16 / 36
AEs Leading to Dose
Reduction or Interruption
16
• The majority of patients in the dabrafenib plus trametinib arm had ≥ 1 dose interruption, and dose
interruption was the most common intervention for pyrexia events
AEs, n (%)
Dabrafenib + Trametinib
n = 435
Placebo
n = 432
Any AE leading to dose reduction
167 (38)
11 (3)
Pyrexia
81 (19)
1 (< 1)
Chills
17 (4)
0
Fatigue
13 (3)
1 (< 1)
Ejection fraction decrease
11 (3)
3 (< 1)
Any AE leading to dose interruption
289 (66)
65 (15)
Pyrexia
194 (45)
14 (3)
Chills
65 (15)
0
Fatigue
27 (6)
1 (< 1)
Headache
25 (6)
4 (< 1)
Vomiting
23 (5)
5 (1)
Nausea
22 (5)
4 (< 1)
Influenza-like illness
20 (5)
1 (< 1)
Atkinson V, et al. ESMO 2018