| Causality term | Assessment criteria | Yes/No |
| certain | Event or laboratory test abnormality, with plausible time relationship to drug intake. | Yes |
| certain | Cannot be explained by disease or other drugs. | Yes |
| certain | Response to withdrawal plausible (pharmacologically, pathologically). | Yes |
| certain | Event definitive pharmacologically or phenomenologically (i.e., an objective and specific medical disorder or a recognized pharmacological phenomenon). | Yes |
| certain | Rechallenge satisfactory, if necessary. | Yes |
|
| Final outcome | Certain |