A serious adverse events is described by 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.
