Table 2.

Major safety end points

End Point	Reference ESA (n=1409)	Methoxy Polyethylene Glycol-Epoetin Beta (n=1409)	Hazard Ratio (95% CI)	P Value
End Point	No. of Patients (%)	No. of Patients (%)	Hazard Ratio (95% CI)	For Noninferiority^a	For Difference^b
Primary end point (composite of all-cause death, nonfatal MI, and nonfatal stroke)	644 (46)	640 (45)	1.03 (0.93 to 1.15)	0.004	0.54
Secondary end point
Death	557 (40)	558 (40)	1.06 (0.94 to 1.19)		0.36
Nonfatal MI or stroke	191 (14)	168 (12)	0.91 (0.74 to 1.12)		0.39
Fatal or nonfatal MI	158 (11)	143 (10)	0.95 (0.76 to 1.19)		0.66
Fatal or nonfatal stroke	98 (7)	89 (6)	0.94 (0.70 to 1.25)		0.66

ESA, erythropoiesis-stimulating agent; 95% CI, 95% confidence interval; MI, myocardial infarction.
↵a P value for the test for noninferiority at a hazard ratio of 1.20 (primary endpoint only).
↵b P value from the Wald test for hazard ratio difference from 1.