An observational study assessing the management of gastrointestinal and urogenital bleeding events in patients with atrial fibrillation treated with dabigatran etexilate (GI/GU bleeding management in AF patients using dab)

Study type

• Study topic:
  Disease /health condition

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

  Disease epidemiology

  Other
• If ‘other’, further details on the scope of the study:
  Disease Management
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational study based on a medical chart review

Study drug and medical condition

• Name of medicine:
  PRADAXA
• Name of medicine, other:
  Pradax
• Study drug International non-proprietary name (INN) or common name:
  DABIGATRAN ETEXILATE
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Adult patients ≥ 18 years of age with confirmed diagnosis of non valvular atrial fibrillation (AF); documentation of presentation to an emergency departments/rooms (ED/ER) for an acute gastrointestinal (GI) and urogenital (GU) bleeding event (index event) between October 28, 2010 and August 21, 2013; and documentation that the index event occurred in a patient who reported having taken at least one dose of dabigatran within the 5 days prior to the index event.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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 atrial fibrillation
• Estimated number of subjects:
  220

Study design details

• Main study objective:
  To assess the clinical characteristics of the GI and GU bleeding events in patients with AF taking dabigatran, and additionally to collect information describing the management to resolve those events and the clinical outcomes of these events.
• Outcomes:
  Frequencies of patients with index event safety outcomes (ongoing/resolved/deceased)Frequencies of patients receiving different type of interventions to stop the index eventFrequencies of bleeding types and anatomic locations of the index event
• Data analysis plan:
  Descriptive statistics will be used to analyse the data by means of absolute and relative frequencies, means, standard deviations, medians, inter quartile ranges, minimum and maximum values, 95% confidence intervals and proportions, as appropriate.