TABLE A2.

Potentially Immune-Mediated Adverse Events in All Treated Participants

Adverse Event	Lenvatinib + Pembrolizumab + Chemotherapy (n = 441), No. (%)		Chemotherapy (n = 429), No. (%)
	Any	Grade ≥3	Any	Grade ≥3
Any	202 (46)	44 (10)	51 (12)	6 (1)
Adrenal insufficiency	13 (3)	4 (1)	1 (<1)	0
Arthritis	1 (<1)	0	0	0
Cholangitis sclerosing	1 (<1)	0	0	0
Colitis	11 (2)	6 (1)	1 (<1)	1 (<1)
Encephalitis	1 (<1)	1 (<1)	0	0
Exocrine pancreatic insufficiency	0	0	1 (<1)	0
Gastritis	9 (2)	1 (<1)	4 (1)	1 (<1)
Hemolytic anemia	1 (<1)	1 (<1)	0	0
Hepatitis	8 (2)	5 (1)	1 (<1)	0
Hyperthyroidism	33 (7)	1 (<1)	7 (2)	0
Hypophysitis	5 (1)	1 (<1)	0	0
Hypothyroidism	128 (29)	3 (1)	5 (1)	0
Infusion reactions	24 (5)	5 (1)	34 (8)	3 (1)
Myelitis	0	0	1 (<1)	0
Myositis	1 (<1)	1 (<1)	0	0
Myocarditis	2 (<1)	1 (<1)	0	0
Nephritis	5 (1)	2 (<1)	0	0
Pancreatitis	6 (1)	3 (1)	1 (<1)	0
Pneumonitis	15 (3)	1 (<1)	2 (<1)	1 (<1)
Severe skin reactions	15 (3)	12 (3)	0	0
Thyroiditis	2 (<1)	0	0	0
Type 1 diabetes mellitus	2 (<1)	2 (<1)	0	0
Vasculitis	3 (1)	1 (<1)	1 (<1)	0