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

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-|RefScope=G
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-|RefDocPart=II B.
+|unit=5.1.3
 Serious/Severe
-|RefLanguage=EN
+|language=EN
-|RefTags=TAG-00319-Dif-ers ++ TAG-00046-Ser-sSc ++ TAG-00259-AEs-ten ++ TAG-00045-Adv-hte
+|entry_by=Florian Adragna
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+|tags_display=[[Glossary:TAG-00319-Dif-ers|Differentiation]], [[Glossary:TAG-00046-Ser-sSc|Serious adverse event]], [[Glossary:TAG-00259-AEs-ten|AE severity]], [[Glossary:TAG-00045-Adv-hte|Adverse event]]
+|comment=Distinction between serious and severe adverse events
-{{:Document:ICH ICH E2A Guideline 1994}}
+|content=[…]
 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.
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	}}		}}

	~~== Document Information ==~~
	{{:Document:ICH ICH E2A Guideline 1994}}		{{:Document:ICH ICH E2A Guideline 1994}}

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	Serious/Severe		Serious/Severe
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	== ~~Text~~ ==		== Content ==
	[…]		[…]
	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:		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: