{"analyses":[{"ciLowerLimit":"-9.13","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"30.18","estimateComment":"Absolute difference \\>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.301","pValueComment":"P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.","paramType":"Absolute Rate Difference","paramValue":"10.53","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21.1"},{"groupId":"OG001","value":"31.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"38"}],"units":"Participants"}],"description":"Disease responses for HR MDS/CMML per modified IWG response criteria for MDS and for low-blast AML on revised IWG response criteria for AML.CR for HR MDS/CMML: \\<=5% myeloblasts with normal maturation of all cell lines in bone marrow, \\>=11 g/dL Hb; \\>=100\\*10\\^9/L plt; \\>=1.0\\*10\\^9/L ANC and 0% blasts in peripheral blood.PR for HR MDS/CMML: considered achieved if all CR criteria is met except for bone marrow blasts decreased by\\>=50% over pretreatment but still\\>5%.CR for low-blast AML: morphologic leukemia-free state, ANC of\\>1.0\\*10\\^9/L and plt of\\>=100\\*10\\^9/L, transfusion independence, no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery for low-blast AML: fulfill all criteria for CR except for residual neutropenia (\\<100\\*10\\^9/L)/TTP (\\<100\\*10\\^9/L). PR for low-blast AML: all hematological values for CR but with decrease of \\>=50% in percentage of blasts to 5%-25% in bone marrow aspirate. The percentages are rounded off to report the nearest whole numbers.","groups":[{"description":"Azacitidine 75 mg/m\\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).","id":"OG000","title":"Azacitidine 75 mg/m^2"},{"description":"Azacitidine 75 mg/m\\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).","id":"OG001","title":"Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2"}],"paramType":"NUMBER","populationDescription":"REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. Overall number analyzed is the number of participants with data available for analyses.","reportingStatus":"POSTED","timeFrame":"From date of randomization until CR and PR, by Cycle 4 (cycle length=28 days)","title":"Percentage of Participants With CR and PR by Cycle 4","type":"SECONDARY","unitOfMeasure":"percentage of participants"}