{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"15"}]}],"title":"AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"title":"AEs suspected to be drug related"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}],"title":"On-treatment death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"}]}],"title":"SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"SAEs suspected to be drug related"}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"description":"An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs or SAEs were defined as AEs or SAEs that were suspected to be related to study treatment as per investigator. On treatment death was a fatal event leading to permanent cessations of all vital functions of the body.","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":"NUMBER","populationDescription":"The analysis was performed in safety set population, defined as the participants who received at least one dose of midostaurin.","reportingStatus":"POSTED","timeFrame":"Baseline (start of study treatment) up to End of treatment (up to 24 months after last dose or until death whichever occurred first)","title":"Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs or SAEs and Death During the Study","type":"SECONDARY","unitOfMeasure":"Participants"}