Pharmacovigilance Glossary Terms

AESI: The acronym AESI refers to an adverse event of special interest.

This term is commonly used in clinical trials to establish the adverse events that might be a concern of the medicinal product and/or that should be carefully monitored throughout the study.

An AESI should be handled according to Sponsor’s instructions and in some cases, an expedited communication of the AESI to the Sponsor might be requested.