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. 2022 Jun 30;26(2):119–128. doi: 10.5213/inj.2142382.191

Table 4.

Adverse event (safety set)

Adverse event Placebo (n = 76) DA-8010 2.5 mg (n = 75) DA-8010 5 mg (n = 76) Solifenacin 5 mg (n = 75)
TEAEsa) 14 (18.42) 19 (25.33) 23 (30.26) 25 (33.33)
 Dry mouth 0 (0) 4 (5.33) 10 (13.16) 8 (10.67)
 Constipation 1 (1.32) 0 (0) 1 (1.32) 3 (4.00)
 Nasopharyngitis 1 (1.32) 3 (4.00) 2 (2.63) 4 (5.33)
 Dizziness 0 (0) 1 (1.33) 4 (5.26) 2 (2.67)
 Headache 0 (0) 1 (1.33) 2 (2.63) 0 (0)
 Pain in extremity 2 (2.63) 0 (0) 0 (0) 0 (0)
 Dysuria 0 (0) 0 (0) 2 (2.63) 2 (2.67)
 Fatigue 0 (0) 0 (0) 2 (2.63) 0 (0)
Serious TEAEs 1 (1.32) 1 (1.33) 0 (0) 1 (1.33)
ADRs 3 (3.95) 5 (6.67) 14 (18.42) 13 (17.33)
Serious ADRs 0 (0) 0 (0) 0 (0) 0 (0)

Values are presented as number (%).

TEAE, treatment-emergent adverse event; ADR, adverse drug reaction.

a)

Only items with incidence rate ≥2% in at least one treatment group were listed.