Table 4.
Safety of valrubicin treatment.
| Safety parameter | Patients, n (%) (N = 113) |
|
|---|---|---|
| Experienced LAR or SAE* | Discontinued valrubicin because of LAR or SAE* | |
| LAR$ | ||
| Any | 56 (49.6) | 4 (3.5) |
| Hematuria | 20 (17.7) | 2 (1.8) |
| Pollakiuria | 20 (17.7) | 0 |
| Micturition urgency | 18 (15.9) | 0 |
| Bladder spasm | 16 (14.2) | 0 |
| Dysuria | 15 (13.3) | 0 |
| Instillation-site pain | 8 (7.1) | 0 |
| Cystitis | 7 (6.2) | 2 (1.8) |
| Nocturia | 5 (4.4) | 0 |
| Urinary incontinence | 2 (1.8) | 0 |
| Bladder pain | 1 (0.9) | 0 |
| SAE | ||
| Any | 7 (6.2) | 2 (1.8) |
| Pneumonia‡ | 3 (2.7) | 1 (0.9)‡ |
| Hematuria | 1 (0.9)‡ | 1 (0.9)§ |
| Back pain | 1 (0.9) | 0 |
| Device-related infection | 1 (0.9) | 0 |
| Failure to thrive‡ | 1 (0.9) | 0 |
| Gastric ulcer | 1 (0.9) | 0 |
| Hydronephrosis | 1 (0.9) | 0 |
| Renal failure | 1 (0.9) | 0 |
| Ureteric calculus | 1 (0.9) | 0 |
Each patient may have experienced one or more LAR or SAE. $Any adverse event that was ‘probably’ or ‘possibly’ related to valrubicin or of unknown causality. ‡An 87-year-old male patient had a reported SAE of ‘failure to thrive’ and pneumonia, from which he was hospitalized, returned home, and was recovering. The patient had a previous history of renal and rectal cancer (in remission) as well as carcinoma in situ of the bladder (current). Valrubicin treatment was discontinued when the patient had pneumonia (SAE). The patient had metastatic disease and died 1.8 months after starting valrubicin treatment (and 35 days after receiving the last valrubicin instillation). Deaths occurring more than 30 days after the last instillation of valrubicin were not included in the safety analysis per the study protocol. §This event of hematuria was counted as both an LAR and an SAE.
LAR, local adverse reaction; SAE, serious adverse event.