(A) Phase I study | ||
---|---|---|
N = 10 | ||
Any AE, n (%) | 9 (90.0) | |
SAE, n (%) | 0 (0.0) | |
AEs related to investigational product, n (%) | 0 (0.0) | |
Most common AEs, n (%) | ||
Nausea | 2 (20.0) | |
Pyrexia | 6 (60.0) | |
Procedural site reaction | 2 (20.0) | |
(B) Phase I/II study | ||
Fibrin pad (N = 4) | Standard of care (N = 3) | |
Total number of AEs | 2 | 2 |
Incidence of AEs, n (%) | 1 (25.0) | 1 (33.3) |
Incidence of SAEs, n (%) | 1 (25.0) | 0 (0.0) |
AEs related to investigational product, n (%) | ||
Post-procedural hemorrhage | 1 (25.0) | 0 (0.0) |
Most common AEs, n (%) | ||
Epididymitis | 1 (25.0) | 0 (0.0) |
Atelectasis | 0 (0.0) | 1 (33.3) |
Postoperative wound infection | 0 (0.0) | 1 (33.3) |