{"analyses":[{"ciLowerLimit":"0.568","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.924","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.00455","paramType":"Cox Proportional Hazard","paramValue":"0.724","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA: Not estimable due to the insufficient number of participants with events","groupId":"OG000","lowerLimit":"42.5","upperLimit":"NA","value":"NA"},{"comment":"NA: Not estimable due to the insufficient number of participants with events","groupId":"OG001","lowerLimit":"37.0","upperLimit":"NA","value":"40.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"484"},{"groupId":"OG001","value":"242"}],"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. As per protocol, the final OS analysis was conducted after approximately 351 deaths were documented.\n\nOS was estimated using the Kaplan-Meier method. The median OS, along with 95% confidence intervals (CIs), was reported for each treatment group.\n\nThe 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 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":"From randomization to death, assessed up to approximately 46 months","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"Months"}