Question Yes No Not known / not done Case Report Score
1. Are there previous conclusive reports on this reaction? +1 0 0 +1
2. Did adverse event appear after the suspected drug was given? +2 -1 -1 +2
3. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was given? +1 0 0 +1
4. Did the adverse reaction appear when the drug was re-administered? +2 -1 0 Not done
5. Are there alternative causes that could have caused the reaction? -1 +2 0 +2
6. Did the reaction reappear when a placebo was given? -1 +1 0 Not done
7. Was the drug detected in any body fluid in toxic concentrations? +1 0 0 Not done
8. Was the reaction more severe when the dose was increased, or less severe when the dose was decreased? +1 0 0 Not done
9. Did the patient have a similar reaction to the same or similar drugs in any previous exposure? +1 0 0 Unknown
10. Was the adverse event confirmed by any objective evidence? +1 0 0 Not done
Total score = 6* Total score = 6* Total score = 6* Total score = 6* Total score = 6*