Table 3.

Summary of drug-related adverse events.

Drug-related AEs occurring in > 10% of patients, N (%)	Age group					Total (n = 65)
		<1 year (n = 11)	1 to < 2 years (n = 11)	2 to < 4 years (n= 23)	4 to < 7 years (n = 20)
Upper respiratory tract infection		3 (27.3%)	2 (18.2%)	3 (13.0%)	4 (20.0%)	12 (18.5%)
Abdominal pain		2 (18.2%)	0	6 (26.1%)	2 (10.0%)	10 (15.4%)
Vomiting		2 (18.2%)	3 (27.3%)	4 (17.4%)	1 (5.0%)	10 (15.4%)
Diarrhea		1 (9.1%)	1 (9.1%)	4 (17.4%)	2 (10.0%)	8 (12.3%)
Drug-related SAEs, N (%)	Age group					Total (n = 65)
	<1 year (n = 11)	1 to < 2 years(n= 11)		2 to < 4 years (n = 23)	4 to < 7 years (n = 20)
Colitis ulcerative	0	0		0	1 (5.0%)	1 (1.5%)
Diarrhea	0	0		0	1 (5.0%)	1 (1.5%)
Convulsion	0	0		1 (4.3%)	0	1 (1.5%)

AE: adverse event; N: number of patients; SAE: serious adverse events.