{"analyses":[{"ciLowerLimit":"0.306","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.339","estimateComment":"Hazard ratio was based on an unadjusted unstratified Cox proportional hazard regression model with treatment as a factor in the model.","groupDescription":"Duration of Complete Remission + Complete Remission with Incomplete Blood Count Recovery (CRi)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.373","pValueComment":"P-value comparing duration of CR+CRi between treatment groups was based on 1-sided unstratified log-rank.","paramType":"Hazard Ratio (HR)","paramValue":"0.846","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The upper limit of 95% CI was not estimable due to low number of participants with event.","groupId":"OG000","lowerLimit":"3.02","upperLimit":"NA","value":"8.5"},{"comment":"The upper limit of 95% CI was not estimable due to low number of participants with event.","groupId":"OG001","lowerLimit":"3.94","upperLimit":"NA","value":"15.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"17"}],"units":"Participants"}],"description":"Duration of CR is first documented CR to the first documentation of PD or relapse from CR (participants with low-blast AML). Disease responses for low-blast AML were based on the Revised IWG Response Criteria for AML. CR is defined as \\<=5% myeloblasts with normal maturation of all cell lines in the bone marrow, and greater than or equal to \\>=11 g/dL hemoglobin (Hgb),\\>=100\\*10\\^9/liter (/L) platelets (pl),\\>=1.0\\*10\\^9/L neutrophils and 0% blasts in peripheral blood. CR for low-blast AML: morphologic leukemia-free state, neutrophils of more than 1.0\\*10\\^9/L and pl of \\>=100\\*10\\^9/L, transfusion independence, and no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery (CRi) for low-blast AML: participants fulfill all of the criteria for CR except for residual neutropenia (\\<1.0\\*10\\^9/L) or thrombocytopenia (pl\\<100\\*10\\^9/L).","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were administered azacitidine 75 mg/m\\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.","id":"OG000","title":"Azacitidine 75 mg/m^2"},{"description":"Participants were administered azacitidine 75 mg/m\\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.","id":"OG001","title":"Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2"}],"paramType":"MEDIAN","populationDescription":"REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. Data is reported for participants with CR and CRi.","reportingStatus":"POSTED","timeFrame":"From CR until first documentation of PD or relapse from CR or relapse after CR or PR (up to approximately 42 months)","title":"Duration of Complete Remission + Complete Remission With Incomplete Blood Count Recovery (CRi)","type":"SECONDARY","unitOfMeasure":"months"}