{"analyses":[{"ciLowerLimit":"-8.83","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"28.04","estimateComment":"Absolute difference \\>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.312","pValueComment":"P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.","paramType":"Absolute Rate Difference","paramValue":"9.61","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"45"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"55"}],"units":"Participants"}],"description":"Disease responses for HR MDS or CMML is based on the modified International Working Group (IWG) response criteria for MDS and for low-blast AML on the revised IWG response criteria for AML. CR for HR MDS or CMML: \\<= 5% myeloblasts with normal maturation of all cell lines in the bone marrow, and \\>= 11 gram/deciliter (g/dL) hemoglobin (Hb), \\>=100\\*10\\^9/liter (/L) platelets (plt), \\>=1.0\\*10\\^9/L absolute neutrophil count (ANC) and 0% blasts in peripheral blood. CR for low-blast AML: morphologic leukemia-free state, ANC of more than 1.0\\*10\\^9/L and plt of \\>=1.0\\*10\\^9/L, transfusion independence, and no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery for low-blast AML: some participants fulfill all of the criteria for CR except for residual neutropenia (\\<1.0\\*10\\^9/L) or thrombocytopenia (TTP) (\\<100\\*10\\^9/L). 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":"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 date of randomization until CR (up to approximately 5 years)","title":"Percentage of Participants With Complete Remission (CR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}