{"analyses":[{"ciLowerLimit":"0.530","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.007","estimateComment":"Stratified Cox regression models were used to estimate hazard ratio and 2-sided CIs for axicabtagene ciloleucel relative to standard of care therapy. The Breslow method was used to handle the ties for the Cox regression models.","groupIds":["OG000","OG001"],"nonInferiorityComment":"One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.","nonInferiorityType":"SUPERIORITY","otherAnalysisDescription":"The Rho family spending function with parameter (Rho = 6) was used to allocate alpha between the interim and primary OS analysis. Given that fewer than the anticipated 210 events were observed at the data cutoff date for the primary OS analysis (25 January 2023), the efficacy boundary for the primary OS analysis was recalculated using the Rho family spending function based on the actual observed event numbers (177 deaths) resulting in an efficacy boundary at 1-sided significance level of 0.0249.","pValue":"0.027","pValueComment":"Stratified log-rank (randomization factor) p-value.","paramType":"Hazard Ratio (HR)","paramValue":"0.730","statisticalComment":"Stratified (randomization factor) log-rank test.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Median and upper limit of CI were not reached due to insufficient number of events.","groupId":"OG000","lowerLimit":"28.3","upperLimit":"NA","value":"NA"},{"comment":"Upper limit of CI was not reached due to insufficient number of events.","groupId":"OG001","lowerLimit":"18.5","upperLimit":"NA","value":"35.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"180"},{"groupId":"OG001","value":"179"}],"units":"Participants"}],"description":"Overall survival is defined as the time from randomization to death from any cause. Kaplan-Meier (KM) estimates were used for analysis.","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"Participants in the Full Analysis Set were analyzed.","reportingStatus":"POSTED","timeFrame":"Up to 74.9 months","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"months"}