Table 2.
Adverse Event | Any Grade n = 12 |
Grade 3 or Higher n = 12 |
Any Grade Dose Level 1 n = 6 |
Grade 3 or Higher Dose Level 1 n = 6 |
Any Grade Dose Level 2 n = 6 |
Grade 3 or Higher Dose Level 2 n = 6 |
---|---|---|---|---|---|---|
Any Adverse Event n (%) | 12 (100%) |
7 (58%) |
6 (100%) |
4 (67%) |
6 (100%) |
3 (50%) |
Hyperglycaemia | 7 (58%) | 0 | 4 (67%) | 0 | 3 (50%) | 0 |
Constipation | 7 (58%) | 0 | 3 (50%) | 0 | 4 (67%) | 0 |
Fatigue | 7 (58%) | 1 (8%) | 4 (67%) | 1 (17%) | 3 (50%) | 0 |
Hypertension | 6 (50%) | 4 (33%) | 5 (83%) | 3 (50%) | 1 (17%) | 1 (17%) |
Nausea | 7 (58%) | 0 | 3 (50%) | 0 | 4 (67%) | 0 |
Diarrhea | 6 (50%) | 0 | 3 (50%) | 0 | 3 (50%) | 0 |
Rash | 6 (50%) | 0 | 3 (50%) | 0 | 3 (50%) | 0 |
Vomiting | 7 (58%) | 0 | 4 (67%) | 0 | 3 (50%) | 0 |
Cough | 4 (33%) | 0 | 3 (50%) | 0 | 1 (17%) | 0 |
Mucositis | 5 (42%) | 0 | 4 (67%) | 0 | 1 (17%) | 0 |
Decreased appetite | 4 (33%) | 0 | 3 (50%) | 0 | 1 (17%) | 0 |
Dry skin | 4 (33%) | 0 | 3 (50%) | 0 | 1 (17%) | 0 |
Fever | 4 (33%) | 0 | 3 (50%) | 0 | 1 (17%) | 0 |
Headache | 4 (33%) | 0 | 1 (17%) | 0 | 3 (50%) | 0 |
Paresthesia | 3 (25%) | 0 | 1 (17%) | 0 | 2 (33%) | 0 |
Weight decreased | 3 (25%) | 0 | 3 (50%) | 0 | 0 | 0 |
Anemia | 2 (17%) | 0 | 1 (17%) | 0 | 1 (17%) | 0 |
Dehydration | 2 (17%) | 0 | 2 (33%) | 0 | 0 | 0 |
Dyspnea | 2 (17%) | 1 (8%) | 1 (17%) | 0 | 1 (17%) | 1 (17%) |
Oedema peripheral | 1 (8%) | 0 | 1 (17%) | 0 | 0 | 0 |
Insomnia | 2 (17%) | 0 | 1 (17%) | 0 | 1 (17%) | 0 |
Paresthesia Oral | 2 (17%) | 0 | 0 | 0 | 2 (33%) | 0 |
Peripheral neuropathy | 2 (17%) | 0 | 1 (17%) | 0 | 1 (17%) | 0 |
Blood Bilirubin increased | 1 (8%) | 1 (8%) | 0 | 0 | 1 (17%) | 1 (17%) |
Gamma GT increased | 1 (8%) | 1 (8%) | 0 | 0 | 1 (17%) | 1 (17%) |
Bile duct obstruction | 1 (8%) | 1 (8%) | 0 | 0 | 1 (17%) | 1 (17%) |
Lymphangitis carcinomatosis | 1 (8%) | 1 (8%) | 0 | 0 | 1 (17%) | 1 (17%) |
* If an event ≥grade 3 occurred in a single patient, the event is included here. Gamma GT–Gamma-Glutamyl Transferase.