Table 3.
Summary of Primary Cause of Death in ESA-Untreated Patients with NDD-CKD by Regions (Safety Population)
| Primary Cause of Death | US, n (%)/(per 100 PY) |
Europe, n (%)/(per 100 PY) |
Non-US/non-Europe, n (%)/(per 100 PY) |
|||
|---|---|---|---|---|---|---|
| VADA (n=531/PY = 1014.4) | DA (n=527/PY = 1009.0) | VADA (n=71/PY = 126.9) | DA (n=68/PY = 122.5) | VADA (n=276/PY = 391.9) | DA (n=275/PY = 423.0) | |
| CV death | 40 (7.5)/(3.9) | 38 (7.2)/(3.8) | 7 (9.9)/(5.5) | 8 (11.8)/(6.5) | 24 (8.7)/(6.1) | 19 (6.9)/(4.5) |
| Non-CV death | 42 (7.9)/(4.1) | 47 (8.9)/(4.7) | 4 (5.6)/(3.2) | 3 (4.4)/(2.4) | 43 (15.6)/(11.0) | 30 (10.9)/(7.1) |
| Renal | 13 (2.4)/(1.3) | 15 (2.8)/(1.5) | 2 (2.8)/(1.6) | 0 (0)/(0) | 25 (9.1)/(6.4) | 20 (7.3)/(4.7) |
| Infection | 10 (1.9)/(1.0) | 8 (1.5)/(0.8) | 1 (1.4)/(0.8) | 2 (2.9)/(1.6) | 10 (3.6)/(2.6) | 6 (2.2)/(1.4) |
| GI | 3 (0.6)/(0.3) | 6 (1.1)/(0.6) | 1 (1.4)/(0.8) | 0 (0)/(0) | 3 (1.1)/(0.8) | 1 (0.4)/(0.2) |
| Other non-CV | 4 (0.8)/(0.4) | 5 (0.9)/(0.5) | 0 (0)/(0) | 0 (0)/(0) | 2 (0.7)/(0.5) | 0 (0)/(0) |
| Malignancy | 4 (0.8)/(0.4) | 7 (1.3)/(0.7) | 0 (0)/(0) | 1 (1.5)/(0.8) | 1 (0.4)/(0.3) | 2 (0.7)/(0.5) |
| Pulmonary | 4 (0.8)/(0.4) | 4 (0.8)/(0.4) | 0 (0)/(0) | 0 (0)/(0) | 1 (0.4)/(0.3) | 0 (0)/(0) |
| Accidental | 4 (0.8)/(0.4) | 2 (0.4)/(0.2) | 0 (0)/(0) | 0 (0)/(0) | 1 (0.4)/(0.3) | 1 (0.4)/(0.2) |
| Unknown | 10 (1.9)/(1.0) | 16 (3.0)/(1.6) | 2 (2.8)/(1.6) | 1 (1.5)/(0.8) | 8 (2.9)/(2.0) | 6 (2.2)/(1.4) |
Abbreviations: NDD-CKD ESA, non–dialysis-dependent chronic kidney disease erythropoiesis-stimulating agent; PY, patient-year; VADA, vadadustat; DA, darbepoetin α; CV, cardiovascular; GI, gastrointestinal.