{"analyses":[{"ciLowerLimit":"0.628","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.932","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.004","paramType":"Hazard Ratio (HR)","paramValue":"0.765","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"52.4","upperLimit":"71.0","value":"63.9"},{"groupId":"OG001","lowerLimit":"47.2","upperLimit":"59.7","value":"51.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"334"},{"groupId":"OG001","value":"334"}],"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 400 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 letrozole 2.5 mg daily oral","id":"OG000","title":"Ribociclib + Letrozole"},{"description":"Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral.\n\nParticipants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole","id":"OG001","title":"Placebo + Letrozole"}],"paramType":"MEDIAN","populationDescription":"FAS including all randomized participants","reportingStatus":"POSTED","timeFrame":"Up to approximately 87 months","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"Months"}