Table 3.

Patients with at least one grade 3 or 4 adverse effect classified by CTC criteria and NCI criteria according to randomization group




Fludarabine

FC

P
No. patients   173   173   
CTC grades 3 and 4, %    
   All grades 3 and 4 toxicities   54.0   72.6   .001  
   Myelotoxicity   39.3   64.2   .001  
   Leukocytopenia   26.0   55.5   < .001  
   Anemia   11.6   8.1   .28  
   AIHA   3.8   2.2   .37  
   Thrombocytopenia   12.7   15.6   .44  
   Infection   8.7   8.7   >.999  
   Gastrointestinal adverse effects   1.7   5.8   .05  
NCI grades 3 and 4, %    
   Anemia   5.2   2.4   .17  
   Thrombocytopenia
 
23.3
 
34.9
 
.02
 



Fludarabine

FC

P
No. patients   173   173   
CTC grades 3 and 4, %    
   All grades 3 and 4 toxicities   54.0   72.6   .001  
   Myelotoxicity   39.3   64.2   .001  
   Leukocytopenia   26.0   55.5   < .001  
   Anemia   11.6   8.1   .28  
   AIHA   3.8   2.2   .37  
   Thrombocytopenia   12.7   15.6   .44  
   Infection   8.7   8.7   >.999  
   Gastrointestinal adverse effects   1.7   5.8   .05  
NCI grades 3 and 4, %    
   Anemia   5.2   2.4   .17  
   Thrombocytopenia
 
23.3
 
34.9
 
.02
 

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