Table 3.
Criteria for drug withdrawal and re-administration
| Drug withdrawal | |
| Neutrophil | Level 3 or 4 |
| Platelet | Level 3 or 4 |
| Serum creatinine | 1.5 times over the upper limit of normal value (44–132 μM) |
| Infection | Infectious fever with temperature > 38 °C |
| Diarrhea, mouth ulcers | Level 3 or 4 |
| Others | When adverse reactions occur in addition to the above, and the investigators cannot judge whether drug administration can be continued or not, the drug will be discontinued |
| Drug re-administration | |
| Neutrophil | > 1.0 × 109/L |
| Platelet | > 50 × 109/L |
| Serum creatinine | < the upper limit of normal value (44–132 μM) |
| Infection | No infectious fever |
| Diarrhea, mouth ulcers | ≤ Level 1 |
| Others | When adverse reactions leading to drug withdrawal are alleviated or disappear, the administration can be resumed as determined by the investigators |
Drug withdrawal and re-administration will be assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 430