Table 2.

Incidence of treatment-emergent adverse events (≥20% of patients) and treatment-related adverse events.^a

AE, n (%)	All patients (N = 70)
	All AEs	Treatment-related AEs
		Regorafenibb		Nivolumab		Both regorafenib and nivolumab		Relationship to any study drug
	Any grade	Grade 1/2	Grade ≥3	Grade 1/2	Grade ≥3	Grade 1/2	Grade ≥3	Any grade	Grade 1/2	Grade ≥3
Total	69 (99)	33 (47)	21 (30)	22 (31)	5 (7)	19 (27)	13 (19)	68 (97)	36 (51)	32 (46)
Fatigue	30 (43)	9 (13)	1 (1)	2 (3)	0	11 (16)	3 (4)	26 (37)	22 (31)	4 (6)
Decreased appetite	21 (30)	8 (11)	0	0	0	6 (9)	0	14 (20)	14 (20)	0
Maculopapular rash	20 (29)	3 (4)	8 (11)	2 (3)	0	2 (3)	2 (3)	17 (24)	7 (10)	10 (14)
Pyrexia/fever	20 (29)	3 (4)	1 (1)	2 (3)	0	4 (6)	0	10 (14)	9 (13)	1 (1)
HFSR/PPES	19 (27)	15 (21)	3 (4)	1 (1)	0	0	0	19 (27)	16 (23)	3 (4)
Blood bilirubin increased	18 (26)	11 (16)	1 (1)	0	0	1 (1)	1 (1)	14 (20)	12 (17)	2 (3)
Dysphonia	18 (26)	10 (14)	0	0	0	1 (1)	0	11 (16)	11 (16)	0
Nausea	16 (23)	6 (9)	0	0	0	1 (1)	0	7 (10)	7 (10)	0
Abdominal pain	15 (21)	1 (1)	0	0	0	3 (4)	0	4 (6)	4 (6)	0
Diarrhoea	14 (20)	6 (9)	1 (1)	0	0	5 (7)	0	12 (17)	11 (16)	1 (1)
AST increased	14 (20)	7 (10)	1 (1)	0	1 (1)	2 (3)	1 (1)	12 (17)	9 (13)	3 (4)

AEs throughout the treatment period were summarised according to MedDRA v23.0 and the severity was categorised by the NCI-CTCAE v5.0.

AE = adverse event; AST = aspartate aminotransferase; HFSR = hand–foot skin reaction; MedDRA = Medical Dictionary for Regulatory Activities; NCI-CTCAE = National Cancer Institute Common Terminology Criteria for Adverse Events; PPES = palmar-plantar erythrodysesthesia syndrome.

^aEvents listed are those that occurred in ≥20% of patients regardless of relation to treatment (all AEs), listed in order of descending frequency of AEs of any grade.

^bNo corresponding grade 4 regorafenib-related AEs were reported.