Table 5.
Other treatment-emergent safety topics of interest
| Overall population, N = 3274 | ||||
|---|---|---|---|---|
| TEAEs at injection site, n (%) | Hepatic events, n (%) | New onset or worsening of diabetes, n (%) | MACE-related safety events, n (%) | |
| TEAEs | 193 (5.9) | 166 (5.1) | 584 (17.8) | 300 (9.2) |
| TESAEs | 0 | 7 (0.2) | 12 (0.4) | 228 (7.0) |
| Fatal TESAEs | 0 | 1 (0.03) | 0 | 86 (2.6) |
| TEAEs leading to study treatment discontinuation | 7 (0.21) | 4 (0.1) | 0 | 8 (0.2) |
MACE, major adverse cardiovascular event; MedDRA, Medical Dictionary for Regulatory Activities; N, total number of patients; n, number of patients in each category; TEAE, treatment-emergent adverse event; TEASE, treatment-emergent serious adverse event.