{"analyses":[{"ciLowerLimit":"0.40","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.83","estimateComment":"Hazard ratio \\<1 favours olaparib.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0033","pValueComment":"PFS2 tested using a multiple testing procedure with a recycling strategy. With 157 PFS2 events, a priori threshold for statistical significance (2-sided) was 0.008.","paramType":"Hazard Ratio (HR)","paramValue":"0.57","statisticalComment":"Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.9","upperLimit":"15.3","value":"13.2"},{"groupId":"OG001","lowerLimit":"7.3","upperLimit":"10.4","value":"9.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"205"},{"groupId":"OG001","value":"97"}],"units":"Participants"}],"description":"Time from randomisation to the earliest of the progression event subsequent to the first objective radiological progression, or death. Second progression may involve any of; objective radiological or symptomatic progression or death. 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. Symptomatic progression is assessed by investigators based on clinical examination.","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":"Second progression status reviewed every 8 weeks following the first objective radiological progression as per investigator assessment. Assessed up to a maximum of 30 months.","title":"Time to Second Progression or Death (PFS2)","type":"SECONDARY","unitOfMeasure":"Months"}