{"analyses":[{"ciLowerLimit":"0.16","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.69","estimateComment":"Hazard ratio is estimated using a Cox's proportional hazards model stratified by the randomization stratification factors (AML status and geographic region) with placebo + azacitidine as the denominator.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0011","pValueComment":"P-value is calculated from the one-sided log-rank test stratified by the randomization stratification factors (AML status and geographic region).","paramType":"Hazard Ratio (HR)","paramValue":"0.33","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.03","upperLimit":"11.01","value":"0.03"},{"comment":"The upper and lower limit of 95% confidence interval (CI) were not estimable due to low number of participants with events.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"0.03"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"74"}],"units":"Participants"}],"description":"EFS was defined as the time from randomization until treatment failure, relapse from remission, or death from any cause, whichever occurs first. Treatment failure was defined as failure to achieve complete remission (CR) by Week 24. CR: Bone marrow blasts \\<5% and no Auer rods; absence of extramedullary disease; Absolute neutrophil count (ANC) ≥1.0 × 10\\^9 per litre (10\\^9/L) (1000 per microlitre \\[1000/μL\\]); platelet count ≥100 × 10\\^9/L (100,000/μL); independence of red blood cell transfusions. Participants who had an EFS event (relapse or death) after, 2 or more missing disease assessments were censored at the last adequate disease assessment documenting no relapse before the missing assessments. The reported data represents the Kaplan-Meier median value.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received AG-120 500 mg orally, QD in combination with azacitidine 75 mg/m\\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.","id":"OG000","title":"AG-120 + Azacitidine"},{"description":"Participants received AG-120 matching placebo orally, QD in combination with azacitidine 75 mg/m\\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.","id":"OG001","title":"Placebo + Azacitidine"}],"paramType":"MEDIAN","populationDescription":"FAS included all participants who were randomized.","reportingStatus":"POSTED","timeFrame":"Up to Week 24","title":"Event-Free Survival (EFS)","type":"PRIMARY","unitOfMeasure":"months"}