{"analyses":[{"ciLowerLimit":"0.441","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.694","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0000001","paramType":"Hazard Ratio, log","paramValue":"0.553","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA = The value was not estimable due to insufficient number of participants with events","groupId":"OG000","lowerLimit":"19.2","upperLimit":"NA","value":"23.8"},{"groupId":"OG001","lowerLimit":"11.0","upperLimit":"16.4","value":"13.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"337"}],"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 via local radiology assessment according to RECIST 1.1. As per protocol, the final PFS analysis was conducted after approximately 392 PFS events were documented. 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 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":"The Full Analysis Set (FAS) including all randomized patients.","reportingStatus":"POSTED","timeFrame":"From randomization to first documented progression or death, assessed up to approximately 29 months","title":"Progression Free Survival (PFS) by Investigator Assessment","type":"PRIMARY","unitOfMeasure":"Months"}