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)

ENCePP Code of conduct

Yes

Data sources

• Data source(s):
  Système National des Données de Santé (French national health system main database)

  The Information System for Research in Primary Care (SIDIAP)
• 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, USA; - PharMetrics Plus, USA; - National Registers, Finland
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Drug dispensing/prescription data

  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