Common use of Definition of Serious Adverse Clause in Contracts

Definition of Serious Adverse. Event (SAE) A serious adverse event (SAE) is any untoward medical occurrence or effect that led to one of the following outcomes: · death of a patient, user or other person · serious injury of a patient, user or other person Serious injury (also known as serious deterioration in state of health) is either: · a life threatening illness or injury * · permanent impairment of a body function or permanent damage to a body structure† · a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure