Table 3.
Adverse events and adverse reactions
| Patients | Safety population (N = 504) |
|
|---|---|---|
| Adverse events | Adverse reactions | |
| Total number of events, n | 57 | 17 |
| Number of serious events | 17 | 0 |
| Number of non-serious events | 40 | 17 |
| Patients with events, n (%) | 38 (7.5) | 13 (2.6) |
| Patients with non-serious events | 33 (6.5) | 13 (2.6) |
| Patients with serious events | 9 (1.8) | 0 |
| Deathsa | 1 (0.2) | 0 |
| Patients with non-serious events(s) by intensity, n (%) | ||
| Mild | 13 (2.6) | 7 (1.4) |
| Moderate | 16 (3.2) | 5 (1.0) |
| Severe | 2 (0.4) | 1 (0.2) |
| Not available | 2 (0.4) | 0 |
| Urinary-related events with a frequency ≥ 0.4%, n (%) | ||
| Urinary retentionb | 5 (1.0) | |
| Urinary tract infectionc | 2 (0.4) | |
Adverse reactions were defined as events for which a causal relationship to onabotulinumtoxinA treatment was rated as reasonably possible
aCerebrovascular accident
bCIC was initiated in all five patients
cThe two patients with urinary tract infection had received antibiotic prophylaxis orally on the day of injection
CIC clean intermittent catheterization