{"analyses":[{"groupDescription":"Physical Health Domain Score - Change from Baseline at Week 24","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.666","pValueComment":"Significance level of 0.050 for 2-sided tests.","statisticalMethod":"t-test, 2 sided"},{"groupDescription":"Total Score - Change from Baseline at Week 24","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.384","pValueComment":"Significance level of 0.050 for 2-sided tests.","statisticalMethod":"t-test, 2 sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.26","value":"-1.5"},{"groupId":"OG001","spread":"14.24","value":"-0.7"}]}],"title":"Physical Health Domain Score - Change from Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.56","value":"0.8"},{"groupId":"OG001","spread":"11.62","value":"-0.4"}]}],"title":"Total Score - Change from Baseline"}],"denoms":[{"counts":[{"groupId":"OG000","value":"200"},{"groupId":"OG001","value":"94"}],"units":"Participants"}],"description":"The TranQol is a self-administered quality of life tool developed for beta-thalassemia patients. The adult self-report version used in this study, includes 36 questions assessed on a 5-point response, that are grouped into 5 domains (Physical Health, Emotional Health, Sexual Health, Family Functioning, School/Career Functioning). Scores are calculated according to specific scoring algorithms developed by the authors. Both individual domains score and the total score range from 0 (worst) to 100 (best). Total Score and Physical Health domain score are reported. Positive change from baseline values indicate improvement.","dispersionType":"Standard Deviation","groups":[{"description":"Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period. BSC = Best Supportive Care","id":"OG000","title":"Luspatercept + BSC"},{"description":"Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days. BSC = Best Supportive Care","id":"OG001","title":"Placebo + BSC"}],"paramType":"MEAN","populationDescription":"All randomized participants with an evaluable TranQoL questionnaire at screening visit and at least one post-screening visit","reportingStatus":"POSTED","timeFrame":"Baseline: 4 weeks prior to Day 1; Treatment: Week 24","title":"Mean Change From Baseline in the Transfusion-dependent Quality of Life (TranQol) Questionnaire At Week 24","type":"SECONDARY","unitOfMeasure":"Score on a scale"}