{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"484"},{"groupId":"OG001","value":"242"}],"units":"Participants"}],"title":"Pre-treatment deaths"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"483"},{"groupId":"OG001","value":"241"}],"units":"Participants"}],"title":"On-treatment deaths"},{"categories":[{"measurements":[{"groupId":"OG001","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"title":"Crossover on-treatment deaths"},{"categories":[{"measurements":[{"groupId":"OG000","value":"264"},{"groupId":"OG001","value":"153"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"380"},{"groupId":"OG001","value":"210"}],"units":"Participants"}],"title":"Post-treatment efficacy/survival deaths"},{"categories":[{"measurements":[{"groupId":"OG001","value":"1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Crossover post-treatment efficacy/survival deaths"},{"categories":[{"measurements":[{"groupId":"OG000","value":"277"},{"groupId":"OG001","value":"162"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"484"},{"groupId":"OG001","value":"242"}],"units":"Participants"}],"title":"All deaths"}],"denoms":[{"counts":[{"groupId":"OG000","value":"484"},{"groupId":"OG001","value":"242"}],"units":"Participants"}],"description":"Pre-treatment deaths were collected from day of participant's informed consent to the day before first dose of study medication.\n\nOn-treatment deaths were collected from start of treatment to 30 days after last dose of treatment or one day before first administration of crossover treatment (for crossover participants), whichever came first Crossover on-treatment deaths were collected from start of crossover treatment up to 30 days after last dose of crossover treatment.\n\nPost-treatment efficacy/survival follow-up deaths were collected from day 31 after last dose of study treatment to end of study.\n\nCrossover post-treatment efficacy/survival follow-up deaths were collected from day 31 after last dose of crossover treatment to end of study.","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":"OG000","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":"OG001","title":"Placebo + Fulvestrant"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"FAS including all randomized participants","reportingStatus":"POSTED","timeFrame":"Pre-treatment: Up to 28 days prior to treatment. On-treatment: Up to 82 months. Crossover on-treatment: Up to 3.5 months. Post-treatment efficacy/survival follow-up: Up to 82 months. Crossover post-treatment efficacy/survival follow-up: Up to 1 year","title":"All Collected Deaths","type":"POST_HOC","unitOfMeasure":"Participants"}