{"analyses":[{"groupDescription":"Cochran-Mantel-Haenszel test for general association stratified by tumor location. Placebo was reference treatment.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","pValueComment":"Two-sided p-value","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"29.8","upperLimit":"53.8","value":"41"},{"groupId":"OG001","lowerLimit":"3.1","upperLimit":"17.3","value":"8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"72"}],"units":"Participants"}],"description":"Objective response rate (ORR) is defined as the proportion of participants having a confirmed Best Overall Response (BOR) of CR or PR by central reader using RECIST v1.1 criteria. Responses obtained up until progression, or last evaluable assessment in the absence of progression, will be included in the assessment of ORR. However, any responses, which occurred after a new anticancer therapy was received, will not be included. ORR is presented by percentages of responders.","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":"NUMBER","populationDescription":"Intent-to-Treat Population (All Randomized)","reportingStatus":"POSTED","timeFrame":"On the first day of every 3 cycles (each cycle is 28 days) through study completion, an average of 2 years","title":"Objective Response Rate Using RECIST Version 1.1 Criteria.","type":"SECONDARY","unitOfMeasure":"percentage of participants"}