‘Serious adverse event’ means 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 according to (EU) 2017/745 Article 2 No. 58]