Table 3 Non-serious adverse events (AEs) and serious adverse events (SAEs)
Etanercept*Etanercept and methotrexate†
Non-serious AEs:
Infectious AEs (n = 58)Upper respiratory tract infection (6)Upper respiratory tract infection (28)
Soft tissue infection (2)Soft tissue infection (6)
Dental infectionUrinary tract infection (4)
Diarrhoea (4)
Herpes zoster (2)
Fever (2)
Herpes labialis
Fungal infection
Non infectious AEs (n = 80)Nausea/vomiting (4)Neuropsychological (14)
Headache (2)Laboratory abnormalities (11)
Skin changes (2)Skin reaction (8)
Bowel pain (8)
Injection site reaction (7)
Headache (6)
JIA (6)
Uveitis (5)
Nausea/vomiting (3)
Various (3)
Hair loss
Serious AEs:
Infectious SAEs (n = 26)Herpes zosterSoft tissue infections (3)
Septic arthritis
Herpes zoster (2)
Gastroenteritis (2)
Urinary tract infection
Upper respiratory tract infection (8)
Pneumonia (3)
Further unspecific infections (3)
Non-infectious SAEs (n = 26)Uveitis (2)Thyroid carcinoma
Hearing lossYolk sac carcinoma
Non-Hodgkin’s lymphoma
Unspecific white matter changes detected by MRI
Stevens–Johnson syndrome
Uveitis (4)
Crohn disease
Abdominal pain
Ovarial cyst bleeding
Colicky cholelithiasis
Skin lesions
Elevated serum creatinine (2)
Osteochondritis dissecans
Painful urination
Diffuse pain probably due to flare-up of disease (3)
  • No. of events (n) is given if different from 1.

  • *For AEs, n = 17; for SAEs, n = 4. †For AEs, n = 121; for SAEs, n = 48.

  • JIA, juvenile idiopathic arthritis.