Table 2.

The most common adverse events observed in at least two patients at 50 mg/m²

	Dose level (mg/m2), N (%)
	15.5 (N = 3)		25 (N = 3)		35 (N = 3)		50 (N = 6)
	All grades	Grades 3 and 4	All grades	Grades 3 and 4	All grades	Grades 3 and 4	All grades	Grades 3 and 4
Patients with any AE	3 (100 %)	0	3 (100 %)	0	3 (100 %)	0	6 (100 %)	3 (50.0 %)
Patients with any related AE	3 (100 %)	0	2 (66.7 %)	0	3 (100 %)	0	6 (100 %)	2 (33.3 %)
Patients with any serious AE	0	0	0	0	0	0	0	0
AE (PT: alphabetical order)
Blood bilirubin increased	0	0	0	0	0	0	2 (33.3 %)	0
Chills	0	0	0	0	0	0	2 (33.3 %)	0
Conjunctival hyperemia	0	0	0	0	0	0	3 (50.0 %)	0
Constipation	1 (33.3 %)	0	1 (33.3 %)	0	0	0	1 (16.7 %)	0
Decreased appetite	2 (66.7 %)	0	1 (33.3 %)	0	1 (33.3 %)	0	3 (50.0 %)	0
Diarrhea	1 (33.3 %)	0	0	0	1 (33.3 %)	0	5 (83.3 %)	1 (16.7 %)
Fatigue	1 (33.3 %)	0	1 (33.3 %)	0	1 (33.3 %)	0	3 (50.0 %)	0
Headache	0	0	0	0	1 (33.3 %)	0	3 (50.0 %)	0
Hot flush	0	0	0	0	1 (33.3 %)	0	3 (50.0 %)	0
Hypertension	1 (33.3 %)	0	0	0	1 (33.3 %)	0	4 (66.7 %)	0
Injection site phlebitis	0	0	0	0	1 (33.3 %)	0	2 (33.3 %)	0
Nasopharyngitis	1 (33.3 %)	0	2 (66.7 %)	0	0	0	1 (16.7 %)	0
Nausea	2 (66.7 %)	0	0	0	2 (66.7 %)	0	5 (83.3 %)	0
Pyrexia	1 (33.3 %)	0	0	0	0	0	2 (33.3 %)	0
Sinus bradycardia	0	0	0	0	0	0	3 (50.0 %)	0
Ventricular extrasystoles	0	0	0	0	2 (66.7 %)	0	1 (16.7 %)	0
Vomiting	2 (66.7 %)	0	0	0	1 (33.3 %)	0	3 (50.0 %)	0

AE is defined as an adverse event that is reported during the on-treatment period (from the first dose to 30 days after the last dose)

PT preferred term (MedDRA 14.0 and graded using NCI CTC version 3.0)