A randomized, 29-day, dose-ranging, efficacy and safety study of daprodustat, administered three times weekly in patients with anemia on hemodialysis

Table 3 Adverse Events (Safety Population)

Preferred Term, n (%)	Placebo n = 19	Total Daprodustat n = 84	Daprodustat Dose
Preferred Term, n (%)	Placebo n = 19	Total Daprodustat n = 84	10 mg n = 20	15 mg n = 20	25 mg n = 22	30 mg n = 22
On-Treatment Common AEs ≥ 2 Participants^a
Any Event	5 (26)	28 (33)	9 (45)	6 (30)	7 (32)	6 (27)
Hypotension	0	3 (4)	1 (5)	1 (5)	1 (5)	0
Angina unstable	0	2 (2)	1 (5)	0	0	1 (5)
Cardiac failure congestive	0	2 (2)	2 (10)	0	0	0
Diarrhea	0	2 (2)	2 (10)	0	0	0
Fluid overload	0	2 (2)	0	0	1 (5)	1 (5)
Procedural hypotension	0	2 (2)	1 (5)	0	1 (5)	0
On-Treatment Serious AEs^b
Any Event	2 (11)	8 (10)	3 (15)	2 (10)	1 (5)	2 (9)
Angina unstable	0	2 (2)	1 (5)	0	0	1 (5)^c
Cardiac failure congestive	0	2 (2)	2 (10)^d	0	0	0
Fluid overload	0	2 (2)	0	0	1 (5)^d	1 (5)
Hypertensive crisis	0	1 (1)	0	1 (5)^c	0	0
Mesenteric artery stenosis	0	1 (1)	0	1 (5)	0	0
Postprocedural myocardial infarction	0	1 (1)	1 (5)	0	0	0
Arteriovenous fistula thrombosis	1 (5)	0	0	0	0	0
Orthostatic hypotension	1 (5)^d	0	0	0	0	0

AE adverse event
^aCommon AE is defined as an AE with ≥2 participants in any treatment group or ≥ 2% (based on unrounded value) in the total daprodustat group
^bParticipants could have ≥1 AE
^cStudy-withdrawn or drug-withdrawn
^dDrug-interrupted

ISSN: 1471-2369