{"analyses":[{"ciLowerLimit":"0.608","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.263","estimateComment":"HR:unadjusted stratified Cox proportional hazard regression with stratification factors (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":"Event-Free Survival in Participants who have TP53 Mutations, 17p Deletions, and/or are Determined to be in an Adverse Cytogenetic Risk Group","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.240","pValueComment":"P-value comparing EFS between treatment groups was based on 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":"0.877","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.44","upperLimit":"14.32","value":"12.8"},{"groupId":"OG001","lowerLimit":"9.99","upperLimit":"18.99","value":"14.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"227"},{"groupId":"OG001","value":"227"}],"units":"Participants"}],"description":"Event was defined as death or transformation to AML in participants with MDS or CMML, whichever occurred first. Transformation to AML was defined, according to World Health Organization (WHO) Classification as a participant having \\>20% blasts in the blood or marrow and increase of blast count by 50%. 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 AML if eligible or death (up to approximately 42 months)","title":"Event-Free Survival in Participants Who Have TP53 Mutations, 17p Deletions, and/or Are Determined to be in an Adverse Cytogenetic Risk Group","type":"SECONDARY","unitOfMeasure":"months"}