Table 4.

Effect of palifermin and methotrexate on oral mucositis severity



Maximum grade of oral mucositis, no. (%)


0
1
2
3
4
P*
Palifermin       .42  
    With methotrexate on day 11   4 (8)   4 (8)   8 (16)   33 (67)   0 (0)   
    Without methotrexate on day 11   1 (6)   3 (19)   2 (13)   10 (63)   0 (0)   
Placebo       
    With methotrexate on day 11   0 (0)   0 (0)   7 (27)   18 (69)   1 (4)   
    Without methotrexate on day 11
 
0 (0)
 
0 (0)
 
0 (0)
 
4 (80)
 
1 (20)
 

 


Maximum grade of oral mucositis, no. (%)


0
1
2
3
4
P*
Palifermin       .42  
    With methotrexate on day 11   4 (8)   4 (8)   8 (16)   33 (67)   0 (0)   
    Without methotrexate on day 11   1 (6)   3 (19)   2 (13)   10 (63)   0 (0)   
Placebo       
    With methotrexate on day 11   0 (0)   0 (0)   7 (27)   18 (69)   1 (4)   
    Without methotrexate on day 11
 
0 (0)
 
0 (0)
 
0 (0)
 
4 (80)
 
1 (20)
 

 
*

P value is comparison of grades 0 to 2 versus 3 to 4 in groups with or without day 11 methotrexate by palifermin versus placebo.

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