{"analyses":[{"ciLowerLimit":"0.22","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.41","estimateComment":"A hazard ratio \\< 1 favours olaparib","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","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":"0.30","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":"0.17","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.19","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":"0.44","statisticalComment":"Model includes a treatment factor only","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"16.3","upperLimit":"25.7","value":"19.1"},{"groupId":"OG001","lowerLimit":"5.2","upperLimit":"5.8","value":"5.5"},{"groupId":"OG002","lowerLimit":"6.5","upperLimit":"16.6","value":"13.8"},{"comment":"Insufficient PFS events to estimate upper 95% CI","groupId":"OG003","lowerLimit":"2.7","upperLimit":"NA","value":"5.5"}]}]}],"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 by progression free survival (PFS) (using investigator assessment according to modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)) 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.","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 \\[Primary analysis\\] China Full Analysis Set (FAS) includes all patients who were randomised at sites in China.","reportingStatus":"POSTED","timeFrame":"Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.","title":"Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)","type":"PRIMARY","unitOfMeasure":"Months"}