{"analyses":[{"ciLowerLimit":"0.55","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.86","estimateComment":"The hazard ratio is from a Cox proportional hazards model stratified by age, cytogenetic risk category, and received consolidation therapy or not.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","otherAnalysisDescription":"The confidence interval (CI) for the difference was derived using Kosorok's method.","pValue":"0.0009","pValueComment":"The p-value is 2-sided from a log-rank test stratified by age, cytogenetic risk category, and received consolidation therapy or not.","paramType":"Hazard Ratio (HR)","paramValue":"0.69","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"18.7","upperLimit":"30.5","value":"24.7"},{"groupId":"OG001","lowerLimit":"11.7","upperLimit":"17.6","value":"14.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"238"},{"groupId":"OG001","value":"234"}],"units":"Participants"}],"description":"Overall survival was defined as time from randomization to death from any cause; participants surviving at the end of the follow-up period, or who withdraw consent, or who were lost to follow up were censored at the date last known alive.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.","id":"OG000","title":"Oral Azacitidine Plus Best Supportive Care"},{"description":"Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.","id":"OG001","title":"Placebo Plus Best Supportive Care"}],"paramType":"MEDIAN","populationDescription":"The intent to treat (ITT) population includes participants who were randomized, regardless of whether they received treatment or not.","reportingStatus":"POSTED","timeFrame":"Day 1 (randomization) up to data cut off date of 15 July 2019; median follow-up for OS estimated by the reverse K-M method was 41.2 months for all participants.","title":"Kaplan-Meier (K-M) Estimate for Overall Survival (OS)","type":"PRIMARY","unitOfMeasure":"Months"}