Table 3.

Summary of treatment-related AEs (all treated patients).

Treatment-related AEs, n (%)a	Nivolumab + ipilimumab + cabozantinib  (N = 50)
	Any grade	Grade 3	Grade 4
At least one adverse event	48 (96.0)	28 (56.0)	14 (28.0)
Diarrhoea	27 (54.0)	2 (4.0)	0
ALT increased	24 (48.0)	8 (16.0)	2 (4.0)
AST increased	19 (38.0)	6 (12.0)	2 (4.0)
PPE syndrome	19 (38.0)	7 (14.0)	0
Fatigue	16 (32.0)	1 (2.0)	0
Nausea	16 (32.0)	0	0
Rash	15 (30.0)	2 (4.0)	0
Hypothyroidism	15 (30.0)	0	0
Lipase increased	14 (28.0)	3 (6.0)	4 (8.0)
Hypertension	14 (28.0)	4 (8.0)	0
Decreased appetite	14 (28.0)	1 (2.0)	0
Mucosal inflammation	13 (26.0)	1 (2.0)	0
Hepatotoxicity	10 (20.0)	6 (12.0)	2 (4.0)
Anaemia	10 (20.0)	6 (12.0)	0
Amylase increased	10 (20.0)	2 (4.0)	1 (2.0)
Pruritus	10 (20.0)	0	0
Asthaenia	9 (18.0)	3 (6.0)	0
Abdominal pain	8 (16.0)	1 (2.0)	0
Dysgeusia	8 (16.0)	0	0
Weight decreased	8 (16.0)	0	0
Myalgia	7 (14.0)	1 (2.0)	0
Blood alkaline phosphatase increased	6 (12.0)	1 (2.0)	0
Blood bilirubin increased	6 (12.0)	1 (2.0)	0
Maculo-papular rash	6 (12.0)	1 (2.0)	0
Arthralgia	6 (12.0)	0	0
Blood creatinine increased	6 (12.0)	0	0
Dysphonia	6 (12.0)	0	0
Headache	6 (12.0)	0	0
Muscle spasms	6 (12.0)	0	0
Stomatitis	6 (12.0)	0	0

AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; PPE, palmar-plantar erythrodysaesthesia syndrome.

^aIncludes individual treatment-related AEs occurring in ≥ 6 patients (≥ 12%) during treatment or within 30 days after the last dose of study therapy.