Table 3.

Adverse Events in ≥ 3 More Patients in Any Study Group^a

Preferred Term	NRF (n = 8)		SRI (n = 9)		ESRD (n = 9)
	Any Grade	Grade 3–4	Any Grade	Grade 3–4	Any Grade	Grade 3–4
Total patients with AE	8 (100)	7 (88)	9 (100)	8 (89)	9 (100)	7 (78)
Musculoskeletal and connective tissue disorders	8 (100)	1 (13)	7 (78)	1 (11)	5 (56)	1 (11)
Back pain	3 (38)	0	3 (33)	1 (11)	4 (44)	0
Muscle spasms	3 (38)	0	1 (11)	0	1 (11)	0
Gastrointestinal disorders	7 (88)	0	7 (78)	1 (11)	7 (78)	1 (11)
Constipation	6 (75)	0	3 (33)	0	1 (11)	0
Diarrhea	2 (25)	0	5 (56)	1 (11)	4 (44)	1 (11)
Nausea	2 (25)	0	1 (11)	0	3 (33)	0
Stomatitis	1 (13)	0	4 (44)	0	1 (11)	0
General disorders and administration-site conditions	7 (88)	2 (25)	7 (78)	0	9 (100)	1 (11)
Fatigue	6 (75)	2 (25)	4 (44)	0	6 (67)	0
Pyrexia	4 (50)	0	1 (11)	0	4 (44)	0
Malaise	3 (38)	0	1 (11)	0	0	0
Peripheral edema	1 (13)	0	4 (44)	0	4 (44)	0
Blood and lymphatic system disorders	6 (75)	4 (50)	6 (67)	4 (44)	6 (67)	4 (44)
Neutropenia	3 (38)	2 (25)	1 (11)	1 (11)	1 (11)	1 (11)
Anemia	2 (25)	0	5 (56)	2 (22)	3 (33)	0
Thrombocytopenia	1 (13)	0	4 (44)	1 (11)	3 (33)	1 (11)
Infections and infestations	6 (75)	2 (25)	6 (67)	1 (11)	4 (44)	3 (33)
Skin and subcutaneous tissue disorders	6 (75)	0	6 (67)	1 (11)	4 (44)	0
Hyperhidrosis	4 (50)	0	1 (11)	0	0	0
Rash	2 (25)	0	4 (44)	0	1 (11)	0
Pruritus	1 (13)	0	0	0	3 (33)	0
Metabolism and nutrition disorders	5 (63)	2 (25)	7 (78)	3 (33)	6 (67)	3 (33)
Hyperglycemia	3 (38)	1 (13)	3 (33)	2 (22)	2 (22)	1 (11)
Hypokalemia	1 (13)	0	3 (33)	1 (11)	3 (33)	0
Decreased appetite	0	0	2 (22)	0	3 (33)	0
Hypocalcemia	0	0	3 (33)	0	3 (33)	2 (22)
Nervous system disorders	5 (63)	0	7 (78)	4 (44)	4 (44)	0
Peripheral neuropathy	2 (25)	0	1 (11)	0	3 (33)	0
Syncope	0	0	4 (44)	4 (44)	0	0
Psychiatric disorders	5 (63)	0	2 (22)	0	3 (33)	0
Respiratory, thoracic, and mediastinal disorders	5 (63)	2 (25)	5 (56)	0	3 (33)	1 (11)
Cough	4 (50)	0	2 (22)	0	1 (11)	0
Dyspnea	3 (38)	1 (13)	2 (22)	0	2 (22)	1 (11)
Cardiac disorders	4 (50)	0	0	0	2 (22)	1 (11)
Eye disorders	3 (38)	0	2 (22)	1 (11)	1 (11)	0
Investigations	2 (25)	0	7 (78)	2 (22)	3 (33)	2 (22)
Increased blood creatinine	0	0	5 (56)	1 (11)	1 (11)	1 (11)
Injury, poisoning, and procedural complications	1 (13)	0	4 (44)	0	2 (22)	0
Renal and urinary disorders	1 (13)	0	3 (33)	1 (11)	0	0
Vascular disorders	1 (13)	0	4 (44)	3 (33)	2 (22)	1 (11)

Data presented as n (%).

Abbreviations: AE = adverse event; ESRD = end-stage renal disease; NRF = normal renal function; SRI = severe renal impairment.

^aNo grade 5 events occurred.