{"classes":[{"categories":[{"measurements":[{"comment":"NA = The value was not estimable due to insufficient number of participants with events","groupId":"OG000","lowerLimit":"22.2","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"15.4","upperLimit":"23.0","value":"21.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"337"}],"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 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 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)","id":"OG000","title":"Ribociclib + NSAI/Tamoxifen + Goserelin"},{"description":"Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days).","id":"OG001","title":"Placebo + NSAI/Tamoxifen+ Goserelin"}],"paramType":"MEDIAN","populationDescription":"FAS including all randomized participants","reportingStatus":"POSTED","timeFrame":"Up to approximately 29 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"}