{"analyses":[{"ciLowerLimit":"0.024","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.138","groupDescription":"Difference in mean change of scores from Baseline at Day 100.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0112","pValueComment":"False Discovery Rate Methodology.","paramType":"Mixed Model with Repeated Measures","paramValue":"0.081","statisticalMethod":"Mixed Model with Repeated Measures"},{"ciLowerLimit":"-0.034","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.091","groupDescription":"Difference in mean change of scores from Baseline at Day 150.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3703","pValueComment":"False Discovery Rate Methodology.","paramType":"Mixed Model with Repeated Measures","paramValue":"0.028","statisticalMethod":"Mixed Model with Repeated Measures"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.210","value":"0.803"},{"groupId":"OG001","spread":"0.250","value":"0.799"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"165"},{"groupId":"OG001","value":"131"}],"units":"Participants"}],"title":"Score at Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.205","value":"-0.049"},{"groupId":"OG001","spread":"0.198","value":"-0.003"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"123"}],"units":"Participants"}],"title":"Change from Baseline at Study Day 50"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.191","value":"0.012"},{"groupId":"OG001","spread":"0.246","value":"-0.068"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"65"}],"units":"Participants"}],"title":"Change from Baseline at Study Day 100"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.212","value":"0.050"},{"groupId":"OG001","spread":"0.208","value":"0.014"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"56"}],"units":"Participants"}],"title":"Change from Baseline at Study Day 150"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.190","value":"0.064"},{"groupId":"OG001","spread":"0.197","value":"0.015"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"39"}],"units":"Participants"}],"title":"Change from Baseline at Study Month 9"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.241","value":"0.072"},{"groupId":"OG001","spread":"0.200","value":"0.051"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"32"}],"units":"Participants"}],"title":"Change from Baseline at Study Month 12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.209","value":"0.051"},{"groupId":"OG001","spread":"0.125","value":"0.080"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"26"}],"units":"Participants"}],"title":"Change from Baseline at Study Month 15"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.180","value":"0.094"},{"groupId":"OG001","spread":"0.188","value":"0.072"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"Change from Baseline at Study Month 18"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.235","value":"0.089"},{"groupId":"OG001","spread":"0.177","value":"0.110"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"20"}],"units":"Participants"}],"title":"Change from Baseline at Study Month 21"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.239","value":"0.051"},{"groupId":"OG001","spread":"0.138","value":"0.117"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"12"}],"units":"Participants"}],"title":"Change from Baseline at Study Month 24"}],"denoms":[{"counts":[{"groupId":"OG000","value":"165"},{"groupId":"OG001","value":"131"}],"units":"Participants"}],"description":"The Euro-QOL (EQ) Five Dimensions (5D) Five Levels (5L), EQ-5D-5L questionnaire was a generic measure of health status that provided a simple descriptive profile and a single index value. The EQ-5D-5L comprised 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health stated using a visual analog scale (VAS). The total score for EQ-5D-5L index was presented on a range from 0 to 1 where higher scores indicated better outcome. A positive change from Baseline indicates improvement.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received cyclophosphamide 500 mg/m\\^2/day IV infusion and fludarabine 30 mg/m\\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.","id":"OG000","title":"Axicabtagene Ciloleucel"},{"description":"Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:\n\n* R-ICE: rituximab 375mg/m\\^2 before chemotherapy, ifosfamide 5g/m\\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\\^2/day on Days 1-3;\n* R-ESHAP: rituximab 375mg/m\\^2 Day 1, etoposide 40mg/m\\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\\^2/day CI Days 1-4, cytarabine 2g/m\\^2 on Day 5;\n* R-GDP: rituximab 375mg/m\\^2 Day 1 (or Day 8), gemcitabine 1g/m\\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\\^2 Day 1 or carboplatin AUC=5; or\n* R-DHAP: rituximab 375mg/m\\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\\^2.\n\nParticipants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.","id":"OG001","title":"Standard of Care Therapy"}],"paramType":"MEAN","populationDescription":"Participants in QoL analysis set with data available at given timepoint were analyzed.","reportingStatus":"POSTED","timeFrame":"Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24","title":"Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score","type":"SECONDARY","unitOfMeasure":"Score on scale"}