{"analyses":[{"ciLowerLimit":"-2.191","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.126","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.9765","paramType":"Mean Difference (Final Values)","paramValue":"-0.03","statisticalComment":"Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4.131","upperLimit":"-1.673","value":"-2.90"},{"groupId":"OG001","lowerLimit":"-4.643","upperLimit":"-1.097","value":"-2.87"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"94"}],"units":"Participants"}],"description":"To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.","dispersionType":"95% Confidence Interval","groups":[{"description":"Taken orally twice daily","id":"OG000","title":"Olaparib 300mg Tablets (Global Cohort)"},{"description":"Taken orally twice daily","id":"OG001","title":"Placebo Tablets (Global Cohort)"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China) with a baseline and post baseline TOI score available \\[This endpoint was not assessed in the China Cohort\\]","reportingStatus":"POSTED","timeFrame":"Questionnaires completed by patient at baseline, Day 29 and then every 12 weeks for 12 months. Assessed until 19 Sep 2016 DCO.","title":"Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)","type":"SECONDARY","unitOfMeasure":"Change in TOI over 12 months"}