{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.98","value":"14.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M3 change from baseline - Emotional"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.96","value":"15.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M6 change from baseline - Emotional"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.74","value":"24.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M12 change from baseline - Emotional"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.85","value":"27.02"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M24 change from baseline - Emotional"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.53","value":"21.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M60 change from baseline - Emotional"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.90","value":"7.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M3 change from baseline - Social"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.04","value":"8.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M6 change from baseline - Social"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.68","value":"14.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M12 change from baseline - Social"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.85","value":"17.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M24 change from baseline - Social"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.77","value":"17.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M60 change from baseline - Social"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.35","value":"8.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M3 change from baseline - School"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.58","value":"10.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M6 change from baseline - School"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.97","value":"19.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M12 change from baseline - School"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.98","value":"13.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M24 change from baseline - School"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.46","value":"17.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M60 change from baseline - School"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.36","value":"17.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M3 change from baseline - Physical"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.81","value":"21.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M6 change from baseline - Physical"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.57","value":"31.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M12 change from baseline - Physical"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.12","value":"37.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M24 change from baseline - Physical"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.90","value":"37.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M60 change from baseline - Physical"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.38","value":"10.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M3 change from baseline - Psychosocial health"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.08","value":"11.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M6 change from baseline - Psychosocial health"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.80","value":"19.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M12 change from baseline - Psychosocial health"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.34","value":"20.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M24 change from baseline - Psychosocial health"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.15","value":"18.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M60 change from baseline - Psychosocial health"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.28","value":"13.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M3 change from baseline - Total score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.00","value":"14.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M6 change from baseline - Total score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.56","value":"2.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M12 change from baseline - Total score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.70","value":"26.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M24 change from baseline - Total score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.45","value":"25.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"M60 change from baseline - Total score"}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"The PedsQL questionnaire was for patients ≥ 8-years-old who achieved BOR as CR or CRi within 3 months and the questionnaire was on emotional, social, school, physical, and psychosocial health. Scores are transformed on a scale from 0 to 100, with the sum of all the items over the number of items answered on all the scales. The total scale score is the averaged value of scores of subscales, which means for each subscale and the total scale, the allowed ranges are 0-100. Higher scores on the PedsQL questionnaire for these subscales indicate consistent improvement of health-related quality of life (HRQol).","dispersionType":"Standard Error","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":"MEAN","populationDescription":"FAS: the Full analysis set comprised all patients who received infusion of tisagenlecleucel and who had evaluable results at the measured time points. This analysis included a subset of FAS who had any data of the particular questionnaire at the specific timepoint. Therefore, no participants in Cohort 1 had questionnaire data for tisagenlecleucel at the measured time points, so no data was collected for Cohort 1.","reportingStatus":"POSTED","timeFrame":"Month 3, M6, M12, M24, M60","title":"Effects of CTL019 Therapy on Patient Reported Outcomes as Measured by PedsQL Questionnaire","type":"SECONDARY","unitOfMeasure":"Scores on a scale"}