TABLE 2.

Summary of treatment emergent adverse events (TEAEs)

MedDRA SYSTEM ORGAN CLASS	TOTAL (n=105)
	Not related to treatment n (%)	Related to treatment n (%)
Patients with at least one TEAE	17(16.2)	4 (3.8)
Nervous system disorders	3 (2.9)	3 (2.9)
Headache	3 (2.9)	4 (3.8)
Infections and infestations	3 (2.9)	0 (0.0)
Respiratory, thoracic and mediastinal disorders	3 (2.9)	0 (0.0)
Respiratory disorder	3 (2.9)	0 (0.0)
Blood and lymphatic system disorders	2(1.9)	0 (0.0)
Skin and subcutaneous tissue disorders	2(1.9)	0 (0.0)

TEAE=treatment emergent adverse events. TEAEs are defined as AEs with onset or worsening during or after treatment. Incidence ≥1 % of system organ class