Table 2.
Age group | <1 year | 1 to <2 years | ≥2 years | P valueb | |||
---|---|---|---|---|---|---|---|
Before amendment | After amendment | P valuea | Total | ||||
n = 28 | n = 17 | n = 45 | n = 58 | n = 340 | |||
<5 % bone marrow blast after Ind-1 | 16 (57.1 %) | 12 (70.5 %) | 0.367 | 28 (62.2 %) | 51 (87.9 %) | 290 (85.2 %) | 0.001 |
CR rate (after Ind-2) | 19 (67.9 %) | 14 (82.4 %) | 0.488 | 33 (73.3 %) | 49 (84.4 %) | 299 (87.9 %) | 0.036 |
Early death (≤42 days) | 5 (17.9 %) | 0 (0.0 %) | 0.140 | 5 (11.1 %) | 1 (1.7 %) | 1 (0.2 %) | <0.001 |
Non-response | 2 (7.1 %) | 3 (17.6 %) | 0.350 | 5 (11.1 %) | 6 (10.3 %) | 32 (9.4 %) | 0.922 |
Other | 2 (7.0 %) | 0 (0.0 %) | 0.519 | 2 (4.4 %) | 2 (3.4 %) | 8 (2.3 %) | 0.670 |
Ind-1 induction course 1, CR complete remission, Ind-2 induction course 2
aBefore versus after the protocol amendments
bComparison among the three age groups