Table 6.
Drug-related treatment-emergent adverse events ≥1% in either treatment group (SAF)
| TEAEs, n (%) | Placebo (n = 442) | Mirabegron Total (n = 445) |
|---|---|---|
| Drug-related TEAEsa | 57 (12.9) | 84 (18.9) |
| Dry mouth | 7 (1.6) | 6 (1.3) |
| Nausea | 3 (0.7) | 6 (1.3) |
| Constipation | 4 (0.9) | 3 (0.7) |
| Diarrhea | 1 (0.2) | 5 (1.1) |
| Headache | 7 (1.6) | 18 (4.0) |
| Dizziness | 6 (1.4) | 2 (0.4) |
| Somnolence | 1 (0.2) | 2 (0.4) |
| Escherichia urinary tract infection | 7 (1.6) | 9 (2.0) |
| Fatigue | 10 (2.3) | 7 (1.6) |
aPossible or probable, as assessed by the investigator, or where relationship was missing
SAF safety analysis set, TEAEs treatment-emergent adverse events