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 |