{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"30.3","upperLimit":"30.3","value":"30.3"},{"groupId":"OG001","lowerLimit":"6.8","upperLimit":"43.0","value":"26.40"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"27"}],"units":"Participants"}],"description":"Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan clearance are obtained using post hoc analysis.","dispersionType":"Full Range","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":"MEDIAN","populationDescription":"Eligible patients who received intravenous topotecan during consolidation cycle 1 and had PK samples collected were included in this analysis. Per protocol, low- 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":"Topotecan Clearance in Consolidation Chemotherapy","type":"SECONDARY","unitOfMeasure":"L/h/m^2"}