{"analyses":[{"ciLowerLimit":"0.699","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.081","estimateComment":"HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\\>1 for the treatment indicates a shorter time to first CR, CRi or PR in the Pevonedistat Combination arm compared to the Azacitidine only arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.498","pValueComment":"P-value is from an unstratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"1.206","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The upper limit of 95% CI was not estimable due to low number of participants with the event.","groupId":"OG000","lowerLimit":"6.4","upperLimit":"NA","value":"13.2"},{"comment":"The upper limit of 95% CI was not estimable due to low number of participants with the event.","groupId":"OG001","lowerLimit":"4.5","upperLimit":"NA","value":"8.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"55"}],"units":"Participants"}],"description":"Time to first CR or PR: time from randomization to first documented CR or PR, whichever occurs first. Disease responses (HR MDS/CMML) based on modified IWG response criteria for MDS; low-blast AML on revised IWG response criteria for AML. HR MDS/CMML-CR: \\<=5% myeloblasts with normal maturation of all bone marrow cell lines, \\>=11 g/dL Hb, \\>=100\\*10\\^9/L plt,\\>=1.0\\*10\\^9/L ANC, 0% blasts in peripheral blood; PR: all CR criteria met except bone marrow blasts \\>=50% decrease over pretreatment but still \\>5%; For low-blast AML-CR: morphologic leukemia-free state, \\>1.0\\*10\\^9/L ANC, plt \\>=100\\*10\\^9/L, 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/TTP \\<100\\*10\\^9/L; PR: all CR hematological values but with a decrease of \\>=50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate.","dispersionType":"95% Confidence Interval","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":"MEDIAN","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 or PR (up to approximately 5 years)","title":"Time to First CR or PR","type":"SECONDARY","unitOfMeasure":"months"}