Question | Yes | Do not know | Score | |
---|---|---|---|---|
1. Are there 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 event improve when the drug was discontinued or a specific antagonist was administered? | + 1 | 0 | 0 | + 1 |
4. Did the adverse event reappear when the drug was readministered? | + 2 | − 1 | 0 | 0 |
5. Are there alternative causes that could on their own have caused the reaction? | − 1 | + 2 | 0 | + 2 |
6. Did the reaction reappear when a placebo was given? | − 1 | + 1 | 0 | 0 |
7. Was the drug detected in 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 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 | 0 |
Total score: 6 |