{"analyses":[{"groupDescription":"Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline DEsmoid Tumor Symptom Scale score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 40 and 32 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalComment":"An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1.569","upperLimit":"-0.651","value":"-1.110"},{"groupId":"OG001","lowerLimit":"-0.009","upperLimit":"0.923","value":"0.457"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"72"}],"units":"Participants"}],"description":"The DEsmoid Tumor Symptom Scale is an 11-point, numeric rating scale from 0 to 10 to measure severity from \"none\" to \"as bad as you can imagine,\" with a 24-hour recall period. The Total Symptom Score is calculated as the mean of Pain items (Items 1-3) as a single score, then a mean of this with items 4-7). Weekly summary scores will be created by averaging the daily scores over the 7 days period prior to each visit. A weekly score will be derived only if 4 or more out of 7 days period have non-missing scores. The weekly summary score will be used in analyses. If no weekly summary score is calculable, the participant will have data considered as missing at that visit. Higher scores represent worse symptom severity. The minimum and maximum of the actual score are (0,7) for Nirogacestat and (0,10) for Placebo. A positive change from Baseline value indicated worsening of symptoms. The minimum and maximum of change from baseline are (-6,1) for Nirogacestat and (-4,5) for Placebo.","dispersionType":"95% Confidence Interval","groups":[{"description":"Nirogacestat 150 mg by mouth, twice daily\n\nNirogacestat oral tablet: Nirogacestat tablet","id":"OG000","title":"Double-Blind Phase - Nirogacestat"},{"description":"Placebo by mouth, twice daily\n\nPlacebo Oral Tablet: Sugar pill manufactured to mimic nirogacestat 50 mg tablet","id":"OG001","title":"Double-Blind Phase - Placebo"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"Intent-to-Treat Population","reportingStatus":"POSTED","timeFrame":"Daily for the last 7 days of every cycle (each cycle is 28 days) through study completion, an average of 2 years","title":"Change From Baseline at Cycle 10 in the GOunder/Desmoid Tumor Research Tumor Foundation (DTRF) DEsmoid Tumor Symptom Scale (DTSS) - Total Score","type":"SECONDARY","unitOfMeasure":"score on a scale"}