{"analyses":[{"ciLowerLimit":"0.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.0","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for Global health status/ QoL","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0313","pValueComment":"The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.","paramType":"Mean Difference (Final Values)","paramValue":"3.1","statisticalComment":"Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.","statisticalMethod":"Mixed Model Analysis (2-sided)"},{"ciLowerLimit":"-1.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.5","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for physical functioning","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.4000","pValueComment":"The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.","paramType":"Mean Difference (Final Values)","paramValue":"1.0","statisticalComment":"Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.","statisticalMethod":"Mixed Model Analysis (2-sided)"},{"ciLowerLimit":"-1.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.3","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for role functioning","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.2615","pValueComment":"The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.","paramType":"Mean Difference (Final Values)","paramValue":"1.9","statisticalComment":"Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.","statisticalMethod":"Mixed Model Analysis (2-sided)"},{"ciLowerLimit":"1.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"7.4","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for emotional functioning","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0016","pValueComment":"The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.","paramType":"Mean Difference (Final Values)","paramValue":"4.6","statisticalComment":"Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.","statisticalMethod":"Mixed Model Analysis (2-sided)"},{"ciLowerLimit":"-1.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.8","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for cognitive functioning","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.3650","pValueComment":"The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.","paramType":"Mean Difference (Final Values)","paramValue":"1.2","statisticalComment":"Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.","statisticalMethod":"Mixed Model Analysis (2-sided)"},{"ciLowerLimit":"-3.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.5","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for social functioning","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.9615","pValueComment":"The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.","paramType":"Mean Difference (Final Values)","paramValue":"0.1","statisticalComment":"Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.","statisticalMethod":"Mixed Model Analysis (2-sided)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2.5","spread":"64.5","upperLimit":"0.7","value":"-0.9"},{"groupId":"OG001","lowerLimit":"-6.3","spread":"26.25","upperLimit":"-1.7","value":"-4.0"}]}],"title":"Global health status / QoL"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2.1","spread":"22.76","upperLimit":"0.7","value":"-0.7"},{"groupId":"OG001","lowerLimit":"-3.7","spread":"21.24","upperLimit":"0.2","value":"-1.7"}]}],"title":"Physical functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.7","spread":"30.70","upperLimit":"0.1","value":"-1.8"},{"groupId":"OG001","lowerLimit":"-6.5","spread":"28.04","upperLimit":"-0.9","value":"-3.7"}]}],"title":"Role functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.1","spread":"25.97","upperLimit":"4.3","value":"2.7"},{"groupId":"OG001","lowerLimit":"-4.2","spread":"21.19","upperLimit":"0.5","value":"-1.9"}]}],"title":"Emotional functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.1","spread":"20.97","upperLimit":"-0.2","value":"-1.7"},{"groupId":"OG001","lowerLimit":"-5.0","spread":"20.22","upperLimit":"-0.7","value":"-2.9"}]}],"title":"Cognitive functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2.5","spread":"32.07","upperLimit":"1.5","value":"-0.5"},{"groupId":"OG001","lowerLimit":"-3.4","spread":"32.27","upperLimit":"2.3","value":"-0.6"}]}],"title":"Social functioning"}],"denoms":[{"counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"166"}],"units":"Participants"}],"description":"The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from \"not at all\" to \"very much\" and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.","id":"OG000","title":"Palbociclib + Fulvestrant"},{"description":"Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.","id":"OG001","title":"Placebo + Fulvestrant"}],"paramType":"MEAN","populationDescription":"The PRO -evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post -baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.","reportingStatus":"POSTED","timeFrame":"From Cycle 1 to 14, as of 05 December 2014.","title":"Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores","type":"SECONDARY","unitOfMeasure":"Units on a scale"}