Post-authorization safety study of iptacopan in adult patients with paroxysmal nocturnal hemoglobinuria (PNH) using data from the non-interventional IPIG PNH Registry

Data sources

• Data source(s):
  The International PNH Interest Group PNH Registry / The IPIG 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:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  Yes