Table 4.

Treatment-emergent adverse events and treatment-related adverse events leading to discontinuation

Adverse events leading to discontinuation	Adult patients (n = 166)		Pediatric patients (n = 200)
	TEAEs	TRAEs	TEAEs	TRAEs
	13 (7.8)	5 (3.0)	7 (3.5)	4 (2.0)
General disorders and administration site conditions	1 (0.6)		0 (0.0)
Malaise	1 (0.6)		0 (0.0)
Psychiatric disorders	1 (0.6)		0 (0.0)
Sleep disorder	1 (0.6)		0 (0.0)
Skin and subcutaneous tissue disorders	10 (6.0)	5 (3.0)	7 (3.5)	4 (2.0)
Pruritus	2 (1.2)	1 (0.6)	0 (0.0)	0 (0.0)
Dermatitis atopic	3 (1.8)	1 (0.6)	5 (2.5)	2 (1.0)
Pruritus allergic	0 (0.0)	0 (0.0)	1 (0.5)	1 (0.5)
Post-inflammatory pigmentation change	1 (0.6)	0 (0.0)	0 (0.0)	0 (0.0)
Erythema	1 (0.6)	1 (0.6)	0 (0.0)	0 (0.0)
Dermatitis contact	2 (1.2)	1 (0.6)	1 (0.5)	1 (0.5)
Skin burning sensation	1 (0.6)	1 (0.6)	0 (0.0)	0 (0.0)
Neoplasms benign, malignant, and unspecified (including cysts and polyps)	1 (0.6)		0 (0.0)
Diffuse large B-cell lymphoma	1 (0.6)		0 (0.0)

Data are number of patients (%) unless otherwise indicated. TEAEs and TRAEs were coded to preferred terms according to the Medical

Dictionary for Regulatory Activities (MedDRA) version 22.1

TEAEs treatment-emergent adverse events, TRAEs treatment-related adverse events