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Table 5 Adverse events reported on study

From: Comparison of darbepoetin alfa dosed weekly (QW) vs. extended dosing schedule (EDS) in the treatment of anemia in patients receiving multicycle chemotherapy in a randomized, phase 2, open-label trial

Type of Adverse Event

QW

(n = 374)

n (%)

EDS

(n = 378)

n (%)

Patients who had any adverse events

357 (95)

360 (95)

Patients who had adverse events of historical interest

106 (28)

100 (26)

   Neoplasms benign, malignant and unspecified

59 (16)

54 (14)

   Embolism/thrombosis

23 (6)

21 (6)

Deep vein thrombosis

14 (4)

9 (2)

Pulmonary embolism

2 (1)

9 (2)

Phlebitis

2 (1)

2 (1)

Jugular vein thrombosis

0 (0)

1 (<1)

Subclavian vein thrombosis

0 (0)

1 (<1)

Superior vena caval occlusion

0 (0)

1 (<1)

Thrombophlebitis superficial

2 (1)

1 (<1)

Thrombosis

2 (1)

1 (<1)

Atrial thrombosis

1 (<1)

0 (0)

Phlebitis superficial

1 (<1)

0 (0)

   Arrhythmias

19 (5)

12 (3)

   Congestive heart failure

12 (3)

10 (3)

   Hypertension

10 (3)

9 (2)

   Cerebrovascular accident

2 (1)

7 (2)

   Myocardial infarction/coronary artery disorders

4 (1)

5 (1)

   Immune system disorders

0 (0)

3 (1)

   Seizure

3 (1)

2 (1)

Patients who had treatment-related adverse events

18 (5)

14 (4)

Patients who had serious adverse events

154 (41)

133 (35)

Patients who had serious treatment-related adverse events

2 (1)

3 (1)

   Pulmonary embolism

0 (0)

2 (1)

   Arthralgia

0 (0)

1 (<1)

   Neutropenia

1 (<1)

0 (0)

   Myocardial infarction

1 (<1)

0 (0)

   Pyrexia

1 (<1)

0 (0)

Patients who had life-threatening adverse events

22 (6)

16 (4)

Patients who discontinued from the study because of adverse events

58 (16)

46 (12)

Patients who died

39 (10)

39 (10)

  1. QW = once weekly; EDS = extended dosing schedule