An Observational Multi-Country Post-Authorisation Safety Study to Evaluate the Risk of Serious Adverse Cardiovascular Events in Adolescent and Adult Patients with Severe Asthma taking Tezepelumab (TRESPASS)

24/05/2024
14/10/2026
EU PAS number:
EUPAS1000000169
Study
Ongoing

ENCePP Code of conduct

Yes
Data sources

Data source(s)

Data source(s), other

- National Registers and Register of Selected Chronic Diseases and Severe Mental Disorders (RUKS), Denmark
- Statutory Health Insurance Claims (SHI), Germany
- Carelon Reseach, USA

Data sources (types)

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

CDM mapping

Yes

CDM Mappings

CDM name (other)

TRESPASS CDM
Data quality specifications

Check conformance

Unknown

Check completeness

Unknown

Check stability

Unknown

Check logical consistency

Unknown
Data characterisation

Data characterisation conducted

No
Procedures
No information provided.