There is often a lot of confusion about the difference between a severe adverse event and a serious adverse event. Severity is a grading. Adverse Events (AEs) can be classified as mild, moderate or severe. An AE can be severe without being a Serious Adverse Event.
A Serious Adverse Event (SAE) is an adverse event that meets one of the following criteria:
- results in death
- is life-threatening
- requires inpatient hospitalization or prolongation of existing hospitalization
- results in persistent or significant disability/incapacity
- is a congenital anomaly/birth defect
A SAE can be graded as mild, moderate or severe. It is most common for SAEs to fall into the severe grading category but it is not always the case.
When classifying an AE, first work out if it meets the SAE criteria. Then work out the grading. If you follow this order, it should be much clearer.