Table 2.
Safety profile with adverse events.
| Adverse events (AEs) | N | Sum | Proportion |
|---|---|---|---|
| Serious adverse events | 10 | 1 | 0.1 |
| SAEs, study related | 10 | 0 | 0.0 |
| SAEs, not related | 10 | 1 | 0.1 |
| Stroke | |||
| Grade 1 | 10 | 0 | 0.0 |
| Grade 2 | 10 | 0 | 0.0 |
| Grade 3 | 10 | 1 | 0.1 |
| Death | 10 | 0 | 0.0 |
| Adverse events, study related | |||
| Pain at injection site | 10 | 1 | 0.1 |
| Grade 1 | 10 | 10 | 1.0 |
| Grade 2 | 10 | 0 | 0.0 |
| Grade 3 | 10 | 0 | 0.0 |
| Syncope, vasovagal | |||
| Grade 3 | 10 | 1 | 0.1 |
| Adverse events, not study relateda | 10 | 3 | 0.3 |
| Flu-like symptoms | |||
| Grade 1 | 10 | 3 | 0.3 |
| Grade 2 | 10 | 0 | 0.0 |
| Grade 3 | 10 | 0 | 0.0 |
Not study-related adverse events are patient-reported all occurring between day 5 and 4 months.
AE, adverse event; SAE, serious adverse event.