Table 2.

AEs occurring in >30% of patients in any treatment arma

D+P (n = 20)T+P (n = 51)bD+T+P (n = 91)
AE, n (%)TotalGrade 3/4TotalGrade 3/4TotalGrade 3/4
Any event20 (100)9 (45)50 (98)34 (67)91 (100)64 (70)
Diarrhea9 (45)037 (73)1 (2)59 (65)6 (7)
Dermatitis acneiform12 (60)027 (53)9 (18)54 (59)9 (10)
Nausea10 (50)018 (35)1 (2)51 (56)2 (2)
Dry skin7 (35)1 (5)17 (33)3 (6)49 (54)2 (2)
Fatigue10 (50)013 (25)045 (49)6 (7)
Pyrexia7 (35)020 (39)044 (48)4 (4)
Vomiting6 (30)015 (29)1 (2)39 (43)2 (2)
Decreased appetite5 (25)012 (24)036 (40)2 (2)
Rash3 (15)016 (31)3 (6)28 (31)10 (11)
Hypomagnesemia8 (40)1 (5)12 (24)2 (4)26 (29)1 (1)
Constipation7 (35)1 (5)7 (14)017 (19)1 (1)
  • aSafety data were based on the most recent interim analyses (data cutoff May 6, 2016). The median follow-up time (defined as time in months from study start to last contact or death) for patients treated with D+P was 10.6 months (2.1–22 months), for patients treated with D+T+P was 6.2 months (1.5–47.2 months), and for patients with a BRAFV600E mutation treated with T+P was 6.4 months (0.4–18.6 months).

  • bSafety data for the T+P arm are for all patients, including those with BRAF wild-type (n = 20) and BRAFV600E (n = 31).