Table 4.
Summary of treatment-related adverse events during week 0–24
| Treatment-relative adverse event (week 0–24) | HA N = 8 |
16M N = 17 |
32M N = 17 |
64M N = 15 |
Total N = 57 |
|||||
|---|---|---|---|---|---|---|---|---|---|---|
| [Event # (E)/subject # (S) (%)] | E | S (%) | E | S (%) | E | S (%) | E | S (%) | E | S (%) |
| At least one below | 1 | 1 (12.5%) | 12 | 6 (35.3%) | 16 | 10 (58.8%) | 17 | 8 (53.3%) | 46 | 25 (43.9%) |
| General disorders and administration site conditions | 1 | 1 (12.5%) | 4 | 3 (17.6%) | 7 | 7 (41.2%) | 7 | 6 (40.0%) | 19 | 17 (29.8%) |
| ~ Injection site erythema | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 0 | 0 (0.0%) | 1 | 1 (1.8%) |
| ~ Injection site joint effusion | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 1 | 1 (6.7%) | 1 | 1 (1.8%) |
| ~ Injection site joint inflammation | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 1 | 1 (1.8%) |
| ~ Injection site joint pain | 1 | 1 (12.5%) | 1 | 1 (5.9%) | 3 | 3 (17.6%) | 4 | 4 (26.7%) | 9 | 9 (15.8%) |
| ~ Injection site joint swelling | 0 | 0 (0.0%) | 2 | 2 (11.8%) | 3 | 3 (17.6%) | 2 | 2 (13.3%) | 7 | 7 (12.3%) |
| Infections and infestations | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 1 | 1 (1.8%) |
| ~ Pharyngitis | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 1 | 1 (1.8%) |
| Injury, poisoning, and procedural complications | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 0 | 0 (0.0%) | 1 | 1 (1.8%) |
| ~ Procedural vomiting | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 0 | 0 (0.0%) | 1 | 1 (1.8%) |
| Investigations | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 0 | 0 (0.0%) | 1 | 1 (1.8%) |
| ~ Alpha tumor necrosis factor increased | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 0 | 0 (0.0%) | 1 | 1 (1.8%) |
| Musculoskeletal and connective tissue disorders | 0 | 0 (0.0%) | 4 | 2 (11.8%) | 6 | 5 (29.4%) | 10 | 4 (26.7%) | 20 | 11 (19.3%) |
| ~ Arthralgia | 0 | 0 (0.0%) | 3 | 2 (11.8%) | 2 | 2 (11.8%) | 6 | 4 (26.7%) | 11 | 8 (14.0%) |
| ~ Joint stiffness | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 2 | 1 (6.7%) | 3 | 2 (3.5%) |
| ~ Joint swelling | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 3 | 3 (17.6%) | 2 | 2 (13.3%) | 6 | 6 (10.5%) |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 1 | 1 (1.8%) |
| ~ Pharyngeal neoplasm benign | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 1 | 1 (1.8%) |
| Nervous system disorders | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 1 | 1 (5.9%) | 0 | 0 (0.0%) | 2 | 2 (3.5%) |
| ~ Dizziness | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 1 | 1 (5.9%) | 0 | 0 (0.0%) | 2 | 2 (3.5%) |
| Skin and subcutaneous tissue disorders | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 1 | 1 (1.8%) |
| ~ Cold sweat | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 1 | 1 (1.8%) |
Dictionary: MedDRA version 19.0