Table 1.

Demographics and baseline clinical characteristics

CharacteristicRavulizumab (N = 125)Eculizumab (N = 121)Total (N = 246)
Sex, n (%)
 Male65 (52.0)69 (57.0)134 (54.5)
 Female60 (48.0)52 (43.0)112 (45.5)
Age at first infusion of study drug, mean (SD), y44.8 (15.2)46.2 (16.2)45.5 (15.7)
Race, n (%)
 Asian72 (57.6)57 (47.1)129 (52.4)
  Japanese19 (15.2)15 (12.4)34 (13.8)
 White43 (34.4)51 (42.1)94 (38.2)
 Black or African American2 (1.6)4 (3.3)6 (2.4)
 American Indian or Alaska Native1 (0.8)1 (0.8)2 (0.8)
 Other4 (3.2)4 (3.3)8 (3.3)
 Not reported3 (2.4)4 (3.3)7 (2.8)
Weight, mean (SD), kg68.2 (15.6)69.2 (14.9)68.7 (15.2)
Height, mean (SD), cm166.3 (9.0)166.2 (10.7)166.2 (9.8)
LDH ratio, n (%)
 1.5 to <3× ULN*18 (14.4)16 (13.2)34 (13.8)
 ≥3× ULN107 (85.6)105 (86.8)212 (86.2)
Packed RBC units received within 1 y before study entry, randomization strata, n (%)
 0 U23 (18.4)21 (17.4)44 (17.9)
 1-14 U79 (63.2)78 (64.5)157 (63.8)
 >14 U23 (18.4)22 (18.2)45 (18.3)
Age at PNH diagnosis, mean (SD), y37.9 (14.9)39.6 (16.7)38.7 (15.8)§
Number of years from PNH diagnosis to consent, median (minimum, maximum), y3.8 (0, 41)3.9 (0, 34)3.9 (0, 41)§
LDH, mean (SD), U/L1633.5 (778.8)1578.3 (727.1)1606.4 (752.7)
PNH clone size, mean (SD), %
 Type II RBCs12.4 (20.5)||13.7 (17.7)13.0 (19.2)#
 Type III RBCs26.3 (17.2)||25.2 (16.9)25.8 (17.1)#
 Total RBCs38.4 (23.7)38.7 (23.2)38.6 (23.4)
 Granulocytes84.2 (21.0)85.3 (19.0)84.7 (20.0)
 Monocytes86.9 (18.1)89.2 (15.2)88.0 (16.7)
History of major adverse vascular events, n (%)17 (13.6)25 (20.7)42 (17.1)
  • PNH, paroxysmal nocturnal hemoglobinuria; RBC, red blood cell; SD, standard deviation.

  • * The ULN for LDH is 246 U/L.

  • n = 123.

  • n = 118.

  • § n = 241.

  • || n = 124.

  • n = 120.

  • # n = 244.