TABLE 3.
Summary of safety results
| Needle type | |||
| Umbrella-shaped | Single needle | Total | |
| N = 25 | N = 5 | N = 30 | |
| Patients with at least one AE [n (%)] | 18 (72%) | 2 (40%) | 20 (66.7%) |
| Patients with at least one serious AE [n (%)] | 5 (20%) | 0 (0%) | 5 (16.7%) |
| Patients with at least one RFA-related AE [n (%)] | 11 (44%) | 0 (0%) | 11 (36.7%) |
| Patients with at least one serious RFA-related AE [n (%)] | 2 (8%) | 0 (0%) | 2 (7%) |
| Safety-specific secondary outcomes | |||
| Pneumothorax | 3 | 0 | 3 |
| Transient post-RFA pain | 3 | 0 | 3 |
| Retroperitoneal hematoma | 0 | 0 | 1 |
| Infection | 0 | 0 | 1 |
| Number of RFA-related AEs (n = 14)a | |||
| Pneumothorax | 3 | 0 | 3 |
| Transient post-RFA pain | 3 | 0 | 3 |
| Dorsalgia | 1 | 0 | 1 |
| Renal polar arterial injury | 1 | 0 | 1 |
| Chest painc | 1 | 0 | 1 |
| Malaise | 1 | 0 | 1 |
| Small adjacent hepatic RF injury | 1 | 0 | 1 |
| Chronic kidney failureb | 1 | 0 | 1 |
| Acute kidney failureb | 1 | 0 | 1 |
| Vomiting | 1 | 0 | 1 |
RFA, radiofrequency ablation.
a
Fourteen (14) RFA-related adverse events (AE)s in 11 patients.
b
Acute and chronic kidney failure were declared for the same patient.
c
Chest pain was a ‘serious’ event leading to the prolongation of hospitalization.