A Post-Authorization Safety Study of the Use of Intravenous Telavancin (VIBATIV®) in the Clinical Setting (Telavancin PASS)

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Other
• Data sources (types), other:
  Prescription event monitoring, Clinigen sells product direct to hospitals (no wholesalers involved) therefore contact with prescribing physicians will begin from orders placed for telavancin with Clinigen's customer services department.

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

Procedures

Procedure of results generation

CLIN_2014_TLV_001 Statistical Analysis Plan 08Jul14 v2