Table 2.

Study drug–related (possibly/probably, as deemed by investigator) treatment-emergent adverse events (TEAEs) by CTCAE grade/severity in the safety population, in descending order of total frequency. (Includes all TEAEs for which the total of all grades of the particular TEAE exceeded 20%.)

MedDRA SOC CTCAE Gradea/Severity (2)	Melanoma Expansion Cohortb 10.0 mg bid (n=26) n (%)	Entire Study Population (N=77) n (%)
Any AE
Total	26 (100.0)	68 (88.3)
1	0	6 (7.8)
2	10 (38.5)	30 (39.0)
3	13 (50.0)	28 (36.4)
4	3 (11.5)	4 (5.2)
3+4	16 (61.5)	32 (41.6)
Hypertension
Total	16 (61.5)	33 (42.9)
1	1 (3.8)	2 (2.6)
2	9 (34.6)	18 (23.4)
3	6 (23.1)	13 (16.9)
4	0	0
3+4	6 (23.1)	13 (16.9)
Fatigue
Total	13 (50.0)	32 (41.6)
1	3 (11.5)	10 (13.0)
2	7 (26.9)	17 (22.1)
3	3 (11.5)	5 (6.5)
4	0	0
3+4	3 (11.5)	5 (6.5)
Proteinuria
Total	15 (57.7)	30 (39.0)
1	5 (19.2)	7 (9.1)
2	7 (26.9)	18 (23.4)
3	2 (7.7)	4 (5.2)
4	1 (3.8)	1 (1.3)
3+4	3 (11.5)	5 (6.5)
Nausea
Total	6 (23.1)	19 (24.7)
1	1 (3.8)	9 (11.7)
2	3 (11.5)	8 (10.4)
3	2 (7.7)	2 (2.6)
4	0	0
3+4	2 (7.7)	2 (2.6)
Weight decreased
Total	10 (38.5)	19 (24.7)
1	2 (7.7)	6 (7.8)
2	4 (15.4)	7 (9.1)
3	4 (15.4)	6 (7.8)
4	0	0
3+4	4 (15.4)	6 (7.8)
Anorexia
Total	12 (46.2)	19 (24.7)
1	3 (11.5)	8 (10.4)
2	9 (34.6)	11 (14.3)
3	0	0
4	0	0
3+4	0	0
Diarrhea
Total	8 (30.8)	17 (22.1)
1	3 (11.5)	7 (9.1)
2	2 (7.7)	6 (7.8)
3	3 (11.5)	4 (5.2)
4	0	0
3+4	3 (11.5)	4 (5.2)

^aThe grade of AE was assigned based on NCI-CTCAE criteria.

^bSubtotal of the full study population.

Abbreviations: SOC, System Order Class; MedDRA, Medical Dictionary for Regulatory Activities.