Table 3. Patient/Disease Characteristics of the BM Training, Verification and Validation Analysis Sets.
Patient/Disease Characteristics | Subgroups | BM Training Analysis Set (n = 43) | BM Validation Analysis Set (n = 42) | P b | BM Verification Analysis Set (n = 24) |
---|---|---|---|---|---|
Response to induction therapy a | RD | 12 | 10 | 0.92 | 12 |
CR/CRi without CCR1 | 19 | 20 | 12 | ||
CCR1 | 12 | 12 | 0 | ||
Age (Years) | (Min, Max), Median | (56.8, 83.9), 68.2 | (58.0, 82.0), 69.0 | 0.98 | (57, 80), 69 |
Cytogenetic risk group | Better | 4 | 2 | 0.86 | 0 |
Intermediate c | 26 | 25 | 10 | ||
Poor | 6 | 8 | 5 | ||
Missing | 7 | 7 | 9 | ||
FLT3 ITD | Mutant | 8 | 10 | 0.60 | 4 |
Wildtype | 35 | 32 | 17 | ||
Unknown | 0 | 0 | 3 | ||
Sex | F | 16 | 15 | 1.00 | 9 |
M | 27 | 27 | 15 | ||
AML onset | De novo | 38 | 34 | 0.38 | 17 |
Secondary | 5 | 8 | 7 | ||
WBC (10 9 /L) | (Min, Max), Median | (1.3, 263.0), 33.2 | (1.4, 274.0), 19.1 | 0.62 | (1.6, 120.2), 28.6 |
Percent Health at 15 mins | (Min, Max), Median | (26.0, 87.2), 52.2 | (31.8, 86.3), 60.0 | 0.077 | (29.8, 79.76), 50.4 |
a) CR = complete response; CRi = complete response with incomplete peripheral blood recovery; CCR1 = CR/CRi with duration > 1 yr; RD = resistant disease.
b) P-value for comparison of BM Training and BM Validation Analysis Sets.
c) Includes patients with known karyotype of indeterminate risk classification.