Non-Interventional Post-Authorization Safety Study on the Long-Term Safety of HyQvia in Subjects Treated with HyQvia (161302)

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Other
• Data sources (types), other:
  Source data comprised hospital records, medical records, clinical and office charts, laboratory notes, memoranda, subject diaries, home treatment records or evaluation checklists, outcomes reported by subjects, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, medical imaging data (eg, microfiches, photographic negatives, microfilm or magnetic media, X-rays), subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the study.

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