From: Evolocumab lowers LDL-C safely and effectively when self-administered in the at-home setting
THOMAS-1 | THOMAS-2 | All | |||
---|---|---|---|---|---|
Autoinjector (n = 74) | PFS (n = 75) | Autoinjector (n = 82) | AMD (n = 82) | (n = 313) | |
Total treatment-emergent AEs | 20 (27.0) | 22 (29.3) | 27 (32.9) | 21 (25.6) | 90 (28.8) |
Grade 3 or 4 | 2 (2.7) | 3 (4.0) | 1 (1.2) | 1 (1.2) | 7 (2.2) |
AEs leading to study drug discontinuation | 1 (1.4) | 2 (2.7) | 1 (1.2) | 0 | 4 (1.3) |
Serious | 1 (1.4) | 1 (1.3) | 0 | 0 | 2 (0.7) |
Nonserious | 0 | 1 (1.3) | 1 (1.2) | 0 | 2 (0.7) |
Serious AEs | 2 (2.7) | 3 (4.0) | 1 (1.2) | 0 | 6 (1.9) |
Adverse device effects | 0 | 0 | 2 (2.4) | 1 (1.2) | 3 (1.0) |
Injection-site reactions | 0 | 0 | 0 | 1 (1.2) | 1 (0.3) |