Table 2.
Discontinuations for patients receiving placebo or palifermin
Palifermin
|
||||||
---|---|---|---|---|---|---|
Cohort 1
|
Cohort 2
|
Cohort 3
|
||||
Placebo | 40 μg/kg or 240 μg/kg total dose | 60 μg/kg or 360 μg/kg total dose | 60 μg/kg or 540 μg/kg total dose | 60 μg/kg or 720 μg/kg total dose | All | |
Patients randomly assigned, no. | 31 | 8 | 10 | 14 | 37 | 69 |
Patients discontinued and replaced, no. (%) | 1 (3) | 1 (13) | 0 | 2 (14) | 14 (38) | 17 (25) |
Patients with DLT who discontinued and were not replaced, no. (%) | 1 (3) | 0 | 0 | 2 (14) | 1 (3) | 3 (4) |
Deaths of patients who received a transplant, no. (%) | 5 (16) | 2 (25)* | 1 (10) | 3 (21) | 6 (17)* | 12 (18) |
One patient was replaced.