Table 5.

Preferred terms of AEs (underlined events are ADRs).

AEs/ADRs	All	Baseline eGFR Category								Hemodialysis
		G1		G2		G3a–G3b		G4–G5
n	189	21		123		34		8		3
Serious	16	2		4		5		2		3
		G1-1	Diabetes mellitus	G2-1	Inguinal hernia Cryptorchism	G3-1	Aortic aneurysm	G45-1	Gastric adenoma Adenocarcinoma gastric	H-1	Shunt occlusion Shunt stenosis
		G1-2	Myocardial ischemia	G2-2	Sepsis	G3-2	Adenocarcinoma gastric	G45-2	Spinal compression fracture Aortic aneurysm Aortic dissection Carotid artery dissection	H-2	Malaise
				G2-3	Cerebral infarction	G3-3	Pneumonia			H-3	Shunt stenosis Cataract Upper respiratory tract inflammation
				G2-4	Acute myocardial infarction	G3-4	Pneumonia
						G3-5	Myocardial ischemia
Leading to withdrawal	11	2		3		3		3		0
		G1-3	Cholelithiasis	G2-5	AST increased ALT increased	G3-2	Adenocarcinoma gastric	G45-2	Aortic aneurysm Aortic dissection Carotid artery dissection
		G1-4	Diabetes mellitus	G2-6	Cholelithiasis	G3-3	Pneumonia
				G2-4	Acute myocardial infarction	G3-6	LDL increased Cholelithiasis	G45-3	Chronic kidney disease
								G45-4	Drug eruption

Preferred terms are based on MedDRA Ver. 18.0. Baseline eGFR categories are as follows: G1, eGFR ≥90 mL/min/1.73 m²; G2, eGFR ≥60 and <90 mL/min/1.73 m²; G3a–G3b, eGFR ≥30 and <60 mL/min/1.73 m²; G4–G5, eGFR <30 mL/min/1.73 m². AE, adverse event; ADR, adverse drug reaction; eGFR, estimated glomerular filtration rate; LDL, low-density lipoprotein; AST, aspartate aminotransferase; ALT, alanine aminotransferase.