{"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. 38 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":"7.080","upperLimit":"19.506","value":"13.293"},{"groupId":"OG001","lowerLimit":"-12.320","upperLimit":"1.139","value":"-5.590"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"72"}],"units":"Participants"}],"description":"The EORTC Quality of Life Questionnaire-Core 30 version 3.0 was used with a 7-day recall period. It consists of 30 questions with all items scored 1 (\"not at all\") to 4 (\"very much\") except for the 2 items contributing to the global health status/QoL, which are scored 1 (\"very poor\") to 7 (\"excellent\"). The instrument yields the following scales:5 functional scales, 3 symptom scales, and a global health status/quality of life scale. A positive change from baseline indicated improvement of global health status and a negative change from baseline value indicated worsening of global health status and functioning scores. The minimum and maximum of change from baseline score are (-17, 83) for Nirogacestat and (-100, 50) 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":"Last day 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 European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Role Functioning.","type":"SECONDARY","unitOfMeasure":"score on a scale"}