Table 2.

Toxicity Related to Pazopanib Therapy

Toxicity Type	No. of Patients
	Maximum Grade Observed per Patient During Cycle 1				Maximum Grade Observed per Patient Across All Subsequent Cycles
	Grade 1	Grade 2	Grade 3	Grade 4	Grade 1	Grade 2	Grade 3	Grade 4
Tablet formulation (parts 1 and 2b)*
GI/metabolic†
Diarrhea	12	4			7	2 (1‡)
Nausea	9	2			6	1
Vomiting	9	3			5	2
Abdominal pain	2	2			1	2
Anorexia	2	2			1		1‡
ALT increased	8	1			4	1‡	1‡
AST increased	8				7	1
Serum amylase increased	3	1	1‡		1	3
Lipase increased	1	2		1‡	1	1	1‡
Hyperglycemia	4				7	1
Hypophosphatemia	2	1	1		2	4
Constitutional†
Fatigue	9	4			3	2
Headache	6	5			1	3
Dizziness	6
Back/tumor pain	2	1	1‡				2‡
Rash maculopapular/hand-foot	1	3			1	1	1‡
Hematologic§
Thrombocytopenia	8	1			11
Absolute lymphocyte count	5		1		5	7
Absolute neutrophil count	3	5	1		3	6	4	1‡
Anemia	1	1			6	1	2 (1‡)
MTKI class targeted†
Proteinuria	5	2	1‡		8	1
Hypertension	3	6	2‡		3	5
Left ventricular systolic dysfunction	3	1			4	2
Sinus bradycardia	4				3
Hypothyroidism	4	1			5	3
Suspension formulation (part 2a)†
GI/metabolic†
Diarrhea	4				2
Nausea	3	1			2
Vomiting	3	1
Abdominal pain	2
ALT increased	3		2‡		2	1
AST increased	2	1			2
Constitutional†
Fatigue	2	1			1
Headache	2				1	1
Hematologic§
Thrombocytopenia	3
Absolute lymphocyte count	2		2		1
Absolute neutrophil count	2	1	1		1
Anemia	1				1	1
MTKI class targeted†
Proteinuria	4				2

Abbreviation: MTKI, multitargeted tyrosine kinase receptor inhibitor.

^*Cycle 1, n = 33 cycles; cycles 2 to 23, n = 148 cycles.

^†Nonhematologic toxicities related to protocol therapy that occurred in more than 10% of patients as determined in the first cycle of protocol therapy.

^‡Dose-limiting toxicity.

^§Hematologic toxicities independent of frequency and attribution.

^†Cycle 1, n = 15 cycles; cycles 2 to 8, n = 22 cycles.