Table 3:

Patients experiencing non-hematologic toxicities during cycle 1 of therapy

Toxicity	Dose level	1			2a		2b		3				4
	CTCAE toxicity grade	2	3	4	3	4	3	4	2	3	4	5	3	4
Gastrointestinal
	Nausea/Vomiting												1 (11%)
	Dental caries												1 (11%)
	ALT increase						1 (33%)						1 (11%)
	AST increase												1 (11%)
	Rectal hemorrhage									1 (9%)
Infections and infestations
	Febrile Neutropenia		4 (57%)		2 (40%)		3 (100%)			6 (55%)			7 (78%)
	Colitis or typhlitis						1 (33%)			2 (18%)			2 (22%)
	Lung or sinus infection				1 (20%)		1 (33%)						2 (22%)
	Mucosal	1 (14%)							3 (27%)
	Infections: other		2 (29%)				1 (33%)			3 (27%)			2 (22%)
	Sepsis											1 (9%)		1 (11%)
	Multi-organ failure											1 (9%)
Metabolism and nutrition
	Hyperglycemia									1 (9%)
	Hyperkalemia									1 (9%)
	Anorexia\ weight loss		1 (14%)										1 (11%)
	Hypokalemia									1 (9%)
	Tumor lysis syndrome									1 (9%)
Respiratory
	Respiratory failure										1 (9%)
	Pulmonary edema												1 (11%)
	Pulmonary hypertension												1 (11%)
Cardiac
	Hypotension												1 (11%)
	Hypertension												1 (11%)
	Cardiac arrest										1 (9%)
	Sinus tachycardia									1 (9%)
Other
	Acute kidney injury									1 (9%)
	Allergic reaction		1 (14%)
	DIC									1 (9%)
	Syncope									1 (9%)

CTCAE: Common terminology criteria for adverse events version 4.03; ARDS: adult respiratory distress syndrome; DIC: disseminated intravascular coagulopathy. Listed toxicities include both those attributable to therapy and those deemed not attributable to therapy. The table includes all non-hematologic grade 3 or higher events and clinically significant grade 2 events occurring in at least 10% of the population. Grade 1 events were not recorded within the research database.