{"analyses":[{"ciLowerLimit":"-8.60","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.41","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.068","estimateComment":"A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.","groupDescription":"Cycle 3, Day 1","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-4.507"},{"ciLowerLimit":"-10.03","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.19","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.580","estimateComment":"A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.","groupDescription":"Cycle 5 Day 1","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-4.923"},{"ciLowerLimit":"-5.98","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.36","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.609","estimateComment":"A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.","groupDescription":"Cycle 7 Day 1","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-0.807"},{"ciLowerLimit":"-7.94","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.64","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.176","estimateComment":"A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.","groupDescription":"Cycle 9 day 1","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-1.648"},{"groupDescription":"A linear mixed effects regression model with a variable covariance structure was fitted to the longitudinal data (considering all time points) to test for differences between treatment arms.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.126","statisticalComment":"Model included AML status (de novo vs. secondary), age (18-\\< 75 vs. ≥ 75), treatment arm, time, and treatment arm by time interaction as fixed factors","statisticalMethod":"Linear Mixed Effects Regression Model"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.855","value":"1.567"},{"groupId":"OG001","spread":"1.093","value":"-2.940"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"69"}],"units":"Participants"}],"title":"Cycle 3 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.307","value":"-0.336"},{"groupId":"OG001","spread":"1.308","value":"-5.259"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"40"}],"units":"Participants"}],"title":"Cycle 5 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.314","value":"-3.818"},{"groupId":"OG001","spread":"1.354","value":"-4.625"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"36"}],"units":"Participants"}],"title":"Cycle 7 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.811","value":"-3.453"},{"groupId":"OG001","spread":"1.606","value":"-5.101"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"Cycle 9 day 1"}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"127"}],"units":"Participants"}],"description":"PROMIS Fatigue SF 7a is a seven-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 7a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from Baseline) indicates improvement in fatigue; the minimum important difference used in this study was 3 points.","dispersionType":"Standard Error","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":"LEAST_SQUARES_MEAN","populationDescription":"Full analysis set with available data at baseline and each time point","reportingStatus":"POSTED","timeFrame":"Baseline and Day 1 of Cycles 3, 5, 7, and 9","title":"Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a","type":"SECONDARY","unitOfMeasure":"score on a scale"}