{"groups":[{"description":"Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.","id":"FG000","title":"Ribociclib + Fulvestrant"},{"description":"Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. Participants were unblinded after the implementation of protocol amendment 4 (29-Jan-20) and were given the option to crossover to treatment with ribociclib and fulvestrant.","id":"FG001","title":"Placebo + Fulvestrant"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"314"},{"groupId":"FG001","numSubjects":"200"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"51"},{"groupId":"FG001","numSubjects":"9"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"8"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"8"}],"type":"Subject/guardian decision"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Technical problems"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Protocol deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"46"},{"groupId":"FG001","numSubjects":"14"}],"type":"Study terminated as per protocol"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"484"},{"groupId":"FG001","numSubjects":"242"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Untreated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"comment":"Participants in the placebo+fulvestrant arm who crossed over to the ribociclib+fulvestrant arm and received at least one dose of the study treatment.","type":"Crossover Cohort"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"comment":"Treatment ongoing at the time of the cut-off 11-Jan-2023","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"484"},{"groupId":"FG001","numSubjects":"242"}],"type":"NOT COMPLETED"}],"title":"Treatment Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"6"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Study Terminated as per protocol"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"1"}],"type":"Subject/Guardian Decision"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"34"},{"groupId":"FG001","numSubjects":"9"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"34"},{"groupId":"FG001","numSubjects":"9"}],"type":"NOT COMPLETED"}],"title":"Post-treatment Efficacy Follow-up"}],"preAssignmentDetails":"Screening assessments were conducted up to 28 days prior to the randomization","recruitmentDetails":"174 sites across 30 countries enrolled participants"}