{"analyses":[{"ciLowerLimit":"0.750","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.130","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2132","pValueComment":"P Value is 1-sided","paramType":"Hazard Ratio (HR)","paramValue":"0.921","statisticalComment":"log-rank test stratified by randomization stratification factor (Intermediate risk MDS, High risk MDS, Very High risk MDS, CMML-2) as per IRT","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.96","upperLimit":"15.90","value":"13.37"},{"groupId":"OG001","lowerLimit":"10.15","upperLimit":"13.86","value":"11.76"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"265"},{"groupId":"OG001","value":"265"}],"units":"Participants"}],"description":"FACIT-Fatigue score is a 13-item questionnaire designed to assess fatigue in cancer participants. All items use a 5-point scale ranging from 0 to 4 (0=Not at All to 4=Very Much). The total score ranges from 0 to 52 with higher values representing better quality of life. Time to definitive deterioration of fatigue is defined as time from randomization to at least 3 points worsening from baseline in FACIT-fatigue scores with no subsequently observed improvement above this threshold, or death due to any cause, whichever occurred first.","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":"Key Secondary Endpoint 1: Time to Definitive Deterioration of Fatigue Using Functional Assessment of Cancer Therapy (FACIT)-Fatigue Score","type":"SECONDARY","unitOfMeasure":"Months"}