{"analyses":[{"ciLowerLimit":"-4.779","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-1.216","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0010","paramType":"Mean Difference (Final Values)","paramValue":"-3.00","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":"-0.717","upperLimit":"1.318","value":"0.30"},{"groupId":"OG001","lowerLimit":"1.839","upperLimit":"4.758","value":"3.30"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"260"},{"groupId":"OG001","value":"131"}],"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 high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line 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":"Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) with a baseline and post baseline TOI scores available.","reportingStatus":"POSTED","timeFrame":"Questionnaires will be given to the patient at baseline, at Day 29 and then every 12 weeks for 156 weeks, then every 24 weeks or until the data cut off for the PFS analysis, change in TOI over 24 months reported","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":"Scores on a scale"}