Table 3.
Safety and tolerability in the pooled safety population for patients with data available at week 12
| Patients, n (%) |
|||
|---|---|---|---|
| Placebo | OA | All | |
| Female patients | 510 | 729 | 1239 |
| Patients with any AE | 266 (52.2) | 412 (56.5) | 678 (54.7) |
| TEAEs in ≥3% patients | |||
| Bacteriuria | 17 (3.3) | 30 (4.1) | 47 (3.8) |
| Urinary tract infection a | 103 (20.2) | 152 (20.9) | 255 (20.6) |
| Dysuria | 24 (4.7) | 55 (7.5) | 79 (6.4) |
| Urinary retention b | 22 (4.3) | 41 (5.6) | 63 (5.1) |
| Male patients | 72 | 96 | 168 |
| Patients with any AE | 33 (45.8) | 46 (47.9) | 79 (47.0) |
| TEAEs in ≥3% patients | |||
| Urinary tract infection a | 4 (5.6) | 8 (8.3) | 12 (7.1) |
| Residual urine volume | 5 (6.9) | 8 (8.3) | 13 (7.7) |
| Dysuria | 6 (8.3) | 7 (7.3) | 13 (7.7) |
| Hematuria | 4 (5.6) | 7 (7.3) | 11 (6.5) |
| Pollakiuria | 2 (2.8) | 4 (4.2) | 6 (3.6) |
| Urinary retention b | 9 (12.5) | 8 (8.3) | 17 (10.1) |
AE = adverse event; CIC = clean intermittent catheterization; OA = onabotulinumtoxinA 100 U; PVR = postvoid residual urine volume; TEAE = treatment-emergent AE.
a
Urinary tract infection was defined as a positive urine culture result with a bacteriuria count of >105 cfu/ml and leukocyturia of >5 cells per high-power field, regardless of the patient’s symptoms.
b
Urinary retention was defined as PVR ≥200 ml requiring CIC. CIC was initiated if PVR was ≥350 ml regardless of symptoms, or ≥200 to <350 ml with associated symptoms that, in the investigator’s opinion, required CIC.