{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.000155","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"35.4","upperLimit":"46.0","value":"40.7"},{"groupId":"OG001","lowerLimit":"22.8","upperLimit":"32.3","value":"27.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"334"},{"groupId":"OG001","value":"334"}],"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 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.","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":"Overall Response Rate (ORR) by Investigator Assessment","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}