{"analyses":[{"ciLowerLimit":"-13.18","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.83","groupDescription":"Number of Participants With Complete Remission (CR) and CR+Complete Remission with Incomplete Blood Count Recovery (CRi)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.374","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":"-4.18","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"63"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"206"},{"groupId":"OG001","value":"208"}],"units":"Participants"}],"description":"CR for HR MDS or CMML is defined as \\<=5% myeloblasts with normal maturation of all cell lines in the bone marrow, and greater than or equal to \\>=11 gram per deciliter (g/dL) hemoglobin (Hgb),\\>=100\\*10\\^9/liter (/L) platelets (pl),\\>=1.0\\*10\\^9/L neutrophils and 0% blasts in peripheral blood. CR for low-blast AML: morphologic leukemia-free state, neutrophils of more than 1.0\\*10\\^9/L and pl of \\>=100\\*10\\^9/L, transfusion independence, and no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery (CRi) for low-blast AML: participants fulfill all of the criteria for CR except for residual neutropenia (\\<1.0\\*10\\^9/L) or thrombocytopenia (pl\\<100\\*10\\^9/L).","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":"Response-Evaluable Population (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 randomization until CR (up to approximately 42 months)","title":"Number of Participants With Complete Remission (CR) and CR+ Complete Remission With Incomplete Blood Count Recovery (CRi)","type":"SECONDARY","unitOfMeasure":"Participants"}