{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.286","value":"-2.477"},{"groupId":"OG001","spread":"2.324","value":"-0.369"},{"groupId":"OG002","spread":"2.578","value":"1.524"},{"groupId":"OG003","spread":"2.601","value":"2.698"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"142"},{"groupId":"OG001","value":"140"},{"groupId":"OG002","value":"98"},{"groupId":"OG003","value":"92"}],"units":"Participants"}],"title":"Week 8"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.349","value":"-1.796"},{"groupId":"OG001","spread":"2.455","value":"-2.685"},{"groupId":"OG002","spread":"2.809","value":"2.866"},{"groupId":"OG003","spread":"2.835","value":"1.700"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"124"},{"groupId":"OG001","value":"107"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"66"}],"units":"Participants"}],"title":"Week 16"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.415","value":"-3.010"},{"groupId":"OG001","spread":"2.587","value":"-0.337"},{"groupId":"OG002","spread":"3.087","value":"1.383"},{"groupId":"OG003","spread":"3.385","value":"4.909"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"105"},{"groupId":"OG001","value":"81"},{"groupId":"OG002","value":"46"},{"groupId":"OG003","value":"34"}],"units":"Participants"}],"title":"Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.519","value":"-2.802"},{"groupId":"OG001","spread":"2.646","value":"-0.891"},{"groupId":"OG002","spread":"3.420","value":"1.063"},{"groupId":"OG003","spread":"3.731","value":"4.345"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"32"},{"groupId":"OG003","value":"25"}],"units":"Participants"}],"title":"Week 32"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.581","value":"-2.815"},{"groupId":"OG001","spread":"2.739","value":"-1.854"},{"groupId":"OG002","spread":"4.783","value":"13.232"},{"groupId":"OG003","spread":"4.003","value":"4.923"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"20"}],"units":"Participants"}],"title":"Week 40"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.621","value":"-3.635"},{"groupId":"OG001","spread":"2.853","value":"-1.460"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"title":"Week 48"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.701","value":"-1.617"},{"groupId":"OG001","spread":"2.935","value":"0.248"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"45"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"title":"Week 56"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.835","value":"-1.937"},{"groupId":"OG001","spread":"2.984","value":"-1.979"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"title":"Week 64"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.823","value":"-2.525"},{"groupId":"OG001","spread":"3.098","value":"-1.526"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"title":"Week 72"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.958","value":"-1.135"},{"groupId":"OG001","spread":"3.143","value":"-1.495"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"title":"Week 84"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.054","value":"-3.869"},{"groupId":"OG001","spread":"3.423","value":"-3.581"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"title":"Week 96"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.328","value":"-2.158"},{"groupId":"OG001","spread":"3.609","value":"-2.068"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"title":"Week 108"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.251","value":"-2.928"},{"groupId":"OG001","spread":"3.868","value":"-2.593"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"title":"Week 120"}],"denoms":[{"counts":[{"groupId":"OG000","value":"142"},{"groupId":"OG001","value":"140"},{"groupId":"OG002","value":"98"},{"groupId":"OG003","value":"92"}],"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 change from baseline in the GHS/QoL score was assessed. A positive change from baseline indicated improvement.\n\nFor each cohort, this analysis only included assessments up to the time point where there were at least 10 patients on each of the 2 treatment groups.","dispersionType":"Standard Error","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":"LEAST_SQUARES_MEAN","populationDescription":"Randomized participants with baseline scores and at least one non-missing post-baseline assessment. Number analyzed refers to the number of participants with an evaluable value at the specified time point","reportingStatus":"POSTED","timeFrame":"Baseline, every 8 weeks after randomization during the first 18 months and thereafter every 12 weeks, up to 120 weeks.","title":"Change From Baseline in the GHS/QOL Scale Score of the EORTC QLQ-C30","type":"SECONDARY","unitOfMeasure":"Score on a Scale"}