Table 4.
Adverse events.
| Evolocumab (n = 60) | SOC (n = 60) | p a | |
|---|---|---|---|
| Any adverse event | 5 | 6 | 0.75 |
| Serious adverse event | 0 | 1 (3.33%) | 0.32 |
| Events of special interest | |||
| ALT or AST >3×ULN | 2 (3.33%) | 2 (3.33%) | 1.00 |
| General allergic reaction | 0 | 0 | - |
| Local injection site reaction | 2 (3.33%) | — | — |
| Neurocognitive event | 1 (1.67%) | 1 (1.67%) | 1.00 |
| Musculoskeletal pain | 0 | 1 (1.67%) | 0.32 |
| Cerebrovascular event | 0 | 1 (3.33%) | 0.32 |
| Cerebral hemorrhage | 0 | 1 (3.33%) | 0.32 |
| Myocardial infarction | 0 | 0 | — |
| Cardiovascular death | 0 | 0 | — |
| All-cause death | 0 | 0 | — |
SOC, standard of care; ALT, alanine aminotransferase; AST, aspartate aminotransferase.
Fisher exact test.