{"analyses":[{"ciLowerLimit":"8.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"18.8","groupDescription":"Difference in mean change of scores from Baseline at Day 100.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"False Discovery Rate Methodology","paramType":"Mixed Model with Repeated Measures","paramValue":"13.7","statisticalComment":"Mixed Model with Repeated Measures Differences in Change from Baseline.","statisticalMethod":"Mixed Model with Repeated Measures"},{"ciLowerLimit":"5.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"17.1","groupDescription":"Difference in mean change of scores from Baseline at Day 150.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0004","pValueComment":"False Discovery Rate Methodology","paramType":"Mixed Model with Repeated Measures","paramValue":"11.3","statisticalMethod":"Mixed Model with Repeated Measures"},{"ciLowerLimit":"-2.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"10.0","groupDescription":"Difference in mean change of scores from Baseline at Month 9.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2549","pValueComment":"False Discovery Rate Methodology.","paramType":"Mixed Model with Repeated Measures","paramValue":"3.8","statisticalComment":"Mixed Model with Repeated Measures Differences in Change from Baseline.","statisticalMethod":"Mixed Model with Repeated Measures"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.7","value":"72.4"},{"groupId":"OG001","spread":"20.1","value":"74.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"165"},{"groupId":"OG001","value":"129"}],"units":"Participants"}],"title":"Score at Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.7","value":"-1.9"},{"groupId":"OG001","spread":"16.7","value":"-4.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"124"}],"units":"Participants"}],"title":"Change from Baseline at Study Day 50"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.4","value":"4.0"},{"groupId":"OG001","spread":"19.8","value":"-8.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"145"},{"groupId":"OG001","value":"64"}],"units":"Participants"}],"title":"Change from Baseline at Study Day 100"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.4","value":"9.1"},{"groupId":"OG001","spread":"22.2","value":"-2.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"110"},{"groupId":"OG001","value":"54"}],"units":"Participants"}],"title":"Change from Baseline at Study Day 150"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.9","value":"11.4"},{"groupId":"OG001","spread":"19.0","value":"4.4"}]}],"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":"19.9","value":"10.1"},{"groupId":"OG001","spread":"17.8","value":"6.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"31"}],"units":"Participants"}],"title":"Change from Baseline at Study Month 12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.7","value":"10.7"},{"groupId":"OG001","spread":"13.7","value":"8.2"}]}],"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":"17.1","value":"15.1"},{"groupId":"OG001","spread":"13.6","value":"9.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"23"}],"units":"Participants"}],"title":"Change from Baseline at Study Month 18"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.2","value":"14.0"},{"groupId":"OG001","spread":"14.3","value":"10.1"}]}],"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":"18.8","value":"10.9"},{"groupId":"OG001","spread":"15.3","value":"12.2"}]}],"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":"129"}],"units":"Participants"}],"description":"The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the participants' health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each participant for his or her current HRQoL state and scored 0 (\"the worst health you can imagine\") to 100 (\"the best health you can imagine\"). The value 100 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":"Change From Baseline in EQ-5D-5L VAS Scale Score","type":"SECONDARY","unitOfMeasure":"Score on scale"}