Table 2.
Adverse events and serious adverse events by type and relations to study device through Week 12 (safety population)
| AE Category MeDRA (v.23.1) preferred term |
Number of events (% of 61 enrolled subjects) n (%) |
|---|---|
| Any AE | 40 (65.6) |
| Unrelated AE | 38 (62.3) |
| Related AE | 11 (18) |
| Implant Procedure Related AE | 12 (14.8) |
| Implant site hypoaesthesia | 1 (1.6) |
| Implant site inflammation | 1 (1.6) |
| Swelling | 1 (1.6) |
| Incision site swelling | 1 (1.6) |
| Suture related complication | 1 (1.6) |
| Hypoaesthesia | 1 (1.6) |
| Paraesthesia | 1 (1.6) |
| Vocal cord paresis | 1 (1.6) |
| Dysphonia (Hoarseness) | 1 (1.6) |
| Oropharyngeal pain | 1 (1.6) |
| Rash | 1 (1.6) |
| Scar pain | 1 (1.6) |
| Stimulation Related AE | 3 (4.9) |
| Medical device pain | 1 (1.6) |
| Dysphonia (Hoarseness) | 1 (1.6) |
| Dermatitis contact | 1 (1.6) |
| Any Unrelated, SAE | 5 (8.2) |
| Acute Osteomyelitis | 1 (1.6) |
| Thoracic vertebral fracture | 1 (1.6) |
| Sternal fracture | 1 (1.6) |
| Gastrointestinal hemorrhage | 1 (1.6) |
| Cervical spinal stenosis | 1 (1.6) |
| Implant Procedure Related SAE | 2 (3.3) |
| Vocal cord paresis | 1 (1.6) |
| Dysphonia (Hoarseness) | 1 (1.6) |
| Device Related SAE | 0 |
| Stimulation Related SAE | 0 |
| AEs Leading to study discontinuation | 0 |
| Deaths | 0 |
Given in the table are subject counts and percentages. At each level of summation, subjects are counted only once