Table 2.
Injection Site Reactionsa
| ISR | Overall incidence, n (%) | Overall severity, n (%) | Duration, day 1 injection, n (%) | Duration, day 14 injection, n (%) | ||||
|---|---|---|---|---|---|---|---|---|
| Mild | Moderate | Severe | ≤14 d | ≥15 d | ≤14 d | ≥15 d | ||
| Swelling | 56 (98.2) | 14 (24.6) | 25 (43.9) | 17 (29.8) | 55 (96.5) | 1 (1.8) | 11 (100) | 0 (0.0) |
| Firmness | 52 (91.2) | 25 (43.9) | 20 (35.1) | 7 (12.3) | 48 (84.2) | 4 (7.0) | 9 (81.8) | 0 (0.0) |
| Tenderness | 47 (82.5) | 27 (47.4) | 19 (33.3) | 1 (1.8) | 47 (82.5) | 0 (0.0) | 10 (90.9) | 0 (0.0) |
| Lumps | 45 (78.9) | 24 (42.1) | 14 (24.6) | 7 (12.3) | 34 (59.6) | 11 (19.3) | 4 (36.4) | 0 (0.0) |
| Redness | 44 (77.2) | 27 (47.4) | 14 (24.6) | 3 (5.3) | 43 (75.4) | 0 (0.0) | 6 (54.5) | 0 (0.0) |
| Pain | 43 (75.4) | 32 (56.1) | 10 (17.5) | 1 (1.8) | 42 (73.7) | 0 (0.0) | 7 (63.6) | 0 (0.0) |
| Bruising | 32 (56.1) | 17 (29.8) | 12 (21.1) | 3 (5.3) | 32 (56.1) | 0 (0.0) | 3 (27.3) | 0 (0.0) |
| Discoloration | 17 (29.8) | 14 (24.6) | 3 (5.3) | 0 (0.0) | 17 (29.8) | 0 (0.0) | 2 (18.2) | 0 (0.0) |
| Itching | 12 (21.1) | 11 (19.3) | 1 (1.8) | 0 (0.0) | 10 (17.5) | 0 (0.0) | 2 (18.2) | 0 (0.0) |
ISR, injection site reaction.
aN = 57 for day 1 injection and N = 11 for day 14 injection; all subjects reported at least 1 ISR following each injection.