1. | Are there previous conclusive reports on this reaction? | +1 | 0 | 0 | Yes |
2. | Did the adverse event appear after the suspected drug was administered? | +2 | −1 | 0 | Yes |
3. | Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered? | +1 | 0 | 0 | Yes |
4. | Did the adverse reaction reappear when the drug was readministered? | +2 | −1 | 0 | Do not know |
5. | Are there alternative causes (other than the drug) that could on their own have caused the reaction? | −1 | +2 | 0 | No |
6. | Did the reaction reappear when a placebo was given? | −1 | +1 | 0 | Do not know |
7. | Was the drug detected in the blood (or other fluids) in concentrations known to be toxic? | +1 | 0 | 0 | Do not know |
8. | Was the reaction more severe when the dose was increased, or less severe when the dose was decreased? | +1 | 0 | 0 | Do not know |
9. | Did the patient have a similar reaction to the same or similar drugs in any previous exposure? | +1 | 0 | 0 | Do not know |
10. | Was the adverse event confirmed by any objective evidence? | +1 | 0 | 0 | Yes |