Table 3.
Number of AEs by SIR Class for All Patients in the CCD
| SIR Class and AE Categorya | MRgFUS (n=43) |
UAE (n=40) |
|---|---|---|
| Class D (major therapy, unplanned increase in level of care, prolonged hospitalization) |
2 | 2 |
| Surgical treatment within 6 wk | 2 | 0 |
| Rehospitalization (≥48 h) | 0 | 1 |
| Postembolization syndrome | 0 | 1 |
| Class C (required therapy, minor hospitalization) |
1 | 2 |
| Rehospitalization (<48 h) | 0 | 2 |
| Other: urinary retention requiring catheterization |
1 | 0 |
| Class B (nominal therapy, observation, no consequences) |
11 | 13 |
| Postembolization syndrome | 0 | 2 |
| Severe/prolonged pain | 3 | 1 |
| Vaginal passage of leiomyoma tissue | 1 | 3 |
| Peripheral nerve injury: sacral neuropathy | 2 | 0 |
| Urinary tract infection | 3 | 1 |
| Allergic reaction/rash | 1 | 2 |
| Other | 1 | 4 |
| Class A (no therapy, no consequences) | 13 | 5 |
| Severe/prolonged pain | 2 | 0 |
| Vaginal passage of leiomyoma tissue | 1 | 0 |
| Peripheral nerve injury | 3 | 0 |
| Upper/lower extremity tingling | 2 | |
| Sacral neuropathy | 1 | |
| Urinary tract infection | 1 | 0 |
| Allergic reaction/rash | 2 | 0 |
| Other | 4 | 5 |
Abbreviations: AE, adverse event; CCD, comprehensive cohort design; MRgFUS, magnetic resonance imaging–guided ultrasound surgery; SIR, Society of Interventional Radiology; UAE, uterine artery embolization.
a
No AEs of class F (death) or E (permanent adverse sequelae) occurred in the CCD cohort.