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.