Table 2 Treatment-emergent adverse events overall and occurring in at least 2 subjects
DFN-11 (n = 111) n (%) | Placebo (n = 119) n (%) | Total (N = 230) n (%) | |
|---|---|---|---|
Subjects with ≥1 TEAE | 37 (33.3) | 16 (13.4) | 53 (23.0) |
Subjects with ≥1 injection site reaction | 26 (23.4) | 14 (11.8) | 40 (17.4) |
Injection site pain | 8 (7.2) | 7 (5.9) | 15 (6.5) |
Injection site swelling | 8 (7.2) | 1 (0.8) | 9 (3.9) |
Injection site bruising | 5 (4.5) | 3 (2.5) | 8 (3.5) |
Injection site irritation | 4 (3.6) | 3 (2.5) | 7 (3.0) |
Injection site erythema | 2 (1.8) | 1 (0.8) | 3 (1.3) |
Injection site induration | 2 (1.8) | 0 (0.0) | 2 (0.9) |
Paresthesia | 3 (2.7) | 0 (0.0) | 3 (1.3) |
Nausea | 2 (1.8) | 0 (0.0) | 2 (0.9) |
Throat tightness | 2 (1.8) | 0 (0.0) | 2 (0.9) |
Chest discomfort | 1 (0.9) | 2 (1.7) | 3 (1.3) |