| |
Number (%) of Patients
|
| Event |
Placebo (N = 161) |
Tadalafil 10 mg (N = 161) |
Tadalafil 20 mg (N = 161) |
P |
|
| Headache |
1 (0.6) |
9 (5.6) |
17 (10.6) |
<.001 |
| Back pain |
2 (1.2) |
11 (6.8) |
10 (6.2) |
.024 |
| Dyspepsia |
1 (0.6) |
6 (3.7) |
8 (5.0) |
.057 |
| Nasopharyngitis |
5 (3.1) |
8 (5.0) |
5 (3.1) |
.719 |
| Nasal congestion |
0 |
3 (1.9) |
6 (3.7) |
.048 |
| Upper respiratory tract infection |
3 (1.9) |
4 (2.5) |
5 (3.1) |
.933 |
| Myalgia |
0 |
2 (1.2) |
5 (3.1) |
.076 |
| Influenza |
3 (1.9) |
2 (1.2) |
4 (2.5) |
.913 |
|
| *Treatment-emergent adverse events (TEAEs) of all causes occurring in at least
2% of any treatment group (tadalafil 10 mg and/or 20 mg) |
| N = all randomized patients |
| Data is presented as number of patients, with percentage in
parentheses. Patients may be counted in more than one category |
| Frequencies were analyzed by Fisher's exact test, applied to the 3
treatment groups. The P value represents comparisons between adverse
events reported by patients on tadalafil 10 mg and 20 mg pooled together vs
patients on placebo |
