| 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 infection | Urinary tract infection (4) | |
| Diarrhoea (4) | ||
| Herpes zoster (2) | ||
| Fever (2) | ||
| Varicella | ||
| 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 zoster | Soft tissue infections (3) |
| Septic arthritis | ||
| Sepsis | ||
| Herpes zoster (2) | ||
| Varicella | ||
| 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 loss | Yolk sac carcinoma | |
| Non-Hodgkin’s lymphoma | ||
| Unspecific white matter changes detected by MRI | ||
| Papillitis | ||
| Stevens–Johnson syndrome | ||
| Uveitis (4) | ||
| Crohn disease | ||
| Abdominal pain | ||
| Ovarial cyst bleeding | ||
| Colicky cholelithiasis | ||
| Skin lesions | ||
| Seizures | ||
| 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.