Table 3.

Overview of treatment-emergent adverse events in the pooled safety analysis (SAF)

		Mirabegron
Number of patients (%)	Placebo (n = 1380)	25 mg (n = 432)	50 mg (n = 1375)	100 mg (n = 929)	Total (n = 2736)	Tolterodine ER 4 mg (n = 495)
Any TEAE	658 (47.7)	210 (48.6)	647 (47.1)	402 (43.3)	1259 (46.0)	231 (46.7)
Drug-related TEAE	232 (16.8)	87 (20.1)	256 (18.6)	172 (18.5)	515 (18.8)	131 (26.5)
TEAE leading to discontinuation	46 (3.3)	17 (3.9)	53 (3.9)	34 (3.7)	104 (3.8)	22 (4.4)
Drug-related TEAE leading to discontinuation	27 (2.0)	11 (2.5)	35 (2.5)	25 (2.7)	71 (2.6)	20 (4.0)
SAE	29 (2.1)	7 (1.6)	29 (2.1)	26 (2.8)	62 (2.3)	11 (2.2)
Drug-related SAE	6 (0.4)	3 (0.7)	7 (0.5)	3 (0.3)	13 (0.5)	6 (1.2)
Common TEAEs by preferred term (reported by ≥ 3% in total mirabegron group)
Hypertension	105 (7.6)	49 (11.3)	103 (7.5)	48 (5.2)	200 (7.3)	40 (8.1)
Nasopharyngitis	35 (2.5)	15 (3.5)	54 (3.9)	25 (2.7)	94 (3.4)	14 (2.8)
Urinary tract infection	25 (1.8)	18 (4.2)	40 (2.9)	25 (2.7)	83 (3.0)	10 (2.0)
Antimuscarinic AEs of interest by preferred term (reported by ≥ 2% in any group)
Headache	43 (3.1)	10 (2.3)	47 (3.4)	23 (2.5)	80 (2.9)	18 (3.6)
Dry mouth	29 (2.1)	8 (1.9)	23 (1.7)	23 (2.5)	54 (2.0)	50 (10.1)
Constipation	20 (1.4)	7 (1.6)	22 (1.6)	15 (1.6)	44 (1.6)	10 (2.0)
Drug-related* TEAEs by preferred term (reported by ≥ 2% in any group)
Hypertension	63 (4.6)	30 (6.9)	65 (4.7)	32 (3.4)	127 (4.6)	30 (6.1)
Headache	18 (1.3)	4 (0.9)	28 (2.0)	12 (1.3)	44 (1.6)	11 (2.2)
Dry mouth	22 (1.6)	7 (1.6)	13 (0.9)	20 (2.2)	40 (1.5)	47 (9.5)

SAF, safety analysis set; ER, extended release; TEAE, treatment-emergent adverse event; SAE, serious adverse event.

^*Possible or probable, as assessed by the investigator, or records where relationship was missing.