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 |