Safety and Effectiveness of Edoxaban in Japanese Venous Thromboembolism Patients　- Final Analysis of One-Year Follow-up Data From a Japanese Postmarketing Observational Study (ETNA-VTE-Japan).

ABSTRACT: Background: ETNA-VTE-Japan is a prospective, observational study conducted as part of a postmarketing study regarding the safety and effectiveness of edoxaban in Japanese patients with venous thromboembolism (VTE). The results of the final analysis of data collected at 1 year are presented. Methods and Results: A total of 1,732 patients were included in this study. The safety and effectiveness were evaluated in 1,702 patients (safety analysis set; SAS) and in 1,698 patients (effectiveness analysis set). In the SAS, 39.4% of patients were aged ≥75 years, 58.2% had body weight ≤60 kg, and 22.2% had creatinine clearance <50 mL/min. Approximately 90% of patients received a dose recommended on the package insert. A total of 46.1% of patients continued treatment for 1

SUBMITTER: Nakamura M 

PROVIDER: S-EPMC7921355 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature