{"analyses":[{"ciLowerLimit":"0.28","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.48","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":"0.37","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":"0.21","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.08","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":"0.47","statisticalComment":"Model includes a treatment factor only","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"22.6","upperLimit":"31.1","value":"27.4"},{"groupId":"OG001","lowerLimit":"6.3","upperLimit":"8.5","value":"7.2"},{"groupId":"OG002","lowerLimit":"9.1","upperLimit":"15.9","value":"13.9"},{"groupId":"OG003","lowerLimit":"1.4","upperLimit":"18.4","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 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 from randomization to first subsequent therapy or death (TFST).","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":"Time elapsed from randomization to first subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.","title":"Efficacy of Olaparib by Time to First Subsequent Therapy or Death (TFST)","type":"SECONDARY","unitOfMeasure":"Months"}