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)
 



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.

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