Table 2.

Major safety end points

End PointReference ESA (n=1409)Methoxy Polyethylene Glycol-Epoetin Beta (n=1409)Hazard Ratio (95% CI)P Value
No. of Patients (%)No. of Patients (%)For NoninferiorityaFor Differenceb
Primary end point (composite of all-cause death, nonfatal MI, and nonfatal stroke)644 (46)640 (45)1.03 (0.93 to 1.15)0.0040.54
Secondary end point
 Death557 (40)558 (40)1.06 (0.94 to 1.19)0.36
 Nonfatal MI or stroke191 (14)168 (12)0.91 (0.74 to 1.12)0.39
 Fatal or nonfatal MI158 (11)143 (10)0.95 (0.76 to 1.19)0.66
 Fatal or nonfatal stroke98 (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.