{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"}],"units":"Participants"}],"description":"ORR: Number of participants with best response of Complete Response (CR), Partial Response (PR), or Minor Response (MR) per International Neuroblastoma Response Criteria (INRC).\n\n* CR is defined as complete response in all response components:\n\n  * Primary Tumor: \\<10 mm residual soft tissue primary site and complete resolution of MIBG-avid tumors\n  * Soft tissue and bone metastatic response: nonprimary target and nontarget lesions \\<10 mm and nodes identified as targets decreased to short axis \\<10mm and MIBG-avid update of nonprimary lesions completely resolved\n  * Bone marrow response: no tumor infiltration on reassessment; disappearance of all target lesions;\n* PR is defined as PR in \\>1component and all other components are either CR, minimal disease (MD) (bone marrow only), PR (soft tissue or bone), or not involved (NI) and no components with progressive disease (PD).\n* MR is defined PR or CR in \\>1 component and SD in \\>1 component and no component with PD","groups":[{"description":"Participants received:\n\n* Abemaciclib: 55 mg/m², administered orally BID.\n* Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.\n* Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.\n* Dinutuximab: 17.5mg/m²/day, administered IV on Days 2-5 of each cycle.\n* Granulocyte-macrophage colony-stimulating factor (GM-CSF): 250 μg/m²/day, administered subcutaneously (SC) on Days 6-12 of each cycle.\n\nTreatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.","id":"OG000","title":"Part C Cohort C1"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All part C participants who received at least one dose of study drug. However, Part C was terminated early and only 1 participant was enrolled in this part.","reportingStatus":"POSTED","timeFrame":"Date of first dose to disease progression or death (Up to 25 Months)","title":"Number of Participants With Overall Response Rate (ORR) in Part C.","type":"PRIMARY","unitOfMeasure":"Participants"}