Table 1.
Questions | Yes | No | Do not know | Score |
---|---|---|---|---|
1. Are there any previous conclusive reports on this reaction? | +1 | 0 | 0 | +1 |
2. Did the adverse event appear 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 drug was readministered? | +2 | -1 | 0 | 0 |
5. Are there alternative causes (other than the drug) that could on their own have caused the reaction? | -1 | +2 | 0 | +2 |
6. Did the reaction reappear when placebo was given? | -1 | +1 | 0 | +1 |
7. Was the drug detected in the blood (or other fluids) in concentrations known to be toxic? | +1 | 0 | 0 | 0 |
8. Was the reaction more severe when the dose was increased or less severe when 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 | 0 |
Total* | 7 |
the adverse drug reaction is assigned to a probability category from the total score as follows: definite, > 8; probable, 5–8; possible, 1–4; doubtful, < 1.