{"analyses":[{"ciLowerLimit":"0.22","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.40","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"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"16.5","upperLimit":"27.3","value":"19.3"},{"groupId":"OG001","lowerLimit":"5.0","upperLimit":"5.8","value":"5.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"190"},{"groupId":"OG001","value":"96"}],"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 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":"Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China) and confirmed as Myriad gBRCAm \\[This endpoint was not assessed in the China Cohort\\]","reportingStatus":"POSTED","timeFrame":"Radiologic scans performed at baseline then every ~12 weeks for the first 72 weeks, then every ~24 weeks thereafter, assessed until disease progression. Assessed until 19 Sep 2016 DCO.","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"}