Table 3.

Adverse events related to the canfosfamide and pegylated liposomal doxorubicin combination (NCI-CTC v2.0) (N = 39)

	Grade 1 n (%)	Grade 2 n (%)	Grade 3 n (%)	Grade 4 n (%)
Hematologic (All Patients)
Anemia	9 (23.1)	21 (53.8)	5 (12.8)	1 (2.6)
Leucopenia	3 (7.7)	13 (33.3)	15 (38.5)	2 (5.1)
Neutropenia	0 (0.0)	8 (20.5)	12 (30.8)	11 (28.2)
Thrombocytopenia	10 (25.6)	5 (12.8)	10 (25.6)	0 (0.0)
Leukocytosis	8 (20.5)	0 (0.0)	0 (0.0)	0 (0.0)
Febrile Neutropenia	0 (0.0)	0 (0.0)	2 (5.1)	0 (0.0)
Non-hematologic (≥ 5% of patients)
Nausea	9 (23.1)	20 (51.3)	6 (15.4)	0 (0.0)
Fatigue	1 (2.6)	11 (28.2)	20 (51.3)	1 (2.6)
Vomiting	10 (25.6)	8 (20.5)	4 (10.3)	0 (0.0)
Rash	8 (20.5)	12 (30.8)	3 (7.7)	0 (0.0)
Diarrhea	1 (2.6)	6 (15.4)	3 (7.7)	0 (0.0)
Drug Hypersensitivity	1 (2.6)	1 (2.6)	1 (2.6)	0 (0.0)
Infusion Site Pain	4 (10.3)	0 (0.0)	0 (0.0)	0 (0.0)
Pyrexia	2 (5.1)	2 (5.1)	0 (0.0)	0 (0.0)
Dysuria**	1 (2.6)	1 (2.6)	0 (0.0)	0 (0.0)
Stomatitis*	4 (10.3)	16 (41.0)	1 (2.6)	0 (0.0)
PPE Syndrome*	3 (7.7)	10 (25.6)	6 (15.4)	0 (0.0)
Mucosal Inflammation*	8 (20.5)	11 (28.2)	0 (0.0)	0 (0.0)
Alopecia*	16 (41.0)	1 (2.6)	0 (0.0)	0 (0.0)
Neuropathy*	3 (7.7)	2 (5.1)	2 (5.1)	0 (0.0)
Pain in Extremity*	2 (5.1)	3 (7.7)	3 (7.7)	0 (0.0)
Erythema*	5 (12.8)	2 (5.1)	0 (0.0)	0 (0.0)
Dry Skin*	2 (5.1)	2 (5.1)	0 (0.0)	0 (0.0)
Pruritus*	3 (7.7)	0 (0.0)	0 (0.0)	0 (0.0)
Gingivitis*	1 (2.6)	1 (2.6)	0 (0.0)	0 (0.0)
Dermatitis*	0 (0.0)	1 (2.6)	1 (2.6)	0 (0.0)
Pigmentation Disorder*	1 (2.6)	1 (2.6)	0 (0.0)	0 (0.0)
Flushing*	2 (5.1)	0 (0.0)	0 (0.0)	0 (0.0)

*Related to pegylated liposomal doxorubicin only

**Related to canfosfamide only