n (%) | Alirocumab (n = 213) | Control (n = 104) |
---|---|---|
TEAEs | 142 (66.7) | 70 (67.3) |
Treatment-emergent SAEs | 28 (13.1) | 10 (9.6) |
TEAEs leading to death | 1 (0.5) | 1 (1.0) |
TEAEs occurring in ≥ 2% of individuals by preferred term | ||
 Urinary tract infection | 8 (3.8) | 6 (5.8) |
 Diarrhea | 8 (3.8) | 6 (5.8) |
 Hypertension | 8 (3.8) | 4 (3.8) |
 Influenza | 7 (3.3) | 4 (3.8) |
 Headache | 7 (3.3) | 1 (1.0) |
 Musculoskeletal pain | 7 (3.3) | 3 (2.9) |
 Nasopharyngitis | 6 (2.8) | 5 (4.8) |
 Back pain | 6 (2.8) | 2 (1.9) |
 Dizziness | 6 (2.8) | 3 (2.9) |
 Fatigue | 5 (2.3) | 3 (2.9) |
 Cataract | 5 (2.3) | 1 (1.0) |
 Myalgia | 5 (2.3) | 1 (1.0) |
 Nausea | 4 (1.9) | 3 (2.9) |
 Pain in extremity | 4 (1.9) | 3 (2.9) |
 Arthralgia | 3 (1.4) | 3 (2.9) |
 Bronchitis | 3 (1.4) | 3 (2.9) |
 Hypotension | 2 (0.9) | 3 (2.9) |
 Cough | 1 (0.5) | 3 (2.9) |
 Hyperglycemia | 0 (0.0) | 3 (2.9) |