Number and percentage of AE of interest by treatment group
| AE, n (%) patients | ADA+MTX (n=515) | PBO+MTX (n=517) |
|---|---|---|
| Any AE | 379 (73.6) | 368 (71.2) |
| AE leading to discontinuation of study drug | 26 (5.0) | 15 (2.9) |
| Serious AE | 37 (7.2) | 32 (6.2) |
| Serious infectious AE | 13 (2.5) | 6 (1.2) |
| Opportunistic infections (excluding tuberculosis) | 1 (0.2) | 3 (0.6) |
| Tuberculosis | 1 (0.2) | 0 |
| Malignancies (excluding NMSC) | 1 (0.2) | 0 |
| NMSC | 1 (0.2) | 0 |
| Congestive heart failure related | 1 (0.2) | 1 (0.2) |
| Fatal AE | 6 (1.2)* | 1 (0.2) |
↵* Includes one non-treatment-emergent death.
ADA, adalimumab; AE, adverse events; MTX, methotrexate; NMSC, non-melanoma skin cancer; PBO, placebo.