{"analyses":[{"ciLowerLimit":"0.392","ciNumSides":"TWO_SIDED","ciPctValue":"99.5","ciUpperLimit":"0.831","estimateComment":"Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \\<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0000257","pValueComment":"A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.","paramType":"Hazard Ratio (HR)","paramValue":"0.574","statisticalComment":"Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"89"},{"groupId":"OG001","value":"152"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"921"},{"groupId":"OG001","value":"915"}],"units":"Participants"}],"description":"A DDFS event is defined as documented evidence of first distant recurrence of breast cancer or death from any cause","groups":[{"description":"Olaparib tablets 300mg taken orally twice daily.","id":"OG000","title":"Olaparib"},{"description":"Placebo tablets taken orally twice daily.","id":"OG001","title":"Placebo"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Full Analysis Set (FAS)","reportingStatus":"POSTED","timeFrame":"From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)","title":"Distant Disease Free Survival (DDFS)","type":"SECONDARY","unitOfMeasure":"Participants"}