{"id":6948,"date":"2026-04-01T11:16:51","date_gmt":"2026-04-01T09:16:51","guid":{"rendered":"https:\/\/mediconomics.com\/?post_type=glossary&#038;p=6948"},"modified":"2026-07-13T19:09:21","modified_gmt":"2026-07-13T17:09:21","slug":"adverse-event-of-special-interest-aesi","status":"publish","type":"glossary","link":"https:\/\/mediconomics.com\/en\/glossar\/adverse-event-of-special-interest-aesi\/","title":{"rendered":"Adverse Event of Special Interest (AESI)"},"content":{"rendered":"<p>An Adverse Event of Special Interest (AESI) is a predefined category of adverse events that, on the basis of scientific and medical knowledge, requires particular attention and for which a predefined, expedited collection and assessment procedure is planned \u2013 regardless of whether the event is classified as serious.<\/p>\n<p>AESIs are defined, depending on the known or suspected safety profile of the investigational medicinal product, in the study protocol and in the Risk Management Plan. Typical AESI categories are: immune-mediated reactions (e.g. with checkpoint inhibitors: pneumonitis, colitis), infusion reactions, hepatotoxic events, cardiovascular events (e.g. QT prolongation), or \u2013 as prominently seen in COVID-19 vaccine trials \u2013 myocarditis.<\/p>\n<p>Unlike an SAE, an AESI does not require a severity classification but rather a predefined reporting and adjudication process. AESIs are generally assessed by a Clinical Endpoint Committee (CEC). For CROs, the correct capture, coding (MedDRA) and timely reporting of AESIs is a central pharmacovigilance task. Regulatory reference: ICH E6(R2), EMA Good Pharmacovigilance Practices (GVP).<\/p>\n<p><a href=\"https:\/\/mediconomics.com\/en\/glossary\/\">Back to overview<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>An Adverse Event of Special Interest (AESI) is a predefined category of adverse events that, on the basis of scientific and medical knowledge, requires particular attention and for which a predefined, expedited collection and assessment procedure is planned \u2013 regardless of whether the event is classified as serious. AESIs are defined, depending on the known [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[],"class_list":["post-6948","glossary","type-glossary","status-publish","hentry"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6948","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":1,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6948\/revisions"}],"predecessor-version":[{"id":6950,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6948\/revisions\/6950"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6948"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6948"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}