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 1/2Grade 3Grade 1/2Grade 3Grade 1/2Grade 3Grade 1/2Grade 3Total (N = 135)
Combined rasha3 (60)0 (0)3 (75)0 (0)65 (56)22 (19)8 (72)1 (9)102 (76)
Diarrhea5 (100)0 (0)1 (25)0 (0)44 (38)7 (6)5 (45)3 (27)65 (48)
Fatigue3 (60)0 (0)1 (25)0 (0)43 (37)3 (3)5 (45)2 (18)57 (42)
Nausea3 (60)0 (0)2 (50)0 (0)44 (38)2 (2)6 (54)0 (0)57 (42)
Decreased appetite0 (0)0 (0)0 (0)0 (0)28 (24)0 (0)6 (54)0 (0)34 (25)
Pruritus0 (0)0 (0)1 (25)0 (0)27 (23)1 (<1)4 (36)0 (0)33 (24)
Vomiting0 (0)0 (0)2 (50)0 (0)18 (16)1 (<1)4 (36)1 (9)26 (19)
Combined ocular eventsb1 (20)0 (0)0 (0)0 (0)14 (12)1 (<1)2 (18)0 (0)18 (13)
Edema peripheral1 (20)0 (0)0 (0)0 (0)12 (10)1 (<1)1 (9)0 (0)15 (11)
Anemia0 (0)1 (20)0 (0)0 (0)6 (5)5 (4)0 (0)3 (27)15 (11)
Dehydration0 (0)0 (0)0 (0)0 (0)9 (8)1 (<1)1 (9)2 (18)13 (10)
Alopecia1 (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.