HVA)/ Vanillylmandelic acid (VMA) may still be elevated.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12.\n\nDinutuximab: Given IV\n\nIrinotecan Hydrochloride: Given IV\n\nLaboratory Biomarker Analysis: Optional correlative studies\n\nSargramostim: Given SC or IV\n\nTemozolomide: Given PO","id":"OG000","title":"Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)"}],"paramType":"NUMBER","populationDescription":"Includes all eligible patients either randomized or non-randomly assigned to Arm II. Of the 54 participants assigned to Arm II, 1 was ineligible and not included in the analysis. The remaining 53 eligible participants are included in the analysis, 17 randomized and 36 non-randomly assigned to Arm II.","reportingStatus":"POSTED","timeFrame":"Up to the first 6 cycles of treatment","title":"Percentage of Patients in the Dinutuximab Arm Who Are Responders","type":"PRIMARY","unitOfMeasure":"Percentage of patients"}