Table 6.
Frequency and severity of adverse events (AEs) for FAS population (n = 592) receiving at least one instillation of HIVEC MMC.
|
Grade 1–2 n (%) |
Grade 3–4 n (%) |
Total n (%) |
|
|---|---|---|---|
| Dysuria | 59 (34.7) | 0 (0) | 59 (9.9) |
| Frequency | 5 (2.9) | 0 (0) | 5 (0.8) |
| Irritative symptoms | 18 (9.4) | 1 (6.25) | 17 (2.9) |
| Bladder Pain | 37 (21.8) | 5 (31.25) | 42 (7.1) |
| Urgency | 34 (20) | 0 (0) | 34 (5.7) |
| Urinary retention | 0 (0) | 0 (0) | 0 (0) |
| Bladder spasms | 21 (12.35) | 1 (6.25) | 22 (3.7) |
| Bacterial cystitis | 11 (6.5) | 1 (6.25) | 12 (2) |
| Renal colic | 1 (0.6) | 0 (0) | 1 (0.2) |
| Hematuria | 18 (10.6) | 3 (18.75) | 21 (3.55) |
| Incontinence | 8 (4.7) | 1 (6.25) | 9 (1.5) |
| Fever | 2 (1.2) | 1 (6.25) | 3 (0.5) |
| Flu-like symptoms | 0 (0) | 0 (0) | 0 (0) |
| Skin rash | 27 (15.9) | 2 (12.5) | 29 (4.9) |
| Other AEs | 7 (4.1) | 3 (18.75) | 12 (2) |
| Total number EAs | 248 (100) | 18 (100) | 266 (100) |
| Number of patients with AES | 170 | 16 | 186 |
| Number of patients w/o AEs | - | - | 406 |
| SAF population | - | - | 592 |
AEs, Adverse effects; SAF, safety population.