{"analyses":[{"groupIds":["OG000"],"nonInferiorityComment":"testing the null hypothesis that ORR with MRD negative within 3 months is less than or equal to 15%","nonInferiorityType":"OTHER","pValue":"<.0001","statisticalMethod":"Clopper-Pearson"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"70.6","upperLimit":"89.0","value":"81.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"79"}],"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 all manufacturing facilities by IRC assessment. MRD negative = MRD% \\< 0.01%","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"}],"paramType":"NUMBER","populationDescription":"FAS: The Full analysis set comprised all patients who received infusion of tisagenlecleucel from all manufacturing facilities.","reportingStatus":"POSTED","timeFrame":"3 months after tisagenlecleucel administration","title":"Percentage of Participants With Best Overall Response (BOR) of CR or CRi With MRD Negative Bone Marrow by Flow Cytometry From All Manufacturing Facilities as Per IRC in the Main Cohort Only (Key Secondary)","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}