Frequency of adverse events seen at the Phase 2 dose of 50 mg/m2, considered at least possibly related to treatment and seen in ≥2 patients
Toxicity . | Grade . | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
1 . | 2 . | 3 . | 4 . | All . | ||||||
N . | % . | N . | % . | N . | % . | N . | % . | N . | % . | |
Thrombocytopenia | 4 | 26.7 | 4 | 26.7 | 1 | 6.7 | 9 | 60.0 | ||
Leukopenia | 2 | 13.3 | 1 | 6.7 | 1 | 6.7 | 4 | 26.7 | ||
Neutropenia | 1 | 6.7 | 1 | 6.7 | 1 | 6.7 | 1 | 6.7 | 4 | 26.7 |
Lymphopenia | 4 | 26.7 | 4 | 26.7 | ||||||
Diarrhea | 9 | 60.0 | 2 | 13.3 | 1 | 6.7 | 1 | 6.7 | 13 | 86.7 |
Nausea | 6 | 40.0 | 2 | 13.3 | 8 | 53.3 | ||||
Vomiting | 4 | 26.7 | 1 | 6.7 | 5 | 33.3 | ||||
Fatigue | 5 | 33.3 | 4 | 26.7 | 1 | 6.7 | 10 | 66.7 | ||
Aspartate aminotransferase increased | 3 | 20.0 | 3 | 20.0 | ||||||
Alanine aminotransferase increased | 2 | 13.3 | 2 | 13.3 | ||||||
Peripheral sensory neuropathy | 2 | 13.3 | 2 | 13.3 | ||||||
Vision blurred | 1 | 6.7 | 1 | 6.7 | 2 | 13.3 | ||||
Hypotension | 2 | 13.3 | 2 | 13.3 | ||||||
Pruritus | 2 | 13.3 | 2 | 13.3 | ||||||
Dry eye syndrome | 1 | 6.7 | 1 | 6.7 |
Toxicity . | Grade . | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
1 . | 2 . | 3 . | 4 . | All . | ||||||
N . | % . | N . | % . | N . | % . | N . | % . | N . | % . | |
Thrombocytopenia | 4 | 26.7 | 4 | 26.7 | 1 | 6.7 | 9 | 60.0 | ||
Leukopenia | 2 | 13.3 | 1 | 6.7 | 1 | 6.7 | 4 | 26.7 | ||
Neutropenia | 1 | 6.7 | 1 | 6.7 | 1 | 6.7 | 1 | 6.7 | 4 | 26.7 |
Lymphopenia | 4 | 26.7 | 4 | 26.7 | ||||||
Diarrhea | 9 | 60.0 | 2 | 13.3 | 1 | 6.7 | 1 | 6.7 | 13 | 86.7 |
Nausea | 6 | 40.0 | 2 | 13.3 | 8 | 53.3 | ||||
Vomiting | 4 | 26.7 | 1 | 6.7 | 5 | 33.3 | ||||
Fatigue | 5 | 33.3 | 4 | 26.7 | 1 | 6.7 | 10 | 66.7 | ||
Aspartate aminotransferase increased | 3 | 20.0 | 3 | 20.0 | ||||||
Alanine aminotransferase increased | 2 | 13.3 | 2 | 13.3 | ||||||
Peripheral sensory neuropathy | 2 | 13.3 | 2 | 13.3 | ||||||
Vision blurred | 1 | 6.7 | 1 | 6.7 | 2 | 13.3 | ||||
Hypotension | 2 | 13.3 | 2 | 13.3 | ||||||
Pruritus | 2 | 13.3 | 2 | 13.3 | ||||||
Dry eye syndrome | 1 | 6.7 | 1 | 6.7 |