{"classes":[{"categories":[{"measurements":[{"comment":"NA: Not estimable due to the insufficient number of participants with events","groupId":"OG000","lowerLimit":"22.1","upperLimit":"NA","value":"NA"},{"comment":"NA: Not estimable due to the insufficient number of participants with events","groupId":"OG001","lowerLimit":"16.6","upperLimit":"NA","value":"19.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"484"},{"groupId":"OG001","value":"242"}],"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 time to definitive 10% deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10% relative to baseline worsening of the QoL score (without further improvement above the threshold) or death due to any cause. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive 10% deterioration, along with 95% confidence intervals, was reported for each treatment group. 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":"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":"MEDIAN","populationDescription":"FAS including all randomized participants","reportingStatus":"POSTED","timeFrame":"Up to approximately 26 months","title":"Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (GHS/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"}