{"analyses":[{"ciLowerLimit":"0.23","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.40","estimateComment":"A hazard ratio \\< 1 favours olaparib","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Determined using a log-rank test stratified by response to previous platinum chemotherapy","paramType":"Hazard Ratio (HR)","paramValue":"0.30","statisticalComment":"Model includes a factor for response to previous platinum chemotherapy","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"0.23","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.99","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":"0.47","statisticalComment":"Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"comment":"Insufficient events to estimate median, lower and upper confidence limit.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"10.8","upperLimit":"16.6","value":"12.0"},{"comment":"Insufficient events to estimate median, lower and upper confidence limit.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Insufficient events to estimate upper confidence limit.","groupId":"OG003","lowerLimit":"6.4","upperLimit":"NA","value":"8.9"}]}]}],"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 time to earliest progression by RECIST or Cancer Antigen-125 (CA-125) or death","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":"CA-125 performed at baseline + every 4 weeks. Radiologic scans performed at baseline + every 12 weeks up to 156 weeks, then every 24 weeks until objective radiological disease progression. DCO:17May2018","title":"Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death","type":"SECONDARY","unitOfMeasure":"Months"}