Table 4 Overview of adverse events (AEs)
Type of AE | Number (% out of total AEs) | Device-related (% out of AE-type) | Procedure-related (% out of AE-type) | Underlying disease-related (% out of AE-type) | Other causes or undetermined relation (% out of AE-type) |
|---|---|---|---|---|---|
Skin lesion | 27 (33.3) | 5 (18.5) | 0 (0) | 1 (3.7) | 21 (77.8) |
Pain | 22 (27.2) | 3 (13.6) | 6 (27.3) | 4 (18.2) | 9 (40.9) |
Neuropathic pain | 9 (11.1) | 0 (0) | 0 (0) | 9 (100) | 0 (0) |
Urinary tract/gastrointestinal infection | 8 (9.9) | 0 (0) | 0 (0) | 5 (62.5) | 3 (37.5) |
Fatigue | 3 (3.7) | 0 (0) | 3 (100) | 0 (0) | 0 (0) |
Spasticity | 3 (3.7) | 0 (0) | 0 (0) | 3 (100) | 0 (0) |
Hypotension | 5 (6.2) | 0 (0) | 3 (60.0) | 2 (40.0) | 0 (0) |
Inflammation | 2 (2.5) | 0 (0) | 0 (0) | 0 (0) | 2 (100) |
Other | 2 (2.5) | 0 (0) | 1 (50) | 0 (0) | 1 (50) |
Total | 81 (100) | 8 (9.9) | 13 (16.0) | 24 (29.6) | 36 (44.4) |