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