{"groups":[{"description":"Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral","id":"FG000","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":"FG001","title":"Placebo + Letrozole"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"206"},{"groupId":"FG001","numSubjects":"265"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"10"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"25"}],"type":"Subject/guardian decision"},{"reasons":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"21"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}],"type":"Protocol deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"11"}],"type":"Sponsor decision"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"334"},{"groupId":"FG001","numSubjects":"334"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"334"},{"groupId":"FG001","numSubjects":"330"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"}],"comment":"Participants in the placebo arm who crossed over to the ribociclib arm and received at least one dose of ribociclib","type":"Crossover Cohort"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"334"},{"groupId":"FG001","numSubjects":"334"}],"type":"NOT COMPLETED"}],"title":"Treatment"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"3"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"}],"type":"Sponsor decision"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"}],"type":"Subject/Guardian decision"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"9"}],"comment":"Patients who discontinue treatment for reasons other than disease progression entered the post-treatment efficacy follow-up. period.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"9"}],"type":"NOT COMPLETED"}],"title":"Post-treatment Efficacy Follow-up"}],"preAssignmentDetails":"Screening assessments were conducted up to 21 days prior to the randomization","recruitmentDetails":"Participants were enrolled in 223 sites across 29 countries."}