A serious adverse event is 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.
