The American Food and Drug Administration defines a serious adverse event as one when the patient outcome is one of the following:
* Death
* Life-Threatening
* Hospitalization (initial or prolonged)
* Disability - significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.
* Congenital Anomaly
* Requires Intervention to Prevent Permanent Impairment or Damage
Severity is a point on an arbitrary scale of intensity of the adverse event in question. The terms "severe" and "serious" when applied to adverse events are technically very different. They are easily confused but can not be used interchangeably, require care in usage.
A headache is severe, if it causes intense pain. There are scales like "visual analog scale" that help us assess the severity. On the other hand, a headache can hardly ever be serious, unless it also satisfies the criteria for seriousness listed above.
I'm just a little bit confused....
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