Table 2.
Safety characteristics according to diabetes status at baseline in the pool of 14 phase 2/3 trials (safety population)
| People with diabetes N = 1554 | People without diabetes N = 3680 | |||
|---|---|---|---|---|
| n (%) | Control n = 558 | Alirocumab n = 996 | Control n = 1336 | Alirocumab n = 2344 |
| TEAEs | 431 (77.2) | 781 (78.4) | 1030 (77.1) | 1818 (77.6) |
| Serious TEAEs | 110 (19.7) | 193 (19.4) | 181 (13.5) | 341 (14.5) |
| TEAEs leading to death | 7 (1.3) | 9 (0.9) | 15 (1.1) | 13 (0.6) |
| TEAEs leading to discontinuation | 43 (7.7) | 87 (8.7) | 94 (7.0) | 145 (6.2) |
AE, adverse event; TEAE, treatment‐emergent adverse event.