{"analyses":[{"ciLowerLimit":"0.54","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.00","estimateComment":"A hazard ratio \\<1 favours olaparib","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0537","pValueComment":"Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment","paramType":"Hazard Ratio (HR)","paramValue":"0.74","statisticalComment":"Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"0.38","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.49","estimateComment":"A hazard ratio \\<1 favours olaparib","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValueComment":"Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.","paramType":"Hazard Ratio (HR)","paramValue":"0.93","statisticalComment":"Model includes a treatment factor only","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"41.5","upperLimit":"59.1","value":"51.7"},{"groupId":"OG001","lowerLimit":"31.4","upperLimit":"48.6","value":"38.8"},{"comment":"Insufficient OS events to estimate upper 95% CI","groupId":"OG002","lowerLimit":"17.6","upperLimit":"NA","value":"41.7"},{"comment":"Insufficient OS events to estimate upper 95% CI","groupId":"OG003","lowerLimit":"13.2","upperLimit":"NA","value":"36.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"196"},{"groupId":"OG001","value":"99"},{"groupId":"OG002","value":"22"},{"groupId":"OG003","value":"10"}],"units":"Participants"}],"description":"To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of overall survival (OS).","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)"},{"description":"Taken orally twice daily","id":"OG002","title":"Olaparib 300mg Tablets (China Cohort)"},{"description":"Taken orally twice daily","id":"OG003","title":"Placebo Tablets (China Cohort)"}],"paramType":"MEDIAN","populationDescription":"Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China) China Full Analysis Set (FAS) includes all patients who were randomised at sites in China.","reportingStatus":"POSTED","timeFrame":"Survival assessed every 4 weeks until treatment discontinues, then every 12 weeks. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.","title":"Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Overall Survival","type":"SECONDARY","unitOfMeasure":"Months"}