Table 3.
Safety summary (randomized population)
DM-DYSLIPIDEMIA | DM-INSULIN | |||
---|---|---|---|---|
Alirocumab (n = 95) | UC (n = 47) | Alirocumab (n = 118) | Placebo (n = 57) | |
TEAEs occurring in ≥ 2% of individuals by preferred term, n (%) | ||||
Urinary tract infection | 5 (5.3) | 2 (4.3) | 3 (2.5) | 4 (7.0) |
Diarrhea | 5 (5.3) | 3 (6.4) | 3 (2.5) | 3 (5.3) |
Hypertension | 3 (3.2) | 1 (2.1) | 5 (4.2) | 3 (5.3) |
Influenza | 3 (3.2) | 3 (6.4) | 4 (3.4) | 1 (1.8) |
Musculoskeletal pain | 4 (4.2) | 1 (2.1) | 3 (2.5) | 2 (3.5) |
Back pain | 2 (2.1) | 2 (4.3) | 4 (3.4) | 0 |
Dizziness | 3 (3.2) | 1 (2.1) | 3 (2.5) | 2 (3.5) |
Fatigue | 2 (2.1) | 2 (4.3) | 3 (2.5) | 1 (1.8) |
Cataract | 1 (1.1) | 1 (2.1) | 4 (3.4) | 0 |
Myalgia | 2 (2.1) | 1 (2.1) | 3 (2.5) | 0 |
Nausea | 2 (2.1) | 1 (2.1) | 2 (1.7) | 2 (3.5) |
Pain in extremity | 2 (2.1) | 2 (4.3) | 2 (1.7) | 1 (1.8) |
Bronchitis | 0 | 2 (4.3) | 3 (2.5) | 1 (1.8) |