Table 3 Adverse Events Reported by ≥2 Patients in Any Treatment Group (Safety Population)a
AE, n (%) | CCH 0.25 mg (n = 22) | CCH 0.40 mg (n = 18) | CCH 0.60 mg (n = 18) | Placebo (n = 17) |
|---|---|---|---|---|
Any AE | 21 (95.5) | 18 (100.0) | 17 (94.4) | 7 (41.2) |
Discontinuations due to AEs | 0 | 0 | 0 | 0 |
Any serious AE | 0 | 0 | 0 | 0 |
Contusion/bruising | 13 (59.1) | 9 (50.0) | 9 (50.0) | 1 (5.9) |
Extremity pain | 10 (45.5) | 10 (55.6) | 7 (38.9) | 1 (5.9) |
Local swelling | 8 (36.4) | 7 (38.9) | 10 (55.6) | 3 (17.6) |
Injection-site bruising | 5 (22.7) | 4 (22.2) | 6 (33.3) | 0 |
Axillary pain | 6 (27.3) | 1 (5.6) | 4 (22.2) | 0 |
Injection-site pain | 4 (18.2) | 4 (22.2) | 2 (11.1) | 0 |
Injection-site swelling | 5 (22.7) | 4 (22.2) | 0 | 0 |
Injection-site pruritus | 2 (9.1) | 3 (16.7) | 2 (11.1) | 1 (5.9) |
Injection-site edema | 2 (9.1) | 0 | 2 (11.1) | 0 |
Pruritus | 2 (9.1) | 2 (11.1) | 1 (5.6) | 0 |
Injection-site hemorrhage | 2 (9.1) | 0 | 1 (5.6) | 0 |