Table 3.

Overall and most frequent AE (≥5% of patients) during the complete study period (safety population)

Parameter% of Patients with AEs
C.E.R.A. (n = 161)Darbepoetin alfa(n = 162)
Hypertension1615
Peripheral edema918
Diarrhea915
Nasopharyngitis1212
Constipation711
Upper respiratory tract infection810
Headache69
Urinary tract infection78
Dizziness96
Hyperkalemia77
Renal impairment94
Back pain76
Pain in extremity49
Vomiting48
Gout65
Influenza56
Hypotension37
Nausea29
Cough63
Any AE90.191.4
Serious AE30.435.8
AE leading to withdrawal3.16.2
Arteriovenous thromboembolic events
    Limb venothrombosis0<1
    Pulmonary embolism00
    Myocardial infarction20
    Stroke<10
Deaths56