TABLE 3.
Summary of adverse events and local skin reactions around injection site
| Adverse event | Study cohort |
|||
|---|---|---|---|---|
| Group A (1 μg/ml) (n = 6) | Group B (5 μg/ml) (n = 6) | Group C (10 μg/ml) (n = 6) | Group D (20 μg/ml) (n = 6) | |
| Systemic adverse event | Mild bilateral hydrothorax during chest X-ray examination | None | None | None |
| Local adverse events and skin reactions around injection site | ||||
| Total (n [%]) | 1 (16.7) | 1 (16.7) | 0 (0) | 0 (0) |
| Injection site pain | None | None | None | None |
| Injection site induration | None | None | None | None |
| Injection site redness | None | Red spots scattered within an area 32 by 25 mm | None | None |
| Injection site swelling | None | None | None | None |
| Injection site skin rash | None | None | None | None |
| Injection site itching | None | None | None | None |
| Injection site mucocutaneous lesion | None | None | None | None |
| Other local adverse events | 2- by 2-mm subcutaneous hemorrhage | None | None | None |