{"analyses":[{"ciLowerLimit":"-1.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.3","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for systemic therapy side effects","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.7273","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":"0.4","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":"-2.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.7","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for breast symptoms","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.2671","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":"-0.9","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":"-2.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.2","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for arm symptoms","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.8750","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":"-0.2","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":"1.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"16.6","groupDescription":"Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for upset by hair loss","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0255","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":"8.9","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)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.6","spread":"15.19","upperLimit":"4.9","value":"3.8"},{"groupId":"OG001","lowerLimit":"1.8","spread":"14.31","upperLimit":"5.0","value":"3.4"}]}],"title":"Systemic therapy side effects"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.2","spread":"21.32","upperLimit":"-1.3","value":"-2.2"},{"groupId":"OG001","lowerLimit":"-2.7","spread":"17.49","upperLimit":"0.0","value":"-1.3"}]}],"title":"Breast symptoms"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.6","spread":"20.59","upperLimit":"-0.9","value":"-2.2"},{"groupId":"OG001","lowerLimit":"-4.0","spread":"20.08","upperLimit":"-0.1","value":"-2.0"}]}],"title":"Arm symptoms"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1.7","spread":"30.19","upperLimit":"7.4","value":"2.9"},{"groupId":"OG001","lowerLimit":"-12.3","spread":"20.91","upperLimit":"0.3","value":"-6.0"}]}],"title":"Upset by hair loss"}],"denoms":[{"counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"166"}],"units":"Participants"}],"description":"The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from 'not at all' to 'very much'. All scores are converted to a 0 to 100 scale. For symptom-oriented scales, a higher score represent more severe symptoms.","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 BR23 Symptom Scale Scores","type":"SECONDARY","unitOfMeasure":"Units on a scale"}