Table 4.
Adverse events by system organ class (N = 48).
| System organ class (MedDRA) Preferred term |
Number (%) of subjectsa |
|
|---|---|---|
| General disorders and administration site conditions | 14 | (29.2) |
| Influenza-like illness | 1 | (2.1) |
| Injection site hematoma | 12 | (25.0) |
| Injection site swelling | 2 | (4.2) |
| Infections and infestations | 3 | (6.3) |
| Acute tonsillitis | 1 | (2.1) |
| Bronchitis | 1 | (2.1) |
| Nasopharyngitis | 1 | (2.1) |
| Oral herpes | 1 | (2.1) |
| Musculoskeletal and connective tissue disorders | 1 | (2.1) |
| Tenosynovitis | 1 | (2.1) |
| Trigger finger | 1 | (2.1) |
| Reproductive system and breast disorders | 1 | (2.1) |
| Uterine polyp | 1 | (2.1) |
| Vaginal hemorrhage | 1 | (2.1) |
| Total | 15 | (31.3) |
aPercentages are based on the total number of subjects in the safety analysis data.
MedDRA = Medical Dictionary for Regulatory Activities, N = number of subjects.