A post-authorization safety study (PASS) to evaluate the paternal exposure to valproate and the risk of neurodevelopmental disorders including autism spectrum disorders as well as congenital abnormalities in offspring - a population-based retrospective study

30/04/2020
03/09/2025
EU PAS number:
EUPAS34201
Study
Finalised

ENCePP Code of conduct

No
Data sources

Data source(s)

Data source(s), other

Swedish National Registries, Danish National Registries

Data sources (types)

Administrative healthcare records (e.g., claims)
Use of a Common Data Model (CDM)

CDM mapping

No
Data quality specifications

Check conformance

Unknown

Check completeness

Unknown

Check stability

Unknown

Check logical consistency

Unknown
Data characterisation

Data characterisation conducted

No