Toxicity | Grade 1-2 | Grade 3 | Grade 4 | Grade 5 |
---|---|---|---|---|
Dose Level #1* (N = 6) | ||||
Neutropenia | 1 | 2 | 1 †† | --- |
Thrombocytopenia | 1 | 1 | 1 †† | --- |
Anemia | 3 | 1 | --- | --- |
Esophagitis | 3 | 1 | --- | --- |
Pneumonitis | 2 | 1 | --- | --- |
Sepsis | -- | -- | 1 †† | -- |
Fatigue | 4 | -- | --- | --- |
Elevated LFT's | 4 | 1 †† | --- | --- |
Elevated Creatinine | 1 | -- | --- | --- |
Worst Toxicity Overall | 2 | 3 | 1 | --- |
Worst non-heme Toxicity Overall | 4 | 1 | 1 | --- |
Dose Level #1A* (N = 8) | ||||
Neutropenia | 4 | 3 | 1 | --- |
Thrombocytopenia | 2 | 1 | --- | --- |
Anemia | 6 | 1 | --- | --- |
Esophagitis | 5 | 2 | --- | --- |
Pneumonitis | 3 | --- | --- | 1 § |
Sepsis | --- | --- | --- | --- |
Fatigue | 5 | --- | 1 § | --- |
Elevated LFT's | 1 | --- | --- | --- |
Elevated Creatinine | 1 | --- | --- | --- |
Worst Toxicity Overall | 3 | 3 | --- | 1 |
Worst non-heme Toxicity Overall | 4 | 1 | --- | 1 |
--- | ||||
Overall Study Population (N = 16) † | ||||
Neutropenia | 5 | 5 | 2 | --- |
Thrombocytopenia | 3 | 2 | 1 †† | --- |
Anemia | 9 | 2 | --- | --- |
Esophagitis | 8 | 3 | --- | --- |
Pneumonitis | 5 | 1 | --- | 1 § |
Fatigue | 9 | 0 | 1 | --- |
Elevated LFT's | 5 | 1 | --- | --- |
Elevated Creatinine | 2 | --- | --- | --- |
Worst Toxicity Overall | 5 | 6 | 1 †† | 1 § |
Worst non-heme Toxicity Overall | 8 | 2 | 1 †† | 1 § |