Toxicity and resource usage by randomization arm
Toxicity . | LDAC . | Clofarabine . | P 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 |
Toxicity . | LDAC . | Clofarabine . | P 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.