Serious adverse event

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.