{"analyses":[{"ciLowerLimit":"0.54","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.81","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":"<0.0001","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.","paramType":"Hazard Ratio (HR)","paramValue":"0.66","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":"168"},{"groupId":"OG001","value":"226"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"399"},{"groupId":"OG001","value":"397"}],"units":"Participants"}],"description":"An rPFS event is defined as progression determined by Response Evaluation Criteria in Solid Tumours version 1.1 \\[RECIST 1.1\\] and/or Prostate Cancer Working Group 3 \\[PCWG-3\\] or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomised therapy or receives another anticancer therapy prior to progression.\n\nPer RECIST v1.1, progression is defined as the sum of TLs has a 20% and absolute ≥ 5mm increase from nadir, and/or unequivocal progression in any non target lesions, and/or any new lesion identified.\n\nPer PCWG3, progression on a bone scan is defined as 2 or more new lesions observed from the first visit after baseline compared to baseline, or from all other visits compared to first visit after baseline. A confirmatory scan is required.","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 (DCO1): 30Jul2021 (Approx. 2 years 9 months)","title":"Number of Participants With Radiological Progression Free Survival (rPFS) Event by Investigator Assessment","type":"PRIMARY","unitOfMeasure":"Participants"}