Table 4 Any treatment-emergent adverse events up to the study end (safety population)
Type of adverse event | Participants (N = 22) | Adverse events (N* = 65) |
|---|---|---|
| Â | % (95% CI) | n |
Any | 81.8 (59.7–94.8) | 56 |
TEAEs related to the treatment° | 13.6 (2.9–34.9) | 3 |
 Oedema peripheral | 4.5 (0.1–22.8) | 1 |
 Arthralgia | 4.5 (0.1–22.8) | 1 |
 Pruritus | 4.5 (0.1–22.8) | 1 |
TEAEs related to the study procedure° | 27.3 (10.7–50.2) | 9 |
 Oedema peripheral | 4.5 (0.1–22.8) | 1 |
 Procedural pain | 22.7 (7.8–45.4) | 5 |
 Arthralgia | 4.5 (0.1–22.8) | 1 |
 Dysesthesia | 4.5 (0.1–22.8) | 1 |
 Pruritus | 4.5 (0.1–22.8) | 1 |
Serious TEAEs | 9.1 (1.1–29.2) | 3 |
 Medical device site infection | 4.5 (0.1–22.8) | 1 |
 Angioedema | 4.5 (0.1–22.8) | 1 |
 Urticaria | 4.5 (0.1–22.8) | 1 |