Study patients and data collection
This study consists of 510 patients who were prescribed by Seoul National University Hospital with edoxaban between March 1, 2016 and June 30, 2017. Patients who were 18 or older and received proper dosage of edoxaban based on Lixiana package insert (Korean version) [12] were eligible for the study. Patients who received inappropriate dose of edoxaban were excluded. Data collection was conducted using electronic medical records. Data on age, sex, weight, serum creatinine, comorbidities, concurrent medication, international normalized ratio (INR) measurements, history of bleeding complications, and liver function test (cirrhosis or bilirubin >2x normal, or aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase >3x normal) were collected. Bleeding complications were classified as major, clinically relevant non-major, or minor bleeding using the scheme detailed in the International Society on Thrombosis and Hemostasis criteria [13].
This study was approved by the Institutional Review Board of the Seoul National University Hospital (approval number: H-1809-044-971).