Table 5.
Summary of the serious adverse events and serious adverse device effects for the control and therapy patients
| Therapy (N = 63) |
Control (N = 32) |
|||||
|---|---|---|---|---|---|---|
| Events | Patients | % | Events | Patients | % | |
| Death and/or HF hospitalization | 11 | 7 | 11.1 | 11 | 5 | 15.6 |
| Death | 1 | 1 | 1.6 | 2 | 2 | 6.3 |
| HF hospitalization | 10 | 7 | 11.1 | 9 | 5 | 15.6 |
| Cardiovascular–Non-HF | 9 | 7 | 11.1 | 7 | 5 | 15.6 |
| Non-cardiovascular | 8 | 8 | 12.7 | 12 | 11 | 34.4 |
| Pulmonary | 0 | 0 | 0.0 | 3 | 3 | 9.4 |
| Genitourinary | 1 | 1 | 1.6 | 2 | 2 | 6.3 |
| Other Non-cardiovascular | 7 | 7 | 11.1 | 7 | 7 | 21.9 |
| Investigational system related* | 9 | 9 | 14.3 | 4 | 4 | 12.5 |
Data are reported for events ≥5%.
*Includes post-surgical infections of the lead and pulse generator, pulse generator failure leading to loss of therapy, and right recurrent laryngeal nerve injury.