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
| Category | Placebo week 0–2 n=13, n (%) |
CZP week 0–2 n=27, n (%) |
CZP at any time* N=40, n (%) |
|---|---|---|---|
| Any AEs | 5 (38.5) | 7 (25.9) | 26 (65.0) |
| AEs by severity | |||
| Mild | 3 (23.1) | 7 (25.9) | 17 (42.5) |
| Moderate | 2 (15.4) | 0 | 8 (20.0) |
| Severe | 0 | 0 | 1 (2.5) |
| Discontinuations due to AEs | 0 | 0 | 2 (5.0) |
| Drug-related AEs | 1 (7.7) | 4 (14.8) | 13 (32.5) |
| Serious AEs | 0 | 0 | 2 (5.0) |
| Infections and infestations | 2 (15.4) | 1 (3.7) | 14 (35.0) |
| Deaths | 0 | 0 | 0 |
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.