Table 1. Subject Characteristics.
| Development Cohort Median (range)/N (%) | Independent Cohort Median (range)/N (%) | |
|---|---|---|
| Number of Patients | 87 | 240 |
| Administered single day dose (mg), median (range) | 75 (46-100) | 67 (42-100) |
| Age (years), median (range) | 55 (20-69) | 59 (19-75) |
| Males, N (%) | 56 (64.4) | 139 (57.9) |
| Actual body weight (kg), median (range) | 82.5 (41.5-140) | 84.4 (46.6-183) |
| Ideal body weight (kg), median (range) | 65.9 (40.6-81.0) | 67.8 (97.7-42.0) |
| Body surface area (m2), median (range) | 1.95 (1.30-2.50) | 1.98 (1.38-3.12) |
| BMI, N% (kg/m2) | ||
| <25 | 28(32.2%) | 64(26.7%) |
| 25-29.9 | 29(33.3%) | 81(33.8%) |
| 30-34.9 | 20(23.0%) | 58(24.2%) |
| >35 | 10(11.5%) | 37(15.4%) |
| Serum creatinine (mg/dL), median (range) | 0.90 (0.40-1.50) | 0.82 (0.32-1.96) |
| Creatinine clearance (ml/min), median (range) | 82.1 (45.0-153) | 88.0 (29.3-206)a |
| Total bilirubin (mg/dL), median (range) | 0.40 (0.10-1.20) | Not collected |
| Recipient CMV positive, N (%) | 45 (51.7) | 135 (56.3) |
| Disease, N (%) | ||
| Acute lymphoid leukemia | 6 (7.00%) | 22 (9.16%) |
| Acute myeloid leukemia | 26 (30.0%) | 71 (29.6%) |
| Chronic myeloid leukemia | 1 (1.00%) | 6 (2.50%) |
| Other leukemiasb | 6 (7.00%) | 21 (8.75%) |
| Myelodysplastic syndrome | 14 (16.0%) | 40 (16.7%) |
| Non-Hodgkin's lymphoma | 17 (20.0%) | 36 (15.0%) |
| Hodgkin's lymphoma | 8 (9.00%) | 15 (6.25%) |
| Other Malignanciesc | 9 (10.0%) | 29 (12.1%) |
| Donor Source, N (%) | ||
| Cord blood | 64 (73.3%) | 104 (43.3%) |
| Related | 22 (25.3%) | 35 (14.6%) |
| Unrelated | 1 (0.01%) | 101 (42.1%) |
a
Estimated creatinine clearances are shown but were capped at 150 ml/min in the analysis since values greater than those seemed implausible
b
Other leukemias are acute myeloid leukemias not otherwise specified and chronic lymphocytic leukemias, not otherwise specified as per standard WHO criteria.
c
Other Malignancies are myelofibrosis, prolymhocytic leukemia, and renal cell carcinoma