Baseline Hemoglobin < 10 g/dL | Baseline Hemoglobin ≥10 g/dL | |||
---|---|---|---|---|
Darbepoetin alfa 500 mcg Q3W N = 176 | Darbepoetin alfa 2.25 mcg/kg QW N = 175 | Darbepoetin alfa 500 mcg Q3W N = 177 | Darbepoetin alfa 2.25 mcg/kg QW N = 177 | |
Adverse events of historical interest, death on-study, and disease progression, n (%) | 84 (48) | 80 (46) | 67 (38) | 75 (42) |
On-study deaths, n (%) | 24 (14) | 32 (18) | 14 (8) | 20 (11) |
Disease progression, n (%) | 42 (24) | 37 (21) | 29 (16) | 36 (20) |
Cardiovascular and thromboembolic events, n (%) | 22 (12) | 27 (15) | 33 (19) | 34 (19) |
Arrhythmias | 7 (4) | 7 (4) | 9 (5) | 13 (7) |
Cerebrovascular accident | 0 (0) | 2 (1) | 0 (0) | 1 (0.6) |
Congestive heart failure | 5 (3) | 7 (4) | 4 (2) | 6 (3) |
Myocardial infarction/Coronary artery disorders | 2 (1) | 3 (2) | 3 (2) | 0 (0) |
Embolism/Thrombosis | 11 (6) | 11 (6) | 19 (11) | 17 (10) |
Seizure, n (%) | 1 (0.6) | 0 (0) | 0 (0) | 1 (0.6) |
Hypertension, n (%) | 6 (3) | 7 (4) | 2 (1) | 6 (3) |
Pure red blood cell aplasia, n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Immune system disorders, n (%) | 0 (0) | 1 (0.6) | 1 (0.6) | 2 (1) |
Neoplasms benign, malignant, or unspecified (includes cysts/polyps), n (%) | 44 (25) | 33 (19) | 14 (8) | 26 (15) |