Definition

The intensity or grade of an adverse event (mild, moderate, severe, life-threatening, fatal), which is distinct from regulatory seriousness.

Example

A patient reports severe abdominal pain (Grade 3 intensity) that resolved with OTC medication and didn't require medical attention. This is severe but not serious.

Regulatory source

ICH E2A, CTCAE

Common mistakes

Using severity and seriousness interchangeably. A mild event can be serious (e.g., mild symptoms leading to hospitalization for observation).

Inspector question

How do you document severity in your database? What grading scale do you use?

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