{"analyses":[{"ciLowerLimit":"0.75","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.50","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":"0.7456","paramType":"Hazard Ratio (HR)","paramValue":"1.06","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":"68"},{"groupId":"OG001","value":"60"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"399"},{"groupId":"OG001","value":"397"}],"units":"Participants"}],"description":"A TTPP event is defined as pain progression based on the Brief Pain Inventory-Short Form (BPI-SF) Item 3 (range 0-10, a higher score indicates worse pain) and opiate analgesic use (Analgesic quantification algorithm \\[AQA\\] score, range 0-7, a higher score indicates increased opioid use). For patients who are asymptomatic at baseline (average worst pain score of 0 and not taking opioids): A ≥2 point change from baseline in average (4-7 days) worst pain score observed at 2 consecutive visits or initiation of opioid use; For patients who are symptomatic at baseline (average worst pain score \\>0 and/or receiving opioids): A ≥2 point change from baseline in average (4-7 days) worst pain score observed at 2 consecutive visits and an average worst pain score ≥4, and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of ≥2), or increase in opioid use (≥1-point increase, or ≥2-point increase if the starting value is 0) at 2 consecutive follow-up visits.","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)","title":"Number of Participants With Time to Pain Progression (TTPP) Event","type":"SECONDARY","unitOfMeasure":"Participants"}