{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.018","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"75.3","upperLimit":"84.0","value":"79.6"},{"groupId":"OG001","lowerLimit":"68.0","upperLimit":"77.5","value":"72.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"334"},{"groupId":"OG001","value":"334"}],"units":"Participants"}],"description":"Percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1 as per investigator 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; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease: PD = At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20% the sum must also demonstrate an absolute increase of at least 5 mm.","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":"NUMBER","populationDescription":"FAS including all randomized participants","reportingStatus":"POSTED","timeFrame":"Up to 23 months","title":"Clinical Benefit Rate (CBR) by Investigator Assessment","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}