Table 2.
The overall response rates of patients (ITT analysis set)
| 3-day treatment group (n = 34) | 5-day treatment group (n = 98) | Overall (N = 132) | |
|---|---|---|---|
| n | 10 | 25 | 35 |
| ORR, % (95% CI) | 29.4 (15.1, 47.5)a | 25.5 (17.2, 35.3)b | 26.5 (19.2, 34.9)b |
| CR, n (%) | 3 (8.8) | 10 (10.2) | 13 (9.8) |
| PR, n (%) | NA | NA | NA |
| mCR, n (%) | 7 (20.6) | 15 (15.3) | 22 (16.7) |
P value calculated using single sample test using exact binomial proportion test, p 0 = 10%. ITT analysis set included all patients who received at least 1 dose of decitabine
ORR = CR + PR + mCR
CI confidence interval, CR complete response, ITT intent to treat, mCR marrow complete response, ORR overall response rate, PR partial response
a P = 0.003
b P < 0.001