TABLE 3.
Summary of AEs and SAEs
|
Patients n (%) |
AEs n |
|
|---|---|---|
| AE | 18 (9.0) | 22 |
| Adverse drug reaction a | 14 (7.0) | 17 |
| SAE | 8 (4.0) | 11 |
| Serious adverse drug reaction a | 5 (2.5) | 7 |
| AE leading to the discontinuation b | 12 (6.0) | 13 |
Abbreviations: AE, adverse event; SAE, serious adverse event.
a
Adverse drug reaction: AE the causality with adalimumab of which is probable, possible, probably not, or not assessable.
b
AE leading to discontinuation of adalimumab: an AE for which the action taken was transiently discontinued or permanently discontinued.