Table 2.

Treatment-emergent adverse events

Type of AE	Dapoxetine 30 mg only (N = 1,060) n (%)	Dapoxetine 30→60 mg (N = 192) n (%)	Total (N = 1,252) n (%)
Number of patients with:
AEs	186 (17.5)	76 (39.6)	262 (20.9)
SAEs∗	1 (0.1)	3 (1.6)	4 (0.3)
Drug-related AEs	172 (16.2)	71 (37.0)	243 (19.4)
Drug-related SAEs	0	0	0
Number of patients with:
TEAEs	167 (15.8)	66 (34.4)	233 (18.6)
Serious TEAEs	0	0	0
Drug-related TEAEs	167 (15.8)	66 (34.4)	233 (18.6)
Drug-related serious TEAEs	0	0	0
Dizziness	93 (8.8)	38 (19.8)	131 (10.5)
Nausea	62 (5.8)	24 (12.5)	86 (6.9)
Headache	19 (1.8)	5 (2.6)	24 (1.9)
Somnolence	9 (0.8)	4 (2.1)	13 (1.0)
Thirst	5 (0.5)	3 (1.6)	8 (0.6)
Erectile dysfunction	2 (0.2)	3 (1.6)	5 (0.4)

AE = adverse event, SAE = serious adverse event, TEAE = treatment-emergent AE.

TEAE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered.

^∗4 (0.3%) patients reported SAEs during the study, with one patient reporting cholecystitis, one patient reporting salivary gland cyst.