Table 5.

Most common AEs (≥5%) by preferred term (ITT analysis set)^a

Preferred Term	Roxadustat (n=1384)			Placebo (n=1377)
	Patients with Event	%	Event Rate (per 100 PY)b	Patients with Event	%	Event Rate (per 100 PY)b
ESKD	290	21.0	11.7	282	20.5	11.8
UTI	177	12.8	6.8	110	8.0	4.2
Pneumonia	165	11.9	6.2	130	9.4	4.9
Hypertension	159	11.5	6.1	125	9.1	4.8
Edema peripheral	149	10.8	5.7	111	8.1	4.3
Diarrhea	144	10.4	5.5	119	8.6	4.6
Nausea	125	9.0	4.8	104	7.6	4.1
Hyperkalemia	118	8.5	4.4	95	6.9	3.6
Cough	105	7.6	3.9	69	5.0	2.6
Viral upper respiratory tract infection	101	7.3	3.8	106	7.7	4.1
Upper respiratory tract infection	96	6.9	3.6	76	5.5	2.9
Headache	94	6.8	3.5	82	6.0	3.1
Constipation	92	6.6	3.4	88	6.4	3.4
Hypoglycemia	91	6.6	3.4	73	5.3	2.8
Gastritis	81	5.9	3.0	72	5.2	2.7
Azotemia	80	5.8	2.9	73	5.3	2.7
Dyspnea	78	5.6	2.9	74	5.4	2.8
Bronchitis	78	5.6	2.9	73	5.3	2.8
Vomiting	78	5.6	2.9	69	5.0	2.6
Dizziness	77	5.6	2.9	87	6.3	3.4
AKI	75	5.4	2.7	47	3.4	1.7
Asthenia	74	5.3	2.7	75	5.4	2.8
Arthralgia	73	5.3	2.7	54	3.9	2.0
Back pain	72	5.2	2.6	57	4.1	2.1
Pruritus	68	4.9	2.5	80	5.8	3.1
Edema	66	4.8	2.4	69	5.0	2.6

Percentages were on the basis of the No. of patients in the ITT analysis set in that treatment arm. PY, patient yr at risk.

^aIncluded AEs with an onset date on or after the date of randomization and up to and including the EOS visit; or date of last contact or withdrawal of consent, if before the EOS visit.

^bCalculated as [No. of patients with AEs divided by (the total No. of days at risk for that AE across all patients in given group divided by 365.25)] × 100.