TABLE 3.

Treatment‐related adverse events occurring in ≥5% of patients in phase 1 and phase 2

Adverse event, No. (%)	Phase 1		Phase 2
	Total (N = 34)		100 mg Epa a (n = 49)		300 mg Epa a (n = 93)		Total (N = 142)
	Any grade	Grade 3/4	Any grade	Grade 3/4	Any grade	Grade 3/4	Any grade	Grade 3/4
Total	27 (79.4)	7 (20.6)	35 (71.4)	3 (6.1)	79 (84.9)	23 (24.7)	114 (80.3)	26 (18.3)
Fatigue	11 (32.4)	3 (8.8)	12 (24.5)	0	31 (33.3)	4 (4.3)	43 (30.3)	4 (2.8)
Nausea	4 (11.8)	0	11 (22.4)	0	22 (23.7)	1 (1.1)	33 (23.2)	1 (0.7)
Decreased appetite	3 (8.8)	0	5 (10.2)	0	15 (16.1)	0	20 (14.1)	0
Maculopapular rash	2 (5.9)	2 (5.9)	8 (16.3)	1 (2.0)	9 (9.7)	5 (5.4)	17 (12.0)	6 (4.2)
Pruritus	6 (17.6)	0	3 (6.1)	0	13 (14.0)	0	16 (11.3)	0
Diarrhea	4 (11.8)	0	4 (8.2)	0	10 (10.8)	0	14 (9.9)	0
Vomiting	0	0	3 (6.1)	1 (2.0)	10 (10.8)	1 (1.1)	13 (9.2)	2 (1.4)
Increased AST	1 (2.9)	0	2 (4.1)	0	9 (9.7)	2 (2.2)	11 (7.7)	2 (1.4)
Rash	1 (2.9)	0	2 (4.1)	0	9 (9.7)	0	11 (7.7)	0
Increased ALP	1 (2.9)	0	0	0	9 (9.7)	2 (2.2)	9 (6.3)	2 (1.4)
Chills	1 (2.9)	0	4 (8.2)	0	5 (5.4)	0	9 (6.3)	0
Headache	1 (2.9)	0	2 (4.1)	0	7 (7.5)	0	9 (6.3)	0
Pyrexia	2 (5.9)	0	6 (12.2)	0	2 (2.2)	0	8 (5.6)	0
Increased ALT	0	0	1 (2.0)	0	7 (7.5)	2 (2.2)	8 (5.6)	2 (1.4)
Dizziness	2 (5.9)	0	2 (4.1)	0	3 (3.2)	1 (1.1)	5 (3.5)	1 (0.7)
Tumor flare	3 (8.8)	0	1 (2.0)	0	3 (3.2)	0	4 (2.8)	0
Constipation	2 (5.9)	0	1 (2.0)	0	3 (3.2)	2 (2.2)	4 (2.8)	2 (1.4)
Dyspnea	2 (5.9)	1 (2.9)	3 (6.1)	0	1 (1.1)	0	4 (2.8)	0
Influenza‐like illness	2 (5.9)	0	0	0	4 (4.3)	0	4 (2.8)	0
Anxiety	2 (5.9)	0	0	0	0	0	0	0
Bone pain	2 (5.9)	0	2 (4.1)	0	1 (1.1)	0	3 (2.1)	0
Dry mouth	2 (5.9)	0	0	0	3 (3.2)	0	3 (2.1)	0
Hyponatremia	2 (5.9)	0	1 (2.0)	0	1 (1.1)	1 (1.1)	2 (1.4)	1 (0.7)
Decreased weight	2 (5.9)	0	0	0	2 (2.2)	0	2 (1.4)	0
Cough	2 (5.9)	0	0	0	1 (1.1)	0	1 (0.7)	0

Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; Epa, epacadostat.

^a Plus durvalumab 10 mg/kg every 2 weeks.