{"analyses":[{"ciLowerLimit":"0.429","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.720","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.00000329","paramType":"Hazard Ratio (HR)","paramValue":"0.556","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA = not estimable due to the insufficient number of participants with events","groupId":"OG000","lowerLimit":"19.3","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"13.0","upperLimit":"16.5","value":"14.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"334"},{"groupId":"OG001","value":"334"}],"units":"Participants"}],"description":"PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression.PFS was assessed by investigator assessment according to RECIST 1.1. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. A stratified Cox regression model was used to estimate the hazard ratio of PFS, along with 95% confidence interval","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":"Full Analysis Set (FAS) including all randomized participants","reportingStatus":"POSTED","timeFrame":"Up to 23 months","title":"Progression Free Survival (PFS) by Investigator Assessment","type":"PRIMARY","unitOfMeasure":"months"}