Serious adverse event

A serious adverse events is described by any adverse event that led to any of the following:

1. death,
2. serious deterioration in the health of the subject, that resulted in any of the following:
   1. life-threatening illness or injury,
   2. permanent impairment of a body structure or a body function,
   3. hospitalisation or prolongation of patient hospitalisation,
   4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
   5. chronic disease,
3. foetal distress, foetal death or a congenital physical or mental impairment or birth defect.