unexpected serious risk
- Guideline or reference source
- CDISC Glossary of terms
- Definition
- A serious adverse drug experience that is not listed in the labeling of a drug, or that may be symptomatically or pathophysiologically related to an adverse drug event identified in the labeling, but differs because of greater severity, specificity, or prevalence.
- Broader Term
- serious adverse event
- Related Term
- suspected unexpected serious adverse event
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