Table 3

Serious adverse events

Serious adverse eventsADA/MTX (n=87)PBO/MTX (n=85)
Serious infections, total34
 Upper tract infections1
Disorders of the nervous system, total13
Cardiac disorders, total13
 Bypass surgery1
Psychiatric disorders, total01
 Reactive depression1
Solid malignant tumours, total03
 Carcinoma of the prostate1
 Carcinoma of the cervix1
 Carcinoma in situ of the cervix1
Benign neoplasms, total10
 Hyperplasia of the prostate1
Gastrointestinal disorders, total10
Gastrointestinal perforation, total10
 Gastric haemorrhage1
Vascular disorders, total11
 Varicose veins1
 Peripheral artery angioplasty1
Autoimmune disorders, total10
Musculoskeletal disorders, total26
 Shoulder impingement syndrome1
 Prolapsed lumbar disc1
 Arthritis flare3
Other, total01
Total serious adverse events1222
  • ADA, adalimumab; MTX, methotrexate; PBO, placebo.