Table 3.
MACE including undetermined death evaluated by a specialist after the start of the study drug and up to week 52 (safety analysis set)
| Category and event by adjudicatora | Molidustat (n = 153) | Darbepoetin (n = 76) | Total (N = 229) |
|---|---|---|---|
| Patients with ≥1 MACE,bn (%) | 5 (3.3) | 2 (2.6) | 7 (3.1) |
| Cardiovascular death, n (%) | 2 (1.3) | 1 (1.3) | 3 (1.3) |
| Myocardial infarction, n (%) | 1 (0.7) | 0 | 1 (0.4) |
| Ischemic stroke, n (%) | 2 (1.3) | 1 (1.3) | 3 (1.3) |
MACE, major adverse cardiovascular events.
a
Primary system organ class term from Medical Dictionary for Regulatory Activities, version 22.0.
b
MACE including cardiovascular or undetermined death, myocardial infarction, unstable angina pectoris, ischemic stroke, pulmonary thromboembolism, and acute limb ischemia.