{"analyses":[{"groupDescription":"Physical Functioning Domain - Change from Baseline at Week 24","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.918","pValueComment":"Significance level of 0.050 for 2-sided tests.","statisticalMethod":"t-test, 2 sided"},{"groupDescription":"General Health Domain - Change from Baseline at Week 24","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.857","pValueComment":"Significance level of 0.050 for 2-sided tests.","statisticalMethod":"t-test, 2 sided"},{"groupDescription":"PCS - Change from Baseline at Week 24","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.839","pValueComment":"Significance level of 0.050 for 2-sided tests.","statisticalMethod":"t-test, 2 sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.93","value":"-0.3"},{"groupId":"OG001","spread":"7.86","value":"-0.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"197"},{"groupId":"OG001","value":"91"}],"units":"Participants"}],"title":"Physical Functioning Domain Score - Change from Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"7.18","value":"0.4"},{"groupId":"OG001","spread":"7.03","value":"0.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"197"},{"groupId":"OG001","value":"91"}],"units":"Participants"}],"title":"General Health Domain Score - Change from Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"7.01","value":"-0.4"},{"groupId":"OG001","spread":"7.97","value":"-0.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"197"},{"groupId":"OG001","value":"91"}],"units":"Participants"}],"title":"PCS - Change from Baseline"}],"denoms":[{"counts":[{"groupId":"OG000","value":"210"},{"groupId":"OG001","value":"103"}],"units":"Participants"}],"description":"The SF-36 (version 2) is a generic, self-administered instrument consisting of 8 multi-item scales that assess 8 health domains. The raw score for each health domain is transformed into a 0 (worst) to 100 (best) domain score. The 0-100 scale score for each health domain is further converted to normbased scores using a T-score transformation, with a mean of 50 and a standard deviation (SD) of 10. Higher norm-based T-scores indicate better heath/QoL. The domains/summaries reported are: 1. Physical Functioning (Range of possible T-scores is 19.26 - 57.54) 2. General Health (Range of possible T-scores is 18.95 - 66.50) 3. Physical Component summary (PCS) (Range of possible T-scores is 5.02 - 79.78). 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 SF-36 questionnaire at screening visit and at least one post-screening visit","reportingStatus":"POSTED","timeFrame":"Baseline: 4 weeks prior to Day 1; Treatment: Weeks 24","title":"Mean Change From Baseline in the 36-item Short Form Health Survey (SF-36) Questionnaire At Weeks 24","type":"SECONDARY","unitOfMeasure":"T-score"}