Table 4.

Adverse events occurring in at least 10% of patients (any grade) or 5% of patients (grade 3/4) by preferred term.

Adverse event, n (%)	TGA (1,000 mg) n=15		TGB (2,000 mg) n=22		Total N=37
	All grade	Grade 3/4	All grade	Grade 3/4	All grade	Grade 3/4
Urticaria	4 (27)	0	9 (41)	0	13 (35)	0
Pruritus	8 (53)	0	11 (50)	0	19 (51)	0
Throat irritation	7 (47)	0	3 (14)	0	10 (27)	0
Flushing	6 (40)	0	4 (18)	0	10 (27)	0
Rash	6 (40)	1 (7)	3 (14)	0	9 (24)	1 (3)
Pyrexia	3 (20)	0	6 (27)	1 (5)	9 (24)	1 (3)
Upper respiratory tract infection	7 (47)	0	2 (9)	0	9 (24)	0
Headache	5 (33)	1 (7)	4 (18)	0	9 (24)	1 (3)
Fatigue	4 (27)	0	4 (18)	1 (5)	8 (22)	1 (3)
Oropharyngeal pain	2 (13)	0	5 (23)	0	7 (19)	0
Insomnia	2 (13)	0	4 (18)	0	6 (16)	0
Cough	4 (27)	0	2 (9)	0	6 (16)	0
Epistaxis	3 (20)	1 (7)	3 (14)	0	6 (16)	1 (3)
Nasal congestion	3 (20)	0	3 (14)	0	6 (16)	0
Chills	1 (7)	0	5 (23)	0	6 (16)	0
Abdominal pain	3 (20)	0	2 (9)	0	5 (14)	0
Diarrhoea	2 (13)	0	3 (14)	0	5 (14)	0
Sinusitis	2 (13)	0	3 (14)	0	5 (14)	0
Decreased appetite	3 (20)	0	2 (9)	0	5 (14)	0
Muscle spasms	4 (27)	0	1 (5)	0	5 (14)	0
Myalgia	1 (7)	0	4 (18)	0	5 (14)	0
Infusion-related reactions*	2 (13)	0	3 (14)	0	5 (14)	0
Constipation	2 (13)	0	2 (9)	0	4 (11)	0
Urinary tract infection	3 (20)	0	1 (5)	1 (5)	4 (11)	1 (3)
Paraesthesia	1 (7)	0	3 (14)	0	4 (11)	0
Hyperglycaemia	1 (7)	0	3 (14)	0	4 (11)	0
Arthralgia	1 (7)	0	3 (14)	0	4 (11)	0
Haemolysis	1 (7)	1 (7)	1 (5)	1 (5)	2 (5)	2 (5)
Neutropenia	1 (7)	1 (7)	1 (5)	1 (5)	2 (5)	2 (5)
Chest pain	1 (7)	1 (7)	3 (14)	1 (5)	4 (11)	2 (5)

Data are n (%) as reported by investigator.

^*Reported as preferred term and does not reflect the study defined criteria for infusion-related reactions.

TGA=Treatment Group A. TGB=Treatment Group B.