Table 3

Summary of adverse events (safety population)

ABP 501 (n=67)Adalimumab (USA) (n=69)Adalimumab (EU) (n=67)
Any treatment-emergent AE, n (%)39 (58.2)33 (47.8)46 (68.7)
Any serious AE, n (%)001 (1.5)
Treatment-emergent AEs reported in >5% of subjects in any treatment group, n (%)*
 Headache19 (28.4)16 (23.2)13 (19.4)
 Oropharyngeal pain6 (9.0)6 (8.7)3 (4.5)
 Sinus congestion6 (9.0)6 (8.7)0
 Nasopharyngitis4 (6.0)07 (10.4)
 Nausea5 (7.5)2 (2.9)4 (6.0)
 Diarrhoea1 (1.5)1 (1.4)8 (11.9)
 Vomiting1 (1.5)2 (2.9)5 (7.5)
 Back pain1 (1.5)1 (1.4)5 (7.5)
 Dizziness1 (1.5)1 (1.4)4 (6.0)
 Dysmenorrhoea1 (1.5)4 (5.8)1 (1.5)
 Nasal congestion1 (1.5)4 (5.8)0
  • *By preferred term.

  • AE, adverse event.