Table 4:

Treatment-Related Adverse Events

	dMMR/MSI-H per local assessment (N=74)*
	Grade 1–2	Grade 3	Grade 4
Any Event	36 (48·6)	13 (17·6)	2 (2·7)
Fatigue	16 (21·6)	1 (1·4)	0
Diarrhoea	15 (20·3)	1 (1·4)	0
Pruritus	10 (13·5)	0	0
Rash	8 (10·8)	0	0
Nausea	7 (9·5)	0	0
Hypothyroidism	7 (9·5)	0	0
Asthenia	5 (6·8)	0	0
Aspartate aminotransferase increase	5 (6·8)	0	0
Arthralgia	4 (5·4)	0	0
Pyrexia	4 (5·4)	0	0
Dry skin	4 (5·4)	0	0
Maculopapular rash	4 (5·4)	1 (1·4)	0
Alanine aminotransferase increase	3 (4·1)	1 (1·4)	0
Lipase increase	3 (4·1)	4 (5·4)	2 (2·7)
Amylase increase	2 (2·7)	2 (2·7)	0
Stomatitis	2 (2·7)	1 (1·4)	0
Abdominal pain	1 (1·4)	1 (1·4)	0
Creatinine increased	1 (1·4)	1 (1·4)	0
Lymphocyte count decreased	1 (1·4)	1 (1·4)	0
Colitis	0	1 (1·4)	0
Acute kidney injury	0	1 (1·4)	0
Adrenal insufficiency	0	1 (1·4)	0
Oesophagitis	0	1 (1·4)	0
Gamma-glutamyltransferase increased	0	1 (1·4)	0
Gastritis	0	1 (1·4)	0
Pain	0	1 (1·4)	0

Data presented as n (%). This table reports grade 1–2 treatment-related events in ≥10% of patients in any treatment cohort and all grade 3–4 events.

^*One grade 5 event of sudden death was reported.