Determination of correlation between adverse event and drug
| Criteria | Definitely relevant | Probably relevant | Probably irrelevant | Definitely irrelevant | Unable to decide |
|---|---|---|---|---|---|
| Within the reasonable post-dosage time sequence | + | + | − | − | − |
| Within known types of reaction of suspected drug | + | + | − | − | ? |
| Symptoms improved after withdrawal of drug | + | ? | ? | − | ? |
| Reactions recur after repeated administration | + | ? | ? | − | ? |
| Related to other treatment | − | + | + | + | ? |
‘+’ means YES; ‘−’ means NO; ‘?’ means unclear situation.