ETNA-VTE-Europe

Non-Interventional Study on Edoxaban Treatmentin Routine Clinical Practice in Patientswith Venous Thromboembolism in Europe

09/06/2016 to 31/12/2019

Primary objective is the analysis of the overall symptomatic VTE recurrence rate during an overall observational period of 18 months in unselected patients with acute VTE treated with edoxaban.
The co-primary objective of this study is to collect real world safety data on bleeding events, drug related adverse events such as liver adverse events, and mortality (VTE-related and all-cause) in patients treated with edoxaban. Furthermore, safety analyses in pre-specified subpopulations such as patients with renal impairment and patients with hepatic impairment will be performed.
Secondary objective is to assess the effect of edoxaban on relevant patient outcomes as recurrence rate of symptomatic VTE during treatment, recurrence rate of symptomatic VTE after cessation of edoxaban treatment, hospitalisations, postthrombotic syndrome (PTS), persistence to therapy (rate of permanent discontinuation, duration of time on therapy, reasons for permanent discontinuation), patient/physician reported outcomes, health care utilization, resource use.