Table 4.
Treatment-emergent adverse events (OT-28).
n (%), IR/100 PEY | ||
---|---|---|
Roxadustat (N = 215) PEY = 336.2 |
ESA (N = 204) PEY = 323.7 |
|
TEAE | 190 (88.4), 56.5 | 176 (86.3), 54.4 |
Serious TEAE | 125 (58.1), 37.2 | 116 (56.9), 35.8 |
TEAE leading to discontinuation of study drug | 19 (8.8), 5.7 | 11 (5.4), 3.4 |
Grade ≥ 3 TEAE | 93 (43.3), 27.7 | 89 (43.6), 27.5 |
TEAE leading to death | 27 (12.6), 8.0 | 26 (12.7), 8.0 |
PEY for each patient = ([last dose date − first dose date] + 1)/365.25. ESA, erythropoiesis-stimulating agent; IR, incidence rate; IR/100 PEY = 100 × number of patients with events/PEY; OT-28, on-treatment period plus 28 days; PEY, patient exposure years; TEAE, treatment-emergent adverse event.