{"analyses":[{"ciLowerLimit":"-2.63","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.98","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.7822","paramType":"Mean Difference (Final Values)","paramValue":"-0.325","statisticalComment":"Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1.42","upperLimit":"1.21","value":"-0.106"},{"groupId":"OG001","lowerLimit":"-1.68","upperLimit":"2.12","value":"0.219"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"439"},{"groupId":"OG001","value":"218"}],"units":"Participants"}],"description":"FACT is a modular approach to assess participant health-related quality of life using a 'core' set of questions (FACT-G) as well as a cancer site-specific module. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The FACT-B consisted of the FACT-G (27-item) and a breast-specific module: a 10-item instrument designed to assess participant concerns relating to breast cancer. For all questions, participants were asked to respond to a five-level scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. FACT-B total score = Physical Well-Being + Social/Family Well-Being + Emotional Well-Being + Functional Well-Being + Breast Cancer Subscale. As each of the items ranges from 0-4, the range of possible scores is 0-144, with 0 being the worst possible score and 144 the best.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.","id":"OG000","title":"Palbociclib Plus Letrozole"},{"description":"Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.","id":"OG001","title":"Placebo Plus Letrozole"}],"paramType":"MEAN","populationDescription":"Patient Reported Outcome (PRO) Analysis Set is a subset of ITT participants, who had both baseline and at least one follow-up PRO assessment.","reportingStatus":"POSTED","timeFrame":"From Baseline up to 2.5 years","title":"Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy-Breast (FACT-B)","type":"SECONDARY","unitOfMeasure":"Units on a scale"}