{"analyses":[{"ciLowerLimit":"0.416","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.817","estimateComment":"The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \\< 75, ≥ 75).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.002","paramType":"Hazard Ratio (HR)","paramValue":"0.583","statisticalComment":"Log-rank test stratified by AML status (de novo, secondary) and age (18 - \\< 75, ≥ 75).","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.430","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.839","estimateComment":"The hazard ratio was estimated using the Cox proportional hazards model.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.003","paramType":"Hazard Ratio (HR)","paramValue":"0.601","statisticalComment":"Unstratified analysis","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.6","upperLimit":"3.1","value":"2.0"},{"groupId":"OG001","lowerLimit":"3.7","upperLimit":"6.4","value":"4.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"143"}],"units":"Participants"}],"description":"Event-free survival is defined as the time from randomization to the date of progressive disease (PD), confirmed morphologic relapse from CR or CRi, treatment failure (failure to achieve CR, CRi or morphologic leukemia free state (MLFS) after at least 6 cycles of study treatment), or death from any cause, assessed by the investigator according to the modified IWG criteria.\n\nPD:\n\n* \\> 50% increase in marrow blasts (minimum 15% increase required if blasts \\< 30% at baseline); or persistent marrow blast \\> 70% for ≥ 3 months; without at least a 100% improvement in ANC to an absolute level \\> 0.5 × 10⁹/L, and/or platelets to \\> 50 × 10⁹/L non-transfused; or\n* 50% increase in peripheral blasts to \\> 25 × 10⁹/L; or\n* New extramedullary disease\n\nParticipants with no events prior to the cut-off date were censored at their last assessment date; participants with no events prior to post-treatment therapy initiated before the cut-off date were censored on the start date of post-treatment therapy.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.","id":"OG000","title":"Placebo + Low Dose Cytarabine (LDAC)"},{"description":"Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.","id":"OG001","title":"Venetoclax + Low Dose Cytarabine (LDAC)"}],"paramType":"MEDIAN","populationDescription":"Full analysis set","reportingStatus":"POSTED","timeFrame":"From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.","title":"Event-free Survival (EFS)","type":"SECONDARY","unitOfMeasure":"months"}