Table 3.

Treatment-related AEs and SAEs occurring in ≥1% of patients (SS population).^a

Event	Pegmolesatide (N = 246)					Epoetin alfa (N = 124)
	No. of patients (%)	CTCAE				No. of patients (%)	CTCAE
		Grade 1∼2	Grade 3	Grade 4	Grade 5		Grade 1∼2	Grade 3	Grade 4	Grade 5
Any adverse event	231 (93.9)	144 (58.5)	73 (29.7)	10 (4.1)	4 (1.6)	110 (88.7)	59 (47.6)	42 (33.9)	5 (4.0)	4 (3.2)
Any treatment-related adverse eventb	57 (23.2)	35 (14.2)	21 (8.5)	1 (0.4)	0	26 (21.0)	16 (12.9)	10 (8.1)	0	0
Treatment-related adverse events occurring in ≥1% of patients in either group
Hypertensionc	26 (10.6)	13 (5.3)	13 (5.3)	0	0	12 (9.7)	5 (4.0)	7 (5.6)	0	0
Hyperkalemia	6 (2.4)	1 (0.4)	4 (1.6)	1 (0.4)	0	7 (5.6)	5 (4.0)	2 (1.6)	0	0
Prolonged QT interval on ECG	5 (2.0)	4 (1.6)	1 (0.4)	0	0	1 (0.8)	1 (0.8)	0	0	0
Elevated alanine aminotransferase	1 (0.4)	1 (0.4)	0	0	0	2 (1.6)	2 (1.6)	0	0	0
Any serious adverse event	59 (24.0)	10 (4.1)	40 (16.3)	5 (2.0)	4 (1.6)	27 (21.8)	4 (3.2)	15 (12.1)	4 (3.2)	4 (3.2)
Serious adverse events occurring in ≥1% of patients in either group
Arteriovenous fistula site complications	9 (3.7)	3 (1.2)	6 (2.4)	0	0	3 (2.4)	1 (0.8)	2 (1.6)	0	0
Infectious pneumonia	4 (1.6)	0	3 (1.2)	1 (0.4)	0	3 (2.4)	0	2 (1.6)	1 (0.8)	0
Peripheral edema	5 (2.0)	1 (0.4)	4 (1.6)	0	0	1 (0.8)	1 (0.8)	0	0	0
Heart failure	2 (0.8)	0	2 (0.8)	0	0	4 (3.2)	0	3 (2.4)	1 (0.8)	0
Cerebral hemorrhage	4 (1.6)	0	0	1 (0.4)	3 (1.2)	1 (0.8)	0	0	0	1 (0.8)
Arteriovenous fistula thrombosis	4 (1.6)	2 (0.8)	2 (0.8)	0	0	0	0	0	0	0
Peritoneal dialysis complications	3 (1.2)	0	3 (1.2)	0	0	1 (0.8)	0	1 (0.8)	0	0
Acute myocardial infarction	1 (0.4)	0	1 (0.4)	0	0	2 (1.6)	0	0	1 (0.8)	1 (0.8)
Uremic encephalopathy	0	0	0	0	0	2 (1.6)	0	2 (1.6)	0	0
Chest discomfort	0	0	0	0	0	2 (1.6)	0	2 (1.6)	0	0
Composite safety events	6 (2.4)					5 (4.0)
All-cause death	4 (1.6)	0	0	0	4 (1.6)	4 (3.2)	0	0	0	4 (3.2)
Stroke	4 (1.6)	0	1 (0.4)	0	3 (1.2)	2 (1.6)	0	0	0	2 (1.6)
Myocardial infarction	1 (0.4)	0	1 (0.4)	0	0	2 (1.6)	0	0	1 (0.8)	1 (0.8)
Other cardiovascular events
Heart failure requiring hospitalization	1 (0.4)	0	1 (0.4)	0	0	5 (4.0)	0	4 (3.2)	1 (0.8)	0
Unstable angina requiring hospitalization	2 (0.8)	1 (0.4)	1 (0.4)	0	0	0	0	0	0	0

^aSS population included patients who had been received at least one dose of treatment regimen and had records of safety endpoints. Safety events were recorded from enrollment to 28 days after discontinuation of study drugs.

^bRelated to the study drug was defined as definitely related, possibly related, and undeterminable.

^cHypertension including preferred terms of “elevated blood pressure” and “high blood pressure”.