Key result
A standardized definition for clinically significant bleeding was developed for the ASPREE trial, requiring events to be substantiated and involve transfusion, hospitalization, surgery, or death.
This paper provides a benchmark methodology for defining clinically significant bleeding in future aspirin primary prevention trials.
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Adopt this substantiated bleeding definition in future aspirin primary prevention trials; extends benchmark methodology for consistent event ascertainment.
Margolis et al. (2018) studied Primary prevention (n=19,114). Aspirin vs. Placebo was evaluated on Disability-free survival (composite of all-cause mortality, incident dementia, or persistent physical disability). A standardized definition for clinically significant bleeding was developed for the ASPREE trial, requiring events to be substantiated and involve transfusion, hospitalization, surgery, or death.
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