Investor Presentaiton
Principal Secondary Endpoints
Hazard ratio (95% CI)+
0.93 (0.81, 1.07)
Principal secondary endpoints did not meet multiplicity-adjusted statistical significance for superiority*
asceND D
DIALYSIS
MACE (superiority)
asceND ND
NON-DIALYSIS
MACE (superiority)
Hazard ratio (95% CI)+
1.03 (0.89, 1.19)
MACE + thromboembolic
events (DVT, PE, VAT)
0.88 (0.78, 1.00)
MACE + thromboembolic events
(DVT, PE, VAT)
1.06 (0.93, 1.22)
MACE + hospitalization for
heart failure
0.97 (0.85, 1.11)
MACE + hospitalization for heart
failure
1.09 (0.95, 1.24)
Adjusted Mean Treatment
Difference daprodustat-ESA
(95% CI)*
Hazard ratio (95% CI)$
-9.1 (-18.4, 0.2)
On-treatment average monthly
IV iron dose (mg) from
baseline to Week 52
CKD progression
(40% decline in eGFR OR ESRD, i.e.,
chronic dialysis, not initiating dialysis
when indicated or kidney transplant)
0.98 (0.84, 1.13)
*Holm-Bonferroni multiplicity adjustment used for principal secondary endpoints. *HR estimated using a Cox proportional hazards regression model with treatment group, dialysis type (ASCEND-D) or baseline ESA
use (ASCEND-ND) and region as covariates. *Based on an ANCOVA model with terms for treatment, baseline monthly IV iron dose, dialysis type and region; $Subdistribution hazard ratio estimated using Fine &
Gray's proportional subdistribution hazard regression model with treatment group, baseline ESA use, and region as covariates. A HR <1 indicates a lower risk with daprodustat compared with ESA/darbepoetin alfa.
Cl, confidence interval; CKD, chronic kidney disease; DVT, deep vein thrombosis; eGFR, estimated glomerular filtration rate; ESA, erythropoiesis-stimulating agent; ESRD, end stage renal disease; HR, hazard
ratio; IV, intravenous; MACE, major adverse cardiovascular event; PE, pulmonary embolism; VAT, vascular access thrombosis.
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