Table 3.

On-study drug-related SAEs^a,b,c

Organ categorya	Treated patients (N = 15)
	Worst grade, n (%)
	Grade 1	Grade 2	Grade 3	Grade 4	Any grade
Any drug-related SAE	0	1 (6.7)	9 (60)	1 (6.7)	11 (73.3)
Investigations	0	0	9 (60)	1 (6.7)	10 (66.7)
ALT increased	0	0	9 (60)	1 (6.7)	10 (66.7)
AST increased	0	1 (6.7)	6 (40)	0	7 (46.7)
Gastrointestinal disorders	0	1 (6.7)	1 (6.7)	0	2 (13.3)
Colitis	0	1 (6.7)	0	0	1 (6.7)
Diarrhea	0	0	1 (6.7)	0	1 (6.7)
Nervous system disorders	1 (6.7)	0	0	0	1 (6.7)
Dizziness	1 (6.7)	0	0	0	1 (6.7)

ALT alanine aminotransferase, AST aspartate aminotransferase, SAE serious adverse event

^aPatients may have had more than 1 event

^bDrug-related events are those reported as related or missing

^cOn-study events are those reported between the first dose and 90 days after the last dose date of study treatment