Methods
bleeding, death, sight-threatening, gastrointestinal bleeding, haemoptysis, haematuria, Diabetes, epistaxis, diabetes
BLEEDING, GASTROINTESTINAL BLEEDING, INTRACRANIAL HAEMORRHAGE, HAEMATURIA, EVENTS, DIABETES, EPISTAXIS, EVENTS, DIABETES
The ASCEND (A Study of Cardiovascular Events iN Diabetes) primary prevention trial randomised 15 480 UK people with diabetes to aspirin versus matching placebo. The primary safety outcome was major bleeding (including intracranial haemorrhage, sight-threatening eye bleeding, serious gastrointestinal bleeding and other major bleeding (epistaxis, haemoptysis, haematuria, vaginal and other bleeding)) ascertained by direct-participant mail-based follow-up, with >90% of outcomes undergoing adjudication. Nearly all participants were linked to routinely collected hospitalisation and death data (ie, routine data). An algorithm categorised bleeding events from routine data as major/minor. Kappa statistics were used to assess agreement between data sources, and randomised comparisons were re-run using routine data.