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.