{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"51.6","upperLimit":"97.9","value":"83.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"These are the percentage of participants with ORR who achieved overall remission rate which includes complete response (CR) and CR with incomplete blood count recovery (CRi) as determined by IRC assessment after having been infused with tisagenlecleucel from Fraunhofer Institute manufacturing facility.","dispersionType":"95% Confidence Interval","groups":[{"description":"Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).","id":"OG000","title":"Main Cohort: Single Dose of CTL019"},{"description":"Pediatric B-ALL patients who are very high risk at first relapse.","id":"OG001","title":"Cohort 1: Single Dose of CTL019"}],"paramType":"NUMBER","populationDescription":"FAS: The Full analysis set comprised all patients who received infusion of tisagenlecleucel from Fraunhofer Institue Manufacturing Facility. Participants in Cohort 1 were from the Fraunhofer Institute manufacturing facility and not the US where the data was collected from, so no data was collected for this Cohort.","reportingStatus":"POSTED","timeFrame":"60 months","title":"Percentage of Participants With Overall Remission Rate (ORR) - From Fraunhofer Institute Manufacturing Facility","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}