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) ToxicityCohort 4 (n=20)Cohort 5 (n=20)Cohort 6 (n=16)Total (n=56)
ALT elevation7108
Lipase elevation4307
AST elevation4105
Lymphopenia1203
Amylase elevation1203
Hyperglycemia0202
Colitis/diarrhea1214
Headache2103
Hypertension1203
Fatigue2002
Nausea1102
Vomiting0202
Fever0011
(B) ToxicityCohort 4 (n=20)Cohort 5 (n=20)Cohort 6 (n=16)Total (n=56)
Lipase elevation56011
Amylase elevation3306
Hypertension3205
Hyperglycemia2204
Hyponatremia2114
Lymphopenia2114
ALT elevation3003
Vomiting1203
Adrenal insufficiency2002
AST elevation2002
Colitis2002
Hypophysitis2002
Nausea1102
Abdominal pain0011
Myalgia0011
Pruritus0011
Rash0011
  • ALT, alanine transaminase; AST, aspartate transaminase.