An Observational Cohort Study to Assess Long-Term Safety of Danicopan Add-on Therapy in Patients with Paroxysmal Nocturnal Hemoglobinuria: Analysis of IPIG-Registry Data

ENCePP Code of conduct

Yes

Data sources

• Data source(s), other:
  IPIG PNH Registry (including retrospective data from the International Alexion PNH Registry)
• Data sources (types):
  Disease registry

Use of a Common Data Model (CDM)

• CDM mapping:
  Yes

CDM Mappings

• CDM name:
  CDISC SDTM
• CDM website:
  https://www.cdisc.org/standards/foundational/sdtm

Data quality specifications

• Check conformance:
  Yes
• Check completeness:
  Yes
• Check stability:
  Yes
• Check logical consistency:
  Yes

Data characterisation

• Data characterisation conducted:
  Yes