Table 1 Number (%) of patients with the most common TEAE (⩾10% in any treatment group)
Body system TEAEEtanercept (n  =  103)Etanercept + sulfasalazine (n  =  101)Sulfasalazine (n  =  50)
Non-infectious adverse events
    Any TEAE (excluding infection)90 (87.4)80 (79.2)32 (64.0)*
    Injection site reaction34 (33.0)21 (20.8)2 (4.0)*‡
    Headache11 (10.7)25 (24.8)†4 (8.0)‡
    Back pain9 (8.7)20 (19.8)5 (10.0)
    Nausea7 (6.8)19 (18.8)†5 (10.0)
    Accidental injury16 (15.5)17 (16.8)1 (2.0)*‡
    Asthenia5 (4.9)16 (15.8)†1 (2.0)‡
    Rash15 (14.6)8 (7.9)3 (6.0)
    Dyspepsia14 (13.6)12 (11.9)2 (4.0)
    Abdominal pain14 (13.6)12 (11.9)1 (2.0)
    Injection site haemorrhage9 (8.7)14 (13.9)3 (6.0)
    Arthralgia8 (7.8)14 (13.9)7 (14.0)
    Rheumatoid arthritis10 (9.7)12 (11.9)5 (10.0)
    Diarrhoea11 (10.7)6 (5.9)0.0*
    Cough increased7 (6.8)12 (11.9)4 (8.0)
    Parasthesia4 (3.9)11 (10.9)1 (2.0)
Infectious adverse events
    Any TEAE infection76 (73.8)60 (59.4)†21 (42.0) *
    Upper respiratory tract infection29 (28.2)29 (28.7)10 (20.0)
    Pharyngitis/laryngitis24 (23.3)10 (9.9)3 (6.0)*‡
    Bronchitis21 (20.4)12 (11.9)4 (8.0)
    Flu syndrome18 (17.5)12 (11.9)2 (4.0)
    Gingival/dental infection7 (6.8)12 (11.9)2 (4.0)
    Sinusitis12 (11.7)3 (3.0)†0.0*
    Miscellaneous skin infections§19 (18.4)12 (11.9)0.0*‡
  • Fisher’s exact pairwise comparisons: *p<0.05 etanercept versus sulfasalazine; †p<0.05 etanercept versus combination and ‡p<0.05 combination versus sulfasalazine. §The types of skin infections included commonly reported events such as acne, phlebitis, fungal infections and nail disorders. TEAE, treatment-emergent adverse event.