|
MTX-TSU
|
COBRA Slim
|
---|
n = 47
|
n = 43
|
---|
AEs related to therapy | 32 | 30 |
Type of related AEs | 23 | 23 |
 | Discomfort |  |  |
 | Toxicity | 7 | 4 |
 | Infection | 1 | 0 |
 | Others | 1 | 3 |
 | Surgery | 0 | 0 |
Severity of related AEs | 29 | 28 |
 | Mild |  |  |
 | Moderate | 3 | 2 |
 | Severe | 0 | 0 |
Serious AEs | 0 | 0 |
-
aAE, Adverse event; COBRA Slim, COmbinatie therapie bij Reumatoïde Artritis; MTX-TSU, Methotrexate with tight step-up, 15 mg of MTX weekly, no oral steroids allowed. Protocol determines the severity rating of the adverse event: mild (does not interfere with daily living), moderate (somewhat interferes with daily living or medications needed to relieve event) or severe (incapacitating).