Table 6.

Overall and most frequent AE (≥8% patients in at least one group; safety population)a

AE, n (%)Twice-Monthly C.E.R.A. (n= 190)Once-Monthly C.E.R.A. (n= 191)Epoetin One to Three Times a Week(n= 191)
Hypertension27 (14)30 (16)25 (13)
Procedural hypotensionb17 (9)29 (15)20 (10)
Nasopharyngitis18 (9)19 (10)18 (9)
Headache15 (8)20 (11)19 (10)
Diarrhea20 (11)15 (8)14 (7)
Muscle spasms16 (8)14 (7)17 (9)
Fluid overload9 (5)15 (8)18 (9)
Arteriovenous fistula site hemorrhage18 (9)15 (8)5 (3)
Arteriovenous fistula thrombosis13 (7)15 (8)8 (4)
Angina pectoris2 (1)15 (8)4 (2)
Any AE171 (90.0)177 (93.2)167 (87.4)
Serious AE70 (36.8)73 (38.4)85 (44.5)
AE leading to withdrawal1 (0.5)0 (0.0)2 (1.0)
Deathsc13 (6.8)18 (9.5)12 (6.3)
  • a AE, adverse event.

  • b Hypotension during dialysis.

  • c Two deaths occurred within 30 d of the last dose of study drug; therefore, only 41 deaths were recorded as reasons for premature withdrawal.