List of serious adverse reactions
According to the Law on Medicines, serious adverse reaction to a medicine is any adverse reaction that can cause death, is life-threatening, hospitalization or prolongation of hospitalization if for that there was no need before the usage of medicine, permanent or significant impairment or disability, congenital anomalies or distortions during nursing and other medically significant condition.
Important Medical Event Terms-IME List, created on the initiative of EudraVigilance Expert Working Group, EV-EWG, is a guideline aimed at facilitating classification, analysis and assessment of collected data on adverse reactions. Important medical events from this list are marked by CS (Core Serious) and are considered adverse serious reactions even when they are not precisely defined by basic seriousness criteria.
IME list is based on coding of adverse reactions by using Medical Dictionary for Regulatory Activities (MedDRA).
Coding by using MedDRA is a result of the need for terminology standardisation in communication between regulatory authorities and pharmaceutical companies. Important medical events are given in the IME list according to the PT (Preferred Terms) coding level by using MedDRA. This coding level is commonly used to search database, as well as for data analysis. Seriousness of adverse reaction coded at LLT (Lowest Level Terms) level is determined on the basis of corresponding PT term according to the MedDRA hierarchy. IME list is updated in accordance with current version of MedDRA.
Latest IME List is available here.