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- 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