Table 3.

Adverse events of any cause (by preferred term) reported in >3% of patients in overall population and across age groups.

Adverse events	Overall N = 179		Age at consent, years
			≤2		>2 to ≤9		>9 to <18		≥18
			(N = 7)		(N = 27)		(N = 27)		(N = 118)
	All	Grade 3/4	All	Grade 3/4	All	Grade 3/4	All	Grade 3/4	All	Grade 3/4
	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)
Stomatitis	14 (7.8)	1 (0.6)	1 (14.3)	0	3 (11.1)	1 (3.7)	5 (18.5)	0	5 (4.2)	0
Headache	13 (7.3)	0	0	0	0	0	3 (11.1)	0	10 (8.5)	0
Diarrhoea	12 (6.7)	1 (0.6)	1 (14.3)	0	3 (11.1)	0	1 (3.7)	0	7 (5.9)	1 (0.8)
Vitamin D deficiency	12 (6.7)	0	0	0	0	0	0	0	12 (10.2)	0
Aphthous ulcer	10 (5.6)	0	0	0	2 (7.4)	0	1 (3.7)	0	7 (5.9)	0
Hypercholesterolaemia	10 (5.6)	0	2 (28.6)	0	3 (11.1)	0	2 (7.4)	0	3 (2.5)	0
Urinary tract infection	10 (5.6)	1 (0.6)	1 (14.3)	1 (14.3)	0	0	1 (3.7)	0	8 (6.8)	0
Pyrexia	9 (5.0)	0	3 (42.9)	0	3 (11.1)	0	2 (7.4)	0	1 (0.8)	0
Hypertension	8 (4.5)	2 (1.1)	0	0	0	0	1 (3.7)	0	7 (5.9)	2 (1.7)
Pneumonia	8 (4.5)	5 (2.8)	2 (28.6)	1 (14.3)	2 (7.4)	2 (7.4)	1 (3.7)	0	3 (2.5)	2 (1.7)
Viral upper respiratory tract infection	8 (4.5)	0	0	0	1 (3.7)	0	1 (3.7)	0	6 (5.1)	0
Abdominal pain	7 (3.9)	1 (0.6)	0	0	2 (7.4)	1 (3.7)	0	0	5 (4.2)	0
Anaemia	7 (3.9)	1 (0.6)	0	0	1 (3.7)	0	1 (3.7)	0	5 (4.2)	1 (0.8)
Bronchitis	7 (3.9)	0	2 (28.6)	0	3 (11.1)	0	1 (3.7)	0	1 (0.8)	0
Oedema peripheral	7 (3.9)	0	0	0	1 (3.7)	0	0	0	6 (5.1)	0
Epilepsy	6 (3.4)	2 (1.1)	1 (14.3)	1 (14.3)	1 (3.7)	0	1 (3.7)	0	3 (2.5)	1 (0.8)
Hypertriglyceridaemia	6 (3.4)	2 (1.1)	0	0	0	0	4 (14.8)	2 (7.4)	2 (1.7)	0
Influenza	6 (3.4)	3 (1.7)	1 (14.3)	1 (14.3)	1 (3.7)	0	0	0	4 (3.4)	2 (1.7)
Vomiting	6 (3.4)	1 (0.6)	1 (14.3)	0	3 (11.1)	1 (3.7)	0	0	2 (1.7)	0