Table 2. WHO-UMC causality assessment scale.
WHO-UMC: World Health Organization-Uppsala Monitoring Centre
Causality term | Causality term |
Certain | · Event or laboratory test abnormality, with a 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 (i.e., an objective and specific medical disorder or a recognised pharmacological phenomenon) | |
· 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 | |
Un-assessable / Unclassifiable | · Report suggesting an adverse reaction |
· Cannot be judged because the information is insufficient or contradictory | |
· Data cannot be supplemented or verified |