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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).