Table 4.
Number of Patients with Related AEs by Preferred Term (Safety analysis set)
| AE | Overall | Related to Study Drug | Related to Study Device | Related to Technical Procedure |
|---|---|---|---|---|
| Hematuria | 9 | 5 | 9 | 6 |
| Micturition urgency | 9 | 4 | 9 | 5 |
| Perineal pain | 8 | 2 | 8 | 3 |
| Dysuria | 7 | 2 | 7 | 2 |
| Urinary retention | 7 | 1 | 6 | 5 |
| Erectile dysfunction | 6 | 4 | 6 | 5 |
| Pollakiuria | 4 | 0 | 4 | 1 |
| Ecchymosis | 4 | 1 | 4 | 1 |
| Constipation | 3 | 2 | 3 | 1 |
| Anorectal discomfort | 3 | 0 | 3 | 2 |
| Hematospermia | 3 | 3 | 3 | 3 |
| Back pain | 3 | 1 | 3 | 2 |
| Urinary incontinence | 2 | 2 | 2 | 0 |
| Incontinence* | 2 | 0 | 2 | 2 |
| Urinary tract infection | 2 | 1 | 2 | 1 |
| Groin pain | 2 | 0 | 2 | 2 |
| Penile pain | 2 | 1 | 2 | 1 |
| Headache | 2 | 2 | 2 | 1 |
| Nausea | 2 | 1 | 1 | 0 |
*
SOC Renal and urinary disorders.