Table 6.

Immune-mediated adverse events^a

n (%)	Pembrolizumab + Epacadostat n = 34	Pembrolizumab Monotherapy n = 19	EXTREME n = 34
Hypothyroidism	6 (18)	4 (21)	1 (3)
Pneumonitis	3 (9)	0	0
Colitis	1 (3)	0	0
Hepatitis	1 (3)	0	0
Hyperthyroidism	1 (3)	1 (5)	0
Nephritis	1 (3)	0	0
Severe skin reactions	1 (3)	0	2 (6)
Thyroiditis	1 (3)	0	0

^aImmune-mediated adverse events were based on a list of terms specified by the sponsor and were included regardless of treatment attribution by investigators