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effect of tisagenlecleucel therapy on patient-reported outcomes was assessed using the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) questionnaire, which measures quality of life in participants with lymphoma. FACT-Lym is composed of the FACT-G (27 items across Physical, Social/Family, Emotional, and Functional Well-Being, plus Additional Concerns) and a 15-item lymphoma-specific subscale. All items use a five-point self-administered response scale (0-4), with higher scores indicating better quality of life. The possible score ranges are as follows: - Physical Well-Being (PWB): 0-28 - Social/Family Well-Being (SWB): 0-28 - Emotional Well-Being (EWB): 0-24 - Functional Well-Being (FWB): 0-28 - Lym Subscale (15 items): 0-60 - Lymphoma Trial Outcome Index (TOI: PWB + FWB + Lym): 0-116 - FACT-G Total (PWB + SWB + EWB + FWB): 0-108 - FACT-Lym Total (FACT-G + Lym): 0-168 In all cases, higher scores indicate better outcomes within the corresponding domain.","dispersionType":"Standard Deviation","groups":[{"description":"Participants expressed their emotional well-being.","id":"OG000","title":"CTL019 - Emotional Well-Being"},{"description":"Participants expressed their efunctional well-being.","id":"OG001","title":"CTL019 - Functional Well-Being"},{"description":"Participants expressed their physical well-being.","id":"OG002","title":"CTL019 - Physiscal Well-Being"},{"description":"Participants expressed their social/family well-being.","id":"OG003","title":"CTL019 - Social/Family Well-Being"},{"description":"The calculated Lym-subscale expressed by participants.","id":"OG004","title":"CTL019 - FACT-Lym Subscale"},{"description":"The calculated FACT-Lymphoma trial outcome index expressed by participants.","id":"OG005","title":"CTL019 - FACT-Lym Trial Outcome Index"},{"description":"The FACTG total score expressed by the participants.","id":"OG006","title":"FACT-G Total Score"},{"description":"The total FACT-Lym score expressed by the participants.","id":"OG007","title":"FACT-Lym 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, M6, M9, M12, M18, M24, M36","title":"Summary Scores of PRO Measured by FACT-Lym Quality of Life Questionnaire","type":"SECONDARY","unitOfMeasure":"scores on a scale"}