TABLE 3.
AZA doses and metabolite concentrations in the per protocol subjects at week #16, analyzed by baseline TPMT activity
| INDIVIDUALIZED DOSE | WEIGHT-BASED DOSE | ||||||||
|---|---|---|---|---|---|---|---|---|---|
|
|
|||||||||
| N | Mean (SD) | Median (range) | N | Mean (SD) | Median (range) | Means p value | Medians M-W p | ||
| Dose | Overall | 15 | 2.7 (1.06) | 3.1 (0.6–4.0) | 12 | 2.3 (0.41) | 2.4 (1.6–2.7) | 0.23 | 0.16 |
| Normal TPMT | 9 | 3.4 (0.35) | 3.4 (2.8–4.0) | 10 | 2.3 (0.45) | 2.4 (1.6–2.7) | <0.0001 | 0.0003 | |
| Intermediate TPMT | 6 | 1.5 (0.65) | 1.8 (0.6–2.1) | 2 | 2.4 (0.01) | 2.4 (2.4–2.4) | 0.02 | 0.07 | |
| TGN | Overall | 14* | 216 (102) | 199 (81–413) | 12 | 230.0 (242) | 156 (81–972) | 0.86 | 0.40 |
| Normal TPMT | 8* | 198 (70) | 197 (81–286) | 10 | 163 (71) | 150 (81–297) | 0.32 | 0.36 | |
| Intermediate TPMT | 6 | 242 (137) | 212 (88–413) | 2 | 563 (578) | 563 (154–972) | 0.58 | 0.64 | |
| MMPR | Overall | 14* | 4872 (4437) | 2873 (782–14631) | 12 | 3407 (3877) | 2076 (782–15152) | 0.38 | 0.37 |
| Normal TPMT | 8* | 7035 (4798) | 6362 (2193–14631) | 10 | 3861 (4119) | 2292 (1230–15152) | 0.16 | 0.08 | |
| Intermediate TPMT | 6 | 1987 (1224) | 1977 (782–3494) | 2 | 1138 (503) | 1138 (782–1493) | 0.22 | 0.64 | |
*
Metabolite data at week 16 were missing for one subject with normal TPMT activity in the individualized dosing arm.