Table 5.

Incidence of treatment-emergent confirmed thromboembolic vascular events excluding data collected after dialysis (safety population analysis set)

TIW(n = 123)[n (%)]QW(n = 125)[n (%)]Q2W(n = 125)[n (%)]Total(n = 373)[n (%)]
During the first 22 wk of treatment
    Total no. subjects with TVE2 (2)2 (2)3 (2)7 (2)
    Stroke1 (1)1 (1)1 (1)3 (1)
    Acute coronary syndrome01 (1)1 (1)2 (1)
    Other arterial thrombosis/embolism01 (1)1 (1)2 (1)
    Deep vein thrombosis1 (1)001 (<1)
During the entire 44-wk treatment period
    Total no. subjects with TVE2 (2)5 (4)8 (6)15 (4)
    Stroke1 (1)1 (1)2 (2)4 (1)
    Acute coronary syndrome03 (2)4 (3)7 (2)
    Other arterial thrombosis/embolism02 (2)1 (1)3 (1)
    Deep vein thrombosis1 (1)01 (1)2 (1)
  • Incidence is based on the number of subjects experiencing at least one TVE and not the number of events. TVEs within 30 days of the last dose were included. Adverse events that occurred on the same day as the initiation of dialysis were determined to have occurred before dialysis.