TABLE 6.

Most common adverse events (experienced by more than 15% of patients) in the as-treated population

Characteristic	Dose group
	0.35 mg/kg b.d.	3 mg/kg o.d.	1.5 mg/kg b.d.	4 mg/kg b.d.	100 mg o.d.
No. of patients	7	11	12	11	12
No. (%) of patients with the following adverse events:
Malaise and fatigue	2 (29)	3 (27)	4 (33)	3 (27)	3 (25)
ENTa infections	2 (29)	1 (9)	4 (33)	0	2 (17)
Cough	0	2 (18)	2 (17)	3 (27)	1 (8)
Headache	1 (14)	0	3 (25)	0	2 (17)
Temp regulation disturbance	0	2 (18)	1 (8)	3 (27)	0
Nausea and vomiting	0	0	3 (25)	1 (9)	1 (8)
Viral ENT infections	1 (14)	0	1 (8)	2 (18)	1 (8)
Ear signs and symptoms	0	0	3 (25)	1 (9)	0
Pharyngitis	1 (14)	0	0	2 (18)	0
Gastroenteritis	1 (14)	0	2 (17)	0	0