Table 2.

Patients with AEs that occurred in ≥10% (possibly related or related) including combined rash events and combined ocular events

	<300 mg b.i.d. (n = 5)		300 mg b.i.d. (n = 4)		600 mg (n = 115)		>600 mg b.i.d. (n = 11)
Adverse event, n (%)	Grade 1/2	Grade 3	Grade 1/2	Grade 3	Grade 1/2	Grade 3	Grade 1/2	Grade 3	Total (N = 135)
Combined rash^a	3 (60)	0 (0)	3 (75)	0 (0)	65 (56)	22 (19)	8 (72)	1 (9)	102 (76)
Diarrhea	5 (100)	0 (0)	1 (25)	0 (0)	44 (38)	7 (6)	5 (45)	3 (27)	65 (48)
Fatigue	3 (60)	0 (0)	1 (25)	0 (0)	43 (37)	3 (3)	5 (45)	2 (18)	57 (42)
Nausea	3 (60)	0 (0)	2 (50)	0 (0)	44 (38)	2 (2)	6 (54)	0 (0)	57 (42)
Decreased appetite	0 (0)	0 (0)	0 (0)	0 (0)	28 (24)	0 (0)	6 (54)	0 (0)	34 (25)
Pruritus	0 (0)	0 (0)	1 (25)	0 (0)	27 (23)	1 (<1)	4 (36)	0 (0)	33 (24)
Vomiting	0 (0)	0 (0)	2 (50)	0 (0)	18 (16)	1 (<1)	4 (36)	1 (9)	26 (19)
Combined ocular events^b	1 (20)	0 (0)	0 (0)	0 (0)	14 (12)	1 (<1)	2 (18)	0 (0)	18 (13)
Edema peripheral	1 (20)	0 (0)	0 (0)	0 (0)	12 (10)	1 (<1)	1 (9)	0 (0)	15 (11)
Anemia	0 (0)	1 (20)	0 (0)	0 (0)	6 (5)	5 (4)	0 (0)	3 (27)	15 (11)
Dehydration	0 (0)	0 (0)	0 (0)	0 (0)	9 (8)	1 (<1)	1 (9)	2 (18)	13 (10)
Alopecia	1 (20)	0 (0)	0 (0)	0 (0)	10 (9)	0 (0)	2 (18)	0 (0)	13 (10)

Abbreviation: b.i.d., twice daily.
↵^a“Combined rash” includes preferred terms of dermatitis acneiform (42), acne (1), skin exfoliation (2), and any term containing rash (81).
↵^b“Combined ocular events” includes preferred terms of halo vision (1), photophobia (2), retinal detachment (1), retinal vein occlusion (1), retinopathy (1), vision blurred (6), visual impairment (10), and vitreous floaters (1). Note that retinal vein occlusion event (grade 3) occurred after >10 months on study and resolved with drug cessation.