Table 3.
Summary of treatment‐related AEs occurring in ≥2% of patients in any treatment group, by population (SAF)
| AEs, n (%) | UUI population | MUI population | ||
|---|---|---|---|---|
| Placebo (n = 287) | Mirabegron 50 mg (n = 285) | Placebo (n = 157) | Mirabegron 50 mg (n = 184) | |
| Total TEAEs | 214 (74.6) | 215 (75.4) | 126 (80.3) | 145 (78.8) |
| Treatment‐related AEs | 65 (22.6) | 71 (24.9) | 39 (24.8) | 47 (25.5) |
| Dry mouth | 6 (2.1) | 4 (1.4) | 5 (3.2) | 6 (3.3) |
| Constipation | 4 (1.4) | 11 (3.9) | 5 (3.2) | 5 (2.7) |
| Gamma‐glutamyltransferase increased | 6 (2.1) | 15 (5.3) | 5 (3.2) | 10 (5.4) |
| Alanine aminotransferase increased | 5 (1.7) | 4 (1.4) | 0 | 5 (2.7) |
| Blood creatine phosphokinase increased | 13 (4.5) | 11 (3.9) | 7 (4.5) | 5 (2.7) |
| Protein urine present | 3 (1.0) | 6 (2.1) | 1 (0.6) | 0 |
| Aspartate aminotransferase increased | 5 (1.7) | 2 (0.7) | 3 (1.9) | 3 (1.6) |
| Blood alkaline phosphatase increased | 3 (1.0) | 12 (4.2) | 5 (3.2) | 3 (1.6) |
| Treatment‐related serious AEs | 2 (0.7) | 0 | 0 | 1 (0.5) |
| Treatment‐related AEs leading to withdrawal of treatment | 2 (0.7) | 6 (2.1) | 3 (1.9) | 6 (3.3) |