SAEs

Question 1

What is an SAE?

What are 3 things that qualify as one?

Answer 1

1. Results in death
2. Results in short or long term disability
3. Results in congenital abnormalities or birth defect

Question 2

What is an SAE?

Answer 2

A serious adverse event (SAE) in human drug trials is defined as
any untoward medical occurrence that at any dose. Results in death. Is life-threatening. Requires inpatient hospitalization or causes prolongation of existing hospitalization