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1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.43","value":"7.6"},{"groupId":"OG001","spread":"25.43","value":"-3.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"46"}],"units":"Participants"}],"title":"Cycle 22 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.41","value":"5.2"},{"groupId":"OG001","spread":"25.51","value":"-0.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"title":"Cycle 25 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.54","value":"7.9"},{"groupId":"OG001","spread":"30.28","value":"-8.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Cycle 28 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.79","value":"8.3"},{"groupId":"OG001","value":"-8.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Cycle 31 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.78","value":"-4.4"},{"groupId":"OG001","spread":"23.41","value":"-3.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"179"}],"units":"Participants"}],"title":"End of treatment"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.38","value":"3.7"},{"groupId":"OG001","spread":"32.02","value":"6.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Post-end of treatment 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.73","value":"5.6"},{"groupId":"OG001","spread":"11.79","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"title":"Post-end of treatment 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.43","value":"8.3"},{"groupId":"OG001","spread":"5.89","value":"-4.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"title":"Post-end of treatment 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.35","value":"11.1"},{"groupId":"OG001","value":"-8.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Post-end of treatment 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Post-end of treatment 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"300"},{"groupId":"OG001","value":"280"}],"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 assessed. A positive change from baseline indicated improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits occurred every 8 weeks during the initial 18 months since start of treatment, followed by visits every 12 weeks until disease progression.","dispersionType":"Standard Deviation","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":"OG000","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).","id":"OG001","title":"Placebo + NSAI/Tamoxifen+ Goserelin"}],"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 after randomization during 18 months, then every 3 cycles up to end of treatment (EOT); EOT; and every 8 or 12 weeks post-treatment until progression, assessed up to approximately 29 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"}