An Observational Pregnancy Safety Study in Women with Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (inebilizumab-cdon) during Pregnancy (VIB0551.P4.S4 /20230064)

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Other
• Data sources (types), other:
  Prospective patient-based data collection, Data will also be collected on retrospective cases as well (among patients whose pregnancy outcome has been identified). The data will be collected at enrollment, and if the infant is less than 12 month-old, the infant will be followed up to 12 months after delivery

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