Table 4. Causality categories and description of the relationship between AEs (suspected ADRs) and XBJ.
Causality categories | Cases | Incidence1 | Percentage (%) |
---|---|---|---|
Certain | 0 | 0 | 0 |
Probable/likely | 5 | 7 | 0.02 |
Possible | 91 | 96 | 0.29 |
Unlikely | 39 | 40 | 0.12 |
Conditional/unclassified | 92 | 95 | 0.29 |
Unassessable/unclassifiable | 7 | 7 | 0.02 |
Total | 234 | 245 | 0.73 |
1, the percentage was calculated by dividing the total number of cases by the number of AE cases for each level.