Table II.
Summary of adverse events by dTCApFs dose group.
| dTCApFs dose, mg/m2 | |||||
|---|---|---|---|---|---|
| Adverse events | 6 (n=3) | 12 (n=3) | 24 (n=3) | 48 (n=3) | 96 (n=5) |
| Grade 1 | |||||
| Blood disorders | |||||
| Anemia | 3 | 0 | 0 | 0 | 0 |
| Increased INR | 0 | 0 | 0 | 1 | 0 |
| GI disorders | |||||
| Abdominal pain | 0 | 1 | 2 | 0 | 0 |
| Bowel obstruction | 1 | 0 | 0 | 0 | 0 |
| Diarrhea | 0 | 2 | 0 | 0 | 2 |
| GI hemorrhage | 1 | 0 | 0 | 0 | 0 |
| Vomiting | 2 | 0 | 0 | 0 | 1 |
| General disorders | |||||
| Dehydration | 0 | 0 | 0 | 0 | 1 |
| Fatigue | 0 | 1 | 0 | 1 | 0 |
| Hypertension | 3 | 1 | 1 | 0 | 1 |
| Nervous system disorders | |||||
| Neuropathy | 0 | 1 | 1 | 0 | 0 |
| Grade 2 | |||||
| Pain | |||||
| Pain, leg | 0 | 2 | 0 | 0 | 0 |
| Pain, upper back | 0 | 0 | 0 | 0 | 1 |
| Respiratory system disorders | |||||
| Cough | 0 | 1 | 0 | 0 | 0 |
| Skin disorders | |||||
| Pruritus | 0 | 0 | 0 | 0 | 1 |
| Urticaria | 0 | 0 | 0 | 0 | 1 |
| Hepatic and urinary disorders | |||||
| ALT increase | 0 | 0 | 0 | 0 | 1 |
| AST increase | 0 | 0 | 0 | 0 | 1 |
| Bilirubin increase | 0 | 0 | 0 | 1 | 1 |
| Liver dysfunction | 0 | 0 | 0 | 0 | 1 |
| Urinary tract infection | 0 | 1 | 0 | 0 | 0 |
| Grade 3 | |||||
| Blood disorders | |||||
| Increased INR | 0 | 0 | 0 | 1 | 0 |
| General disorders | |||||
| Hypertension | 2 | 1 | 1 | 0 | 2 |
| Hepatic and urinary disorders | |||||
| Bilirubin increase | 0 | 0 | 0 | 1 | 1 |
| GI disorders | |||||
| Bowel obstruction | 1 | 0 | 0 | 0 | 0 |
| Diarrhea | 0 | 1 | 0 | 0 | 1 |
| GI hemorrhage | 1 | 0 | 0 | 0 | 0 |
| Grade 4 | |||||
| GI disorders | |||||
| Vomiting | 0 | 0 | 0 | 0 | 1 |
ALT, alanine transaminase; AST, aspartate aminotransferase; GI, gastrointestinal; INR, international normalized ratio.