{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.03","upperLimit":"15.28","value":"10.9"},{"groupId":"OG001","lowerLimit":"2.27","upperLimit":"6.11","value":"3.7"},{"groupId":"OG002","lowerLimit":"7.23","upperLimit":"11.01","value":"9.0"},{"groupId":"OG003","lowerLimit":"5.55","upperLimit":"9.20","value":"7.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"94"},{"groupId":"OG002","value":"181"},{"groupId":"OG003","value":"182"}],"units":"Participants"}],"description":"PFS was defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. If a patient did not have an event, PFS was censored at the date of last adequate tumor assessment. The PFS distribution was estimated using Kaplan-Meier methodology.\n\nSubjects were analyzed according to the PIK3CA mutation status (mutant or non-mutant) as identified using plasma ctDNA.\n\nProgression was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.","dispersionType":"95% Confidence Interval","groups":[{"description":"Subjects with advanced breast cancer with a PIK3CA mutation (measured in ctDNA) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)","id":"OG000","title":"PIK3CA Mutant Determined by ctDNA: Alpelisib + Fulvestrant"},{"description":"Subjects with advanced breast cancer with a PIK3CA mutation (measured in ctDNA) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)","id":"OG001","title":"PIK3CA Mutant Determined by ctDNA: Placebo + Fulvestrant"},{"description":"Subjects with advanced breast cancer without a PIK3CA mutation (measured in ctDNA) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)","id":"OG002","title":"PIK3CA Non-mutant Determined by ctDNA: Alpelisib + Fulvestrant"},{"description":"Subjects with advanced breast cancer without a PIK3CA mutation (measured in ctDNA) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)","id":"OG003","title":"PIK3CA Non-mutant Determined by ctDNA: Placebo + Fulvestrant"}],"paramType":"MEDIAN","populationDescription":"Subjects who were randomized to study treatment with an evaluable mutation status by ctDNA at baseline","reportingStatus":"POSTED","timeFrame":"From baseline up to 56.4 months","title":"PFS Per Investigator Criteria in Subjects With PIK3CA Mutation Status Measured in ctDNA at Baseline","type":"SECONDARY","unitOfMeasure":"Months"}