Table 3.
Reported Adverse Events by Study Drug Treatment Among Women Participating in the Phase 1 ION-03 URO-902 Trial
| AE, % | URO-902 by Detrusor Injection 16 mg (n=6) | URO-902 by Detrusor Injection 24 mg (n=3) | Placebo (n=4) |
|---|---|---|---|
| Any AE | 13 | 8 | 17 |
| Any treatment-related AE | 0 | 0 | 0 |
| Any serious AE | 1 | 0 | 0 |
| Any AE leading to premature discontinuation | 0 | 0 | 0 |
| Total participants with at least 1 AE | 4 (66.7) | 3 (100.0) | 4 (100.0) |
| Most common AEs, n (%) | |||
| Hyperglycemia | 3 (50.0) | 2 (66.7) | 4 (100.0) |
| Hematuria | 2 (33.3) | 1 (33.3) | 2 (50.0) |
| Abdominal pain | 1 (16.7) | 1 (33.3) | 1 (25.0) |
| Blood creatine phosphokinase increased | 1 (16.7) | 0 | 1 (25.0) |
| Dysuria | 0 | 1 (33.3) | 1 (25.0) |
| Urinary tract infection | 1 (16.7) | 1 (33.3) | 0 |
| Upper respiratory tract infection | 1 (16.7) | 0 | 0 |
| Bladder pain | 0 | 1 (33.3) | 0 |
| Arthralgia | 0 | 1 (33.3) | 0 |
| Antinuclear antibody positive | 1 (16.7) | 0 | 0 |
| Electrocardiogram QT prolonged | 0 | 0 | 1 (25.0) |
| Hematocrit decreased | 0 | 0 | 1 (25.0) |
| Hemoglobin decreased | 0 | 0 | 1 (25.0) |
| Hypoglycemia | 1 (16.7) | 0 | 0 |
| Asthma | 1 (16.7) | 0 | 0 |
| Urinary retention | 0 | 0 | 0 |
Note: Adapted from Rovner E, Chai TC, Jacobs S, et al. Evaluating the safety and potential activity of URO-902 (hMaxi-K) gene transfer by intravesical instillation or direct injection into the bladder wall in female participants with idiopathic (non-neurogenic) overactive bladder syndrome and detrusor overactivity from two double-blind, imbalanced, placebo-controlled randomized phase 1 trials. Neurourol Urodyn. 2020;39(2):744–753. doi:10.1002/nau.24272. © 2020 The Authors. Neurourology and Urodynamics published by Wiley Periodicals, Inc.22
Abbreviation: AE, adverse event.