Table 3

Safety outcomes

MedDRA 19.0 Term n (%) [#]CZP 200 mg Q2 W
(N=89)
Any AE58 (65.2) [190]
 Infections and infestations27 (30.3) [53]
  Latent tuberculosis1 (1.1) [1]
Serious AEs*5 (5.6) [9]
Discontinuation of CZP due to AEs4 (4.5) [6]
Drug-related AEs14 (15.7) [37]
Severe AEs3 (3.4) [4]
Deaths0
  • Adverse events are reported using the Medical Dictionary for Regulatory Activities (MedDRA) version 19.0.

  • *Serious AEs (recorded as such by the investigator) include vestibular disorder, two cases of uveitis, incarcerated hernia, sarcoidosis, tenosynovitis, hemangioma, prostate cancer, and pregnancy.

  • #, number of occurrences; AE, adverse event; CZP, certolizumab pegol; Q2W, every 2 weeks.