{"analyses":[{"groupDescription":"Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline 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. 39 and 28 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":"-0.808","upperLimit":"-0.418","value":"-0.613"},{"groupId":"OG001","lowerLimit":"-0.113","upperLimit":"0.300","value":"0.094"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"72"}],"units":"Participants"}],"description":"The items are evaluated on a 5-point Likert Scale ranging from \"none of the time\" to \"all of the time\" to measure frequency, with a 7-day recall period. The Physical Function Domain Score are calculated as the average Item 01 Moving, Item 02 Reaching (Freq), Item 06 Vigorous Activity, Item 7 Moderate Activity, and Item 08 Accomplished Less. Higher scores represent worst impact severity. The minimum and maximum of the actual score are (1, 5) for Nirogacestat and (1,5) for Placebo, respectively. A positive change from baseline value indicates worsening impact and a negative change from baseline value indicates improvement in impact. The minimum and maximum of change from baseline score are (-3, 0) for Nirogacestat and (-1, 2) for Placebo, respectively.","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":"On the last day of every cycle (each cycle is 28 days) through study completion, average of 2 years.","title":"Change From Baseline in the GOunder/Desmoid Tumor Research Foundation (DTRF) DEsmoid Tumor Impact Scale (DTIS) - Physical Functioning Domain Score","type":"SECONDARY","unitOfMeasure":"score on a scale"}