{"analyses":[{"ciLowerLimit":"8.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"18.2","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":"13.1","statisticalMethod":"Mixed Model with Repeated Measures"},{"ciLowerLimit":"-0.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"11.0","groupDescription":"Difference in mean change of scores from Baseline at Day 150.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1253","pValueComment":"False Discovery Rate Methodology.","paramType":"Mixed Model with Repeated Measures","paramValue":"5.1","statisticalMethod":"Mixed Model with Repeated Measures"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.7","value":"83.5"},{"groupId":"OG001","spread":"18.9","value":"85.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"164"},{"groupId":"OG001","value":"131"}],"units":"Participants"}],"title":"Score at Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.7","value":"-12.9"},{"groupId":"OG001","spread":"17.5","value":"-8.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"162"},{"groupId":"OG001","value":"126"}],"units":"Participants"}],"title":"Change from Baseline at Study Day 50"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.8","value":"-1.8"},{"groupId":"OG001","spread":"19.1","value":"-15.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"64"}],"units":"Participants"}],"title":"Change from Baseline at Study Day 100"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.9","value":"1.3"},{"groupId":"OG001","spread":"21.3","value":"-5.2"}]}],"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":"17.1","value":"4.1"},{"groupId":"OG001","spread":"23.5","value":"-2.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"40"}],"units":"Participants"}],"title":"Change from Baseline at Study Month 9"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.8","value":"3.4"},{"groupId":"OG001","spread":"20.3","value":"0.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"33"}],"units":"Participants"}],"title":"Change from Baseline at Study Month 12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.3","value":"3.9"},{"groupId":"OG001","spread":"16.1","value":"1.6"}]}],"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":"15.1","value":"5.0"},{"groupId":"OG001","spread":"17.9","value":"3.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"23"}],"units":"Participants"}],"title":"Change from Baseline at Study Month 18"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.1","value":"6.0"},{"groupId":"OG001","spread":"21.4","value":"4.3"}]}],"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":"16.5","value":"3.7"},{"groupId":"OG001","spread":"8.0","value":"5.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"12"}],"units":"Participants"}],"title":"Change from Baseline at Study Month 24"}],"denoms":[{"counts":[{"groupId":"OG000","value":"164"},{"groupId":"OG001","value":"131"}],"units":"Participants"}],"description":"The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).\n\nThe Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were transformed to a scale from 0 to 100, where a high score indicated better QoL. A positive change from baseline indicates better QoL.","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 EORTC QLQ-C30 Physical Functioning Score","type":"SECONDARY","unitOfMeasure":"Score on scale"}