Table 2

TRAEs in ≥5% of patients*

TRAE, n (%)†Galunisertib 50 mg one time per day+durvalumab 1500 mg Q4W n=3Galunisertib 50 mg two times per day+durvalumab 1500 mg Q4W n=4Galunisertib 80 mg two times per day+durvalumab 1500 mg Q4W n=3Galunisertib 150 mg two times per day+durvalumab 1500 mg Q4W n=32Total
N=42
All gradesGrade 3/4All gradesGrade 3/4All gradesGrade 3/4All gradesGrade 3/4All gradesGrade 3/4
≥1 TRAE2 (66.7)02 (50.0)03 (100)013 (40.6)5 (15.6)20 (47.6)5 (11.9)
Diarrhea00001 (33.3)05 (15.6)06 (14.3)0
Fatigue00002 (66.7)04 (12.5)06 (14.3)0
Elevated AST00001 (33.3)04 (12.5)2 (6.3)5 (11.9)2 (4.8)
Elevated ALT00001 (33.3)04 (12.5)1 (3.1)5 (11.9)1 (2.4)
Nausea001 (25.0)0003 (9.4)04 (9.5)0
Vomiting00001 (33.3)03 (9.4)04 (9.5)0
Pruritus0000003 (9.4)03 (7.1)0
Arthralgia0000003 (9.4)03 (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.