Table 1.
Pooled Adverse Events Reported in Fixed-Dose Phase III Trials With Darifenacin
| Darifenacin |
|||
|---|---|---|---|
| 7.5 mg | 15 mg | Placebo | |
| Adverse Event* | (n = 337) | (n = 334) | (n = 388) |
| Dry mouth | 20.2 | 35.5 | 8.2 |
| Constipation | 14.8 | 21.3 | 6.2 |
| Dyspepsia | 2.7 | 8.4 | 2.6 |
| Abdominal pain | 2.4 | 3.9 | 0.5 |
| Nausea | 2.7 | 1.5 | 1.5 |
| Diarrhea | 2.1 | 0.9 | 1.8 |
| Urinary tract infection | 4.7 | 4.5 | 2.6 |
| Dizziness | 0.9 | 2.1 | 1.3 |
| Asthenia | 1.5 | 2.7 | 1.3 |
| Dry eyes | 1.5 | 2.1 | 0.5 |
Values are percentages.
≥ 2% for any group.
Data from Novartis Pharmaceutical Corporation (data on file); pooled studies 1001, 1002, 1041.