A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin
Status:
Terminated
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
The Thelin Patient Safety Registry is a post-marketing program in the European Union (EU)
that is designed to supplement the reporting of spontaneous adverse events (AE) and better
characterize known and potential safety signals for Thelin. The registry is a secure,
restricted access, electronic system which collects anonymous, pre-defined, patient-level
data on demographic variables, safety monitoring measurements (i.e. liver function tests,
haemoglobin and international normalized ratio (INR) measurements), concomitant medications,
information on AEs and Thelin drug discontinuation. Regular review of the data is conducted
to assess the frequency of identified safety risks and to monitor for the emergence of new
safety signals at monthly pharmacovigilance meetings, quarterly signal detection meetings,
and for each Periodic Safety Update Report (PSUR).