Table A2.
Summary of AEs With at Least 10% Incidence (all grades or any grade 3 or 4) Deemed Related (definite, probable, possible) to Protocol Therapy, Cohorts 1 and 2 Combined
| AE | Maximum Grade |
|||
|---|---|---|---|---|
| Total | 1 (mild) | 2 (moderate) | 3 (severe) | |
| Diarrhea without prior colostomy | 55 | 41 | 8 | 6 |
| Fatigue | 45 | 38 | 6 | 1 |
| Acne/acneiform rash | 35 | 21 | 14 | 0 |
| Nausea | 22 | 21 | 1 | 0 |
| AST | 21 | 17 | 4 | 0 |
| Hyperglycemia | 14 | 13 | 1 | 0 |
| Anorexia | 13 | 11 | 2 | 0 |
| Vomiting | 12 | 10 | 2 | 0 |
| ALT | 10 | 6 | 4 | 0 |
| Nail changes | 10 | 7 | 3 | 0 |
| Headache | 9 | 8 | 1 | 0 |
| Hemoglobin | 9 | 8 | 1 | 0 |
| Mucositis/stomatitis by examination of oral cavity | 9 | 7 | 2 | 0 |
| Rash/desquamation | 9 | 6 | 3 | 0 |
| GI, other | 1 | 0 | 0 | 1 |
| Hypokalemia | 1 | 0 | 0 | 1 |
NOTE. All patients who received at least one dose of protocol therapy were included in this analysis (n = 86). No grade 4 toxicities were reported on study.
Abbreviation: AE, adverse event.