{"analyses":[{"ciLowerLimit":"0.43","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.80","estimateComment":"Hazard ratio \\<1 favours olaparib.","groupDescription":"Study is sized to provide 90% power to detect a true treatment effect of PFS hazard ratio 0.653.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0009","pValueComment":"A priori threshold for statistical significance (2-sided) is 0.05.","paramType":"Hazard Ratio (HR)","paramValue":"0.58","statisticalComment":"Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.7","upperLimit":"8.3","value":"7.0"},{"groupId":"OG001","lowerLimit":"2.8","upperLimit":"4.3","value":"4.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"205"},{"groupId":"OG001","value":"97"}],"units":"Participants"}],"description":"Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Olaparib 300 mg bd tablets","id":"OG000","title":"Olaparib 300 mg bd"},{"description":"Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin","id":"OG001","title":"Chemotherapy"}],"paramType":"MEDIAN","populationDescription":"Full Analysis Set (FAS) consisting of all randomised patients","reportingStatus":"POSTED","timeFrame":"Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.","title":"Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)","type":"PRIMARY","unitOfMeasure":"Months"}