Table 3.
Overall Summary of Treatment-Emergent Adverse Events by Treatment Group in the Double-Masked Treatment Phase
| Patients With ≥ 1: | Vehicle Control (N = 22) n (%) m | FD hPL 10% (N = 20) n (%) m | FD hPL 30% (N = 22) n (%) m |
|---|---|---|---|
| AE | 10 (45.5) 34 | 9 (45.0) 12 | 8 (36.4) 11 |
| Treatment-related AEs | 1 (4.5) 2 | 1 (5.0) 1 | 0 |
| Ocular AE | 7 (31.8) 19 | 4 (20.0) 6 | 2 (9.1) 2 |
| Treatment-related ocular AEs | 1 (4.5) 1 | 1 (5.0) 1 | 0 |
| Serious AE | 2 (9.1) 2 | 2 (10.0) 2 | 3 (13.6) 4 |
| AEs leading to study withdrawal | 1 (4.5) 6 | 1 (5.0) 1 | 0 |
AE = adverse event; m = number of events; N = number of patients in a specific group; n = number of patients with a particular AE; calculation of percentages based on N.
Treatment-emergent AEs are defined as AEs that increased in severity or newly developed after first dosing.
FD hPL = fibrinogen-depleted human platelet lysate; SD = standard deviation.