Table 5

 Overall adverse events and discontinuations due to adverse events at 1 year and after 2 years of long-term extension

AEDB phaseLTE
Abatacept 2 mg/kg+etanercept (n = 85)Placebo+etanercept (n = 36)Abatacept 10 mg/kg+etanercept (n = 80)
AE, adverse event; DB, double blind; LTE, long-term extension; SAE, serious adverse event; URTI, upper respiratory tract infection.
Values are number (%).
*Occurring in ⩾10% of patients in the abatacept treatment group.
†Related events include those considered by the investigator to be certain, probable or possibly related to the study drug.
Deaths001 (1.3)
Total AEs79 (92.9)32 (88.9)78 (97.5)
Most common AEs*
    Rheumatoid arthritis37 (43.5)13 (36.1)24 (30)
    URTI20 (23.5)5 (13.9)23 (28.8)
    Headache20 (23.5)5 (13.9)10 (12.5)
    Fatigue14 (16.5)6 (16.7)14 (17.5)
    Sinusitis14 (16.5)3 (8.3)18 (22.5)
    Nausea13 (15.3)1 (2.8)12 (15)
    Arthralgia13 (15.3)3 (8.3)5 (6.3)
    Dizziness13 (15.3)2 (5.6)8 (10)
    Diarrhoea12 (14.1)2 (5.6)13 (16.3)
    Cough11 (12.9)3 (8.3)11 (13.8)
    Rash11 (12.9)3 (8.3)10 (12.5)
Discontinuations due to AEs10 (11.8)1 (2.8)8 (10)
Related AEs†53 (62.4)17 (47.2)52 (65)
SAEs14 (16.5)1 (2.8)26 (32.5)
    Musculoskeletal and connective tissue disorders1 (1.2)09 (11.3)
    Vascular disorders01 (1.2)6 (7.5)
    Malignancies3 (3.8)
    Gastrointestinal disorders3 (3.8)
    Infections and infestations3 (3.5)01 (1.3)
    Nervous system disorders2 (2.4)01 (1.3)
    Respiratory, thoracic and mediastinal disorders30 (35.3)7 (9.4)32 (40)
Related SAEs†5 (5.9)03 (3.8)
Serious infections3 (3.5)01 (1.3)