Table 3.
Related adverse events according to the System Organ Class and Clavien–Dindo classifications.
| SOC and Clavien–Dindo (N = 60) | Clavien–Dindo Grade I |
Clavien–Dindo Grade II |
Clavien–Dindo Grade III (%) |
|||
|---|---|---|---|---|---|---|
| Event (%) | Subject (%) | Event (%) | Subject (%) | Event (%) | Subject (%) | |
| Any | 76 (92.7) | 34 (56.7) | 4 (4.9) | 2 (3.3) | 0 (0.0) | 0 (0.0) |
| Gastrointestinal disorders | 43 (52.4) | 26 (43.3) | ||||
| Reproductive system and breast disorders | 15 (18.3) | 11(18.3) | ||||
| General disorders and admin, site conditions | 11 (13.4) | 9 (15.0) | ||||
| Renal and urinary disorders | 3 (3.7) | 3 (5.0) | 2 (2.4) | 1 (1.7) | ||
| Infections and infestations | 2 (2.4) | 1 (1.7) | ||||
| Skin and subcutaneous disorders | 1 (1.2) | 1 (1.7) | ||||
| Musculoskeletal and connective tissue disorders | 1 (1.2) | 1 (1.7) | ||||
| Nervous system disorders | 1 (1.2) | 1 (1.7) | ||||
| Psychiatric disorders | 1 (1.2) | 1 (1.7) | ||||
Clavien–Dindo was not applicable for two complications: one case of diarrhoea the day before treatment (probably due to the implementation of the study procedures) and one case of cervical stiches (due to a Museux clamp required during the HIFU procedure).
HIFU, high-intensity focused ultrasound.