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. 2019 Mar 6;145(4):1001–1012. doi: 10.1007/s00432-019-02854-x

Table 2.

Patient characteristics by randomization arm

Total patients Arm ASP-5000 Arm ASP-10000 р
n = 334 n = 354
Gender
 Boys 181 192 0.949
 Girls 153 162
Age (years)
 ≥ 1–< 5 161 189 0.370
 ≥ 5–<10 93 92
 ≥ 10 80 73
Initial WBC count
 < 10,000/µl 210 227 0.271
 ≥ 10,000–< 30,000/µl 102 94
 ≥ 30,000–< 50,000/µl 22 33
Spleen enlargement below left costal margin (cm)
 < 4 258 256 0.162
 ≥ 4 76 98
Geneticsa
 t(12;21) 29 24 0.491
Response to treatment on day 8b
 < 1000 leukemic blasts/µl PB 318 331 0.473
 ≥ 1000 leukemic blasts/µl PB 9 14
Response to treatment on day 15c
 < 10% leukemic blasts in BM 272 285 0.790
 ≥ 10–< 25% leukemic blasts in BM 40 39
 ≥ 25% leukemic blasts in BM 19 24
Induction therapy
 Dexamethasone 6 mg/m2 168 176 0.874
 Methylprednisolone 60 mg/m2 163 177

ASP asparaginase, BM bone marrow, IM intramuscular, PB peripheral blood, WBC white blood cell count

aInvestigation of relevant translocations performed in 506 patients (n = 251 in the arm ASP-5000, n = 255 in the arm ASP-10000)

bTreatment response on day 8 was documented for 672 patients (327 patients in the arm ASP-5000, 345 patients in the arm ASP-10000)

cTreatment response on day 15 was documented for 679 patients (331 patients in the arm ASP-5000, 348 patients in the arm ASP-10000)