{"analyses":[{"ciLowerLimit":"-4.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.5","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for fatigue","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.3200","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":"-1.5","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":"-4.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.2","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for nausea and vomiting","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0369","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":"-2.5","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":"-8.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-2.1","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for pain","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0011","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":"-5.3","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":"-3.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.8","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for dyspnoea","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.7699","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":"-0.5","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":"-5.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.6","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for insomnia","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.2721","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":"-2.0","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":"-4.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.9","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for appetite loss","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.7334","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":"-0.6","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":"-2.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.9","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for constipation","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.6491","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":"0.7","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":"-2.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.7","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for diarrhoea","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.6293","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":"-0.6","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":"-3.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.6","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for financial difficulties","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.8812","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":"0.3","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":"0.1","spread":"26.12","upperLimit":"3.5","value":"1.8"},{"groupId":"OG001","lowerLimit":"0.9","spread":"24.82","upperLimit":"5.8","value":"3.3"}]}],"title":"Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.4","spread":"26.06","upperLimit":"3.0","value":"1.7"},{"groupId":"OG001","lowerLimit":"2.3","spread":"19.71","upperLimit":"6.1","value":"4.2"}]}],"title":"Nausea and vomiting"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-5.1","spread":"29.02","upperLimit":"-1.5","value":"-3.3"},{"groupId":"OG001","lowerLimit":"-0.6","spread":"30.04","upperLimit":"4.6","value":"2.0"}]}],"title":"Pain"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.0","spread":"30.32","upperLimit":"4.7","value":"2.8"},{"groupId":"OG001","lowerLimit":"0.6","spread":"24.98","upperLimit":"6.0","value":"3.3"}]}],"title":"Dyspnoea"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4.4","spread":"29.81","upperLimit":"-0.4","value":"-2.4"},{"groupId":"OG001","lowerLimit":"-3.3","spread":"29.30","upperLimit":"2.5","value":"-0.4"}]}],"title":"Insomnia"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.8","spread":"36.43","upperLimit":"3.1","value":"1.1"},{"groupId":"OG001","lowerLimit":"-1.1","spread":"29.61","upperLimit":"4.6","value":"1.7"}]}],"title":"Appetite loss"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.7","spread":"32.05","upperLimit":"5.3","value":"3.5"},{"groupId":"OG001","lowerLimit":"0.1","spread":"26.05","upperLimit":"5.4","value":"2.8"}]}],"title":"Constipation"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.6","spread":"18.97","upperLimit":"3.1","value":"1.9"},{"groupId":"OG001","lowerLimit":"0.5","spread":"26.12","upperLimit":"4.3","value":"2.4"}]}],"title":"Diarrhoea"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-5.6","spread":"28.87","upperLimit":"-1.9","value":"-3.7"},{"groupId":"OG001","lowerLimit":"-6.7","spread":"26.30","upperLimit":"-1.3","value":"-4.0"}]}],"title":"Financial difficulties"}],"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 EORTC QLQ-C30 Symptom Scale Scores","type":"SECONDARY","unitOfMeasure":"Units on a scale"}