{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.000980","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"35.6","upperLimit":"46.2","value":"40.9"},{"groupId":"OG001","lowerLimit":"24.8","upperLimit":"34.6","value":"29.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"337"}],"units":"Participants"}],"description":"ORR is the percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 as per local assessment. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.","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":"NUMBER","populationDescription":"FAS including all randomized participants","reportingStatus":"POSTED","timeFrame":"Up to approximately 29 months","title":"Overall Response Rate (ORR) by Investigator Assessment","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}