View source for Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR)

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{{:Document:ICH ICH E6 Guideline R3 (2025)}}

{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 5 — Unit 5.1.4
|-
! Scope
| G
|-
! Document part
| GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR)
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
| 
|-
! Tags
| [[Glossary:TAG-00048-Sus-ngV|SUSAR]], [[Glossary:TAG-00047-Une-ete|Unexpected SAR]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00066-Cau-enh|Causality]], [[Glossary:TAG-00331-Une-irk|Unexpected adverse reaction]]
|-
! Comment
| Definition of SUSAR
|}

== Content ==
Suspected Unexpected Serious Adverse Reaction (SUSAR): 
an adverse reaction that meets three criteria: suspected, unexpected and serious.

• Suspected: There is a reasonable possibility that the drug caused the adverse drug reaction.

• Unexpected: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure or alternative documents according to applicable regulatory requirements; see RSI).

•Serious: See above for SAE.