{"analyses":[{"ciLowerLimit":"0.628","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.234","estimateComment":"Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.","groupDescription":"Time to First Complete Remission (CR) or Partial Remission (PR) or Complete Remission with Incomplete Blood Count Recovery (CRi)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.228","pValueComment":"P-value comparing time to first CR or PR or CRi (low-blast AML) between treatment groups was based on 1-sided stratified log-rank test stratified by low-blast AML,IPSS-R risk groups of very high,high,or intermediate for HR MDS/CMML.","paramType":"Hazard Ratio (HR)","paramValue":"0.880","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The median, and upper limit of 95% CI was not estimable due to low number of participants with event.","groupId":"OG000","lowerLimit":"12.12","upperLimit":"NA","value":"NA"},{"comment":"The median, and upper limit of 95% CI was not estimable due to low number of participants with event.","groupId":"OG001","lowerLimit":"24.61","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"206"},{"groupId":"OG001","value":"208"}],"units":"Participants"}],"description":"Time to first CR or PR is defined as the time from randomization to first documented CR or PR, whichever occurs first. Disease responses for HR MDS or CMML or low-blast AML cycle 6 are based on Modified IWG Response Criteria for MDS and for low-blast AML on Revised IWG Response Criteria for AML. For HR MDS or CMML-CR:\\<=5% myeloblasts with normal maturation of all bone marrow cell lines,\\>=11 g/dL Hgb,\\>=100\\*10\\^9/L pl,\\>=1.0\\*10\\^9/L neutrophils, 0% blasts in peripheral blood; PR: all CR criteria met except bone marrow blasts\\>=50% decrease over pretreatment but still\\>5%; For low-blast AML-CR: morphologic leukemia-free state,\\>1.0\\*10\\^9/L neutrophils, pl\\>=100\\*10\\^9/L, transfusion independence, no residual evidence of extramedullary leukemia; CR with incomplete blood count recovery: fulfill CR criteria except residual neutropenia\\<1.0\\*10\\^9/L or pl \\<100\\*10\\^9/L; PR: all CR hematological values but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate.","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.","reportingStatus":"POSTED","timeFrame":"From randomization until CR or PR (up to approximately 42 months)","title":"Time to First Complete Remission (CR) or Partial Remission (PR) or Complete Remission With Incomplete Blood Count Recovery (CRi)","type":"SECONDARY","unitOfMeasure":"months"}