Table 3.

AEs Occurring in > 15% of Patients in Part C and Events of Special Interest

AE	Part B: Dabrafenib Plus Trametinib (n = 26)				Part C: Cross-Over to Dabrafenib and Trametinib (n = 45)
	All Grades		Grade 3 or 4*		All Grades		Grade 3 or 4†
	No.	%	No.	%	No.	%	No.	%
Any event	26	100	16	61	45	100	20	44
Pyrexia	15	58	0	0	16	36	1	2
Nausea	10	38	0	0	13	29	1	2
Vomiting	9	35	0	0	13	29	1	2
Fatigue	9	35	1	4	11	24	1	2
Arthralgia	2	8	0	0	11	24	0	0
Diarrhea	7	27	0	0	11	24	0	0
Anemia	3	12	1	4	9	20	1	2
Chills	6	23	0	0	9	20	0	0
Back pain	1	4	0	0	8	18	2	4
Constipation	8	31	0	0	8	18	1	2
Headache	6	23	0	0	8	18	0	0
Rash	4	15	0	0	8	18	0	0
Peripheral edema	3	12	0	0	8	18	0	0
Urinary tract infection	5	19	0	0	7	16	1	2
Decreased appetite	4	15	0	0	7	16	0	0
Dizziness	4	15	0	0	7	16	0	0
Cutaneous SCC	1	4	1	4	4	9	4	9
Skin papilloma	0	0	0	0	0	0	0	0
Hyperkeratosis	3	12	0	0	0	0	0	0
Hypertension	1	4	0	0	4	9	3	7
Hypotension	7	27	3	12	0	0	0	0
Decreased ejection fraction	0	0	0	0	6	13	1	2
Chorioretinopathy	0	0	0	0	0	0	0	0
Blurred vision	4	15	0	0	1	2	0	0

NOTE. Includes treatment- and non–treatment-related AEs.

Abbreviations: AE, adverse event; SCC, squamous cell carcinoma.

^*One patient in part B experienced fatal hyponatremia.

^†One patient in part C experienced fatal neurologic decompensation.