Table 3.
AE summary.
| AEs and ADEsa | Double-blind period |
Open-label period (n = 269) | |
|---|---|---|---|
| nVNS (n = 169) | Sham (n = 172) | ||
| Subjects with ≥1 AE | 74 (43.8) | 91 (52.9) | 118 (43.9) |
| Subjects with ≥1 SAE | 2 (1.2) | 1 (0.6) | 2 (0.7) |
| Subjects with ≥1 ADE | 31 (18.3) | 57 (33.1) | 29 (10.8) |
| Subjects with ≥1 AE leading to discontinuation | 2 (1.2) | 9 (5.2) | 10 (3.7) |
| All study periods |
|||
| Most common AEs and ADEsa |
nVNS (n = 169) |
Sham (n = 172) |
|
| AEs | |||
| Nasopharyngitis | 29 (17.2) | 17 (9.9) | |
| Influenza | 16 (9.5) | 12 (7.0) | |
| Application site pain | 6 (3.6) | 10 (5.8) | |
| Oropharyngeal pain | 9 (5.3) | 7 (4.1) | |
| Dizziness | 8 (4.7) | 4 (2.3) | |
| ADEs | |||
| Application site rash | 1 (0.6) | 12 (7.0) | |
| Application site pain | 5 (3.0) | 10 (5.8) | |
| Application site erythema | 3 (1.8) | 8 (4.7) | |
| Application site discomfort | 7 (4.1) | 5 (2.9) | |
| Dizziness | 5 (3.0) | 3 (1.7) | |
a
Data are n (%) of patients with the event and are from the safety population.
ADE: adverse device effect; AE: adverse event; nVNS: non-invasive vagus nerve stimulation; SAE: serious adverse event.