Table 3.

Treatment-emergent serious adverse events by system organ class reported in >2% of patients in any treatment group − pooled total population

MedDRA system organ class	Vadadustat (N = 3,686) Exposure = 6,335.3 PY		Darbepoetin alfa (N = 3,687) Exposure = 6,420.1 PY
	n (%)	Events (events per 100 PY)	n (%)	Events (events per 100 PY)
Any TE-SAE	2,139 (58.0)	6,981 (110.2)	2,186 (59.3)	7,159 (111.5)
Infections and infestations	858 (23.3)	1,494 (23.6)	884 (24.0)	1,504 (23.4)
Renal and urinary disorders	684 (18.6)	790 (12.5)	667 (18.1)	763 (11.9)
Cardiac disorders	600 (16.3)	1,017 (16.1)	670 (18.2)	1,106 (17.2)
Metabolism and nutrition disorders	394 (10.7)	569 (9.0)	387 (10.5)	537 (8.4)
Respiratory, thoracic, and mediastinal disorders	307 (8.3)	449 (7.1)	336 (9.1)	480 (7.5)
Blood and lymphatic system disorders	131 (3.6)	159 (2.5)	142 (3.9)	172 (2.7)

 MedDRA, Medical Dictionary for Regulatory Activities; PY, patient-years; TE-SAE, treatment-emergent serious adverse event.