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 |