unexpected adverse drug reaction
Glossaries
| Term | Definition |
|---|---|
| unexpected adverse drug reaction |
An adverse drug reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information (e.g., IB for an unapproved investigational product or PI/summary of product characteristics for an approved product, and/or scientific literature). [After ICH E6 (R2)]
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