Comparing Database Harmonisation Methods Applied to Real-World Electronic Healthcare Data

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01AA) Vitamin K antagonists

  Vitamin K antagonists

  (B01AE07) dabigatran etexilate

  dabigatran etexilate

  (B01AF) Direct factor Xa inhibitors

  Direct factor Xa inhibitors
• Medical condition to be studied:
  Haemorrhage

  Ischaemic stroke

  Acute myocardial infarction

  Glaucoma

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)
• Estimated number of subjects:
  44000

Study design details

• Main study objective:
  The objective is to assess whether the implementation of a study specific CDM and a general CDM, versus using a common protocol alone has an impact on the consistency of the study results of a pharmacoepidemiologic study in real-world data.
• Outcomes:
  TBC, TBC
• Data analysis plan:
  TBC