Tafamidis Pregnancy Surveillance Study

ENCePP Code of conduct

No

Data sources

• Data source(s), other:
  Tafamidis Enhanced Surveillance for Pregnancy Outcomes, routine pharmacovigilance activities, and spontaneous safety reporting
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Disease registry

  Electronic healthcare records (EHR)

  Other

  Spontaneous reports of suspected adverse drug reactions
• Data sources (types), other:
  Prescription event monitoring

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