{"analyses":[{"ciLowerLimit":"-9.09","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"26.38","estimateComment":"Absolute difference \\>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.343","pValueComment":"P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.","paramType":"Absolute Rate Difference","paramValue":"8.64","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"71"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"55"}],"units":"Participants"}],"description":"Disease responses (HR MDS/CMML): modified IWG criteria for MDS; low-blast (LB) AML: revised IWG criteria for AML. Overall response(HR MDS/CMML)=CR,PR/HI,LB AML=CR+ CR with incomplete blood count recovery(Cri)+PR.HR MDS/CMML-CR:\\<=5%myeloblasts with normal maturation of bone marrow (BM) cell lines,\\>=11g/dL Hb,\\>=100\\*10\\^9/L plt,\\>=1.0\\*10\\^9/L ANC,0% blasts in peripheral blood; PR:CR criteria met except BM blasts\\>=50%less over pretreatment but still\\>5%; HI:hb increase (inc)\\>=1.5g/dL if baseline\\<11g/dL;plt inc\\>=30\\*10\\^9/L if baseline\\>20\\*10\\^9/L/Inc. from \\<20\\*10\\^9/L-\\>20\\*10\\^9/L, ANC inc. by 100%;absolute inc. of\\>0.5\\*10\\^9/L if baseline\\<100\\*10\\^9/L. LB AML-CR:morphologic leukemia-freestate\\>1.0\\*10\\^9ANC,\\>=100\\*10\\^9/L plt, transfusion independence, no residual evidence of extramedullary leukemia;CRi:fulfill CR criteria except residual neutropenia\\<1.0\\*10\\^9/L/TTP\\<100\\*10\\^9/L;PR:all CR hematological values but\\>=50%less in BM 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.","reportingStatus":"POSTED","timeFrame":"From date of randomization until CR, PR, or hematologic improvement (HI) (up to approximately 5 years)","title":"Percentage of Participants With Overall Response","type":"SECONDARY","unitOfMeasure":"percentage of participants"}