Table 3.
Adverse events (including SAEs) during chemo(radio)therapy: highest grade reported per patient
| Grade 1/2 | Grade 3 | Grade 4 | |
|---|---|---|---|
| Hematologic toxicity | |||
| Anemia | 2 (3.6) | 1 (1.8) | |
| Leukopenia | 2 (3.6) | ||
| Neutropenia | 3 (5.5) | 2 (3.6) | |
| Thrombocytopenia | 2 (3.6) | ||
| Gastrointestinal toxicity | |||
| Anorexia | 1 (1.8) | ||
| Diarrhea | 22 (40.0) | 2 (3.6) | |
| Nausea | 8 (14.5) | ||
| Vomiting | 1 (1.8) | ||
| Constipation | 4 (7.3) | ||
| Rectal tenesmus | 1 (1.8) | ||
| Rectal bleeding | 2 (3.6) | ||
| Rectal/anal pain | 8 (14.5) | ||
| General toxicity | |||
| Asthenia | 8 (14.5) | ||
| Cardiac toxicity | 1 (1.8) | ||
| Erythema | 3 (5.5) | ||
| Infection | 3 (5.5) | ||
| Liver hepatic toxicity | 1 (1.8) | ||
| Nervous system disorders | 1 (1.8) | ||
| Pain | 1 (1.8) | ||
| Pruritus | 1 (1.8) | ||
| Skin toxicity | 2 (3.6) | 2 (3.6) | |
| Stomatitis | 2 (3.6) | ||
| Lipase/amylase increase | 1 (1.8) | ||
| Lower urinary tract disorder | 5 (9.1) | ||
| AST/ALT increase | 1 (1.8) | ||
| Hypokalemia | 1 (1.8) | 1 (1.8) | |
| Other | 10 (18.2) |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; SAE, serious adverse event.