Table 4. Safety summary.
| Data are n (%) | Placebo-controlled pool n = 3492 | Ezetimibe-controlled pool n = 1129 | ||||||
|---|---|---|---|---|---|---|---|---|
| Pooled treatment group | Alirocumab n = 2318 | Placebo n = 1174 | Alirocumab n = 686 | Ezetimibe n = 443 | ||||
| Statin dose subgroup | High-dose n = 1325 | Not high-dose n = 993 | High-dose n = 682 | Not high-dose n = 492 | High-dose n = 430 | Not high-dose n = 256 | High-dose n = 264 | Not high-dose n = 179 |
| TEAEs | 1041 (78.6) | 810 (81.6) | 543 (79.6) | 411 (83.5) | 333 (77.4) | 184 (71.9) | 188 (71.2) | 129 (72.1) |
| Treatment-emergent SAEs | 219 (16.5) | 166 (16.7) | 119 (17.4) | 83 (16.9) | 90 (20.9) | 44 (17.2) | 43 (16.3) | 32 (17.9) |
| TEAEs leading to death | 7 (0.5) | 9 (0.9) | 7 (1.0) | 6 (1.2) | 3 (0.7) | 3 (1.2) | 5 (1.9) | 4 (2.2) |
| TEAEs leading to discontinuation | 66 (5.0) | 78 (7.9) | 42 (6.2) | 25 (5.1) | 31 (7.2) | 25 (9.8) | 15 (5.7) | 16 (8.9) |
| TEAEs in ≥5% of patients | ||||||||
| Nasopharyngitis | 164 (12.4) | 127 (12.8) | 69 (10.1) | 73 (14.8) | 24 (5.6) | 8 (3.1) | 13 (4.9) | 10 (5.6) |
| Injection-site reaction | 108 (8.2) | 59 (5.9) | 40 (5.9) | 22 (4.5) | 13 (3.0) | 5 (2.0) | 3 (1.1) | 2 (1.1) |
| Influenza | 86 (6.5) | 61 (6.1) | 34 (5.0) | 29 (5.9) | 20 (4.7) | 9 (3.5) | 10 (3.8) | 8 (4.5) |
| Upper respiratory tract infection | 81 (6.1) | 81 (8.2) | 56 (8.2) | 38 (7.7) | 34 (7.9) | 19 (7.4) | 16 (6.1) | 14 (7.8) |
| Arthralgia | 70 (5.3) | 48 (4.8) | 40 (5.9) | 36 (7.3) | 14 (3.3) | 18 (7.0) | 10 (3.8) | 5 (2.8) |
| Back pain | 66 (5.0) | 57 (5.7) | 32 (4.7) | 38 (7.7) | 18 (4.2) | 9 (3.5) | 5 (1.9) | 11 (6.1) |
| Bronchitis | 68 (5.1) | 44 (4.4) | 29 (4.3) | 29 (5.9) | 13 (3.0) | 8 (3.1) | 8 (3.0) | 5 (2.8) |
| Urinary tract infection | 68 (5.1) | 60 (6.0) | 27 (4.0) | 38 (7.7) | 6 (1.4) | 11 (4.3) | 8 (3.0) | 11 (6.1) |
| Diarrhoea | 63 (4.8) | 60 (6.0) | 33 (4.8) | 24 (4.9) | 14 (3.3) | 4 (1.6) | 6 (2.3) | 7 (3.9) |
| Headache | 64 (4.8) | 55 (5.5) | 32 (4.7) | 32 (6.5) | 18 (4.2) | 16 (6.3) | 10 (3.8) | 6 (3.4) |
| Myalgia | 54 (4.1) | 57 (5.7) | 33 (4.8) | 13 (2.6) | 20 (4.7) | 9 (3.5) | 9 (3.4) | 9 (5.0) |
| Hypertension | 47 (3.5) | 39 (3.9) | 27 (4.0) | 19 (3.9) | 25 (5.8) | 13 (5.1) | 16 (6.1) | 7 (3.9) |
| Dizziness | 43 (3.2) | 38 (3.8) | 31 (4.5) | 18 (3.7) | 22 (5.1) | 11 (4.3) | 14 (5.3) | 10 (5.6) |
| Pain in extremity | 43 (3.2) | 30 (3.0) | 23 (3.4) | 25 (5.1) | 12 (2.8) | 4 (1.6) | 5 (1.9) | 5 (2.8) |
| Fall | 35 (2.6) | 30 (3.0) | 21 (3.1) | 25 (5.1) | 10 (2.3) | 8 (3.1) | 6 (2.3) | 2 (1.1) |
| Accidental overdose | 16 (1.2) | 14 (1.4) | 10 (1.5) | 7 (1.4) | 30 (7.0) | 23 (9.0) | 9 (3.4) | 13 (7.3) |
SAE, serious adverse event; TEAE, treatment-emergent adverse event.