{"classes":[{"categories":[{"measurements":[{"comment":"NA: Not estimable due to the insufficient number of participants with events","groupId":"OG000","lowerLimit":"26.32","upperLimit":"NA","value":"34.07"},{"comment":"NA: Not estimable due to the insufficient number of participants with events","groupId":"OG001","lowerLimit":"22.11","upperLimit":"NA","value":"NA"},{"comment":"NA: Not estimable due to the insufficient number of participants with events","groupId":"OG002","lowerLimit":"13.83","upperLimit":"NA","value":"NA"},{"groupId":"OG003","lowerLimit":"18.46","upperLimit":"47.21","value":"40.44"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"169"},{"groupId":"OG001","value":"172"},{"groupId":"OG002","value":"115"},{"groupId":"OG003","value":"116"}],"units":"Participants"}],"description":"ECOG PS categorized patients based on their ability to perform daily activities and self-care, with scores ranging from 0 to 5. A score of 0 indicated no restrictions in activity, while higher scores indicated increasing limitations. Time to definitive deterioration of ECOG PS by one score was defined as the time from the date of randomization to the date of the event, defined as experiencing at least one score lower than the baseline. A deterioration was considered definitive if no improvements in the ECOG PS were observed at a subsequent time. The Kaplan-Meier method was used to estimate the distribution. Patients receiving any further therapy prior to definitive worsening were censored at their date of last assessment prior to start of therapy. Patients that had not worsened at the data cutoff point were censored at the date of last assessment.","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"},{"description":"Subjects with advanced breast cancer without 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":"OG002","title":"PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant"},{"description":"Subjects with advanced breast cancer without 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":"OG003","title":"PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant"}],"paramType":"MEDIAN","populationDescription":"All subjects who were randomized to study treatment","reportingStatus":"POSTED","timeFrame":"From baseline up to 56.4 months","title":"Time to Definitive Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score From Baseline","type":"SECONDARY","unitOfMeasure":"Months"}