Reference:ICH ICH E2A Guideline 1994 II B. Serious/Severe

Document Information

Document information
Reference	ICH ICH E2A Guideline 1994
Validity area	ICH
Scope(s)	G
Document name	ICH E2A Guideline
Version / Revision	1994
Status	Current
Document type	International guideline
Language(s)	EN
Description	CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING E2A
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details

Scope	G
Document part	II B. Serious/Severe
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
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Tags (FR)
Comment	Distinction between serious and severe adverse events

Text

[…] To ensure no confusion or misunderstanding of the difference between the terms "serious" and "severe," which are not synonymous, the following note of clarification is provided:

The term "severe" is often used to describe the intensity (severity) of a specific event (as in mild, moderate, or severe myocardial infarction); the event itself, however, may be of relatively minor medical significance (such as severe headache). This is not the same as "serious," which is based on patient/event outcome or action criteria usually associated with events that pose a threat to a patient's life or functioning. Seriousness (not severity) serves as a guide for defining regulatory reporting obligations. [...]