{"analyses":[{"ciLowerLimit":"-10.03","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"9.15","groupDescription":"Number of Participants with OR2","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.891","pValueComment":"P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.","paramType":"Absolute Rate Difference","paramValue":"-0.44","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"94"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"206"},{"groupId":"OG001","value":"208"}],"units":"Participants"}],"description":"OR2=participant with best overall response of CR+PR+HI in HR MDS/CMML participants,or of CR+CRi+PR in low-blast AML participants.CR:≤5% myeloblasts with normal maturation of all bone marrow(BM)cell lines,≥11g/dL Hgb,≥100\\*10\\^9/L pl,≥1.0\\*10\\^9/L neutrophils,0% blasts in peripheral blood;PR:all CR criteria met except BM blasts ≥50% decrease over pretreatment but still \\>5%;HI:Hgb increase(inc) ≥1.5g/dL if baseline(BL)\\<11 g/dL;pl inc≥30\\*10\\^9/L if BL\\>20\\*10\\^9/L or inc from \\<20\\*10\\^9/L to \\>20\\*10\\^9/L and by 100%;neutrophil inc by 100%;absolute inc of \\>0.5\\*10\\^9/L if BL\\<100\\*10\\^9/L.For low-blast AML-CR:morphologic leukemia-free state \\>1.0\\*10\\^9 neutrophils,≥100\\*10\\^9/L pl,transfusion independence,no residual evidence of extramedullary leukemia;CR with incomplete blood count recovery:fulfill CR criteria except residual neutropenia \\<1.0\\*10\\^9/L or pl\\<100\\*10\\^9/L;PR:all CR hematological values but ≥50% decrease in BM aspirate.Number of responders determined by independent review committee(IRC) assessment.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"REP: all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. Data is reported for responders. Three participants were not counted as responders for OR2 as the IRC assessed these participants as non-responders.","reportingStatus":"POSTED","timeFrame":"From randomization until, CR, PR or HI or CR, CRi or PR (up to approximately 42 months)","title":"Number of Participants With Overall Response 2 (OR2)","type":"SECONDARY","unitOfMeasure":"Participants"}