The term ‘severe’ must not be confused with ‘serious’. In the English language, ‘severe’ is used to describe the intensity (severity) of a specific event (mild, moderate or severe); the event itself, however, may be of relatively minor medical significance (such as severe headache). Seriousness (not severity) is based on patient/event outcome or action criteria, and serves as a guide for defining regulatory reporting obligations.
Glossary
Seriousness vs. Severity
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