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Table 5 Incidence of adverse events of historical interest, death on-study, and disease progressiona

From: Darbepoetin alfa for treating chemotherapy-induced anemia in patients with a baseline hemoglobin level < 10 g/dL versus ≥10 g/dL: an exploratory analysis from a randomized, double-blind, active-controlled trial

  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)
  1. Q3W = every three weeks; QW = weekly
  2. 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).