Table 2.

TRAEs in ≥5% of patients*

TRAE, n (%)†	Galunisertib 50 mg one time per day+durvalumab 1500 mg Q4W n=3		Galunisertib 50 mg two times per day+durvalumab 1500 mg Q4W n=4		Galunisertib 80 mg two times per day+durvalumab 1500 mg Q4W n=3		Galunisertib 150 mg two times per day+durvalumab 1500 mg Q4W n=32		Total N=42
	All grades	Grade 3/4	All grades	Grade 3/4	All grades	Grade 3/4	All grades	Grade 3/4	All grades	Grade 3/4
≥1 TRAE	2 (66.7)	0	2 (50.0)	0	3 (100)	0	13 (40.6)	5 (15.6)	20 (47.6)	5 (11.9)
Diarrhea	0	0	0	0	1 (33.3)	0	5 (15.6)	0	6 (14.3)	0
Fatigue	0	0	0	0	2 (66.7)	0	4 (12.5)	0	6 (14.3)	0
Elevated AST	0	0	0	0	1 (33.3)	0	4 (12.5)	2 (6.3)	5 (11.9)	2 (4.8)
Elevated ALT	0	0	0	0	1 (33.3)	0	4 (12.5)	1 (3.1)	5 (11.9)	1 (2.4)
Nausea	0	0	1 (25.0)	0	0	0	3 (9.4)	0	4 (9.5)	0
Vomiting	0	0	0	0	1 (33.3)	0	3 (9.4)	0	4 (9.5)	0
Pruritus	0	0	0	0	0	0	3 (9.4)	0	3 (7.1)	0
Arthralgia	0	0	0	0	0	0	3 (9.4)	0	3 (7.1)	0

*Includes all grade 1–4 TRAEs in the total population (N=42); patients may have had ≥1 TRAE.

†No grade 5 TRAEs occurred.

ALT, alanine aminotransferase; AST, aspartate aminotransferase; Q4W, every 4 weeks; TRAE, treatment-related adverse event.