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1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.43","value":"5.5"},{"groupId":"OG001","spread":"21.23","value":"8.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"129"}],"units":"Participants"}],"title":"Cycle 15 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.85","value":"4.6"},{"groupId":"OG001","spread":"21.75","value":"7.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"80"}],"units":"Participants"}],"title":"Cycle 17 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.08","value":"5.0"},{"groupId":"OG001","spread":"18.81","value":"7.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"40"}],"units":"Participants"}],"title":"Cycle 19 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.09","value":"4.8"},{"groupId":"OG001","spread":"14.15","value":"12.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"14"}],"units":"Participants"}],"title":"Cycle 22 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"8.33","value":"-8.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Cycle 25 Day 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5"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"41.25","value":"20.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Post -treatment efficacy visit 6"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Post -treatment efficacy visit 7"}],"denoms":[{"counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"285"}],"units":"Participants"}],"description":"The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The change from baseline in the GHS/QoL score was assesed. A positive change from baseline indicated improvement.\n\nFor subjects who discontinued treatment earlier and without disease progression, post-treatment efficacy follow-up visits occurred every 8 weeks after End of treatment (EOT) during the initial 18 months since start of treatment, followed by visits every 12 weeks until disease progression or end of study.","dispersionType":"Standard Deviation","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":"MEAN","populationDescription":"Randomized participants with data available at the specified time points. Number analyzed refers to the number of participants with an evaluable value at the specified time point.","reportingStatus":"POSTED","timeFrame":"Baseline, every 2 cycles for 18 months, then every 3 cycles until last dose; at EOT (within 15 days from last dose);every 8 or 12 weeks post-treatment until progression (post-treatment efficacy visits), assessed up to 23 months. Cycle=28 days","title":"Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30","type":"SECONDARY","unitOfMeasure":"Score on a Scale"}