TEAEs leading to dose discontinuation
| Dose disruption . | ||||
|---|---|---|---|---|
| Patient number (n = 9) . | Treatment group Cohort no. or expansion (dose) . | AE term . | Action taken with pralatrexate . | Action taken with CHOP . |
| 1 | Expansion (30 mg/m2) | Anemia | Drug withdrawn | Drug withdrawn |
| 2 | Cohort 5 (30 mg/m2) | Hypovolemic shock | Drug withdrawn | Drug withdrawn |
| 3 | Expansion (30 mg/m2) | Neutrophil count decreased Aspartate aminotransferase increased Febrile neutropenia | Drug withdrawn Drug withdrawn Drug withdrawn | Drug withdrawn Drug withdrawn Drug withdrawn |
| 4 | Expansion (30 mg/m2) | Mucosal inflammation | Drug withdrawn | Dose not changed |
| 5 | Expansion (30 mg/m2) | Abdominal sepsis | Drug withdrawn | Drug withdrawn |
| 6 | Cohort 5 (30 mg/m2) | Neutrophil count decreased | Drug withdrawn | Dose not changed |
| 7 | Expansion (30 mg/m2) | Neutropenia | Drug withdrawn | Drug withdrawn |
| 8 | Expansion (30 mg/m2) | Nausea | Drug withdrawn | Drug withdrawn |
| 9 | Expansion (30 mg/m2) | Confusional state Fatigue | Drug withdrawn | Drug withdrawn |
| Dose disruption . | ||||
|---|---|---|---|---|
| Patient number (n = 9) . | Treatment group Cohort no. or expansion (dose) . | AE term . | Action taken with pralatrexate . | Action taken with CHOP . |
| 1 | Expansion (30 mg/m2) | Anemia | Drug withdrawn | Drug withdrawn |
| 2 | Cohort 5 (30 mg/m2) | Hypovolemic shock | Drug withdrawn | Drug withdrawn |
| 3 | Expansion (30 mg/m2) | Neutrophil count decreased Aspartate aminotransferase increased Febrile neutropenia | Drug withdrawn Drug withdrawn Drug withdrawn | Drug withdrawn Drug withdrawn Drug withdrawn |
| 4 | Expansion (30 mg/m2) | Mucosal inflammation | Drug withdrawn | Dose not changed |
| 5 | Expansion (30 mg/m2) | Abdominal sepsis | Drug withdrawn | Drug withdrawn |
| 6 | Cohort 5 (30 mg/m2) | Neutrophil count decreased | Drug withdrawn | Dose not changed |
| 7 | Expansion (30 mg/m2) | Neutropenia | Drug withdrawn | Drug withdrawn |
| 8 | Expansion (30 mg/m2) | Nausea | Drug withdrawn | Drug withdrawn |
| 9 | Expansion (30 mg/m2) | Confusional state Fatigue | Drug withdrawn | Drug withdrawn |