Table 1.

Adverse events and treatment‐related adverse events occurring in three or more patients

Safety analysis set n = 30	Adverse events		Treatment‐related adverse events
Event	All grades	Grades III–IV	All grades	Grades III–IV
Any events	30 (100.0)	23 (76.7)	30 (100.0)	23 (76.7)
Rash	18 (60.0)	2 (6.7)	18 (60.0)	2 (6.7)
Diarrhea	17 (56.7)	1 (3.3)	17 (56.7)	1 (3.3)
Pyrexia	15 (50.0)	1 (3.3)	14 (46.7)	1 (3.3)
Lipase increased	12 (40.0)	7 (23.3)	12 (40.0)	7 (23.3)
Alanine aminotransferase increased	11 (36.7)	3 (10.0)	11 (36.7)	3 (10.0)
Aspartate aminotransferase increased	11 (36.7)	2 (6.7)	11 (36.7)	2 (6.7)
Pruritus	10 (33.3)	0	10 (33.3)	0
Decreased appetite	9 (30.0)	1 (3.3)	8 (26.7)	1 (3.3)
Hepatic function abnormal	7 (23.3)	4 (13.3)	7 (23.3)	4 (13.3)
Malaise	7 (23.3)	1 (3.3)	7 (23.3)	1 (3.3)
Hypothyroidism	7 (23.3)	0	7 (23.3)	0
Hyponatremia	6 (20.0)	5 (16.7)	5 (16.7)	4 (13.3)
Vomiting	6 (20.0)	1 (3.3)	6 (20.0)	1 (3.3)
Constipation	6 (20.0)	1 (3.3)	5 (16.7)	1 (3.3)
Headache	6 (20.0)	1 (3.3)	5 (16.7)	1 (3.3)
γ‐Glutamyltransferase increased	5 (16.7)	3 (10.0)	5 (16.7)	3 (10.0)
Amylase increased	5 (16.7)	1 (3.3)	5 (16.7)	1 (3.3)
Arthralgia	5 (16.7)	0	5 (16.7)	0
Fatigue	5 (16.7)	0	5 (16.7)	0
Stomatitis	5 (16.7)	0	3 (10.0)	0
Viral upper respiratory tract infection	5 (16.7)	0	0	0
Rash maculo‐papular	4 (13.3)	1 (3.3)	4 (13.3)	1 (3.3)
Nausea	4 (13.3)	0	4 (13.3)	0
Blood alkaline phosphatase increased	4 (13.3)	0	4 (13.3)	0
Diabetes mellitus	3 (10.0)	2 (6.7)	1 (3.3)	1 (3.3)
Hypoalbuminemia	3 (10.0)	1 (3.3)	2 (6.7)	1 (3.3)
Upper respiratory tract infection	3 (10.0)	1 (3.3)	1 (3.3)	0
Vitiligo	3 (10.0)	0	2 (6.7)	0
Dysgeusia	3 (10.0)	0	2 (6.7)	0
Anemia	3 (10.0)	0	2 (6.7)	0

Data are presented as n (%).