{"analyses":[{"ciLowerLimit":"0.22","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"}],"classes":[{"categories":[{"measurements":[{"comment":"Insufficient PFS events to estimate median, lower and upper confidence limit.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"11.1","upperLimit":"18.2","value":"13.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"130"}],"units":"Participants"}],"description":"To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and potential future BRCA mutation assays (gene sequencing and large rearrangement analysis)","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":"MEDIAN","populationDescription":"Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) and confirmed as Myriad gBRCAm.","reportingStatus":"POSTED","timeFrame":"Radiologic scans performed at baseline then every 12 weeks for the first 156 weeks, then every 24 weeks thereafter, assessed until disease progression. Analysis of data assessed up to a maximum of 54 months.","title":"Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS","type":"SECONDARY","unitOfMeasure":"Months"}