Table 2. Summary of Treatment-Related AEs Occurring in at Least 5% of Treated Patients (Vemurafenib; n = 371).

AE by Preferred Term	All Grades	Grade 2	Grade 3	Grade 4
Total patients with ≥1 AE, n (%)	308 (83)	155 (42)	76 (21)	6 (2)
Total no. of AEs	1353	310	126	7*
Rash (all forms)*	137 (37)	45 (12)	12 (3)	0
Arthralgia	129 (35)	31 (8)	17 (5)	0
Photosensitivity reaction†	98 (26)	19 (5)	2 (<1)	0
Fatigue ‡	74 (20)	23 (6)	2 (<1)	0
Nausea	37 (10)	3 (<1)	2 (<1)	0
Alopecia	32 (9)	1 (<1)	0	0
Myalgia	28 (8)	5 (1)	3 (<1)	0
Diarrhea	26 (7)	3 (<1)	2 (<1)	0
Pyrexia	25 (7)	9 (2)	0	0
Dry skin	24 (7)	3 (<1)	0	0
Hyperkeratosis	24 (7)	5 (1)	0	0
Peripheral edema	23 (6)	5 (1)	2 (<1)	0
Squamous cell carcinoma of the skin	22 (6)	3 (<1)	10 (3)	0
Palmar-plantar erythrodysesthesia syndrome	22 (6)	5 (1)	5 (1)	0
Decreased appetite	21 (6)	4 (1)	0	0

^*Grade 4 treatment-related AEs (each in 1 patient): respiratory failure, neutropenia, hyperbilirubinemia, increased blood creatine phosphokinase, prolonged ECG QT, decreased neutrophil count, confusional state.

^*Includes dermatitis, dermatitis bullous, erythema, folliculitis, generalized erythema, rash, rash erythematosus, rash follicular, rash generalized, rash macular, rash maculopapular, rash maculovesicular, rash morbilliform, rash papular, rash papulosquamous, rash pruritic, rash pustule, and rash vesicular.

^†Includes photosensitivity reaction and sunburn.

^‡Includes asthenia, fatigue, lethargy, listless, malaise, and sluggishness.