Table 3.

Most common (≥4% of patients) TRAEs ^a.

	Adjuvant Nivolumab (n = 152)
	Any Grade, n (%)	Grade 3 or 4, n (%) b
TRAE	131 (86)	21 (14)
Fatigue	75 (49)	1 (1)
Pruritus	36 (24)	0
Diarrhea	23 (15)	1 (1)
Hypothyroidism	22 (14)	0
Nausea	16 (11)	0
Hyperthyroidism	14 (9)	0
Dry mouth	12 (8)	0
Rash	12 (8)	0
Dry skin	9 (6)	0
Arthralgia	9 (6)	0
Colitis	8 (5)	2 (1)
Myalgia	8 (5)	1 (1)
Headache	8 (5)	0
Hepatitis	7 (5)	2 (1)

^a Reported between the first nivolumab dose and ≤2 years after the last dose. ^b Grade 3 or 4 TRAEs not listed included pneumonitis (n = 3) and psoriasis, skin reaction, stomatitis, pancreatitis, adrenal insufficiency, osteoarthritis, myositis, elevated alanine aminotransaminase level, elevated aspartate aminotransaminase level, decreased cortisol, abnormal liver function test, aseptic meningitis, infusion-related reaction, and myocarditis (n = 1 each). TRAE, treatment-related adverse event.