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Table. 3.

Table. 3.

Causality assessment using WHO-UMC criteria

Causality term  Assessment criteria
Certain•  Event or laboratory test abnormality, with plausible time relationship to drug intake •  Cannot be explained by disease or other drugs •  Response to withdrawal plausible (pharmacologically, pathologically) •  Event definitive pharmacologically or phenomenologically •  Rechallenge satisfactory, if necessary

Probable/likely•  Event or laboratory test abnormality, with reasonable time relationship to drug intake •  Unlikely to be attributed to disease or other drugs •  Response to withdrawal clinically reasonable • Rechallenge not required

Possible•  Event or laboratory test abnormality, with reasonable time relationship to drug intake •  Could also be explained by disease or other drugs •  Information on drug withdrawal may be lacking or unclear

Unlikely•  Event or laboratory test abnormality, with a time to drug intake that makes a relationship improbable (but not impossible) •  Disease or other drugs provide plausible explanations

Conditional/ Unclassified•  Event or laboratory test abnormality •  More data for proper assessment needed, or •  Additional data under examination

Unassessable/ Unclassifiable•  Report suggesting an adverse reaction •  Cannot be judged because information is insufficient or contradictory •  Data cannot be supplemented or verified

World Health Organization-Uppsala Monitoring Center, WHO-UMC

Korean J Clin Pharm 2019;29:133-7 https://doi.org/10.24304/kjcp.2019.29.2.133
© 2019 Korean J Clin Pharm