{"analyses":[{"ciLowerLimit":"9.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"28.7","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"< 0.001","paramType":"Treatment difference","paramValue":"19.3","statisticalComment":"Adjusted for the stratification factors: age (\\< 35 vs. ≥ 35), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"17.6","upperLimit":"32.8","value":"24.6"},{"groupId":"OG001","lowerLimit":"37.9","upperLimit":"50.0","value":"43.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"271"}],"units":"Participants"}],"description":"Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts.\n\nComplete remission was defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets \\> 100,000/μl, and ANC \\> 1,000/μl.\n\nComplete Remission with partial hematological recovery (CRh\\*) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease and partial recovery of peripheral blood counts: platelets \\> 50,000/μl, and ANC \\> 500/μl.\n\nComplete remission with incomplete hematological recovery (CRi) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease and incomplete recovery of peripheral blood counts: platelets \\> 100,000/μl or ANC \\> 1000 (but not both).","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":"12 weeks","title":"Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) Within 12 Weeks of Treatment Initiation","type":"SECONDARY","unitOfMeasure":"percentage of participants"}