Table 3.
Most Common AEs
| AE | Patients for All Grades(N = 47) |
14/21-Day Dosing Cohorts by Grade (mg) |
21/21-Day Dosing by Grade (mg) |
|||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 10-30 (n = 16) |
130 (n = 4) |
225 (n = 3) |
325 (n = 6) |
425 (n = 5) |
475 (n = 3) |
225 (n = 6) |
325 (n = 6) |
|||||||||||
| No. | % | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | |
| Lymphopenia | 2 | 4.3 | 1 (3) | 1 | ||||||||||||||
| Neutropenia | 1 | 2.1 | 1 (3) | 1 | ||||||||||||||
| Thrombocytopenia | 7 | 14.9 | 1 (4) | 1 (4) | 1 (4) | 1 | 1 (3) | 1 | 1 (3) | |||||||||
| Diarrhea | 19 | 40.4 | 2 | 1 | 4 | 4 | 2 | 2 | 4 | |||||||||
| Enteritis | 1 | 2.1 | 1 | |||||||||||||||
| Nausea | 16 | 34 | 2 | 1 | 1 | 1 | 3 | 1 | 2 | 1 | 4 | |||||||
| Vomiting | 17 | 36.2 | 3 | 1 | 3 | 2 | 1 | 1 | 2 | 4 | ||||||||
| Fatigue | 16 | 34 | 2 | 2 (3) | 3 | 2 | 2 (3) | 1 | 3 | 1 | ||||||||
| Decreased appetite | 9 | 19 | 2 | 1 | 2 | 3 | 1 | |||||||||||
| Weight decrease | 2 | 4.3 | 1 | 1 (3) | ||||||||||||||
| Hypophosphataemia | 1 | 2.1 | 1 (3) | |||||||||||||||
| Hemoptysis | 1 | 2.1 | 1 (3) | |||||||||||||||
| Respiratory failure | 1 | 2.1 | 1 (5) | |||||||||||||||
NOTE. All AEs are reported if > 10% or if grade 3, 4, or 5. If grade 3, 4, or 5, the specific grade is reported in parentheses.
Abbreviation: AE, adverse event.