{"analyses":[{"ciLowerLimit":"0.521","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.198","estimateComment":"HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\\<1for the treatment indicates a longer time to PD, Relapse, or Death in the Pevonedistat Combination arm compared to the Azacitidine only arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.266","pValueComment":"P-value is from an unstratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.790","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.40","upperLimit":"16.53","value":"13.6"},{"groupId":"OG001","lowerLimit":"12.39","upperLimit":"20.83","value":"15.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"58"}],"units":"Participants"}],"description":"Time from randomization until PD/transformation to AML/relapse/death due to any cause, whichever occurs first. Relapse after CR or PR in MDS/CMML: return to pretreatment bone marrow blast % or decrement of \\>=50% from maximum remission levels in ANC or plt, reduction in Hb concentration by \\>=1.5 g/dL or transfusion dependence. PD: at least 50% decrement from maximum remission in ANC or plt, or reduction in Hb by\\>=2g/dL or transfusion dependence;participants with \\<5% blasts: \\>=50% increase (inc) in blasts to \\>5%; 5%-10%: \\>=50% inc to \\>10%; 10%-20%: \\>=50% inc to\\>20%;20%-30%:\\>=50% inc to \\>30%. Relapse after CR in Low blast AML: reappearance of leukemic blasts in peripheral blood or \\>=5% blasts in bone marrow not attributable to any cause (example, bone marrow regeneration after consolidation therapy). If there are no circulating blasts, bone marrow contains 5%-20% blasts, a repeat analysis is performed a week later.","dispersionType":"Full Range","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":"ITT Population was defined as all participants who were randomized.","reportingStatus":"POSTED","timeFrame":"From date of randomization until PD, relapse or death (up to approximately 5 years)","title":"Time to Progressive Disease (PD), Relapse, or Death","type":"SECONDARY","unitOfMeasure":"months"}