Table 3.
Commonly Occurring Maximum Severity (Grade 3/4) Adverse Events across all cycles of treatment (at least “possibly” attributed to therapy). There were no treatment related deaths.
| NCI CTC CATEGORY * | Frequency (%) (N=20) | |
|---|---|---|
|
| ||
| Grade 3 | Grade 4 | |
|
| ||
| Hematologic | ||
| Lymphopenia | 2 (10) | 1 (5) |
| Leukopenia | 2 (10) | 0 (0) |
| Neutropenia | 1 (5) | 1 (5) |
|
| ||
| GI | ||
| Nausea | 3 (15) | 0 (0) |
| Vomiting | 3 (15) | 0 (0) |
| Anorexia | 2 (10) | 0 (0) |
| Constipation | 2 (10) | 0 (0) |
| Dehydration | 2 (10) | 0 (0) |
| Dyspepsia | 1 (5) | 0 (0) |
| Increased alanine aminotransferase | 1 (5) | 0 (0) |
| Increased alkaline phosphatase | 1 (5) | 0 (0) |
|
| ||
| Miscellaneous | ||
| Thrombosis | 1 (5) | 0 (0) |
| Peripheral edema | 1 (5) | 0 (0) |
| Asthenia | 1 (5) | 0 (0) |
| Abdominal pain | 1 (5) | 0 (0) |
| Fatigue | 1 (5) | 0 (0) |
| Rash | 1 (5) | 0 (0) |
| Syncope | 1 (5) | 0 (0) |
*
NCI CTC Version 3.0