Real World Evaluation of Venous Thromboembolism (VTE): Analysis of Electronic Health Record Data

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective Cohort Study

Study drug and medical condition

• Name of medicine:
  ELIQUIS

  PRADAXA

  XARELTO
• Name of medicine, other:
  Coumadin
• Medical condition to be studied:
  Venous thrombosis

Population studied

• Short description of the study population:
  Adults with VTE on or after September 1, 2014 newly treated with an oral anticoagulant and who had at least one medical encounter in the 12 months prior to; the baseline period.
• 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:
  Other
• Special population of interest, other:
  Patients with venous thrombosis
• Estimated number of subjects:
  17000

Study design details

• Main study objective:
  To assess OAC treatment patterns among patients with newly diagnosed VTE.
• Outcomes:
  Predictors of NOAC use. VTE recurrence and bleeding-related events during follow-up.
• Data analysis plan:
  Descriptive analyses, including means, medians, and standard deviations will be conducted for continuous variables. Numbers and percentages will be provided for dichotomous and polychotomous variables. Bivariate comparisons of baseline characteristics and outcomes measures will be provided. Appropriate tests will be used based on the distribution of the measure. The cumulative incidence rate for clinical outcomes will be calculated. Multivariate analyses will be conducted.