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