{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"89"},{"groupId":"OG001","value":"56"}]}],"title":"Any AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"15"}]}],"title":"Any AE of CTCAE Grade 3 or higher"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Any AE with outcome = death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"10"}]}],"title":"Any SAE (including events with outcome = death)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"1"}]}],"title":"AnyAE leading to withdrawal of olaparib/placebo"},{"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"4"}]}],"title":"Any AE leading to dose interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"3"}]}],"title":"Any AE leading to dose reduction"}],"denoms":[{"counts":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"61"}],"units":"Participants"}],"description":"To assess the safety and tolerability of olaparib maintenance monotherapy. SAE: serious adverse events CTCAE: Common Terminology Criteria for Adverse Events","groups":[{"description":"Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.","id":"OG000","title":"Olaparib 300 mg Twice Daily (bd)"},{"description":"Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"Safety Analysis Set consisted of all patients who received at least one dose of study treatment.","reportingStatus":"POSTED","timeFrame":"Up to 4 years","title":"Number of Participants With Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"Participants"}