Table 1.
Injection Site Reactions by Preferred MedDRA Terms.
| MedDRA preferred term | n/N (%) |
|---|---|
| Erythema | 669/1561 (42.8%) |
| Reaction | 395/1561 (23.3%) |
| Pain | 194/1561 (12.4%) |
| Pruritus | 89/1561 (5.7%) |
| Edema | 35/1561 (2.2%) |
| Swelling | 31/1561 (2.0%) |
| Ecchymosis | 23/1561 (1.5%) |
| Irritation | 21/1561 (1.3%) |
| Hematoma | 19/1561 (1.2%) |
| Rash | 19/1561 (1.2%) |
| Nodule | 17/1561 (1.1%) |
| Coldness | 14/1561 (0.9%) |
| Bruising | 11/1561 (0.7%) |
| Induration | 7/1561 (0.4%) |
| Hypersensitivity | 6/1561 (0.4%) |
| Hemorrhage | 5/1561 (0.3%) |
| Urticaria | 2/1561 (0.1%) |
| Inflammation | 1/1561 (0.1%) |
| Macule | 1/1561 (0.1%) |
| Papule | 1/1561 (0.1%) |
| Warmth | 1/1561 (0.1%) |