Table 2.
Treatment-emergent adverse events*
| Number of subjects (%) | Open-label | Double-blind | |
|---|---|---|---|
| Tolterodine ER (n = 990) | Placebo (n = 301) | Fesoterodine (n = 308) | |
| Subjects with AEs | |||
| All-causality | 134 (13.5) | 75 (24.9) | 110 (35.7) |
| Treatment-related | 84 (8.5) | 30 (10.0) | 68 (22.1) |
| Discontinued because of AEs | |||
| All-causality | 12 (1.2) | 12 (4.0) | 11 (3.6) |
| Treatment-related | 7 (0.7) | 6 (2.0) | 7 (2.3) |
| Subjects with serious AEs | 3 (0.3) | 7 (2.3) | 5 (1.6) |
| AE rates† | |||
| Dry mouth† | 61 (6.2) | 12 (4.0) | 51 (16.6) |
| Constipation† | 11 (1.1) | 4 (1.3) | 12 (3.9) |
Includes data up to 7 days after last dose of study drug.
AEs occurring in ≥ 2% of subjects in any treatment group.