{"analyses":[{"ciLowerLimit":"0.689","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.067","estimateComment":"Hazard ratio was based on a stratified Cox proportional hazard regression model stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML, with treatment as a factor in the model.","groupDescription":"Time to Progressive Disease (PD), Relapse after CR (Low-blast AML), Relapse After CR or PR (HR MDS/CMML), or Death","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.084","pValueComment":"P-value was obtained from a stratified 1-sided 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":"0.858","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.25","upperLimit":"13.31","value":"11.8"},{"groupId":"OG001","lowerLimit":"11.01","upperLimit":"15.84","value":"13.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"227"},{"groupId":"OG001","value":"227"}],"units":"Participants"}],"description":"Time to PD, relapse after CR(low-blast AML), relapse after CR or PR(HR MDS/CMML), or death,defined as time from date of randomization until date of first documentation of PD,relapse after CR(low-blast AML),relapse after CR or PR(HR MDS/CMML),or death due to any cause, whichever occurs first. In HR MDS/CMML,PD: Participants with\\<5% blasts:\\>=50% inc \\>5% blasts, with 5%-9% blasts:\\>=50% inc\\>10% blasts, with 10%-19% blasts:\\>=50% inc \\>20% blasts,with 20%-30% blasts, at least 50% decrement from maximum remission/response in granulocytes or pl or reduction in Hgb by\\>=2 g/dL/new transfusion dependence.Relapse after CR or PR: return to pretreatment bone marrow blast %/Decrement of \\>=50% from maximum remission/response levels in granulocytes/pl/reduction in Hgb conc.\\>=1.5 g/dL/transfusion dependence. In AML,PD:\\>50% inc in bone marrow blasts to \\>30% blasts,\\>50% inc in circulating blasts to\\>30% blasts in peripheral blood, Development of extramedullary disease/new sites of extramedullary leukemia.","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":"ITT Population included all participants who were randomized.","reportingStatus":"POSTED","timeFrame":"From randomization until PD, relapse after CR, or relapse after CR or PR, or death due to any cause, whichever occurs first (up to approximately 42 months)","title":"Time to Progressive Disease (PD), Relapse After CR (Low-blast AML), Relapse After CR or PR (HR MDS/CMML), or Death","type":"SECONDARY","unitOfMeasure":"months"}