{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"8.6274","value":"48.234"},{"groupId":"OG001","spread":"10.5072","value":"49.444"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"}],"units":"Participants"}],"title":"Baseline (BL)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.1560","value":"48.829"},{"groupId":"OG001","spread":"8.7843","value":"52.786"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"65"}],"units":"Participants"}],"title":"Month (M) 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"10.0189","value":"48.985"},{"groupId":"OG001","spread":"10.4425","value":"49.449"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"64"}],"units":"Participants"}],"title":"M6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.0057","value":"48.595"},{"groupId":"OG001","spread":"10.2775","value":"49.752"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"44"}],"units":"Participants"}],"title":"M9"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.4622","value":"48.556"},{"groupId":"OG001","spread":"8.9469","value":"49.708"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"49"}],"units":"Participants"}],"title":"M12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.0034","value":"49.174"},{"groupId":"OG001","spread":"11.4296","value":"49.697"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"50"}],"units":"Participants"}],"title":"M18"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"10.8950","value":"46.940"},{"groupId":"OG001","spread":"10.6551","value":"51.266"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"47"}],"units":"Participants"}],"title":"M24"}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"}],"units":"Participants"}],"description":"Effect of tisagenlecleucel therapy on patient reported outcomes were reported using the Short Form Health Survey (SF-36) v2 form. The SF-36 v2 is a widely used and extensively studied instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) were computed by summing the item responses on the questions for each domain in accordance with the respective scoring method provided by the developers. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. A high score defines a more favorable health state.","dispersionType":"Standard Deviation","groups":[{"description":"All participants who were enrolled in the study","id":"OG000","title":"CTL019: Physical Health Total Score"},{"description":"All participants who were enrolled in the study","id":"OG001","title":"CTL019: Mental Health Total Score"}],"paramType":"MEAN","populationDescription":"Efficacy analysis set (EAS): The number of participants in the EAS with an available value at each visit. EAS comprised of all participants who received tisagenlecleucel, and had measurable disease at baseline per IRC. Non-measurable disease at baseline is defined as absence of index lesion at baseline disease evaluation (i.e. no disease at baseline).","reportingStatus":"POSTED","timeFrame":"Baseline (BL) Month (M) 3, M3, M6, M9, M12, M18, M24","title":"Summary Scores of Patient-reported Outcome (PRO) Measured by SF-36v2 Quality of Life Questionnaire by Visit","type":"SECONDARY","unitOfMeasure":"scores on a scale"}