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Glossary of Adverse Drug Experience (ADE) Terms

Number of Animals Evaluated

Total number of animals reported to the FDA for evaluation.

NOTE: After analyzing the reports, CVM veterinarians may determine that some of the potential adverse experiences in the animal were not possibly, probably, or definitely drug related.  Therefore, these ADEs are not included in the Cumulative Adverse Drug Experiences (ADE) Summaries Report.

Sign

Description of reported adverse experience or clinical manifestation associated with drug use.  This is a link to the abbreviations used for these signs.

Missing

The ADE report did not indicate the route of administration.

Unknown

The ADE report states that the route of administration is unknown.

Extra-Label or Off-label

The use of an approved drug in a manner that is not in accordance with the approved label directions.  For example, a product is used for indications or species for which it is not approved.


Web Page Updated by hd - November 29, 2007, 10:08 AM ET




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