Table 4.

Summary of adverse events (AEs) (>10%) in Japanese patients with advanced biliary tract cancers refractory to gemcitabine, treated with trametinib

System organ class, preferred term	All grades n (%)	Grade 3 or highera n (%)
Any event, n (%)	20 (100)	15 (75)
Skin and subcutaneous tissue disorders
Dermatitis acneiform	15 (75)	1 (5)
Rash	4 (20)	1 (5)
Dry skin	3 (15)	0 (0)
Palmar–plantar erythrodysesthesia syndrome	2 (10)	0 (0)
Rash maculopapular	2 (10)	0 (0)
Gastrointestinal disorders
Diarrhea	8 (40)	0 (0)
Vomiting	7 (35)	0 (0)
Nausea	6 (30)	1 (5)
Stomatitis	6 (30)	0 (0)
Constipation	3 (15)	0 (0)
Anal hemorrhage	2 (10)	0 (0)
General disorders and administration site conditions
Fatigue	7 (35)	0 (0)
Pyrexia	7 (35)	0 (0)
Edema peripheral	6 (30)	0 (0)
Malaise	5 (25)	0 (0)
Edema	2 (10)	0 (0)
Metabolism and nutrition disorders
Decreased appetite	11 (55)	2 (10)
Hypoalbuminemia	5 (25)	0 (0)
Infections and infestations
Pharyngitis	4 (20)	0 (0)
Paronychia	4 (20)	0 (0)
Biliary tract infection	2 (10)	2 (10)
Upper respiratory tract infection	2 (10)	0 (0)
Investigations
Blood creatine phosphokinase increased	5 (25)	2 (10)
Aspartate aminotransferase increased	4 (20)	1 (5)
Blood alkaline phosphatase increased	3 (15)	2 (10)
Blood creatinine increased	3 (15)	1 (5)
Alanine aminotransferase increased	2 (10)	1 (5)
Platelet count decreased	2 (10)	1 (5)
Hepatobiliary disorders
Cholangitis	5 (25)	3 (15)
Eye disorders
Vision blurred	2 (10)	0 (0)
Nervous system disorders
Dizziness	3 (15)	0 (0)
Dysgeusia	2 (10)	0 (0)
Respiratory, thoracic, and mediastinal disorders
Cough	2 (10)	0 (0)
Epistaxis	2 (10)	0 (0)
Neoplasms benign, malignant, and unspecified (including cysts and polyps)
Cancer pain	2 (10)	0 (0)
Tumor‐associated fever	2 (10)	0 (0)
Psychiatric disorders
Insomnia	3 (15)	0 (0)
Blood and lymphatic system disorders
Anemia	3 (15)	2 (10)

^aTwo grade 4 AEs (platelet count decreased and blood bilirubin increased) and no grade 5 AEs.