{"analyses":[{"ciLowerLimit":"0.660","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.630","estimateComment":"HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\\<1:better prevention of AML transformation in combination arm than azacitidine arm.","groupDescription":"Time to AML Transformation in HR MDS Participants","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.562","pValueComment":"P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR MDS.","paramType":"Hazard Ratio (HR)","paramValue":"1.037","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.068","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"33.773","estimateComment":"HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\\<1:better prevention of AML transformation in combination arm than azacitidine arm.","groupDescription":"Time to AML Transformation in HR CMML Participants","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.603","pValueComment":"P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR CMML.","paramType":"Hazard Ratio (HR)","paramValue":"1.512","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.663","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.610","estimateComment":"HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\\<1:better prevention of AML transformation in combination arm than azacitidine arm.","groupDescription":"Time to AML Transformation in HR MDS/CMML Participants","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.558","pValueComment":"P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR CMML/MDS.","paramType":"Hazard Ratio (HR)","paramValue":"1.034","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The upper limit of 95% confidence interval (CI) was not estimable due to low number of participants with event.","groupId":"OG000","lowerLimit":"26.51","upperLimit":"NA","value":"35.6"},{"comment":"The median, and upper limit of 95% CI were not estimable due to low number of participants with event.","groupId":"OG001","lowerLimit":"23.29","upperLimit":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"161"}],"units":"Participants"}],"title":"HR MDS Participants"},{"categories":[{"measurements":[{"comment":"The median, lower limit, and upper limit of 95% CI were not estimable due to low number of participants with event.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The median, lower limit, and upper limit of 95% CI were not estimable due to low number of participants with event.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"16"}],"units":"Participants"}],"title":"HR CMML Participants"},{"categories":[{"measurements":[{"comment":"The upper limit of 95% CI was not estimable due to low number of participants with event.","groupId":"OG000","lowerLimit":"29.04","upperLimit":"NA","value":"35.6"},{"comment":"The median, and upper limit of 95% CI were not estimable due to low number of participants with event.","groupId":"OG001","lowerLimit":"24.28","upperLimit":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"174"},{"groupId":"OG001","value":"177"}],"units":"Participants"}],"title":"HR MDS/CMML Participants"}],"denoms":[{"counts":[{"groupId":"OG000","value":"174"},{"groupId":"OG001","value":"177"}],"units":"Participants"}],"description":"Time to AML transformation in HR MDS and CMML participants was defined as time from randomization to documented AML transformation as determined by the independent review committee (IRC) assessment. Participants who died before progression to AML were censored. Transformation to AML was defined, according to WHO classification, as a participant having 20% blasts in the blood or marrow and increase of blast count by 50%.","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. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis for the given category.","reportingStatus":"POSTED","timeFrame":"From randomization until transformation to AML (up to approximately 42 months)","title":"Time to Acute Myelogenous Leukemia (AML) Transformation in Higher-Risk Myelodysplastic Syndromes (HR MDS), Higher-Risk Chronic Myelomonocytic Leukemias (HR CMML) and HR MDS/CMML Participants","type":"SECONDARY","unitOfMeasure":"months"}