Table 2

Adverse events in the full safety set during 16 weeks of the MAgnetic Resonance image VErified earLy respOnse on rheUmatoid factor positive arthritiS (MARVELOUS) study

CategoryPlacebo week 0–2
n=13, n (%)
CZP week 0–2
n=27, n (%)
CZP at any time*
N=40, n (%)
Any AEs5 (38.5)7 (25.9)26 (65.0)
AEs by severity
 Mild3 (23.1)7 (25.9)17 (42.5)
 Moderate2 (15.4)08 (20.0)
 Severe001 (2.5)
Discontinuations due to AEs002 (5.0)
Drug-related AEs1 (7.7)4 (14.8)13 (32.5)
Serious AEs002 (5.0)
Infections and infestations2 (15.4)1 (3.7)14 (35.0)
Deaths000
  • Serious AEs were one case of coronary artery disease and one of sensory loss.

  • *Only AEs occurring while receiving CZP in either treatment arm are included. Results shown for the full safety set.

  • AE, adverse event; CZP, certolizumab pegol.