{"analyses":[{"ciLowerLimit":"-6.917","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.496","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.355","paramType":"Mean Difference (Final Values)","paramValue":"-2.21","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.826","upperLimit":"1.759","value":"-1.03"},{"groupId":"OG001","lowerLimit":"-2.585","upperLimit":"4.939","value":"1.18"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"55"}],"units":"Participants"}],"description":"To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100.\n\nA higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful.\n\nbd twice daily.","dispersionType":"95% Confidence Interval","groups":[{"description":"Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.","id":"OG000","title":"Olaparib 300 mg Twice Daily (bd)"},{"description":"Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.","id":"OG001","title":"Placebo"}],"paramType":"MEAN","populationDescription":"Patient reported outcome (PRO) analysis set was defined as the analysis population for PRO data were a subset of the FAS (ITT) population who had evaluable baseline EORTC QLQ-C30 or QLQ-PAN26 forms where evaluable meant that at least 1 sub-scale baseline score could be determined from at least 1 of the 2 forms.","reportingStatus":"POSTED","timeFrame":"From baseline up to 6 months","title":"Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire","type":"SECONDARY","unitOfMeasure":"Unit on scale"}