Table 3.

(A) Numbers of patients with grade 3–4 treatment-related toxicity during induction phase (cycles 1–4). (B) Numbers of patients with most common grade 3–4 treatment-related toxicity during maintenance phase (cycle 5 and beyond)

(A) Toxicity	Cohort 4 (n=20)	Cohort 5 (n=20)	Cohort 6 (n=16)	Total (n=56)
ALT elevation	7	1	0	8
Lipase elevation	4	3	0	7
AST elevation	4	1	0	5
Lymphopenia	1	2	0	3
Amylase elevation	1	2	0	3
Hyperglycemia	0	2	0	2
Colitis/diarrhea	1	2	1	4
Headache	2	1	0	3
Hypertension	1	2	0	3
Fatigue	2	0	0	2
Nausea	1	1	0	2
Vomiting	0	2	0	2
Fever	0	0	1	1

(B) Toxicity	Cohort 4 (n=20)	Cohort 5 (n=20)	Cohort 6 (n=16)	Total (n=56)
Lipase elevation	5	6	0	11
Amylase elevation	3	3	0	6
Hypertension	3	2	0	5
Hyperglycemia	2	2	0	4
Hyponatremia	2	1	1	4
Lymphopenia	2	1	1	4
ALT elevation	3	0	0	3
Vomiting	1	2	0	3
Adrenal insufficiency	2	0	0	2
AST elevation	2	0	0	2
Colitis	2	0	0	2
Hypophysitis	2	0	0	2
Nausea	1	1	0	2
Abdominal pain	0	0	1	1
Myalgia	0	0	1	1
Pruritus	0	0	1	1
Rash	0	0	1	1

ALT, alanine transaminase; AST, aspartate transaminase.