Non-interventional study on Edoxaban treatment in routine clinical practice in patients with venous thromboembolism

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non Interventional post authorisation safety study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  EDOXABAN TOSYLATE
• Medical condition to be studied:
  Venous thrombosis

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired
• Estimated number of subjects:
  2700

Study design details

• Main study objective:
  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. The co-primary objective of this study is to collect and evaluate real-world safety data on bleeding events, drug related adverse events such as liver adverse events, and mortality (VTE-related, CV mortality, and all-cause
• Outcomes:
  Symptomatic VTE recurrence rate during an overall observational period of 18 months in unselected patients with acute VTE, symptomatic VTE recurrence rate for patients on edoxaban, the symptomatic VTE recurrence rate for patients who discontinued edoxaban, patient relevant outcomes such as strokes (ischaemic and haemorrhagic), systemic embolic events (SEE), hospitalisations related to CV condition (including VTE related hospitalisation), post-thrombotic Syndrom, compliance
• Data analysis plan:
  Binary, categorical, and ordinal parameters will be summarised by means of absolute and relative (percentage) frequencies within the various categories. Continuous parameters will be summarised by means of standard descriptive summary statistics. In addition, adequate graphs (e.g. bar charts, box-whisker plots) will be presented. Kaplan-Meier plots will be generated where ap