Toxicity summary by grade per Bearman criteria
Organ . | DL1: 5 mg (d +60) (n = 3) . | DL1: 5 mg (d +45) (n = 3) . | DL2: 10 mg (d +45) (n = 12) . | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
1 . | 2 . | 3 . | 4 . | 1 . | 2 . | 3 . | 4 . | 1 . | 2 . | 3 . | 4 . | |
Bladder | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
Cardiac | 0 | 0 | 1* | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 |
CNS | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 |
GI | 2 | 0 | 1* | 0 | 2 | 0 | 0 | 0 | 9 | 0 | 0 | 0 |
Hepatic | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Pulmonary | 1 | 0 | 0 | 1* | 0 | 0 | 0 | 0 | 4 | 2 | 0 | 0 |
Renal | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 2 | 1* | 0 |
Stomatitis | 3 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 6 | 2 | 0 | 0 |
Organ . | DL1: 5 mg (d +60) (n = 3) . | DL1: 5 mg (d +45) (n = 3) . | DL2: 10 mg (d +45) (n = 12) . | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
1 . | 2 . | 3 . | 4 . | 1 . | 2 . | 3 . | 4 . | 1 . | 2 . | 3 . | 4 . | |
Bladder | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
Cardiac | 0 | 0 | 1* | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 |
CNS | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 |
GI | 2 | 0 | 1* | 0 | 2 | 0 | 0 | 0 | 9 | 0 | 0 | 0 |
Hepatic | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Pulmonary | 1 | 0 | 0 | 1* | 0 | 0 | 0 | 0 | 4 | 2 | 0 | 0 |
Renal | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 2 | 1* | 0 |
Stomatitis | 3 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 6 | 2 | 0 | 0 |
First 3 patients at DL1 were followed for DLTs until d +60 posttransplantation. The remaining patients were followed for DLTs for 45 d after transplantation.
CNS, central nervous system; GI, gastrointestinal.
DLT.