Determination of clinical endpoints of bleeding and SSE
Bleeding events were categorized into major and minor bleeding, by the
International Society on Thrombosis and Haemostasis (ISTH) criteria
[20]. Major bleeding was defined as (1) fatal bleeding, or (2)
bleeding in a critical area or organ, for example intracranial,
intraspinal, intraocular, retroperitoneal, intra-articular, pericardial,
or intramuscular with compartment syndrome, or (3) bleeding causing a
fall in hemoglobin level of ≥20 g L-1 (1.24 mmol
L-1) or leading to transfusion of ≥2 units of whole
blood or red cells. Minor bleeding was defined as any overt bleeding
that did not fall under the ISTH major bleeding criteria.
Major bleeding and SSE events were adjudicated by the study team
comprising a cardiologist and a cardiology specialist pharmacist based
on doctors’ diagnoses obtained from electronic medical records (EMRs).
Minor bleeding events were likewise obtained from EMRs or based on
clinical signs and symptoms self-reported by patients during the
follow-up phone interviews.