Table 2.

AEs Occurring in ≥ 10% of Cabozantinib-Treated Patients, by Maximum Severity Reported

AE	Cabozantinib (n = 214)				Placebo (n = 109)
	All Grades		Grade ≥ 3		All Grades		Grade ≥ 3
	No.	%	No.	%	No.	%	No.	%
Diarrhea	135	63.1	34	15.9	36	33.0	2	1.8
Palmar-plantar erythrodysesthesia*	107	50.0	27	12.6	2	1.8	0
Decreased weight	102	47.7	10	4.7	11	10.1	0
Decreased appetite	98	45.8	10	4.7	17	15.6	1	0.9
Nausea	92	43.0	3	1.4	23	21.1	0
Fatigue	87	40.7	20	9.3	31	28.4	3	2.8
Dysgeusia	73	34.1	1	0.5	6	5.5	0
Hair color changes	72	33.6	1	0.5	1	0.9	0
Hypertension	70	32.7	18	8.4	5	4.6	1	0.9
Stomatitis	62	29.0	4	1.9	3	2.8	0
Constipation	57	26.6	0		6	5.5	0
Hemorrhage	54	25.2	7	3.3	17	15.6	1	0.9
Vomiting	52	24.3	5	2.3	2	1.8	1	0.9
Mucosal inflammation	50	23.4	7	3.3	4	3.7	0
Asthenia	45	21.0	12	5.6	16	14.7	2	1.8
Dysphonia	43	20.1	0		10	9.2	0
Rash	41	19.2	2	0.9	11	10.1	0
Dry skin	41	19.2	0		3	2.8	0
Headache	39	18.2	1	0.5	9	8.3	0
Oropharyngeal pain	38	17.8	1	0.5	5	4.6	0
Abdominal pain	36	16.8	6	2.8	7	6.4	1	0.9
Alopecia	35	16.4	0		2	1.8	0
Pain in extremity	33	15.4	3	1.4	12	11.0	1	0.9
Back pain	32	15.0	5	2.3	12	11.0	1	0.9
Dyspnea	29	13.6	5	2.3	19	17.4	11	10.1
Arthralgia	29	13.6	2	0.9	8	7.3	0
Dizziness	29	13.6	1	0.5	8	7.3	0
Oral pain	29	13.6	1	0.5	1	0.9	0
Dry mouth	28	13.1	0		9	8.3	0
Dysphagia	27	12.6	9	4.2	7	6.4	1	0.9
Cough	26	12.1	1	0.5	14	12.8	0
Muscle spasms	26	12.1	1	0.5	5	4.6	0
Dyspepsia	24	11.2	0		0		0
Insomnia	23	10.7	0		7	6.4	0
Erythema	23	10.7	2	0.9	2	1.8	0
Glossodynia	22	10.3	3	1.4	0		0

NOTE. Laboratory abnormalities are not included.

Abbreviation: AE, adverse event.

^*Hand-foot syndrome.