Skip to main content

Table 3 Adverse events: most common adverse events reported in the OL phase

From: Twenty-eight-week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse rheumatoid arthritis population

MedDRA v 9.0
System organ class
High level term
OL phase week 12 – week 28
(OL set)
Placebo → CZPa CZP → CZPa
(n = 184) (n = 770)
Most common AEs, incidence/100 pt-yrs (n, %)b:
Infections and infestations 92.9 (73, 39.7) 79.4 (271, 35.2)
Nasopharyngitis 12.9 (13, 7.1) 9.3 (40, 5.2)
Sinusitis 10.8 (11, 6.0) 7.9 (34, 4.4)
Upper respiratory tract infection 16.0 (16, 8.7) 14.2 (60, 7.8)
Urinary tract infection 14.8 (15, 8.2) 11.9 (51, 6.6)
Musculoskeletal and connective tissue disorders 47.4 (178, 23.1) 49.1 (227, 23.8)
Rheumatoid arthritis 18.0 (18, 9.8) 12.4 (53, 6.9)
Nervous system disorders 26.0 (25, 13.6) 15.6 (66, 8.6)
Headache 10.8 (11, 6.0) 5.5 (24, 3.1)
Skin and subcutaneous tissue disorders 33.3 (31, 16.8) 22.5 (93, 12.1)
Rash 10.9 (11, 6.0) 5.5 (24, 3.1)
  1. OL open-label, CZP certolizumab pegol, AE adverse event, Pt-yrs patient-years, n number of patients reporting AE
  2. aPatients who completed 12 weeks of treatment with either CZP 200 mg every other week (Q2W) or placebo during the double-blind phase entered the OL phase and subsequently received active treatment (CZP 200 mg Q2W) for ≥16 weeks
  3. bAEs occurring in ≥5 % of patients in either treatment group are presented