{"analyses":[{"ciLowerLimit":"0.43","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.71","estimateComment":"The hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \\< 1.0 indicates a lower average event rate and a longer survival for Blinatumomab relative to SOC Chemotherapy.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Hazard Ratio (HR)","paramValue":"0.55"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.2","upperLimit":"19.2","value":"12.5"},{"groupId":"OG001","lowerLimit":"25.0","upperLimit":"36.5","value":"30.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"271"}],"units":"Participants"}],"description":"Event free survival was defined as the time from randomization until a documented relapse after achieving CR/CRh\\*/CRi or death, whichever occurred first. Participants who failed to achieve a CR/CRh\\*/CRi within 12 weeks of treatment initiation were considered as non-responders and assigned an EFS duration of 1 day. Participants still alive and relapse-free were censored on their last disease assessment date.\n\nA relapse event was any one of the following:\n\n* Hematological relapse: proportion of blasts in bone marrow \\>5% or blasts in peripheral blood after documented CR or CRh\\* or CRi\n* Progressive disease: An increase from baseline of at least 25% of bone marrow blasts or an absolute increase of at least 5,000 cells/μL in the number of circulating leukemia cells\n* Extramedullary relapse: extramedullary lesion that is new or increased by 50% from nadir as assessed by Cheson criteria.\n\nThe Kaplan-Meier estimate of EFS at 6 months is reported.","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":"NUMBER","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"6 months","title":"Event Free Survival (EFS)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}