Table 4

Toxicity and resource usage by randomization arm

ToxicityLDACClofarabineP value
% grade 3-4 (mean grade)% grade 3-4 (mean grade)
Course 1    
 Nausea 4% (0.5) 9% (0.9) <.0001 
 Oral 5% (0.5) 7% (0.8) 1.0 
 Diarrhea 0% (0.4) 4% (0.4) <.0001 
 Cardiac 6% (0.3) 8% (0.5) .005 
 Liver AST 3% (0.3) 7% (0.6) .16 
 Liver ALT 3% (0.4) 9% (1.0) <.0001 
 Bilirubin 3% (0.5) 7% (1.1) <.0001 
 Mean blood units 5.9 8.9 <.0001 
 Mean platelet units 3.6 7.2 <.0001 
 Mean days on antibiotics 7.1 11.6 <.0001 
 Mean nights in hospital 13.4 20.3 <.0001 
Course 2    
 Nausea 0% (0.4) 2% (0.7) .0004 
 Oral 2% (0.2) 6% (0.5) .02 
 Diarrhea 1% (0.4) 1% (0.2) .02 
 Cardiac 1% (0.1) 2% (0.2) .4 
 Liver AST 0% (0.2) 12% (0.9) .0002 
 Liver ALT 1% (0.3) 9% (0.9) <.0001 
 Bilirubin 1% (0.3) 1% (0.6) .0001 
 Mean blood units 5.4 6.0 .12 
 Mean platelet units 2.7 4.1 .004 
 Mean days on antibiotics 3.7 6.6 .002 
 Mean nights in hospital 9.2 12.3 .003 
ToxicityLDACClofarabineP value
% grade 3-4 (mean grade)% grade 3-4 (mean grade)
Course 1    
 Nausea 4% (0.5) 9% (0.9) <.0001 
 Oral 5% (0.5) 7% (0.8) 1.0 
 Diarrhea 0% (0.4) 4% (0.4) <.0001 
 Cardiac 6% (0.3) 8% (0.5) .005 
 Liver AST 3% (0.3) 7% (0.6) .16 
 Liver ALT 3% (0.4) 9% (1.0) <.0001 
 Bilirubin 3% (0.5) 7% (1.1) <.0001 
 Mean blood units 5.9 8.9 <.0001 
 Mean platelet units 3.6 7.2 <.0001 
 Mean days on antibiotics 7.1 11.6 <.0001 
 Mean nights in hospital 13.4 20.3 <.0001 
Course 2    
 Nausea 0% (0.4) 2% (0.7) .0004 
 Oral 2% (0.2) 6% (0.5) .02 
 Diarrhea 1% (0.4) 1% (0.2) .02 
 Cardiac 1% (0.1) 2% (0.2) .4 
 Liver AST 0% (0.2) 12% (0.9) .0002 
 Liver ALT 1% (0.3) 9% (0.9) <.0001 
 Bilirubin 1% (0.3) 1% (0.6) .0001 
 Mean blood units 5.4 6.0 .12 
 Mean platelet units 2.7 4.1 .004 
 Mean days on antibiotics 3.7 6.6 .002 
 Mean nights in hospital 9.2 12.3 .003 

ALT, alanine transaminase; AST, aspartate transaminase.

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