Table 6.
Number of subjects with non–device-related adverse events, by study group*
| Adjustable stimulation
(N = 33) |
Preset stimulation
(N = 17) |
Medically managed
(N = 17) |
Ancillary
(N = 8) |
|||||
|---|---|---|---|---|---|---|---|---|
| Preferred term | No. of subjects | Percentage of subjects | No. of subjects | Percentage of subjects | No. of subjects | Percentage of subjects | No. of subjects | Percentage of subjects |
| Migraine | 3 | (9.1%) | 7 | (41.2%) | 4 | (23.5%) | 0 | (0.0%) |
| Drug toxicity | 3 | (9.1%) | 2 | (11.8%) | 0 | (0.0%) | 1 | (12.5%) |
| Headache | 1 | (3.0%) | 2 | (11.8%) | 0 | (0.0%) | 1 | (12.5%) |
| Adverse drug reaction | 1 | (3.0%) | 1 | (5.9%) | 1 | (5.9%) | 0 | (0.0%) |
| Sinusitis | 0 | (0.0%) | 1 | (5.9%) | 1 | (5.9%) | 1 | (12.5%) |
| Anxiety | 1 | (3.0%) | 0 | (0.0%) | 1 | (5.9%) | 0 | (0.0%) |
| Bronchitis | 1 | (3.0%) | 1 | (5.9%) | 0 | (0.0%) | 0 | (0.0%) |
| Depression | 2 | (6.1%) | 0 | (0.0%) | 0 | (0.0%) | 0 | (0.0%) |
| Dizziness | 0 | (0.0%) | 1 | (5.9%) | 0 | (0.0%) | 1 | (12.5%) |
| Fall | 2 | (6.1%) | 0 | (0.0%) | 0 | (0.0%) | 0 | (0.0%) |
| Fungal infection | 0 | (0.0%) | 2 | (11.8%) | 0 | (0.0%) | 0 | (0.0%) |
| Hypothyroidism | 0 | (0.0%) | 2 | (11.8%) | 0 | (0.0%) | 0 | (0.0%) |
| Lymphadenopathy | 1 | (3.0%) | 1 | (5.9%) | 0 | (0.0%) | 0 | (0.0%) |
| Sinus headache | 1 | (3.0%) | 0 | (0.0%) | 1 | (5.9%) | 0 | (0.0%) |
| Upper respiratory tract infection | 0 | (0.0%) | 1 | (5.9%) | 1 | (5.9%) | 0 | (0.0%) |
| Total† | 17 | (52%) | 13 | (76%) | 9 | (53%) | 6 | (75%) |
*
Adverse events reported in more than one subject.
†
“Total” row includes all events, including those reported in only one subject.