Table 2.
Cumulative Incidence First MACE in ESA-Untreated Patients with NDD-CKD by Regions (Safety Population)
| Statistics | Overall |
US |
Europe |
Non-US/non-Europe |
||||
|---|---|---|---|---|---|---|---|---|
| VADA (n=878) | DA (n=870) | VADA (n=531) | DA (n=527) | VADA (n=71) | DA (n=68) | VADA (n=276) | DA (n=275) | |
| Cumulative incidence (95% CI) | ||||||||
| 52 wk | 0.14 (0.12-0.16) | 0.13 (0.11-0.15) | 0.11 (0.09-0.14) | 0.13 (0.10-0.16) | 0.06 (0.02-0.15) | 0.12 (0.06-0.23) | 0.21 (0.17-0.27) | 0.14 (0.10-0.18) |
| 104 wk | 0.25 (0.22-0.29) | 0.24 (0.21-0.27) | 0.21 (0.18-0.26) | 0.24 (0.20-0.28) | 0.27 (0.17-0.42) | 0.25 (0.15-0.40) | 0.33 (0.27-0.40) | 0.23 (0.18-0.30) |
| 156 wk | 0.34 (0.29-0.38) | 0.30 (0.26-0.35) | 0.32 (0.27-0.38) | 0.29 (0.25-0.34) | 0.27 (0.17-0.42) | 0.36 (0.21-0.57) | 0.35 (0.29-0.43) | 0.35 (0.25-0.48) |
| 208 wk | 0.43 (0.35-0.52) | 0.35 (0.29-0.41) | 0.40 (0.32-0.50) | 0.34 (0.28-0.41) | NAa | NAa | NAa | NAa |
| Hazard ratio (vadadustat/darbepoetin alfa) (95% CI) | 1.16 (0.96-1.41) | 1.05 (0.81-1.35) | 0.84 (0.41-1.75) | 1.57 (1.11-2.21) | ||||
Abbreviations: MACE, major adverse cardiovascular event; NDD-CKD ESA, non–dialysis-dependent chronic kidney disease erythropoiesis-stimulating agent; VADA, vadadustat; DA, darbepoetin alfa; CI, confidence interval; NA, not available.
a
CI estimates are not available for Europe and non-US/non-Europe given that no patients reached this time point in these regions.