{"analyses":[{"ciLowerLimit":"0.715","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.119","estimateComment":"HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\\<1:longer duration of transfusion independence in combination arm than azacitidine arm.","groupDescription":"Duration of RBC Transfusion Independence","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.774","pValueComment":"P-value comparing duration of RBC or platelet transfusion 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":"1.231","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.567","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.147","estimateComment":"HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\\<1:longer duration of transfusion independence in combination arm than azacitidine arm.","groupDescription":"Duration of Platelet Transfusion Independence","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.801","pValueComment":"P-value comparing duration of platelet transfusion 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":"1.533","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.580","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.614","estimateComment":"HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\\<1:longer duration of transfusion independence in combination arm than azacitidine arm.","groupDescription":"Duration of Transfusion Independence","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.450","pValueComment":"P-value comparing duration of RBC or platelet transfusion 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":"0.968","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.18","upperLimit":"28.09","value":"15.6"},{"groupId":"OG001","lowerLimit":"9.07","upperLimit":"16.66","value":"13.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"58"}],"units":"Participants"}],"title":"Duration of RBC Transfusion Independence"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.09","upperLimit":"23.23","value":"14.9"},{"groupId":"OG001","lowerLimit":"2.73","upperLimit":"16.26","value":"11.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"title":"Duration of Platelet Transfusion Independence"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.90","upperLimit":"19.48","value":"12.0"},{"groupId":"OG001","lowerLimit":"10.38","upperLimit":"16.66","value":"13.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"59"}],"units":"Participants"}],"title":"Duration of Transfusion Independence"}],"denoms":[{"counts":[{"groupId":"OG000","value":"227"},{"groupId":"OG001","value":"227"}],"units":"Participants"}],"description":"Duration of RBC and platelet transfusion independence was defined as the longest time between the last RBC and/or platelet transfusion before the start of the RBC and/or platelet transfusion-independent period and the first RBC and/or platelet transfusion after the start of the transfusion-independent period, which occurs \\>= 8 weeks later.","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. Number analyzed is the number of participants who achieved transfusion independence for the specified category, with data available for analysis.","reportingStatus":"POSTED","timeFrame":"Up to approximately 42 months","title":"Duration of Red Blood Cells (RBCs) and Duration of Platelet-transfusion Independence and Duration of Red Blood Cells (RBCs) and Platelet-transfusion Independence","type":"SECONDARY","unitOfMeasure":"months"}