{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.53","value":"4.5"},{"groupId":"OG001","spread":"17.50","value":"2.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"361"},{"groupId":"OG001","value":"169"}],"units":"Participants"}],"title":"Cycle 3 Day 1 (Cycle= 28 days)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.97","value":"4.2"},{"groupId":"OG001","spread":"18.09","value":"3.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"316"},{"groupId":"OG001","value":"149"}],"units":"Participants"}],"title":"Cycle 5 Day 1 (Cycle= 28 days)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.47","value":"4.9"},{"groupId":"OG001","spread":"17.30","value":"4.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"300"},{"groupId":"OG001","value":"133"}],"units":"Participants"}],"title":"Cycle 7 Day 1 (Cycle= 28 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days)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.84","value":"-5.2"},{"groupId":"OG001","spread":"24.54","value":"-5.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"113"}],"units":"Participants"}],"title":"End of treatment (EOT)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.20","value":"4.5"},{"groupId":"OG001","spread":"23.57","value":"-33.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"title":"Post EOT1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.75","value":"-4.8"},{"groupId":"OG001","spread":"23.57","value":"-16.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"title":"Post EOT2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.88","value":"14.6"},{"groupId":"OG001","spread":"0.00","value":"-16.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"title":"Post EOT3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.75","value":"10.0"},{"groupId":"OG001","value":"-25.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Post EOT4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.97","value":"13.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Post EOT5"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.73","value":"22.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Post EOT6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.97","value":"19.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Post EOT7"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.68","value":"37.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Post EOT8"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"46.40","value":"8.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Post EOT9"},{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Post EOT10"}],"denoms":[{"counts":[{"groupId":"OG000","value":"361"},{"groupId":"OG001","value":"169"}],"units":"Participants"}],"description":"The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, a GHS/QoL scale, and 6 single items. GHS/QoL scale scores range between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.\n\nThe change from baseline in the GHS/QoL score was assessed. A positive change from baseline indicates improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits occurred every 8 weeks during the initial 18 months since start of treatment, followed by visits every 12 weeks until disease progression.","dispersionType":"Standard Deviation","groups":[{"description":"Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.","id":"OG000","title":"Ribociclib + Fulvestrant"},{"description":"Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.","id":"OG001","title":"Placebo + Fulvestrant"}],"paramType":"MEAN","populationDescription":"Randomized participants with data available at the specified time points. 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 18 months, then every 12 weeks up to end of treatment; end of treatment; and every 8 or 12 weeks post-treatment until progression (post-treatment efficacy visits), assessed up to approximately 26 months","title":"Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30","type":"SECONDARY","unitOfMeasure":"Score on a Scale"}