Table 2.
Adverse events in 11 patients
| All grades | Grade 1 | Grade 2 | Grade 3 | Days from implantation to onset range (median) | Days of symptomatic period range (median) | |
|---|---|---|---|---|---|---|
| Total | 40 | 22 | 16 | 2 | 0–27 (1) | 1–128 (17) |
| Blood and lymphatic system disorders | ||||||
| Anemia | 1 | 1 | 0 | 0 | 1 | 83 |
| Vascular disorders | ||||||
| Hypertension | 2 | 1 | 0 | 1 | 0 | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Nasal obstruction | 2 | 2 | 0 | 0 | 3, 22 | 3, 7 |
| Gastrointestinal disorder | ||||||
| Pharyngodynia | 1 | 0 | 1 | 0 | 1 | 1 |
| General disorders and administration site conditions | ||||||
| Application site inflammation | 2 | 0 | 2 | 0 | 1 | 19, 81 |
| Application site pain | 1 | 1 | 0 | 0 | 0 | 30 |
| Medical device site abscess | 1 | 1 | 0 | 0 | 11 | 16 |
| Medical device site erythema | 2 | 2 | 0 | 0 | 1, 14 | 8, 127 |
| Medical device site hemorrhage | 1 | 1 | 0 | 0 | 0 | 15 |
| Medical device site edema | 1 | 1 | 0 | 0 | 10 | 4 |
| Medical device site pain | 9 | 3 | 6 | 0 | 0–20 (0) | 1–128 (19) |
| Medical device site scab | 1 | 1 | 0 | 0 | 6 | 1 |
| Medical device site swelling | 6 | 5 | 1 | 0 | 0–7 (1) | 3–109 (20) |
| Medical device site ulcer | 3 | 0 | 3 | 0 | 14–27 (14) | 15–55 (16) |
| Pain | 1 | 0 | 1 | 0 | 0 | 81 |
| Injury, poisoning and procedural complications | ||||||
| Foreign body | 3 | 1 | 1 | 1 | 14, 14 | N.A |
| Procedural site pain | 1 | 1 | 0 | 0 | 20 | 7 |
| Radiation mucositis | 1 | 0 | 1 | 0 | 3 | 17 |
| Investigations | ||||||
| Creatinine increased | 1 | 1 | 0 | 0 | 7 | 15 |