Treatment-related adverse events during salvage therapy
| Events . | Phase 2 (N = 55) . | |||||
|---|---|---|---|---|---|---|
| Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . | Total . | |
| Hematologic | ||||||
| Neutropenia | 6 | 10 | 14 | 9 | — | 33 |
| Thrombocytopenia | 15 | 5 | 3 | 3 | — | 26 |
| Anemia | 10 | 22 | 5 | — | — | 37 |
| Nonhematologic | ||||||
| Cardiologic | — | 3 | — | 1 | — | 4 |
| Ischemia | — | — | — | 1 | — | 1 |
| Arrhythmia | — | 3 | — | — | — | 3 |
| Neurologic | 11 | 6 | 3 | 1 | — | 21 |
| Sensory neuropathy | 6 | 2 | — | — | — | 8 |
| Neuralgia | 2 | 1 | 1 | — | — | 4 |
| Motor neuropathy | — | — | 1 | — | — | 1 |
| Tremor | — | 1 | — | — | — | 1 |
| Confusion | — | 1 | — | 1 | — | 2 |
| Mood depression | — | 1 | — | — | — | 1 |
| Other | 3 | — | 1 | — | — | 4 |
| Infective | 5 | 14 | 3 | 0 | 2 | 24 |
| Upper respiratory | 2 | 5 | — | — | — | 7 |
| Pneumonia | 2 | 5 | 3 | — | 1 | 11 |
| Sepsis | — | — | — | — | 1 | 1 |
| Other | 1 | 4 | — | — | — | 5 |
| Gastrointestinal | 3 | 7 | 1 | 0 | — | 11 |
| Diarrhea | 1 | — | — | — | — | 1 |
| Constipation | — | 5 | — | — | — | 5 |
| Nausea/Vomiting | 1 | — | — | — | — | 1 |
| Other | 1 | 2 | 1 | — | — | 4 |
| Hepatic/pancreatic | 2 | 2 | 1 | 0 | — | 5 |
| Increased transaminase | 2 | 1 | — | — | — | 3 |
| Liver failure | — | — | 1 | — | — | 1 |
| Pancreatitis | — | 1 | — | — | — | 1 |
| Vascular | 1 | 1 | 0 | 1 | — | 3 |
| Deep-vein thrombosis | — | 1 | — | 1 | — | 2 |
| Phlebitis | 1 | — | — | — | — | 1 |
| Systemic | 8 | 8 | 2 | 0 | — | 18 |
| Fatigue | 5 | 7 | 2 | — | — | 14 |
| Fever | 2 | — | — | — | — | 2 |
| Drowsiness | 1 | — | — | — | — | 1 |
| Weight gain | — | 1 | — | — | — | 1 |
| Dermatologic | — | 3 | 4 | 0 | — | 7 |
| Rash | — | 2 | 4 | — | — | 6 |
| Other | — | 1 | — | — | — | 1 |
| Other | 7 | 6 | 3 | — | — | 16 |
| Events . | Phase 2 (N = 55) . | |||||
|---|---|---|---|---|---|---|
| Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . | Total . | |
| Hematologic | ||||||
| Neutropenia | 6 | 10 | 14 | 9 | — | 33 |
| Thrombocytopenia | 15 | 5 | 3 | 3 | — | 26 |
| Anemia | 10 | 22 | 5 | — | — | 37 |
| Nonhematologic | ||||||
| Cardiologic | — | 3 | — | 1 | — | 4 |
| Ischemia | — | — | — | 1 | — | 1 |
| Arrhythmia | — | 3 | — | — | — | 3 |
| Neurologic | 11 | 6 | 3 | 1 | — | 21 |
| Sensory neuropathy | 6 | 2 | — | — | — | 8 |
| Neuralgia | 2 | 1 | 1 | — | — | 4 |
| Motor neuropathy | — | — | 1 | — | — | 1 |
| Tremor | — | 1 | — | — | — | 1 |
| Confusion | — | 1 | — | 1 | — | 2 |
| Mood depression | — | 1 | — | — | — | 1 |
| Other | 3 | — | 1 | — | — | 4 |
| Infective | 5 | 14 | 3 | 0 | 2 | 24 |
| Upper respiratory | 2 | 5 | — | — | — | 7 |
| Pneumonia | 2 | 5 | 3 | — | 1 | 11 |
| Sepsis | — | — | — | — | 1 | 1 |
| Other | 1 | 4 | — | — | — | 5 |
| Gastrointestinal | 3 | 7 | 1 | 0 | — | 11 |
| Diarrhea | 1 | — | — | — | — | 1 |
| Constipation | — | 5 | — | — | — | 5 |
| Nausea/Vomiting | 1 | — | — | — | — | 1 |
| Other | 1 | 2 | 1 | — | — | 4 |
| Hepatic/pancreatic | 2 | 2 | 1 | 0 | — | 5 |
| Increased transaminase | 2 | 1 | — | — | — | 3 |
| Liver failure | — | — | 1 | — | — | 1 |
| Pancreatitis | — | 1 | — | — | — | 1 |
| Vascular | 1 | 1 | 0 | 1 | — | 3 |
| Deep-vein thrombosis | — | 1 | — | 1 | — | 2 |
| Phlebitis | 1 | — | — | — | — | 1 |
| Systemic | 8 | 8 | 2 | 0 | — | 18 |
| Fatigue | 5 | 7 | 2 | — | — | 14 |
| Fever | 2 | — | — | — | — | 2 |
| Drowsiness | 1 | — | — | — | — | 1 |
| Weight gain | — | 1 | — | — | — | 1 |
| Dermatologic | — | 3 | 4 | 0 | — | 7 |
| Rash | — | 2 | 4 | — | — | 6 |
| Other | — | 1 | — | — | — | 1 |
| Other | 7 | 6 | 3 | — | — | 16 |