Event, n (%) | Cohort 1 (n=8) | Cohort 4 (n=10) | Total (n=18) | ||||
Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | Any grade | |
Any TEAE | 4 (50.0) | 4 (50.0) | 5 (50.0) | 5 (50.0) | 9 (50.9) | 9 (50.0) | 18 (100.0) |
Nausea | 4 (50.0) | 0 | 2 (20.0) | 0 | 6 (33.3) | 0 | 6 (33.3) |
Decreased appetite | 3 (37.5) | 1 (12.5) | 1 (10.0) | 1 (10.0) | 4 (22.2) | 2 (11.1) | 6 (33.3) |
Fatigue | 2 (25.0) | 1 (12.5) | 2 (20.0) | 1 (10.0) | 4 (22.2) | 2 (11.1) | 6 (33.3) |
Anemia | 0 | 2 (25.0) | 0 | 2 (20.0) | 0 | 4 (22.2) | 4 (22.2) |
Fever | 2 (25.0) | 0 | 2 (20.0) | 0 | 4 (22.2) | 0 | 4 (22.2) |
Malaise | 3 (37.5) | 0 | 1 (10.0) | 0 | 4 (22.2) | 0 | 4 (22.2) |
Rash | 1 (12.5) | 0 | 3 (30.0) | 0 | 4 (22.2) | 0 | 4 (22.2) |
Constipation | 2 (25.0) | 0 | 1 (10.0) | 0 | 3 (16.7) | 0 | 3 (16.7) |
Diarrhea | 1 (12.5) | 0 | 2 (20.0) | 0 | 3 (16.7) | 0 | 3 (16.7) |
Stomatitis | 0 | 0 | 3 (30.0) | 0 | 3 (16.7) | 0 | 3 (16.7) |
Cancer pain | 1 (12.5) | 0 | 1 (10.0) | 1 (10.0) | 2 (11.1) | 1 (5.6) | 3 (16.7) |
Edema, peripheral | 1 (12.5) | 0 | 1 (10.0) | 0 | 2 (11.1) | 0 | 2 (11.1) |
White blood cell count decreased | 0 | 0 | 2 (20.0) | 0 | 2 (11.1) | 0 | 2 (11.1) |
Neutrophil count decreased | 0 | 0 | 1 (10.0) | 1 (10.0) | 1 (5.6) | 1 (5.6) | 2 (11.1) |
Disseminated intravascular coagulation | 0 | 0 | 0 | 1 (10.0) | 0 | 1 (5.6) | 1 (5.6) |
Iron deficiency anemia | 0 | 1 (12.5) | 0 | 0 | 0 | 1 (5.6) | 1 (5.6) |
Hypothyroidism | 0 | 0 | 1 (10.0) | 0 | 1 (5.6) | 0 | 1 (5.6) |
Vomiting | 1 (12.5) | 0 | 0 | 0 | 1 (5.6) | 0 | 1 (5.6) |
General physical health deterioration | 0 | 1 (12.5) | 0 | 0 | 0 | 1 (5.6) | 1 (5.6) |
Cholangitis | 0 | 0 | 0 | 1 (10.0) | 0 | 1 (5.6) | 1 (5.6) |
Aspartate aminotransferase increased | 0 | 0 | 0 | 1 (10.0) | 0 | 1 (5.6) | 1 (5.6) |
Alanine aminotransferase increased | 0 | 0 | 1 (10.0) | 0 | 1 (5.6) | 0 | 1 (5.6) |
Hypoalbuminemia | 0 | 0 | 1 (10.0) | 0 | 1 (5.6) | 0 | 1 (5.6) |
Hypoglycemia | 0 | 0 | 0 | 1 (10.0) | 0 | 1 (5.6) | 1 (5.6) |
Peripheral sensory neuropathy | 0 | 0 | 1 (10.0) | 0 | 1 (5.6) | 0 | 1 (5.6) |
Headache | 1 (12.5) | 0 | 0 | 0 | 1 (5.6) | 0 | 1 (5.6) |
Hydronephrosis | 0 | 1 (12.5) | 0 | 0 | 0 | 1 (5.6) | 1 (5.6) |
TEAE, treatment-emergent adverse event.