Table 5.
Incidence of adverse events of historical interest, death on-study, and disease progressiona
| 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) |
Q3W = every three weeks; QW = weekly
aIncludes all events within 28 days of the last dose of study drug (except serious adverse events, which were reported at any time after the first dose of study drug).