Risk of thromboembolic events and thrombocytopenia after vaccination against COVID-19 (Thrombosis risk COVID-19 vaccination)

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:
  Other
• Non-interventional study design, other:
  Self-controlled case series

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BX03) covid-19 vaccines

  covid-19 vaccines
• Medical condition to be studied:
  Venous thrombosis

  Arterial thrombosis

  Thrombocytopenia

Population studied

• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  330

Study design details

• Main study objective:
  To quantify the association between the occurrence of thromboembolic events and thrombocytopenia, separately, as well as thromboembolism together with thrombocytopenia, and the administration of COVID-19 vaccines within pre-specified risk periods after vaccination, stratified by vaccine, age, sex and risk factor groups.
• Outcomes:
  Venous thromboembolism Arterial thromboembolism Thrombocytopenia, Concurrence of arterial or venous thromboembolism with thrombocytopenia
• Data analysis plan:
  Description of the study population characteristics, i.e. patients who have been vaccinated and have the event of interest will be described. For all study designs, we will compare the event rates in the post-vaccination risk period with the control periods using conditional Poisson regression, by type of vaccine.