Table IV.

Subgroup analysis of adverse events by sex.

	1st LEN											2nd LEN
	Male (n=36)					Female (n=3)						Male (n=5)					Female (n=8)
	Grade, n					Grade, n						Grade, n					Grade, n
					All grades					All grades						All grades					All grades
Events	1	2	3	4	(%)	1	2	3	4	(%)	P-value	1	2	3	4	(%)	1	2	3	4	(%)	P-value
Leucopenia	4	6	1	0	11 (30.6)	1	1	0	0	2 (66.7)	0.253	0	0	0	0	0	3	1	0	0	4 (50.0)	0.105
Neutropenia	2	6	2	0	10 (27.8)	0	0	1	0	1 (33.3)	1.253	0	0	0	0	0	3	1	0	0	4 (50.0)	0.105
Platelet count decreased	16	8	1	0	25 (69.4)	1	2	0	0	3 (100)	0.545	2	0	1	0	3 (60.0)	3	3	0	0	6 (75.0)	1
Aspartate	17	1	0	0	18 (50.0)	0	0	0	0	0	0.235	4	0	1	0	5 (100)	3	0	2	0	5 (62.5)	0.231
aminotransferase/alanine
aminotransferase
increased
Blood bilirubin	9	6	2	0	17 (47.2)	1	0	0	0	1 (33.3)	1	0	1	0	0	1 (20.0)	2	2	0	0	4 (50.0)	0.565
increased
Anemia	12	2	2	0	16 (44.4)	1	1	0	0	2 (46.2)	0.586	2	1	0	0	3 (60.0)	2	2	0	0	4 (50.0)	1
Diarrhea	5	0	1	0	6 (16.7)	0	0	0	0	0	1	0	1	0	0	1 (20.0)	3	0	0	0	3 (37.5)	1
Nausea	3	2	0	0	5 (13.9)	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	1 (12.5)	1
Vomiting	2	0	0	-	2 (5.6)	0	0	0	-	0	1	0	0	0	-		0	0	0	-		1
Fatigue	11	4	0	-	15 (41.7)	0	0	1	-	1 (33.3)	1	2	1	0	-	3 (60.0)	4	1	0	-	5 (62.5)	1
Proteinuria	0	9	4	-	13 (36.1)	0	2	0	-	2 (46.2)	0.547	1	0	2	-	3 (60.0)	1	0	1	-	2 (25.0)	0.293
Anorexia	11	2	1	0	14 (38.9)	0	0	0	0	0	0.540	1	0	0	0	1 (20.0)	4	0	0	0	4 (50.0)	0.565
Edema in limbs	7	0	0	-	7 (19.4)	0	0	0	-	0	1	2	0	0	-	2 (40.0)	3	0	0	-	3 (37.5)	1
Hypertension	8	3	2	0	13 (36.1)	0	1	0	0	1 (33.3)	1	0	0	0	0	0	1	0	0	0	1 (12.5)	1
Hand-foot-syndrome	4	4	0	-	8 (22.2)	0	0	0	-	0	1	1	1	0	-	2 (40.0)	3	0	0	-	3 (37.5)	1
Hoarseness	1	0	0	-	1 (2.8)	0	0	0	-	0	1	0	0	0	-	0	0	0	0	-	0	1
Rash	1	0	0	0	1 (2.8)	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1
Musculoskeletal and connective tissue disorder	2	0	0	0	2 (5.6)	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1
Hypothyroidism	2	3	0	0	5 (13.9)	0	0	0	0	0	1	0	0	0	0	0	3	3	0	0	6 (75.0)	0.021a
Epistaxis	1	0	0	0	1 (2.8)	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1
Oral pain	2	0	0	-	2 (5.6)	0	0	0	-	0	1	0	0	0	-	0	0	0	0	-	0	1
Dizziness	1	0	0	-	1 (2.8)	0	0	0	-	0	1	0	0	0	-	0	0	0	0	-	0	1
Abdominal pain	2	0	0	-	2 (5.6)	0	0	0	-	0	1	0	0	0	-	0	0	0	0	-	0	1

Fisher's exact probability tests.

^aP<0.05. LEN, lenvatinib.