{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.49","upperLimit":"14.52","value":"10.97"},{"groupId":"OG001","lowerLimit":"3.65","upperLimit":"7.36","value":"5.65"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"169"},{"groupId":"OG001","value":"172"}],"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.\n\nThe PFS distribution was estimated using Kaplan-Meier methodology. This analysis was conducted at the time of the final OS analysis (when approximately 178 deaths in the PIK3CA mutant cohort had been achieved) and includes a longer follow-up time.\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 (based on central testing of hotspot-mutations in tumor tissue) 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 Cohort by Tumor Tissue: Alpelisib + Fulvestrant"},{"description":"Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) 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 Cohort by Tumor Tissue: Placebo + Fulvestrant"}],"paramType":"MEDIAN","populationDescription":"All subjects with a PIK3CA mutation who were randomized to study treatment","reportingStatus":"POSTED","timeFrame":"Up to 55.7 months","title":"Updated PFS Per Investigator Assessment in the PIK3CA Mutant Cohort (Longer Follow-up)","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Months"}