{"analyses":[{"ciLowerLimit":"0.576","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.875","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"0.710"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.22","upperLimit":"17.74","value":"14.26"},{"groupId":"OG001","lowerLimit":"8.64","upperLimit":"11.14","value":"10.12"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"265"},{"groupId":"OG001","value":"265"}],"units":"Participants"}],"description":"PFS is defined as the time from randomization to disease progression (including transformation to acute leukemia per WHO 2016), relapse from CR (IWG-MDS), or death. Disease progression: bone marrow blasts increase ≥ 50% over baseline, to \\> 5% if initially \\< 5%, \\> 10% if 5%-\\<10%, or \\> 20% if 10%-\\<20%. Includes a peripheral blood count decrease ≥ 50% from maximum remission/response levels: neutrophils \\< 1.0x109/L, platelets \\< 100x109/L, or hemoglobin drop ≥ 2 g/dL to \\< 10 g/dL, becoming transfusion-dependent.\n\nRelapse from CR: baseline bone marrow blast % return, neutrophils decrease ≥ 50% to \\< 1.0x109/L, platelets decrease ≥ 50% to \\< 100x109/L, or hemoglobin drop ≥ 1.5 g/dL to \\< 10 g/dL, becoming transfusion-dependent.\n\nLeukemia transformation: \\> 20% blasts per WHO 2016 (Arber et al 2016).","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were randomized to sabatolimab plus Azacitidine","id":"OG000","title":"Sabatolimab (MBG453) + Azacitidine"},{"description":"Participants were randomized to placebo plus Azacitidine","id":"OG001","title":"Placebo + Azacitidine"}],"paramType":"MEDIAN","populationDescription":"FAS comprised of all participants to whom study treatment had been assigned by randomization.","reportingStatus":"POSTED","timeFrame":"up to approx. 52 months","title":"Progression Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"Months"}