{"analyses":[{"ciLowerLimit":"0.60","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.53","estimateComment":"A hazard ratio \\< 1 favours olaparib","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.8903","pValueComment":"Determined using a log-rank test stratified by response to previous platinum chemotherapy","paramType":"Hazard Ratio (HR)","paramValue":"0.95","statisticalComment":"Model includes a factor for response to previous platinum chemotherapy","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"0.29","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.28","estimateComment":"A hazard ratio \\< 1 favours olaparib","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValueComment":"Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.","paramType":"Hazard Ratio (HR)","paramValue":"0.77","statisticalComment":"Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"comment":"Insufficient OS events to estimate median, lower and upper confidence limit.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Insufficient OS events to estimate median, lower and upper confidence limit.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Insufficient OS events to estimate median, lower and upper confidence limit.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Insufficient OS events to estimate median, lower and upper confidence limit.","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"260"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"44"},{"groupId":"OG003","value":"20"}],"units":"Participants"}],"description":"To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of overall survival (OS). Reports results of a pre-specified interim analysis; results for final OS analysis (235 OS events) anticipated 2029.","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":"Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) \\[Primary analysis\\] China Full Analysis Set (FAS) consisting of all patients randomized at sites in China (including 5 patients also included in the Global Cohort).","reportingStatus":"POSTED","timeFrame":"Assessed every 4 weeks until treatment discontinues (up to a max of 156 weeks), then as per protocol. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.","title":"Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival","type":"SECONDARY","unitOfMeasure":"Months"}