Table 3.
Incidence of adverse events (AEs) (≥5% in any groups)
| Preferred Term | TAP-144-SR (6M) (N = 81) |
TAP-144-SR (3M) (N = 79) |
||
|---|---|---|---|---|
| Subjects with any AEs | 75 | (92.6) | 71 | (89.9) |
| Nasopharyngitis | 18 | (22.2) | 25 | (31.6) |
| Injection site induration | 14 | (17.3) | 11 | (13.9) |
| Injection site erythema | 12 | (14.8) | 6 | (7.6) |
| Blood creatine phosphokinase increased | 5 | (6.2) | 7 | (8.9) |
| Injection site pain | 6 | (7.4) | 5 | (6.3) |
| Arthralgia | 5 | (6.2) | 5 | (6.3) |
| Back pain | 2 | (2.5) | 8 | (10.1) |
| Hot flush | 5 | (6.2) | 5 | (6.3) |
| Fall | 6 | (7.4) | 3 | (3.8) |
| Constipation | 3 | (3.7) | 5 | (6.3) |
| DM | 5 | (6.2) | 3 | (3.8) |
| Hypertension | 5 | (6.2) | 3 | (3.8) |
| Insomnia | 3 | (3.7) | 5 | (6.3) |
| Contusion | 6 | (7.4) | 1 | (1.3) |
| Dental caries | 6 | (7.4) | 1 | (1.3) |
| Musculoskeletal stiffness | 2 | (2.5) | 4 | (5.1) |
| Weight increased | 1 | (1.2) | 5 | (6.3) |
| Inguinal hernia | 1 | (1.2) | 4 | (5.1) |
Values represent n (%).