Table 2:
Definitions of dose-limiting toxicity.
| Overview of DLT | |
| Non-hematologic toxicity (CTCAE) | |
| Grade 3 | Severe/medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care. |
| Grade 4 | Life-threatening consequences; urgent intervention indicated. Excluded: Fatigue, controllable nausea, vomiting, abdominal pain, and diarrhea. |
| Thrombocytopenia (CTCAE) | |
| Grade 4 | 25–50×10³/µl |
| Neutropenia (CTCAE) | |
| Grade 4 | 0.5 –1×10³/µl; lasting more than 7 days OR associated with fever |
| Failure to perform more than one PIPAC due to toxicity | |
| Surgical complication (Dindo-Clavien) | |
| Grade IIIB | Intervention under general anesthesia |
| Grade IV | Life-threatening complication (incl. central nervous system complications) requiring intensive care management |
| Grade IVa | Single-organ dysfunction (including dialysis) |
| Grade IVb | Multiorgan dysfunction (including dialysis) |
| Grade IVc | Death of a patient |