Adyuvancia en melanoma: terapia dirigida con Dabra + Trame en pacientes BRAF con mutación V600

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Common AEs (≥ 15% of patients)
Atkinson V, et al. ESMO 2018
• The most common AE reported in patients who received dabrafenib plus trametinib was pyrexia (63%)
• Of patients with pyrexia, 28% had one occurrence, 20% had 2 occurrences, and 52% had 3 or more
occurrences
AEs, n (%)
Dabrafenib + Trametinib
n = 435
Placebo
n = 432
Any Grade Grade 3/4 Any Grade Grade 3/4
Any AEa 422 (97) 180 (41) 380 (88) 61 (14)
Pyrexia 273 (63) 23 (5) 47 (11) 2 (< 1)
Fatigue 204 (47) 19 (4) 122 (28) 1 (< 1)
Nausea 172 (40) 4 (1) 88 (20) 0
Headache 170 (39) 6 (1) 102 (24) 0
Chills 161 (37) 6 (1) 19 (4) 0
Diarrhea 144 (33) 4 (1) 65 (15) 1 (< 1)
Vomiting 122 (28) 4 (1) 43 (10) 0
Arthralgia 120 (28) 4 (1) 61 (14) 0
a All cause.
AE, adverse event.