The Eplontersen Pregnancy and Lactation Outcomes Study: A Descriptive Safety Study of Pregnant and Lactating Individuals and Their Offspring Exposed to Eplontersen (EPPRO)

ENCePP Code of conduct

Yes

Data sources

• Data source(s), other:
  AstraZeneca PV database (Argus); Clinical Trials; sponteneous post-marketing reports; post-marketing observational studies; patient oriented programs; published literature; personal communication by healthcare providers
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Clinical trial

  Non-interventional study

  Patient surveys

  Pregnancy registry

  Published literature

  Spontaneous reports of suspected adverse drug reactions

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:
  Unknown