{"analyses":[{"ciLowerLimit":"0.67","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.00","estimateComment":"HR and CI calculated using Cox Proportional Hazards model, where a HR \\< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0544","pValueComment":"A multiple testing procedure is employed across primary (rPFS) and key secondary endpoints (OS) to strongly control overall type 1 error at 2.5% one-sided. Alpha spend for OS will not exceed 0.02135.","paramType":"Hazard Ratio (HR)","paramValue":"0.81","statisticalComment":"Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"205"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"399"},{"groupId":"OG001","value":"397"}],"units":"Participants"}],"description":"An OS event is defined as death by any cause, regardless of whether the patient withdraws from randomised therapy or receives another anticancer therapy.","groups":[{"description":"Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily","id":"OG000","title":"Olaparib 300 mg bd + Abiraterone 1000 mg qd"},{"description":"Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.","id":"OG001","title":"Placebo bd + Abiraterone 1000 mg qd"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Full Analysis Set (FAS)","reportingStatus":"POSTED","timeFrame":"Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months). DCO3 is the final data cut-off for the OS analysis and therefore no further updates will be made.","title":"Number of Participants With Overall Survival (OS) Event","type":"SECONDARY","unitOfMeasure":"Participants"}