Characteristics of randomized patients with and without DS
| . | DS . | Total DS, n = 75 . | Non-DS, n = 2003 . | P* . | ||
|---|---|---|---|---|---|---|
| PO MTX, n = 44 . | IV MTX, n = 31 . | P* . | ||||
| Age at diagnosis, y | ||||||
| <2 | 2 | 0 | .33 | 2 | 184 | .07 | 
| 2-5 | 32 | 20 | 52 | 1393 | ||
| 6-9 | 10 | 11 | 21 | 426 | ||
| Sex | ||||||
| Female | 24 | 13 | .28 | 37 | 1110 | .30 | 
| Male | 20 | 18 | 38 | 893 | ||
| WBC | ||||||
| <20 × 109/L | 36 | 29 | .18 | 65 | 1659 | .39 | 
| ≥20 × 109/L | 8 | 2 | 10 | 343 | ||
| Unknown/missing | 0 | 0 | 0 | 1 | ||
| CNS status | ||||||
| CNS-1 | 39 | 27 | .64 | 66 | 1772 | .99 | 
| CNS-2 | 2 | 1 | 3 | 99 | ||
| CNS-3 | 0 | 0 | 0 | 5 | ||
| Unknown/missing | 3 | 3 | 6 | 127 | ||
| Cytogenetics | ||||||
| ETV6-RUNX1† | 1 | 0 | .99 | 1 | 357 | <.001 | 
| Double trisomies 4 and 10‡ | 5 | 1 | .39 | 6 | 244 | .27 | 
| BM day 7 | ||||||
| M1 | 28 | 18 | .64 | 46 | 900 | .016 | 
| M2 | 6 | 7 | 13 | 599 | ||
| M3 | 8 | 6 | 14 | 424 | ||
| Uninterpretable | 2 | 0 | 2 | 35 | ||
| Not done/missing | 0 | 0 | 0 | 45 | ||
| BM day 14 | ||||||
| M1 | 18 | 13 | — | 31 | 1065 | .99 | 
| M2 | 0 | 0 | 0 | 31 | ||
| M3 | 0 | 0 | 0 | 0 | ||
| Uninterpretable | 0 | 0 | 0 | 1 | ||
| Not done/missing | 26 | 18 | 44 | 905 | ||
| . | DS . | Total DS, n = 75 . | Non-DS, n = 2003 . | P* . | ||
|---|---|---|---|---|---|---|
| PO MTX, n = 44 . | IV MTX, n = 31 . | P* . | ||||
| Age at diagnosis, y | ||||||
| <2 | 2 | 0 | .33 | 2 | 184 | .07 | 
| 2-5 | 32 | 20 | 52 | 1393 | ||
| 6-9 | 10 | 11 | 21 | 426 | ||
| Sex | ||||||
| Female | 24 | 13 | .28 | 37 | 1110 | .30 | 
| Male | 20 | 18 | 38 | 893 | ||
| WBC | ||||||
| <20 × 109/L | 36 | 29 | .18 | 65 | 1659 | .39 | 
| ≥20 × 109/L | 8 | 2 | 10 | 343 | ||
| Unknown/missing | 0 | 0 | 0 | 1 | ||
| CNS status | ||||||
| CNS-1 | 39 | 27 | .64 | 66 | 1772 | .99 | 
| CNS-2 | 2 | 1 | 3 | 99 | ||
| CNS-3 | 0 | 0 | 0 | 5 | ||
| Unknown/missing | 3 | 3 | 6 | 127 | ||
| Cytogenetics | ||||||
| ETV6-RUNX1† | 1 | 0 | .99 | 1 | 357 | <.001 | 
| Double trisomies 4 and 10‡ | 5 | 1 | .39 | 6 | 244 | .27 | 
| BM day 7 | ||||||
| M1 | 28 | 18 | .64 | 46 | 900 | .016 | 
| M2 | 6 | 7 | 13 | 599 | ||
| M3 | 8 | 6 | 14 | 424 | ||
| Uninterpretable | 2 | 0 | 2 | 35 | ||
| Not done/missing | 0 | 0 | 0 | 45 | ||
| BM day 14 | ||||||
| M1 | 18 | 13 | — | 31 | 1065 | .99 | 
| M2 | 0 | 0 | 0 | 31 | ||
| M3 | 0 | 0 | 0 | 0 | ||
| Uninterpretable | 0 | 0 | 0 | 1 | ||
| Not done/missing | 26 | 18 | 44 | 905 | ||