| 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.