Table 3.

AEs with ≥5% increase in frequency over time in any subgroup, regardless of attribution to study drugs

	BRAF inhibitor-naive cohort n = 63				Vemurafenib monotherapy–PD cohort n = 66
	Any Grade n (%)	Grade ≥3 n (%)	% change from previous data		Any Grade n (%)	Grade ≥3 n (%)	% change from previous data
			Any Grade	Grade ≥3			Any Grade	Grade ≥3
Photosensitivitya	44 (70)	1 (2)	+22%	+1%	12 (18)	1 (2)	+3%	0%
Vomiting	30 (48)	0	+5%	0%	14 (21)	1 (2)	+1%	0%
CPK level elevation	30 (48)	2 (3)	+5%	0%	10 (15)	1 (2)	0%	0%
Anemia	23 (37)	7 (11)	+5%	+3%	11 (17)	5 (8)	+2%	+2%
Myalgia	20 (32)	1 (2)	+9%	0%	4 (6)	0	0%	0%
Actinic keratosis	19 (30)	0	+20%	0%	3 (5)	0	+2%	0%
Hypokalemia	16 (25)	3 (5)	+9%	0%	4 (6)	0	0%	0%
Seborrheic keratosis	15 (24)	1 (2)	+7%	0%	1 (2)	0	0%	0%
Skin papilloma	15 (24)	0	+5%	0%	0	0	0%	0%
Constipation	13 (21)	0	+5%	0%	10 (15)	1 (2)	+1%	0%
Hypophosphatemia	13 (21)	6 (10)	+7%	+4%	3 (5)	3 (5)	0%	+2%

Abbreviations: AE, adverse event; CPK, creatine phosphokinase; PD, progressive disease.

AEs with an increase of ≥5% from the previous analysis [3] in either cohort are reported; CPK.

^aGrouped terms.