{"analyses":[{"ciLowerLimit":"0.23","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":"0.18","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.03","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":"0.41","statisticalComment":"Model includes a treatment factor only","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.6","upperLimit":"22.3","value":"16.9"},{"groupId":"OG001","lowerLimit":"3.7","upperLimit":"5.6","value":"4.9"},{"groupId":"OG002","lowerLimit":"5.9","upperLimit":"14.0","value":"12.9"},{"groupId":"OG003","lowerLimit":"1.0","upperLimit":"7.4","value":"3.7"}]}]}],"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 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 by assessment of time to earliest progression by RECIST or 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":"Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China).\n\nChina Full Analysis Set (FAS) includes all patients who were randomised at sites in China.","reportingStatus":"POSTED","timeFrame":"CA-125 at baseline then every 4 wks. Radiologic scans at baseline then every ~12 wks up to 72 wks, then every ~ 24 wks until objective radiological disease progression. Assessed until 19Sep2016 DCO (16Jan2017 DCO for China Cohort); up to a max of 36 mths.","title":"Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death","type":"SECONDARY","unitOfMeasure":"Months"}