Table 2.
Summary of AEs and laboratory parameters
| % | Evolocumab; 140 mg Q2W (N = 921) | Evolocumab; 420 mg QM (N = 927) | Ezetimibe (N = 477) | Placebo (N = 821) |
|---|---|---|---|---|
| Any AE | 43.8 | 43.4 | 48.8 | 41.8 |
| Serious AEs | 2.6 | 1.7 | 1.5 | 2.3 |
| Muscle‐related AEs | 3.5 | 3.8 | 7.8 | 2.9 |
| Injection site reactions | 2.5 | 3.0 | 3.6 | 2.4 |
| Neurocognitive AEs | 0.1 | 0.1 | 0.6 | 0 |
| Creatine kinase >5× ULN | 0.1 | 0.4 | 0.6 | 0.7 |
| ALT or AST >3× ULN | 0.5 | 0.2 | 0.8 | 1.3 |
| Neutralizing anti‐evolocumab antibodies | 0 | 0 | Not tested | Not tested |
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; Q2W, every 2 weeks; QM, monthly; ULN, upper limit of normal.