{"analyses":[{"ciLowerLimit":"-6.23","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"12.06","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.617","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":"2.917"},{"ciLowerLimit":"2.18","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"24.59","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.659","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":"13.388"},{"ciLowerLimit":"-4.83","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"19.06","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"6.031","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":"7.119"},{"ciLowerLimit":"-8.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"21.26","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"7.511","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":"6.381"},{"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":"0.085","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":"4.126","value":"1.941"},{"groupId":"OG001","spread":"2.413","value":"4.857"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"69"}],"units":"Participants"}],"title":"Cycle 3 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"5.047","value":"2.627"},{"groupId":"OG001","spread":"2.853","value":"16.015"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"40"}],"units":"Participants"}],"title":"Cycle 5 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"5.337","value":"3.481"},{"groupId":"OG001","spread":"3.092","value":"10.599"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"36"}],"units":"Participants"}],"title":"Cycle 7 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.642","value":"6.918"},{"groupId":"OG001","spread":"3.772","value":"13.299"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"Cycle 9 day 1"}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"127"}],"units":"Participants"}],"description":"The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) consists of a Global Health Status/Quality of Life (GHS/QoL) scale, a Financial Difficulties scale, 5 functional scales (Cognitive, Social, Physical, Emotional, and Role Functioning), and 8 symptom scales/items (Fatigue, Insomnia, Appetite Loss, Pain, Constipation, Diarrhea, Dyspnea, and Nausea and Vomiting).\n\nThe GHS/QoL scale includes 2 questions in which participants were asked to rate their overall health and overall quality of life during the past week on a scale from 1 (very poor) to 7 (excellent). The 2 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life.","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 Global Health Status / Quality of Life","type":"SECONDARY","unitOfMeasure":"scores on a scale"}