Table 6.
ADRs in patients with OAB (safety population, n=525)
| Incidence of ADRs |
||
|---|---|---|
| No. (%) | No. of events | |
| Urinary system disorders | 14 (2.7) | 16 |
| Urinary retention | 8 (1.5) | 8 |
| Dysuria | 3 (0.6) | 3 |
| Hematuria | 1 (0.2) | 1 |
| Pyuria | 1 (0.2) | 1 |
| Urodynia | 1 (0.2) | 1 |
| Urinary frequency | 1 (0.2) | 1 |
| Urinary hesitation | 1 (0.2) | 1 |
| Gastrointestinal system disorders | 1 (0.2) | 1 |
| Nausea | 1 (0.2) | 1 |
| Resistance mechanism disorders | 2 (0.4) | 2 |
| Cystitis | 1 (0.2) | 1 |
| Pyelonephritis | 1 (0.2) | 1 |
| Reproductive disorders, male | 1 (0.2) | 1 |
| Perineal pain male | 1 (0.2) | 1 |
| Total | 17 (3.2) | 20 |
ADRs, adverse drug reactions; OAB, overactive bladder.