Non interventional post-authorisation safety study (PASS) to define the incidence of and potential risk factors for procedure-related neurological adverse events (AE) in patients undergoing ultrasound guided foam sclerotherapy (UGFS) for the treatment of lower limb varicose veins (VV) using Fibrovein 3% and 1% (sodium tetradecyl sulphate, STS, injection) incorporating a drug utilisation study (Fibrovein PASS)

15/01/2015
02/07/2024
EU PAS number:
EUPAS8260
Study
Finalised

ENCePP Code of conduct

No
Data sources

Data sources (types)

Other

Data sources (types), other

Prospective patient-based data collection
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