Table 3:

Study drug-related adverse events

	Grade 1–2	Grade 3	Grade 4–5
Patients with study drug-related adverse events*	103 (66%)	6 (4%)	0
Types of events
Discharge around the catheter during instillation	39 (25%)	0	0
Fatigue	31 (20%)	0	0
Bladder spasm	24 (15%)	1 (1%)	0
Micturition urgency	22 (14%)	2 (1%)	0
Chills	18 (12%)	0	0
Dysuria	17 (11%)	0	0
Pyrexia	16 (10%)	0	0
Syncope	0	1 (1%)	0
Hypertension	2 (1%)	1 (1%)	0
Urinary incontinence	4 (3%)	1 (1%)	0

Data are n (%). The table shows study drug-related adverse events occurring in at least 10% of all treated patients (n=157) during the study.

^*Only one (1%) patient had a grade 1 study drug-related adverse event, which was classified as unknown. Adverse events include all events that occurred or worsened after the first dose of nadofaragene firadenovec. There were no grade 4 or 5 study drug-related adverse events.