Table 2.

Reported Adverse Events by Study Drug Treatment Among Women Participating in the Phase 1 ION-02 URO-902 Trial

AE, %	URO-902 by Intravesical Instillation 5 mg (n=10)	URO-902 by Intravesical Instillation 10 mg (n=6)	Placebo (n=5)
Any AE	36	11	7
Any treatment-related AE	2	0	1
Any serious AE	0	0	0
Any AE leading to premature discontinuation	0	0	0
Total participants with at least 1 AE	6 (60.0)	5 (83.3)	3 (60.0)
Most common AEs, n (%)
Urinary tract infection	5 (50.0)	1 (16.7)	2 (40.0)
Constipation	1 (10.0)	1 (16.7)	0
Gastroesophageal reflux disease	2 (20.0)	0	0
Back pain	0	1 (16.7)	0
Blood creatinine increased	1 (10.0)	0	0
Blood creatinine phosphokinase increased	1 (10.0)	0	0
Blood pressure increased	0	1 (16.7)	0
Diarrhea	1 (10.0)	0	0
Dysuria	0	1 (16.7)	0
Hepatitis C	0	1 (16.7)	0
Hypertensive nephropathy	1 (10.0)	0	0
Nasopharyngitis	0	1 (16.7)	0
Mobitz type II second block	1 (10.0)	0	0
Tendonitis	1 (10.0)	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.