Table 3:

Treatment-related adverse events in either treatment group

	Nivolumab plus cabozantinib (N=320)			Sunitinib (N=320)
Events	Grades 1–2	Grade 3	Grade 4	Grades 1–2	Grade 3	Grade 4
Patients with any event	103 (32)	186 (58)	22 (7)	125 (39)	152 (48)	20 (6)
Diarrhoea	168 (53)	20 (6)	2 (<1)	132 (41)	15 (5)	0
Hypothyroidism	115 (36)	1 (<1)	0	95 (30)	1 (<1)	0
Palmar-plantar erythrodysaesthesia	98 (31)	25 (8)	0	108 (34)	26 (8)	0
Fatigue	79 (25)	8 (3)	0	86 (27)	15 (5)	0
Nausea	73 (23)	1 (<1)	0	87 (27)	0	0
Alanine aminotransferase increased	71 (22)	18 (6)	0	19 (6)	3 (<1)	0
Aspartate aminotransferase increased	71 (22)	12 (4)	0	33 (10)	2 (<1)	0
Dysgeusia	69 (22)	0	0	67 (21)	0	0
Hypertension	65 (20)	39 (12)	1 (<1)	68 (21)	39 (12)	0
Decreased appetite	65 (20)	4 (1)	0	53 (17)	2 (<1)	0
Mucosal inflammation	62 (19)	3 (<1)	0	75 (23)	7 (2)	1 (<1)
Rash	60 (19)	6 (2)	0	21 (7)	0	0
Pruritus	57 (18)	2 (<1)	0	14 (4)	0	0
Asthenia	48 (15)	11 (3)	0	41 (13)	8 (3)	0
Stomatitis	47 (15)	7 (2)	0	69 (22)	8 (3)	0
Vomiting	37 (12)	4 (1)	0	50 (16)	2 (<1)	0
Dysphonia	37 (12)	1 (<1)	0	8 (3)	0	0
Hypomagnesaemia	35 (11)	0	1 (<1)	10 (3)	0	0
Lipase increased	34 (11)	15 (5)	5 (2)	24 (8)	11 (3)	5 (2)
Anaemia	33 (10)	2 (<1)	0	55 (17)	11 (3)	1 (<1)
Amylase increased	32 (10)	14 (4)	0	23 (7)	7 (2)	0
Arthralgia	31 (10)	0	0	16 (5)	0	0
Dyspepsia	21 (7)	0	0	32 (10)	1 (<1)	0
Thrombocytopenia	20 (6)	1 (<1)	0	49 (15)	11 (3)	4 (1)
Platelet count decreased	18 (6)	0	0	45 (14)	12 (4)	2 (<1)
Gastro-oesophageal reflux disease	16 (5)	0	0	33 (10)	0	0
Neutropenia	13 (4)	2 (<1)	1 (<1)	39 (12)	13 (4)	1 (<1)

Data are n (%) Shown are grade 1–2 treatment-related adverse events that occurred in ≥10% of patients in either group while patients were receiving the assigned treatment or within 30 days after the end of the trial treatment period. Events are listed in descending order of frequency in the nivolumab plus cabozantinib group. One grade 5 event occurred in the sunitinib arm (respiratory distress