Table 8.
TEAEs Occurring in ≥5% of Individuals in Either Treatment Group (Safety Population)
| Alirocumab (n = 96) | Placebo (n = 50) | |
|---|---|---|
| Upper respiratory tract infection | 13 (13.5) | 3 (6.0) |
| Injection-site reaction | 9 (9.4) | 2 (4.0) |
| Urinary tract infection | 9 (9.4) | 2 (4.0) |
| Nasopharyngitis | 6 (6.3) | 3 (6.0) |
| Sinusitis | 6 (6.3) | 0 |
| Bronchitis | 5 (5.2) | 1 (2.0) |
| Back pain | 4 (4.2) | 4 (8.0) |
| Diarrhea | 3 (3.1) | 5 (10.0) |
| Anemia | 3 (3.1) | 3 (6.0) |
| Arthralgia | 2 (2.1) | 4 (8.0) |
| Gastroenteritis | 2 (2.1) | 3 (6.0) |
| Nausea | 2 (2.1) | 4 (8.0) |
| Hypertension | 1 (1.0) | 3 (6.0) |
Data reported as n (%).