WP3: Pharmacovigilance

WP3 Objectives:

• To identify available databases of spontaneous adverse event reports on which to perform the study.
• To define a method for detection of drug arrhythmogenic potential by data mining of the spontaneous reporting databases.
• To list drugs included in spontaneous reports of arrhythmia (namely, TdP and proxies of TdP).
• To evaluate the presence of a significant signal for each drug identified in point 1, by using both case/non case method and rate calculation.
• To assign a risk score to each drug in order to allow for integration of results