Table 3

TEAEs of any grade observed in all patients

Event, n (%)Cohort 1 (n=8)Cohort 4 (n=10)Total (n=18)
Grade 1–2Grade 3–4Grade 1–2Grade 3–4Grade 1–2Grade 3–4Any grade
Any TEAE4 (50.0)4 (50.0)5 (50.0)5 (50.0)9 (50.9)9 (50.0)18 (100.0)
Nausea4 (50.0)02 (20.0)06 (33.3)06 (33.3)
Decreased appetite3 (37.5)1 (12.5)1 (10.0)1 (10.0)4 (22.2)2 (11.1)6 (33.3)
Fatigue2 (25.0)1 (12.5)2 (20.0)1 (10.0)4 (22.2)2 (11.1)6 (33.3)
Anemia02 (25.0)02 (20.0)04 (22.2)4 (22.2)
Fever2 (25.0)02 (20.0)04 (22.2)04 (22.2)
Malaise3 (37.5)01 (10.0)04 (22.2)04 (22.2)
Rash1 (12.5)03 (30.0)04 (22.2)04 (22.2)
Constipation2 (25.0)01 (10.0)03 (16.7)03 (16.7)
Diarrhea1 (12.5)02 (20.0)03 (16.7)03 (16.7)
Stomatitis003 (30.0)03 (16.7)03 (16.7)
Cancer pain1 (12.5)01 (10.0)1 (10.0)2 (11.1)1 (5.6)3 (16.7)
Edema, peripheral1 (12.5)01 (10.0)02 (11.1)02 (11.1)
White blood cell count decreased002 (20.0)02 (11.1)02 (11.1)
Neutrophil count decreased001 (10.0)1 (10.0)1 (5.6)1 (5.6)2 (11.1)
Disseminated intravascular coagulation0001 (10.0)01 (5.6)1 (5.6)
Iron deficiency anemia01 (12.5)0001 (5.6)1 (5.6)
Hypothyroidism001 (10.0)01 (5.6)01 (5.6)
Vomiting1 (12.5)0001 (5.6)01 (5.6)
General physical health deterioration01 (12.5)0001 (5.6)1 (5.6)
Cholangitis0001 (10.0)01 (5.6)1 (5.6)
Aspartate aminotransferase increased0001 (10.0)01 (5.6)1 (5.6)
Alanine aminotransferase increased001 (10.0)01 (5.6)01 (5.6)
Hypoalbuminemia001 (10.0)01 (5.6)01 (5.6)
Hypoglycemia0001 (10.0)01 (5.6)1 (5.6)
Peripheral sensory neuropathy001 (10.0)01 (5.6)01 (5.6)
Headache1 (12.5)0001 (5.6)01 (5.6)
Hydronephrosis01 (12.5)0001 (5.6)1 (5.6)
  • TEAE, treatment-emergent adverse event.