Table 4.
Drug-related treatment-emergent adverse events (Medical Dictionary for Regulatory Activities; MedDRA) reported on one or more occasions by two or more subjects (in any group) receiving tadalafil
| Number of subjects | ||||||||
|---|---|---|---|---|---|---|---|---|
| Gender effect study* | Age effect study | Diabetes effect study | Renal Impairment study | |||||
| Adverse event | Male (N = 12) | Female (N = 12) | Elderly (N = 12) | Young (N = 12) | Healthy (N = 12) | Diabetes (N = 12) | Healthy (N = 12) | Impaired (N = 20) |
| Headache | 3 | 4 | 2 | 4 | 3 | 3 | 1 | 2 |
| Back pain | 6 | 5 | 3 | 4 | 1 | 6 | 0 | 3 |
| Myalgia | 5 | 3 | 4 | 3 | 1 | 1 | 2 | 4 |
| Musculoskeletal pain | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 |
| Asthenia | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 |
| Somnolence | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| Pain in extremity | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Number of subjects | |||||
|---|---|---|---|---|---|
| Hepatic impairment study | Renal dialysis study† | ||||
| Adverse event | Healthy (N = 8) | Hepatically impaired (N = 25) | Tadalafil 5 mg (N = 6) | Tadalafil 10 mg (N = 12) | Tadalafil 20 mg (N = 6) |
| Headache | 4 | 4 | 2 | 2 | 0 |
| Back pain | 0 | 1 | 0 | 0 | 0 |
| Myalgia | 2 | 3 | 0 | 0 | 0 |
| Musculoskeletal pain | 0 | 0 | 0 | 0 | 0 |
| Asthenia | 0 | 0 | 0 | 0 | 0 |
| Somnolence | 0 | 0 | 0 | 3 | 0 |
| Pain in extremity | 0 | 0 | 0 | 0 | 0 |
*
Single-dose pharmacokinetic data only. Multiple-dose pharmacokinetic data are discussed in text.
†
Data for treatment-emergent adverse events.