{"analyses":[{"ciLowerLimit":"0.55","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.93","estimateComment":"Hazard ratio obtained from the Cox Proportional Hazard Model. A hazard ratio \\< 1.0 indicated a lower average event rate and longer survival time for blinatumomab relative to SOC chemotherapy.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.012","paramType":"Hazard Ratio (HR)","paramValue":"0.71","statisticalComment":"Stratified by age (\\< 35 years; ≥ 35 years), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).","statisticalMethod":"Stratified Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.9","upperLimit":"5.3","value":"4.0"},{"groupId":"OG001","lowerLimit":"5.6","upperLimit":"9.6","value":"7.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"271"}],"units":"Participants"}],"description":"Overall survival (OS) was calculated from time of randomization until death due to any cause. Participants still alive were censored at the date they were last known to be alive.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh\\*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.\n\nParticipants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\\*/CRi could continue to receive SOC therapy for an additional 12 months.","id":"OG000","title":"Standard of Care Chemotherapy"},{"description":"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh\\*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.\n\nParticipants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\\*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.\n\nThe initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles.","id":"OG001","title":"Blinatumomab"}],"paramType":"MEDIAN","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"From randomization until the data cut-off date of 04 January 2016; median observation time was 11.8 months in the SOC group and 11.7 months in the blinatumomab group.","title":"Overall Survival","type":"PRIMARY","unitOfMeasure":"months"}