{"analyses":[{"ciLowerLimit":"0.15","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.55","groupDescription":"Hazard ratio was estimated from stratified Cox proportional hazards model using the exact method for ties, stratified by tumor location. Placebo was the reference treatment.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","paramType":"Hazard Ratio (HR)","paramValue":"0.29","statisticalComment":"p-value was from a one-sided stratified log-rank test with placebo as reference.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Not reached. Only less than 50% of the participants had events in Nirogacestat treatment arm.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Upper 95% CI is not reached.","groupId":"OG001","lowerLimit":"8.4","upperLimit":"NA","value":"15.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"72"}],"units":"Participants"}],"description":"Progression will be determined radiographically using RECIST v1.1 (Eisenhauer, 2009) or clinically as assessed by the investigator. Clinical progression is defined as the onset or worsening of symptoms resulting in a global deterioration of health status causing the permanent discontinuation from study treatment and the initiation of emergent treatment (e.g., radiotherapy, surgery, or systemic therapy including chemotherapy or tyrosine kinase inhibitors) for DT/AF. Events of clinical progression will be adjudicated by an independent blinded central Endpoint Adjudication Committee (EAC) which will qualify events of clinical progression for inclusion in the PFS endpoint prior to study unblinding according to an EAC Review Charter.","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":"MEDIAN","populationDescription":"Intent-to-Treat Population (All Randomized)","reportingStatus":"POSTED","timeFrame":"On the first day of every 3 cycles (each cycle is 28 days) until disease progression is observed or death, whichever comes first, assessed up to approximately 2 years","title":"Progression Free Survival (PFS) Defined as the Time From Randomization Until Date of Assessment of Progression or Death by Any Cause.","type":"PRIMARY","unitOfMeasure":"Months"}