{"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":"70.8","upperLimit":"90.4","value":"82.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"67"}],"units":"Participants"}],"description":"These are the percentage of participants who achieved Best Overall Response (BOR) of complete response (CR) or complete response with incomplete blood count recovery (CRi) with an MRD-negative bone marrow by central analysis using flow cytometry among participants who received tisagenlecleucel from US 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"}],"paramType":"NUMBER","populationDescription":"FAS: The Full analysis set comprised all patients who received infusion of tisagenlecleucel from US manufacturing facilities.","reportingStatus":"POSTED","timeFrame":"3 months after tisagenlecleucel administration","title":"Percentage of Participants With Best Overall Response (BOR) of CR or CRi With Minimal Residue Disease (MRD) Negative Bone Marrow From US Manufacturing Facility as Per IRC in the Main Cohort Only (Key Secondary)","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}