Table 3.

Summary of treatment‐emergent adverse events (TEAEs) by system organ class and preferred term

System organ class	Placebo	0.5 mg kg–1	5.0 mg kg–1	9.0 mg kg–1	12.5 mg kg–1
Preferred term	N = 8	N = 6	N = 6	N = 6	N = 5
Healthy volunteers (Cohorts 1 and 2)	N [n]	N [n]	N [n]	N [n]	N [n]
Any TEAE	4 [7]	5 [16]	5 [14]	6 [8]	5 [11]
General disorders and administration site conditions
Infusion site pain	0	4 [4]	5 [8]	3 [3]	4 [6]
Infusion site erythema	1 [1]	1 [2]	1 [1]	3 [3]	1 [1]
Infusion site bruising	0	2 [2]	0	0	0
Infusion site hypoaesthesia	0	0	2 [2]	0	0
Catheter site pain	1 [1]	0	0	0	0
Feeling of body temperature change	0	0	0	0	1 [1]
Infusion site swelling	0	1 [1]	0	0	0
Malaise	0	0	0	0	1 [1]
Musculoskeletal and connective tissue disorders
Pain in extremity	1 [1]	0	1 [1]	1 [1]	0
Myalgia	1 [1]	0	0	0	1 [1]
Musculoskeletal pain	1 [1]	0	0	0	0
Nervous system disorders
Headache	0	3 [5]	0	0	1 [1]
Dizziness	0	0	1 [1]	1 [1]	0
Somnolence	0	0	1 [1]	0	0
Immune system disorders
Seasonal allergy	1 [1]	0	0	0	0
Injury, poisoning and procedural complications
Eyelid injury	0	1 [1]	0	0	0
Respiratory, thoracic and mediastinal disorders
Dry throat	1 [1]	0	0	0	0
Skin and subcutaneous tissue disorders
Miliaria	0	1 [1]	0	0	0

System organ class	Placebo	9.0 mg kg–1
Preferred term	N = 2	N = 6
Haemodialysis patients	N [n]	N [n]
Any TEAE	1 [1]	3 [6]
Gastrointestinal disorders
Paraesthesia oral	0	1 [2]
Vomiting	1 [1]	0
Infections and infestations
Cellulitis	0	1 [1]
Nasopharyngitis	0	1 [1]
Cardiac disorders
Palpitations	0	1 [1]
Vascular disorders
Hypertension	0	1 [1]

N, number of subjects; n, number of episodes