{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"42.8","upperLimit":"94.5","value":"75.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"These are the percentage of participants who achieved Best Overall Response (BOR) of CR or CRi with an MRD-negative bone marrow by central analysis using flow cytometry among participants who received tisagenlecleucel from Fraunhofer Institute manufacturing facilities only, by IRC assessment.","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":"3 months","title":"Percentage of Participants With Best Overall Response (BOR) of CR or CRi With Minimal Residue Disease (MRD) Negative Bone Marrow From Fraunhofer Institute Manufacturing Facility as Per IRC","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}