Comparison of incidence of selected nonhematological toxicities among patients with and without DS randomized to MTX regimens
| . | PO MTX . | IV MTX . | DS patients . | Non-DS patients . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DS, % . | Non-DS, % . | P . | DS, % . | Non-DS, % . | P . | PO, % . | IV, % . | P . | PO, % . | IV, % . | P . | |
| ALT (grades 3/4) | ||||||||||||
| IM #1 | 16.3 | 17.1 | .70 | 12.9 | 7.6 | .48 | 16.3 | 12.9 | .69 | 17.1 | 7.6 | <.001 |
| IM #2 | 7.5 | 13.9 | .40 | 6.9 | 8.6 | .84 | 7.5 | 6.9 | .66 | 13.9 | 8.6 | .001 |
| Infection with neutropenia (grades 3/4) | ||||||||||||
| IM #1 | 4.7 | 2.6 | .43 | 0 | 2.3 | .39 | 4.7 | 0 | .22 | 2.6 | 2.3 | .66 |
| IM #2 | 5.0 | 3.9 | .72 | 0 | 1.5 | .51 | 5 | 0 | .22 | 3.9 | 1.5 | .001 |
| Leukoencephalopathy (all grades) | ||||||||||||
| IM #1 | 0 | 0.2 | .96 | 0 | 0.4 | .94 | 0 | 0 | — | 0.2 | 0.4 | .61 |
| IM #2 | 0 | 0.1 | .84 | 0 | 0.5 | .93 | 0 | 0 | — | 0.1 | 0.5 | .25 |
| Mucositis (grades 3/4) | ||||||||||||
| IM #1 | 2.3 | 0.6 | .30 | 29.0 | 3.4 | <.001 | 2.3 | 29.0 | .004 | 0.6 | 3.4 | <.001 |
| IM #2 | 10 | 0.6 | <.001 | 27.6 | 4.1 | <.001 | 10 | 27.6 | .13 | 0.6 | 4.1 | <.001 |
| Seizures (all grades) | ||||||||||||
| IM #1 | 0 | 0.1 | .83 | 3.2 | 1.2 | .55 | 0 | 3.2 | .24 | 0.1 | 1.2 | .02 |
| IM #2 | 0 | 0.1 | .84 | 0 | 0.8 | .89 | 0 | 0 | — | 0.1 | 0.8 | .05 |
| . | PO MTX . | IV MTX . | DS patients . | Non-DS patients . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DS, % . | Non-DS, % . | P . | DS, % . | Non-DS, % . | P . | PO, % . | IV, % . | P . | PO, % . | IV, % . | P . | |
| ALT (grades 3/4) | ||||||||||||
| IM #1 | 16.3 | 17.1 | .70 | 12.9 | 7.6 | .48 | 16.3 | 12.9 | .69 | 17.1 | 7.6 | <.001 |
| IM #2 | 7.5 | 13.9 | .40 | 6.9 | 8.6 | .84 | 7.5 | 6.9 | .66 | 13.9 | 8.6 | .001 |
| Infection with neutropenia (grades 3/4) | ||||||||||||
| IM #1 | 4.7 | 2.6 | .43 | 0 | 2.3 | .39 | 4.7 | 0 | .22 | 2.6 | 2.3 | .66 |
| IM #2 | 5.0 | 3.9 | .72 | 0 | 1.5 | .51 | 5 | 0 | .22 | 3.9 | 1.5 | .001 |
| Leukoencephalopathy (all grades) | ||||||||||||
| IM #1 | 0 | 0.2 | .96 | 0 | 0.4 | .94 | 0 | 0 | — | 0.2 | 0.4 | .61 |
| IM #2 | 0 | 0.1 | .84 | 0 | 0.5 | .93 | 0 | 0 | — | 0.1 | 0.5 | .25 |
| Mucositis (grades 3/4) | ||||||||||||
| IM #1 | 2.3 | 0.6 | .30 | 29.0 | 3.4 | <.001 | 2.3 | 29.0 | .004 | 0.6 | 3.4 | <.001 |
| IM #2 | 10 | 0.6 | <.001 | 27.6 | 4.1 | <.001 | 10 | 27.6 | .13 | 0.6 | 4.1 | <.001 |
| Seizures (all grades) | ||||||||||||
| IM #1 | 0 | 0.1 | .83 | 3.2 | 1.2 | .55 | 0 | 3.2 | .24 | 0.1 | 1.2 | .02 |
| IM #2 | 0 | 0.1 | .84 | 0 | 0.8 | .89 | 0 | 0 | — | 0.1 | 0.8 | .05 |
—, not calculated; ALT, alanine aminotransferase.