From: Oromandibular dystonia: a serious side effect of capecitabine
 | Yes | No | Do not know | Score case |
---|---|---|---|---|
1. Are there previous conclusive reports on this reaction? | +1 | 0 | 0 | +1 |
2. Did the adverse event occur after the suspected drug was administered? | +2 | −1 | 0 | +2 |
3. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered? | +1 | 0 | 0 | +1 |
4. Did the adverse reaction reappear when the drugs was readministered? (‘rechallenge’) | +2 | −1 | 0 | +2* |
5. Are there alternative causes (other than the drug) that could have on their own caused the reaction? | −1 | +2 | 0 | +2 |
6. Did the reaction reappear when a placebo was given? | −1 | +1 | 0 | 0 |
7. Was the blood detected in any body fluid in toxic concentrations? | +1 | 0 | 0 | 0 |
8. Was the reaction more severe when the dose was increased, or less severe when the dose was decreased? | +1 | 0 | 0 | 0 |
9. Did the patient have a similar reaction to the same or similar drugs in any previous exposure? | +1 | 0 | 0 | 0 |
10. Was the adverse event confirmed by any objective evidence? | +1 | 0 | 0 | +1 |
Scoring | ||||
≥9 = definite ADR | ||||
5-8 = probable ADR | ||||
1-4 = possible ADR | ||||
0 = doubtful ADR |