. 2020 Apr 9;85(5):931–940. doi: 10.1007/s00280-020-04065-5

Table 2.

Treatment-related adverse events

Toxicity	Grade	All cohorts (N = 15)	Cohort 1 (N = 3)	Cohort 2 (N = 6)	Cohort 3 (N = 3)	Cohort 4 (N = 3)	Dose < 2400 mg (N = 11)	Dose ≥ 2400 mg (N = 9)	Observed AUC < 100 mg/L/h (N = 14)	Observed AUC ≥ 100 mg/L/h (N = 11)
Fatigue	All	10 (67%)	1 (33%)	5 (83%)	3 (100%)	1 (33%)	4 (36%)	6 (67%)	3 (21%)	7 (64%)
Fatigue	Grade ≥ 3	0	0	0	0	0	0	0	0	0
Nausea	All	10 (67%)	2 (67%)	4 (67%)	2 (67%)	2 (67%)	5 (45%)	5 (56%)	5 (36%)	5 (45%)
Nausea	Grade ≥ 3	0	0	0	0	0	0	0	0	0
Vomiting	All	8 (53%)	2 (67%)	3 (50%)	1 (33%)	2 (67%)	5 (45%)	3 (33%)	7 (50%)	1 (9%)
Vomiting	Grade ≥ 3	0	0	0	0	0	0	0	0	0
Diarrhea	All	4 (27%)	1 (33%)	1 (17%)	1 (33%)	1 (33%)	2 (18%)	2 (22%)	2 (14%)	2 (18%)
Diarrhea	Grade ≥ 3	0	0	0	0	0	0	0	0	0
Anorexia	All	3 (20%)	0	2 (33%)	1 (33%)	0	0	3 (33%)	1 (7%)	2 (18%)
Anorexia	Grade ≥ 3	0	0	0	0	0	0	0	0	0
Bloating	All	2 (13%)	0	1 (17%	0	1 (33%)	1 (9%)	1 (11%)	1 (7%)	1 (9%)
Bloating	Grade ≥ 3	0	0	0	0	0	0	0	0	0
Stomatitis	All	2 (13%)	0	1 (17%)	1 (33%)	0	0	2 (22%)	0	2 (18%)
Stomatitis	Grade ≥ 3	0	0	0	0	0	0	0	0	0
Perforation	All	2 (13%)	0	1 (17%)	0	1 (33%)	0	2 (22%)	1 (7%)	1 (11%)
Perforation	Grade ≥ 3	2 (13%)	0	1 (17%)	0	1 (33%)	0	2 (22%)	1 (7%)	1 (11%)
Multiorgan failure	All	1 (7%)	0	0	0	1 (33%)	0	1 (11%)	1 (7%)	0
Multiorgan failure	Grade ≥ 3	1 (7%)	0	0	0	1 (33%)	0	1 (11%)	1 (7%)	0
ALP increased	All	3 (20%)	0	0	1 (33%)	2 (67%)	0	3 (33%)	1 (7%)	2 (18%)
ALP increased	Grade ≥ 3	2 (13%)	0	0	0	2 (67%)	0	2 (22%)	1 (7%)	1 (9%)
Bilirubin increased	All	2 (13%)	0	0	0	2 (67%)	0	2 (22%)	1 (7%)	1 (9%)
Bilirubin increased	Grade ≥ 3	0	0	0	0	0	0	0	0	0
GGT increased	All	1 (7%)	0	0	0	1 (33%)	0	1 (11%)	1 (7%)	0
GGT increased	Grade ≥ 3	1 (7%)	0	0	0	1 (33%)	0	1 (11%)	1 (7%)	0