Table 3.
Treatment-related adverse events across all cycles
| Characteristics | Cohort 1 | Cohort 2 | Cohort3 | Total | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of Patients | n=6 | n | (%) | n | (%) | n=6 | n | (%) | n | (%) | n=6 | n | (%) | n | (%) | n | (%) | n | (%) | |||||||||
| Grade (CTCAEv.3.0) | 1 | 2 | 3 | 4 | Any | 3/4 | 1 | 2 | 3 | 4 | Any | 3/4 | 1 | 2 | 3 | 4 | Any | 3/4 | Any | 3/4 | ||||||||
| Leukocytes | 1 | 2 | 1 | 0 | 4 | 66.7 | 1 | 16.7 | 1 | 2 | 0 | 0 | 3 | 50 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 16.7 | 0 | 0 | 10 | 55.6 | 3 | 16.7 |
| Neutrophils | 0 | 1 | 1 | 0 | 2 | 33.3 | 1 | 16.7 | 3 | 0 | 0 | 0 | 3 | 50 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 16.7 | 1 | 16.7 | 7 | 38.9 | 2 | 11.1 |
| Hemoglobin | 4 | 0 | 2 | 0 | 6 | 100 | 2 | 33.3 | 4 | 0 | 0 | 0 | 4 | 66.7 | 0 | 0 | 0 | 1 | 1 | 0 | 2 | 33.3 | 1 | 16.7 | 12 | 66.7 | 2 | 11.1 |
| Platelets | 2 | 1 | 1 | 1 | 5 | 83.3 | 2 | 33.3 | 4 | 0 | 2 | 0 | 6 | 100 | 2 | 33.3 | 1 | 0 | 0 | 0 | 1 | 16.7 | 0 | 0 | 12 | 66.7 | 4 | 22.2 |
| AST | 5 | 0 | 1 | 0 | 6 | 100 | 1 | 16.7 | 4 | 1 | 1 | 0 | 6 | 100 | 1 | 16.7 | 1 | 0 | 1 | 0 | 2 | 33.3 | 1 | 16.7 | 14 | 77.8 | 3 | 16.7 |
| ALT | 2 | 2 | 0 | 0 | 4 | 66.7 | 0 | 0 | 3 | 1 | 0 | 0 | 4 | 66.7 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 16.7 | 0 | 0 | 9 | 50 | 0 | 0 |
| Amylase | 4 | 0 | 0 | 0 | 4 | 66.7 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 16.7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 27.8 | 0 | 0 |
| Hand-foot skin reaction | 2 | 1 | 0 | 0 | 3 | 50 | 0 | 0 | 2 | 1 | 1 | 0 | 4 | 66.7 | 1 | 16.7 | 3 | 0 | 0 | 0 | 3 | 50 | 0 | 0 | 10 | 55.6 | 1 | 5.6 |
| Hypertension | 2 | 0 | 0 | 0 | 2 | 33.3 | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 33.3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 22.2 | 0 | 0 |
| Diarrhea | 2 | 1 | 0 | 0 | 3 | 50 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 16.7 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 33.3 | 0 | 0 | 6 | 33.3 | 0 | 0 |
| Erythema multiforme | 0 | 0 | 2 | 0 | 2 | 33.3 | 2 | 33.3 | 0 | 0 | 1 | 0 | 1 | 16.7 | 1 | 16.7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 16.7 | 3 | 16.7 |
| Alopecia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 16.7 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 16.7 | 0 | 0 | 2 | 11.1 | 0 | 0 |
| Anorexia | 1 | 0 | 0 | 0 | 1 | 16.7 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 33.3 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 33.3 | 0 | 0 | 5 | 27.8 | 0 | 0 |
| Fatigue | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 33.3 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 16.7 | 0 | 0 | 3 | 16.7 | 0 | 0 |
| Fever | 1 | 0 | 0 | 0 | 1 | 16.7 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 16.7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 11.1 | 0 | 0 |
| Voice changes | 1 | 0 | 0 | 0 | 1 | 16.7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 5.6 | 0 | 0 |
| Headache | 1 | 0 | 0 | 0 | 1 | 16.7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 5.6 | 0 | 0 |
| Hemorrhage, nasal | 2 | 0 | 0 | 0 | 2 | 33.3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 11.1 | 0 | 0 |
| Stomatitis | 0 | 2 | 0 | 0 | 2 | 33.3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 11.1 | 0 | 0 |
| Nausea | 2 | 0 | 0 | 0 | 2 | 33.3 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 16.7 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 16.7 | 0 | 0 | 4 | 22.2 | 0 | 0 |
| Edema | 1 | 0 | 0 | 0 | 1 | 16.7 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 16.7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 11.1 | 0 | 0 |
| Ascites | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 16.7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 5.6 | 0 | 0 |
CTCAE=Common Terminology Criteria for Adverse Events.