Investor Presentaiton
Adverse Events
Safety population reporting treatment-emergent events
AE and SAE rates were similar between treatment groups in both studies
Rates of AESIs were generally similar between treatment groups in both studies
asceND D
DIALYSIS
Daprodustat
(N=1482)
ESA
(N=1474)
asceND ND
NON-DIALYSIS
Rate of AEs
Rate of SAES
88%
85%
Rate of AES
52%
51%
Rate of SAES
Darbepoetin
Daprodustat
(N=1937)
alfa
(N=1933)
80%
77%
44%
36%
Adverse Events of Special Interest (AESIs) undergoing further investigation:
Esophageal and gastric
4.0% [60]
5.5% [81]
erosions, % [n]
Esophageal and gastric
erosions, % [n]
3.6% [70]
2.1% [41]
Cancer-related mortality
and tumor progression and
recurrence, % [n]
3.2% [47]
3.5% [51]
Cancer-related mortality
and tumor progression and
recurrence, % [n]
3.7% [72]
2.5% [49]
Safety population: all randomized patients who received at least one dose of randomized treatment. Treatment-emergent adverse events are reported which start or worsen on or after the participant's treatment
start date and on or before the day after the participant's last dose of randomized treatment. Adverse events of special interest were investigator reported events and were not adjudicated. They were defined for
da produstat based on data from non-clinical and clinical studies, current information about HIF-associated pathophysiology, and identified risks for ESAs. A programmatic approach for these potential events was
implemented using a broad set of terms of interest. AE, adverse event; AESI, adverse event of special interest; ESA, erythropoiesis-stimulating agent; HIF, hypoxia-inducible factor; SAE, serious adverse event.
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