A regulatory requirement non-interventional study to monitor the safety and effectiveness of Ofev (Nintedanib, 150mg/100mg, BID) in Korean patients

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Other

  Spontaneous reports of suspected adverse drug reactions
• Data sources (types), other:
  Prospective patient-based data collection

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

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

Data characterisation

• Data characterisation conducted:
  Yes