A Post-marketing, Observational, Descriptive Study to Assess the Risk Associated With Pregnancy, the Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Omaveloxolone During Pregnancy and/or Lactation

ENCePP Code of conduct

Yes

Data sources

• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Disease registry

  Electronic healthcare records (EHR)

  Other

  Pregnancy registry

  Published literature
• Data sources (types), other:
  Patient support groups and external data sources, such as pharmacy/medical claims or electronic medical records.

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