{"analyses":[{"ciLowerLimit":"0.535","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.948","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.00973","pValueComment":"One-sided stratified log-rank test","paramType":"Cox Proportional Hazard","paramValue":"0.712","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA: Not estimable due to the insufficient number of participants with events","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"NA: Not estimable due to the insufficient number of participants with events","groupId":"OG001","lowerLimit":"37.8","upperLimit":"NA","value":"40.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"337"}],"units":"Participants"}],"description":"OS was defined as the time from the date of randomization to the date of death from any cause. In cases where the patient's death was not recorded, the OS value was censored at the date of the last known patient's survival status. OS was estimated using the Kaplan-Meier method. As per protocol, the final OS analysis was conducted after approximately 189 deaths were documented.\n\nThe median OS, along with 95% confidence intervals, was reported for each treatment group.The distribution of OS between the two treatment arms was compared using a log-rank test at one-sided cumulative 2.5% level of significance. A stratified Cox regression was used to estimate the OS hazard ratio and the associated 95% CI.","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":"From randomization to death, assessed up to approximately 45 months","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"Months"}