Post-Authorisation Safety Study of Agomelatine and the Risk of Hospitalisation for Acute Liver Injury

ENCePP Code of conduct

No

Data sources

• Data source(s):
  Sweden National Prescribed Drugs Register / Läkemedelsregistret

  The Information System for Research in Primary Care (SIDIAP)

  German Pharmacoepidemiological Research Database
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Drug dispensing/prescription data

  Electronic healthcare records (EHR)

  Other
• Data sources (types), other:
  Hospital discharge data

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