Table 3.

Treatment-emergent adverse events during the study excluding data collected after dialysis (safety population analysis set)

EventsTIW(n = 123)[n (%)]QW(n = 125)[n (%)]Q2W(n = 125)[n (%)]Total(n = 373)[n (%)]
During the first 22 wk of treatment
    Subjects with adverse events83 (68)83 (66)95 (76)261 (70)
    Subjects with drug-related adverse eventsa10 (8)8 (6)6 (5)24 (6)
    Subjects with serious adverse events19 (15)27 (22)28 (22)74 (20)
    Subjects with confirmed thromboembolic vascular events2 (2)2 (2)3 (2)7 (2)
    Subjects with hypertension14 (11)11 (9)6 (5)31 (8)
    Subjects with adverse events leading to study discontinuation1 (1)1 (1)2 (2)4 (1)
    Subjects who died0 (0)6 (5)3 (2)9 (2)
During the entire 44-wk treatment period
    Subjects with adverse events98 (80)98 (78)107 (86)303 (81)
    Subjects with drug-related adverse eventsa11 (9)11 (9)15 (12)37 (10)
    Subjects with serious adverse events36 (29)41 (33)42 (34)119 (32)
    Subjects with confirmed thromboembolic vascular events2 (2)5 (4)8 (6)15 (4)
    Subjects with hypertension16 (13)18 (14)12 (10)46 (12)
    Subjects with adverse events leading to study discontinuation3 (2)3 (2)5 (4)11 (3)
    Subjects who died4 (3)6 (5)4 (3)14 (4)
  • Treatment-emergent adverse events defined as all adverse events that occurred after the first dose of study drug. Incidence is based on the number of subjects experiencing at least one adverse event and not the number of events. Adverse events that occurred on the same day as the initiation of dialysis were determined to have occurred before dialysis.

  • a Drug-related adverse events defined as possible, probable, or very likely related to study drug.

  • Q2W, every 2 wk; QW, once weekly; TIW, three times weekly.