Table I.
Naranjo adverse drug reaction probability scores for patients’ episodes of Sweet’s syndrome, calculated at the time of decision to discontinue vs rechallenge
| Initial presentation with gilteritinib | Reoccurrence with gilteritinib rechallenge | Reoccurence with quizartinib trial | |
|---|---|---|---|
| Previous conclusive reports about reaction | Yes (+1) | Yes (+1) | Yes (+1) |
| Adverse event appeared after drug was given | Yes (+2) | Yes (+2) | Yes (+2) |
| Reaction improved when drug was discontinued | Yes (+1) | Yes (+1) | Not known (0) |
| Reaction appeared when drug was readministered | Not known (0) | Yes (+2) | Not known (0) |
| Alternative causes that could have caused the reaction | Yes (−1) | No (+2) | Yes (−1) |
| Reaction reappeared when placebo given | Not known (0) | Not known (0) | Not known (0) |
| Drug detected in any body fluid in toxic concentrations | Not known (0) | Not known (0) | Not known (0) |
| Reaction more severe with increased dose, less severe with decreased dose | No (0) | No (0) | Not known (0) |
| Similar reaction to same or similar drugs in any previous exposure | No (0) | Yes (+1) | Yes (+1) |
| Adverse event confirmed by any objective evidence | Yes (+1) | Yes (+1) | Yes (+1) |
| Score | 4 (possible) | 10 (definite) | 4 (possible) |
Total scores range from −4 to +13. Doubtful reaction (−4 to 0) is likely related to other factors. Possible reaction (1 to 4) follows a reasonable temporal sequence, possibly follows a recognized pattern, and could be explained by other factors. Probable reaction (5-8) follows a reasonable temporal sequence, follows a recognized pattern, is confirmed by improvement on withdrawal of the drug, and is not reasonably explained by other factors. Definite reaction (9+) follows a reasonable temporal sequence, follows a recognized pattern, and is confirmed by improvement on withdrawal and reappearance on reexposure.