{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"0.16","value":"0.03"},{"groupId":"OG001","lowerLimit":"0.01","upperLimit":"0.33","value":"0.10"}]}],"title":"Younger stratum (≥ 3months -≤ 2 years): (n=2, 5)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"0.13","value":"0.03"},{"groupId":"OG001","lowerLimit":"0.01","upperLimit":"0.26","value":"0.08"}]}],"title":"Older stratum (>2 years- <18years): (n=4,6)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"description":"MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT), based on a Bayesian logistic regression model (BLRM) employing the escalation with overdose control (EWOC) principle. A DLT was defined as a grade 3 or 4 non-hematological adverse event (AE) or abnormal laboratory value related to study drug. Mean and the 95% posterior probability estimates of having a DLT by age strata and dose is presented. Estimation of MTD and/or recommended dose for expansion (RDE) at the dose-escalation phase of the study was based upon the estimation of the probability of DLT for participants in the dose-determining set (DDS).","dispersionType":"97.5% Confidence Interval","groups":[{"description":"Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m\\^2 bid through oral route. The total daily dose in 30 mg/m\\^2 bid cohort was 60 mg/m\\^2.","id":"OG000","title":"Cohort 1: Midostaurin (30 Milligrams/Meters^2)"},{"description":"Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m\\^2 bid through oral route. The total daily dose in 60 mg/m\\^2 bid cohort was 120 mg/m\\^2.","id":"OG001","title":"Cohort 2: Midostaurin (60 mg/m^2)"}],"paramType":"MEAN","populationDescription":"The analysis was performed in dose determining set (DDS) population. Here, 'n' signifies the number of evaluable participants for this measure.","reportingStatus":"POSTED","timeFrame":"Baseline, End of dose escalation phase (6 months)","title":"Maximum Tolerated Dose (MTD) of Midostaurin- Posterior Probability of DLT","type":"PRIMARY","unitOfMeasure":"probability estimates"}