{"analyses":[{"ciLowerLimit":"12.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"23.9","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":"18.1","statisticalMethod":"Mixed Model with Repeated Measures"},{"ciLowerLimit":"2.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"17.0","groupDescription":"Difference in mean change of scores from Baseline at Day 150.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0124","pValueComment":"False Discovery Rate Methodology","paramType":"Mixed Model with Repeated Measures","paramValue":"9.8","statisticalMethod":"Mixed Model with Repeated Measures"},{"ciLowerLimit":"-3.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"12.0","groupDescription":"Difference in mean change of scores from Baseline at Month 9.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2655","pValueComment":"False Discovery Rate Methodology","paramType":"Mixed Model with Repeated Measures","paramValue":"4.4","statisticalMethod":"Mixed Model with Repeated Measures"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.9","value":"68.6"},{"groupId":"OG001","spread":"23.1","value":"70.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"165"},{"groupId":"OG001","value":"130"}],"units":"Participants"}],"title":"Score at Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.2","value":"-7.4"},{"groupId":"OG001","spread":"22.7","value":"-8.5"}]}],"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":"19.6","value":"1.3"},{"groupId":"OG001","spread":"22.7","value":"-15.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"62"}],"units":"Participants"}],"title":"Change from Baseline at Study Day 100"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.9","value":"5.9"},{"groupId":"OG001","spread":"23.7","value":"-4.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"110"},{"groupId":"OG001","value":"56"}],"units":"Participants"}],"title":"Change from Baseline at Study Day 150"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.7","value":"8.0"},{"groupId":"OG001","spread":"23.7","value":"3.5"}]}],"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":"24.9","value":"8.6"},{"groupId":"OG001","spread":"20.2","value":"9.1"}]}],"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":"22.3","value":"9.0"},{"groupId":"OG001","spread":"18.9","value":"9.9"}]}],"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":"20.9","value":"10.2"},{"groupId":"OG001","spread":"21.3","value":"6.5"}]}],"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":"21.5","value":"10.0"},{"groupId":"OG001","spread":"19.6","value":"15.0"}]}],"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":"21.0","value":"8.6"},{"groupId":"OG001","spread":"17.2","value":"13.2"}]}],"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":"165"},{"groupId":"OG001","value":"130"}],"units":"Participants"}],"description":"Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scores were transformed to 0-100. Higher scores for Global Health Status indicated better HRQoL.","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 Quality of Life (QoL) Analysis Set with data available at given timepoint were analyzed. The QoL Analysis Set was defined as the subset of participants in the Full Analysis Set who have a baseline and Day 150 post-randomization QoL assessment.","reportingStatus":"POSTED","timeFrame":"Baseline, Days 50, 100, and 150; Months 9, 12, 15, 18, 21 and 24","title":"Change From Baseline in Global Health Status Scores","type":"SECONDARY","unitOfMeasure":"Score on scale"}