Table 2.
Dose-limiting toxicity
| Regimen | Dose | Number of DLT evaluable patients | Number of patients who experienced a DLT | DLT | Grade |
|---|---|---|---|---|---|
| QD | 4 mg/day | 3 | 0 | – | – |
| 8 mg/day | 6 | 0 | – | – | |
| 10 mg/day | 6 | 1 | Drug-induced liver injury | G3 | |
| 12 mg/day | 3 | 2 | Platelet count decreased | G4 | |
| Urticaria | G3 | ||||
| 16 mg/day | 3 | 2 | Urticaria | G3 | |
| Interstitial lung diseasea | G3 | ||||
| BID | 8 mg/day | 6 | 1 | Interstitial lung diseasea | G3 |
| 12 mg/day | 5 | 2 | Interstitial lung diseasea | G3 | |
| Platelet count decreased | G3 | ||||
| Left ventricular failure | G3 |
BID twice daily, DLT dose-limiting toxicity, QD once daily
aInterstitial lung disease included lung disorder and pneumonitis