pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
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 | |
| •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