Table 2.

Incidence of immune-mediated AEs and corticosteroid use for grade 3–4 immune-mediated AEs

Immune-mediated AE* category, n (%)	All treated patients (N=52)
	Any grade	Grade 3–4	Corticosteroid use† for grade 3–4
Rash	12 (23.1)	3 (5.8)	2 (3.8)
Diarrhea/colitis	7 (13.5)	4 (7.7)	3 (5.8)
Hypothyroidism/ thyroiditis‡	5 (9.6)	0	–
Nephritis and renal dysfunction	2 (3.8)	2 (3.8)	2 (3.8)
Adrenal insufficiency‡	2 (3.8)	1 (1.9)	0
Hepatitis	2 (3.8)	1 (1.9)	1 (1.9)
Hypophysitis‡	2 (3.8)	1 (1.9)	1 (1.9)
Hyperthyroidism‡	2 (3.8)	0	–
Hypersensitivity	1 (1.9)	0	–
Pneumonitis	1 (1.9)	0	–

*Specific events that occurred within 100 days of the last dose of study drug; were of any causality; had no clear alternate etiology based on investigator assessment, or with an immune-mediated component; and treated with immune-modulating medication (with the exception of endocrine events).

†≥40 mg prednisone or equivalent.

‡Considered endocrine immune-mediated AEs.

AE, adverse event.