Table 4.

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

	Placebo	Vibegron	Tolterodine
No. pts	540	545	430
No. summary (%)
Any AE	180 (33.3)	211 (38.7)	166 (38.6)
Any AE of clinical interest	40 (7.4)	36 (6.6)	38 (8.8)
Any serious AE	6 (1.1)	8 (1.5)	10 (2.3)
Any AE leading to treatment discontinuation	6 (1.1)	9 (1.7)	14 (3.3)
No. by AE preferred term (%)*
Urinary tract infection	33 (6.1)	27 (5.0)	25 (5.8)
Headache	13 (2.4)	22 (4.0)	11 (2.6)
Nasopharyngitis	9 (1.7)	15 (2.8)	11 (2.6)
Diarrhea	6 (1.1)	12 (2.2)	9 (2.1)
Nausea	6 (1.1)	12 (2.2)	5 (1.2)
Upper respiratory tract infection	4 (0.7)	11 (2.0)	2 (0.5)
Constipation	7 (1.3)	9 (1.7)	6 (1.4)
Dry mouth	5 (0.9)	9 (1.7)	28 (6.5)
Hypertension	9 (1.7)	9 (1.7)	11 (2.6)
Dizziness	6 (1.1)	5 (0.9)	4 (0.9)
Blood pressure increased	5 (0.9)	4 (0.7)	8 (1.9)
Urinary retention	2 (0.4)	3 (0.6)	3 (0.7)
Fatigue	5 (0.9)	2 (0.4)	6 (1.4)
Alanine aminotransferase increased	2 (0.4)	1 (0.2)	1 (0.2)
Aspartate aminotransferase increased	1 (0.2)	1 (0.2)	1 (0.2)
Cardiac failure congestive	0	1 (0.2)	0
Cerebrovascular accident	0	1 (0.2)	1 (0.2)
Cystitis	1 (0.2)	1 (0.2)	1 (0.2)
Hypotension	1 (0.2)	1 (0.2)	1 (0.2)
Blood pressure diastolic increased	0	0	1 (0.2)
Chest pain	3 (0.6)	0	0
Escherichia urinary tract infection	0	0	1 (0.2)
Pollakiuria	1 (0.2)	0	0
Syncope	2 (0.4)	0	1 (0.2)

Notes: *Includes all AEs with an incidence of 2.0% or greater in the vibegron group and greater than for placebo, plus all protocol-defined AEs of clinical interest. Reprinted with permission from Wolters Kluwer Health, Inc.: Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN, Jr. International phase III, randomized, double-blind, placebo and active controlled study to evaluate the safety and efficacy of vibegron in patients with symptoms of overactive bladder: EMPOWUR. J Urol. 2020;204(2):316–324. Available from: https://www.auajournals.org/doi/10.1097/JU.0000000000000807.¹⁶

Abbreviation: AE, adverse event.