{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"117.7","value":"42800"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"This is the summary of cellular kinetic concentrations for Tisagenlecleucel (CTL019) transgene levels by qPCR, by disease response in blood by IRC assessment. The assessment of the efficacy, safety and in vivo cellular pharmacokinetics are for patients infused with tisagenlecleucel manufactured by Fraunhofer Institute.","dispersionType":"Geometric Coefficient of Variation","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":"GEOMETRIC_LEAST_SQUARES_MEAN","populationDescription":"PAS: The PAS consisted of patients in the FAS who had at least one sample providing evaluable cellular kinetic data for 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":"Month 60","title":"Tisagenlecleucel Transgene Levels by qPCR in Peripheral Blood - Tisagenlecleucel Manufactured From Fraunhofer Institute","type":"SECONDARY","unitOfMeasure":"copies/ug"}