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WHO-UMC Causality Assessment

Work through the WHO-UMC criteria. The tool suggests the highest category whose criteria are all met. The category you report remains your clinical judgement.

1.Is the information in the report enough to assess the case?
2.Is the time between drug intake and the event plausible?
3.Can the disease or other drugs explain the event?
4.What happened when the drug was withdrawn?
5.Is the event definitive pharmacologically or phenomenologically (using a satisfactory rechallenge if necessary)?

The categories

CategoryCriteria (all must apply)
CertainPlausible time relationship; cannot be explained by disease or other drugs; plausible response to withdrawal; event definitive pharmacologically or phenomenologically, using a satisfactory rechallenge if necessary.
Probable / LikelyReasonable time relationship; unlikely to be due to disease or other drugs; clinically reasonable response to withdrawal; rechallenge not required.
PossibleReasonable time relationship; could also be explained by disease or other drugs; information on withdrawal may be lacking or unclear.
UnlikelyTime to onset makes a relationship improbable (but not impossible); disease or other drugs provide plausible explanations.
Conditional / UnclassifiedMore data are needed for proper assessment, or additional data are being examined.
Unassessable / UnclassifiableCannot be judged because information is insufficient or contradictory, and cannot be supplemented or verified.