Shortcut for Serious Adverse Event
Any adverse event that led to any of the following:
a) death,
b) serious deterioration in the health of the subject, that resulted in any of the following:
- i. life-threatening illness or injury,
- ii. permanent impairment of a body structure or a body function,
- iii. hospitalisation or prolongation of patient hospitalisation,
- iv. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body
- function,
- v. chronic disease,
c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect
[Definition of the term according to MDCG 2020-10/1, entspricht auch Begriffsdefinition gemäß (EU) 2017/745 Artikel 2 Nr. 58]