Table IV.

Local reactions (AT population)

Local reaction	Children	Adolescents	Adults
	2–11 years	12–15 years	16–64 years
	N = 18	N = 5	N = 28
	Ni = 678	Ni = 199	Ni = 954
Total, no. of AEs (rate per infusion)
	27 (0.040)	7 (0.035)	76 (0.080)
Mild local reactions, no. of AEs (rate per infusion)
Total	26 (0.038)	3 (0.015)	67 (0.070)
Moderate local reactions, no. of AEs (rate per infusion)
Total	1 (0.001)	3 (0.015)	9 (0.009)
Infusion site nodule	1 (0.001)	0	0
Infusion site pruritus	0	2 (0.010)	0
Infusion site swelling	0	1 (0.005)	1 (0.001)
Infusion site inflammation	0	0	1 (0.001)
Infusion site pain	0	0	2 (0.002)
Infusion site reaction	0	0	3 (0.003)
Infusion-related reaction	0	0	2 (0.002)
Severe local reactions, no. of AEs (rate per infusion)
Total	0	1 (0.005)	0
Infusion site pruritus	0	1 (0.005)	0

AT all treated, N number of patients in age group, N_i number of infusions, AEs adverse events