{"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":"FG000","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).\n\nParticipants were unblinded once the final OS analysis was conducted and after the implementation of protocol amendment 6 (16-Jul-2019) and were given the option to crossover to treatment with ribociclib +NSAI/tamoxifen + goserelin","id":"FG001","title":"Placebo + NSAI/Tamoxifen+ Goserelin"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"234"},{"groupId":"FG001","numSubjects":"260"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"20"}],"type":"Subject/guardian decision"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"14"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"27"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Protocol deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"11"}],"type":"Study terminated as per protocol"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"335"},{"groupId":"FG001","numSubjects":"337"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"17"}],"comment":"Participants in the placebo arm who crossed over to the ribociclib arm and received at least one dose of the crossover study treatment","type":"Crossover Cohort"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"335"},{"groupId":"FG001","numSubjects":"337"}],"type":"NOT COMPLETED"}],"title":"Treatment Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Subject/guardian decision"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"3"}],"type":"Study terminated as per protocol"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"7"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Physician Decision"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"15"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"14"}],"type":"NOT COMPLETED"}],"title":"Post-treatment Efficacy Follow-up"}],"preAssignmentDetails":"Screening assessments were conducted up to 28 days prior to the randomization","recruitmentDetails":"Participants were enrolled in 185 sites across 30 countries."}