Table 4. Summary of adverse events reported by ≥2 subjects in any treatment group (safety population).
Adverse event, n (%) | Placebo(n = 14) | CDP323 100 mg bid (n = 14) | CDP323 500 mg bid (n = 15) | CDP323 1000 mg qd (n = 14) | CDP323 1000 mg bid (n = 14) |
Subjects with at least one AE | 13 (92.9) | 7 (50.0) | 13 (86.7) | 10 (71.4) | 13 (92.9) |
Headache | 3 (21.4) | 2 (14.3) | 0 | 3 (21.4) | 5 (35.7) |
Fatigue | 3 (21.4) | 0 | 3 (20.0) | 1 (7.1) | 4 (28.6) |
Diarrhea | 3 (21.4) | 0 | 2 (13.3) | 1 (7.1) | 0 |
Hypoasthesia | 1 (7.1) | 0 | 1 (6.7) | 1 (7.1) | 2 (14.3) |
Muscle spasms | 1 (7.1) | 1 (7.1) | 1 (6.7) | 0 | 2 (14.3) |
Vomiting | 2 (14.3) | 0 | 1 (6.7) | 0 | 2 (14.3) |
Back pain | 0 | 0 | 1 (6.7) | 2 (14.3) | 1 (7.1) |
Palpitations | 0 | 3 (21.4) | 1 (6.7) | 0 | 0 |
Paresthesia | 2 (14.3) | 0 | 2 (13.3) | 0 | 0 |
Muscular weakness | 0 | 0 | 0 | 1 (7.1) | 2 (14.3) |
Dysphonia | 0 | 0 | 0 | 2 (14.3) | 0 |
Fall | 0 | 0 | 0 | 0 | 2 (14.3) |
Herpes simplex | 0 | 0 | 2 (13.3) | 0 | 0 |
Pain in extremity | 0 | 0 | 2 (13.3) | 0 | 0 |
Pharyngolarungeal pain | 0 | 0 | 0 | 0 | 2 (14.3) |
AE = adverse event; bid = twice daily; qd = once daily.