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 TVE	2 (2)	2 (2)	3 (2)	7 (2)
Stroke	1 (1)	1 (1)	1 (1)	3 (1)
Acute coronary syndrome	0	1 (1)	1 (1)	2 (1)
Other arterial thrombosis/embolism	0	1 (1)	1 (1)	2 (1)
Deep vein thrombosis	1 (1)	0	0	1 (<1)
During the entire 44-wk treatment period
Total no. subjects with TVE	2 (2)	5 (4)	8 (6)	15 (4)
Stroke	1 (1)	1 (1)	2 (2)	4 (1)
Acute coronary syndrome	0	3 (2)	4 (3)	7 (2)
Other arterial thrombosis/embolism	0	2 (2)	1 (1)	3 (1)
Deep vein thrombosis	1 (1)	0	1 (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.