{"analyses":[{"ciLowerLimit":"0.757","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.238","estimateComment":"HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\\<1:better prevention of EFS in combination arm than azacitidine arm.","groupDescription":"IPSS-R indicates the Revised International Prognostic Scoring System.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.557","paramType":"Hazard Ratio (HR)","paramValue":"0.968","statisticalComment":"P-value comparing EFS between treatment groups was based on the 1-sided Cui-Hung-Wang weighted unstratified log-rank test.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.42","upperLimit":"19.68","value":"15.7"},{"groupId":"OG001","lowerLimit":"13.63","upperLimit":"20.24","value":"17.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"227"},{"groupId":"OG001","value":"227"}],"units":"Participants"}],"description":"EFS was defined as the time from randomization to the date of an EFS event. An EFS event was defined as death or transformation to acute myelogenous leukemia (AML) (World Health Organization \\[WHO\\] classification as a participant having greater than 20 % blasts in the blood or marrow and an increase of blast count by 50%), whichever event occurred first, in participants with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemias (CMML). An EFS event was defined as death in participants with low-blast AML.","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 transformation to acute myeloid leukemia, or death due to any cause: up to approximately 42 months","title":"Event-Free Survival (EFS)","type":"PRIMARY","unitOfMeasure":"months"}