{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"20"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"27"}],"units":"Participants"}],"description":"Number of participants who successfully achieve target systemic exposure of intravenous topotecan after a pharmacokinetic-guided dosage adjustment during consolidation phase of therapy are reported.","groups":[{"description":"Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease","id":"OG000","title":"Intermediate-Risk Group"},{"description":"Patients with central nervous system (CNS) metastatic disease","id":"OG001","title":"High-Risk Group"}],"paramType":"NUMBER","populationDescription":"Eligible patients who received topotecan with PK-guided dosage adjustment during consolidation therapy were included in this analysis. Per protocol, low-risk and intermediate-risk patients did not receive topotecan during consolidation unless they experienced disease progression during induction. One such intermediate-risk patient was included.","reportingStatus":"POSTED","timeFrame":"Pre-infusion, 5 min., 1, and 3 hours from end of infusion","title":"Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan","type":"SECONDARY","unitOfMeasure":"participants"}