Table 3.

Safety outcomes

MedDRA 19.0 Term n (%) [#]	CZP 200 mg Q2 W (N=89)
Any AE	58 (65.2) [190]
Infections and infestations	27 (30.3) [53]
Latent tuberculosis	1 (1.1) [1]
Serious AEs*	5 (5.6) [9]
Discontinuation of CZP due to AEs	4 (4.5) [6]
Drug-related AEs	14 (15.7) [37]
Severe AEs	3 (3.4) [4]
Deaths	0

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.