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Table 2 Adverse events: overview of adverse events in the DB and OL phases

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

  DB phase week 0 – week 12 OL phase week 12 – week 28
(Safety set) (OL set)
  Placebo CZP Placebo → CZPa CZP → CZPa
(n = 209) (n = 846) (n = 184) (n = 770)
Any AE, incidence/100 pt-yrs (n, %) 483.2 (129, 61.7) 522.1 (571, 67.5) 328.9 (142, 77.2) 239.1 (521, 67.7)
Patients discontinuing due to AE, n (%) 8 (3.8) 40 (4.7) 3 (1.6) 26 (3.4)
Injection and infusion site reactions, incidence/100 pt-yrs (n, %) 4.2 (2, 1.0) 25.3 (49, 5.8) 8.8 (9, 4.9) 3.2 (14, 1.8)
Serious AEs, incidence/100 pt-yrs (n, %) 25.8 (12, 5.7) 26.7 (52, 6.1) 20.6 (21, 11.4) 13.0 (56, 7.3)
Serious infections, incidence/100 pt-yrs (n, %) 8.3 (4, 1.9) 11.1 (22, 2.6) 5.7 (6, 3.3) 4.1 (18, 2.3)
Deaths, n (%) 0 2 (0.2) 1 (0.5) 1 (0.1)
  1. DB double-blind, 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