{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.55","upperLimit":"28.68","value":"18.14"},{"groupId":"OG001","lowerLimit":"11.50","upperLimit":"25.59","value":"19.98"},{"comment":"NA: not estimable due to the insufficient number of participants with events","groupId":"OG002","lowerLimit":"5.62","upperLimit":"NA","value":"7.39"},{"groupId":"OG003","lowerLimit":"3.94","upperLimit":"13.17","value":"9.23"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"169"},{"groupId":"OG001","value":"172"},{"groupId":"OG002","value":"115"},{"groupId":"OG003","value":"116"}],"units":"Participants"}],"description":"The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The time to definitive 10% deterioration was defined as the time from the date of randomization to the date of event, which was defined as at least 10% relative to baseline worsening of the GHS/QoL score (without further improvement above the threshold) or death due to any cause. The Kaplan-Meier method was used to estimate the distribution. If a patient had not had an event, time to deterioration was censored at the date of the last adequate QoL evaluation.","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 55.7 months","title":"Time to 10% Deterioration in the Global Health Status (GHS) /Quality of Life (QOL) Scale Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)","type":"SECONDARY","unitOfMeasure":"Months"}