Table 5.

Adverse Events by Treatment Group in the EMPOWUR Extension Trial (Safety Set Extension)

	Vibegron	Tolterodine
No. pts	273	232
No. ≥1 treatment-emergent AE (%)	171 (62.6)	126 (54.3)
No. discontinued study medication due to AE	4 (1.5)	8 (3.4)
No. ≥1 treatment-emergent SAE (%)	9 (3.3)	10 (4.3)
No. SAEs resulting in death (%)	1 (0.4)*	0
No. SAEs considered treatment-related by investigator†	1 (0.4)	2 (0.9)
No. AEs >2% in either treatment group (%)
Hypertension‡	24 (8.8)	20 (8.6)
Urinary tract infection	18 (6.6)	17 (7.3)
Headache	15 (5.5)	9 (3.9)
Diarrhea	13 (4.8)	4 (1.7)
Nasopharyngitis	13 (4.8)	12 (5.2)
Constipation	10 (3.7)	6 (2.6)
Nausea	10 (3.7)	7 (3.0)
Upper respiratory tract infection	10 (3.7)	1 (0.4)
Bronchitis	8 (2.9)	3 (1.3)
Anemia	7 (2.6)	2 (0.9)
Hyperglycemia	7 (2.6)	2 (0.9)
Residual urine volume increased	7 (2.6)	3 (1.3)
Back pain	6 (2.2)	3 (1.3)
Musculoskeletal pain	6 (2.2)	1 (0.4)
Dry mouth	5 (1.8)	12 (5.2)

Notes: *Arteriosclerotic disease, judged not related to the study drug by investigators and sponsor. ^†Vibegron: collagenous colitis; tolterodine: syncope and cardiac failure. ^‡Defined as SBP ≥140 mm Hg or DBP ≥90 mm Hg (or both) at 2 consecutive visits in patients without baseline hypertension; an increase in SBP by ≥20 mm Hg or DBP by ≥10 mm Hg at 2 consecutive visits in patients with baseline hypertension; or the initiation of or increase in dose of medication for the treatment of hypertension in any patient. Reprinted with permission from Wolters Kluwer Health, Inc.: Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN, Jr. Once-daily vibegron 75 mg for overactive bladder: long-term safety and efficacy from a double-blind extension study of the international phase 3 trial (EMPOWUR). J Urol. 2021;205(5):1421–1429. Available from:https://www.auajournals.org/doi/10.1097/JU.0000000000001574.³⁰

Abbreviations: AE, adverse event; DBP, diastolic blood pressure; SAE, serious adverse event; SBP, systolic blood pressure.