Table 4.

Safety profiles of epoetin alfa-epbx and epoetin alfa: adverse events with ≥5% incidence and serious adverse events occurring in at least four patients in either treatment group

Preferred TermEpoetin alfa-epbx, n=301Epoetin alfa, n=304
Any adverse event, n (%)232 (77.1)229 (75.3)
 Nausea30 (10.0)25 (8.2)
 Vomiting28 (9.3)15 (4.9)
 Muscle spasms27 (9.0)24 (7.9)
 Arteriovenous fistula-site complication26 (8.6)25 (8.2)
 Headache23 (7.6)16 (5.3)
 Dyspnea22 (7.3)21 (6.9)
 Diarrhea21 (7.0)27 (8.9)
 Dizziness20 (6.6)15 (4.9)
 Hypertension19 (6.3)12 (3.9)
 Cough16 (5.3)22 (7.2)
 Hypotension14 (4.7)23 (7.6)
 Back pain13 (4.3)16 (5.3)
 Pain in extremity10 (3.3)17 (5.6)
 Noncardiac chest pain7 (2.3)17 (5.6)
Any serious adverse event, n (%)75 (24.9)82 (27.0)
 Pneumonia4 (1.3)8 (2.6)
 Acute respiratory failure4 (1.3)0
 Cardiac failure congestive4 (1.3)3 (1.0)
 Dyspnea3 (1.0)8 (2.6)
 Noncardiac chest pain2 (0.7)7 (2.3)
 Hyperkalemia2 (0.7)4 (1.3)
 Angina pectoris1 (0.3)4 (1.3)
 Fluid overload1 (0.3)6 (2.0)
 Cellulitis06 (2.0)