Serious adverse events
| Serious adverse events | ADA/MTX (n=87) | PBO/MTX (n=85) |
|---|---|---|
| Serious infections, total | 3 | 4 |
| Urosepsis | 2 | |
| Pneumonia | 1 | |
| Bronchitis | 1 | |
| Abscess | 2 | |
| Upper tract infections | 1 | |
| Disorders of the nervous system, total | 1 | 3 |
| Stroke | 1 | |
| Concussion | 1 | |
| Diplopia | 1 | |
| Paresthesia | 1 | |
| Cardiac disorders, total | 1 | 3 |
| Syncope | 1 | |
| Bypass surgery | 1 | |
| Claudication | 1 | |
| Myocarditis | 1 | |
| Psychiatric disorders, total | 0 | 1 |
| Reactive depression | 1 | |
| Solid malignant tumours, total | 0 | 3 |
| Carcinoma of the prostate | 1 | |
| Carcinoma of the cervix | 1 | |
| Carcinoma in situ of the cervix | 1 | |
| Benign neoplasms, total | 1 | 0 |
| Hyperplasia of the prostate | 1 | |
| Gastrointestinal disorders, total | 1 | 0 |
| Subileus | 1 | |
| Gastrointestinal perforation, total | 1 | 0 |
| Gastric haemorrhage | 1 | |
| Vascular disorders, total | 1 | 1 |
| Varicose veins | 1 | |
| Peripheral artery angioplasty | 1 | |
| Autoimmune disorders, total | 1 | 0 |
| Vasculitis | 1 | |
| Musculoskeletal disorders, total | 2 | 6 |
| Shoulder impingement syndrome | 1 | |
| Coxarthrosis | 1 | |
| Prolapsed lumbar disc | 1 | |
| Fracture | 1 | 1 |
| Arthritis flare | 3 | |
| Other, total | 0 | 1 |
| Nephrolithiasis | 1 | |
| Total serious adverse events | 12 | 22 |
ADA, adalimumab; MTX, methotrexate; PBO, placebo.