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. 2021 May 4;26(9):731–e1498. doi: 10.1002/onco.13795
Cycle 1
Name NC/NA, % Grade 1, % Grade 2, % Grade 3, % Grade 4, % Grade 5, % All grades, %
Rash maculo‐papular 11 11 67 11 0 0 89
Fatigue (asthenia, lethargy, malaise) 56 22 22 0 0 0 44
Diarrhea 56 22 11 11 0 0 44
Vomiting 78 0 22 0 0 0 22
Anorexia 78 11 11 0 0 0 22
Alanine aminotransferase increased 89 0 0 11 0 0 11
Aspartate aminotransferase increased 78 11 11 0 0 0 22
Distension/bloating, abdominal 89 11 0 0 0 0 11
Hair loss/alopecia (scalp or body) 89 11 0 0 0 0 11
Dry skin 89 11 0 0 0 0 11
Headache 89 11 0 0 0 0 11
Confusion 89 11 0 0 0 0 11
Edema limbs 89 11 0 0 0 0 11
Edema face 89 11 0 0 0 0 11
Creatinine increased 89 11 0 0 0 0 11
Dyspnea (shortness of breath) 89 11 0 0 0 0 11
Pruritus/itching 89 11 0 0 0 0 11
Irritability 89 0 11 0 0 0 11

Adverse Events Legend

Treatment‐related adverse events occurred in all patients (100%). Most were low‐grade, with only one patient (11%) experiencing grade 3 adverse events. No grade 4 or 5 events occurred. Consistent with previously reported data on trametinib [5], the most common toxicity was rash (89%). Six of nine patients required dose reduction secondary to rash (four patients’ dose reduced to 1.5 mg, two patients’ dose reduced to 1.0 mg). Other common toxicities included fatigue (44%), diarrhea (44%), aspartate aminotransferase/alanine aminotransferase (AST/ALT) elevations (22%), and anorexia (22%). One patient discontinued treatment because of toxicity; this patient experienced grade 3 rash as well as diarrhea, elevated AST/ALT, and fatigue (Table 2).

Abbreviation: NC/NA, no change from baseline/no adverse event.