Table 3.
Safety outcomes.
| Event | Ubiquinol N = 63 |
Placebo N = 68 |
|---|---|---|
| Any adverse event | ||
| Number of patients (%) | 44 (69.8%) | 54 (79.4%) |
| Number of events | 147 | 151 |
| Potentially related to the investigational drug | ||
| Number of patients (%) | 15 (23.8%) | 21 (30.9%) |
| Number of events | 28 | 34 |
| Severe adverse event | ||
| Number of patients (%) | 20 (31.7%) | 12 (17.6%) |
| Number of events | 29 | 20 |
| Potentially related to the investigational drug | ||
| Number of patients (%) | 2 (3.2%) | 0 (0.0%) |
| Number of events | 2 | 0 |
| Adverse events leading to discontinuation of treatment | ||
| Number of patients (%) | 11 (17.5%) | 7 (10.3%) |
| Number of events | 13 | 8 |
| Potentially related to the investigational drug | ||
| Number of patients (%) | 1 (1.6%) | 1 (1.5%) |
| Number of events | 1 | 1 |
| Death | ||
| Number of patients (%) | 4 (6.3%) | 0 (0.0%) |
| Number of events | 4a | 0 |
| Potentially related to the investigational drug | ||
| Number of patients (%) | 0 (0.0%) | 0 (0.0%) |
| Number of events | 0 | 0 |
a
All of them were judged not to be causally related to the drug by investigators.