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serious adverse event

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serious adverse event

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.