Table 2.
Summary of treatment-emergent adverse events (TEAEs)
| Treatment-emergent adverse events | HA N = 8 |
16 M N = 17 |
32 M N = 17 |
64 M N = 15 |
Total N = 57 |
|||||
|---|---|---|---|---|---|---|---|---|---|---|
| [Event # (E)/subject # (S) (%)] | E | S (%) | E | S (%) | E | S (%) | E | S (%) | E | S (%) |
| Week 0–24 (early TEAEs) | ||||||||||
| Subjects with AEs | 11 | 4 (50.0%) | 40 | 15 (88.2%) | 41 | 14 (82.4%) | 25 | 11 (73.3%) | 117 | 44 (77.2%) |
| Subjects with treatment-related AEs | 1 | 1 (12.5%) | 12 | 6 (35.3%) | 16 | 10 (58.8%) | 17 | 8 (53.3%) | 46 | 25 (43.9%) |
| Subjects with grade ≥ 3 AEs | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 2 | 2 (11.8%) | 1 | 1 (6.7%) | 3 | 3 (5.3%) |
| Subjects with grade ≥ 3 treatment-related AEs | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 1 | 1 (6.7%) | 1 | 1 (1.8%) |
| Subjects with treatment-modified AE | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) |
| Subjects with SAEs | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 1 | 1 (5.9%) | 0 | 0 (0.0%) | 1 | 1 (1.8%) |
| Subjects with SUSARs | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) |
| Week 24–96 (Long-term TEAEs) | ||||||||||
| Subjects with AEs | 16 | 7 (87.5%) | 19 | 7 (41.2%) | 23 | 8 (47.1%) | 25 | 9 (60.0%) | 83 | 31 (54.4%) |
| Subjects with SAEs | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 3 | 2 (11.8%) | 2 | 2 (13.3%) | 5 | 4 (7.0%) |
| Subjects with SUSARs | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) |
Treatment-related TEAEs included possible, probable, and definite in relation to study treatment
AE, adverse event; TEAE, treatment emergent adverse event; SAE, serious adverse event; SUSAR, suspected unexpected serious adverse reaction