Table 2.
Subjects (n (%)) who experienced drug-related* adverse events by preferred term
Udenafil Treatment Groups | ||||||
---|---|---|---|---|---|---|
| ||||||
37.5 mg daily (N=6) | 37.5 mg twice daily (N=6) | 87.5 mg daily (N=6) | 125 mg daily (N=6) | 87.5 mg twice daily (N=6) | Total udenafil (N=30) | |
Headache | 3 (50) | 4 (67) | 4 (67) | 4 (67) | 4 (67) | 19 (63) |
Flushing | 1 (17) | 2 (33) | 4 (67) | 1 (17) | 2 (33) | 10 (33) |
Nasal congestion | 1 (17) | 2 (33) | 1 (17) | 1 (17) | 1 (17) | 6 (20) |
Spontaneous penile erection^ | 0 (0) | 1 (17) | 1 (17) | 2 (33) | 2 (33) | 6 (35) |
Nausea | 1 (17) | 1 (17) | 0 (0) | 0 (0) | 1 (17) | 3 (10) |
Abdominal discomfort | 0 (0) | 0 (0) | 0 (0) | 1 (17) | 1 (17) | 2 (7) |
Back pain | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (17) | 1 (3) |
Probably or possibly; definitely related adverse events were not reported;
includes only male subjects exposed to udenafil (N=17).