Table 1.
Demographics
| MMF | Placebo | Total | |
|---|---|---|---|
| Patients | 116 | 119 | 235 |
| AML | 41 (35.3%) | 47 (39.5%) | 88 (37.4%) |
| ALL | 16 (13.8%) | 14 (11.8%) | 30 (12.8%) |
| CML | 3 (2.6%) | 5 (4.2%) | 8 (3.4%) |
| MDS | 20 (17.2%) | 17 (14.3%) | 37 (15.7%) |
| Lymphoma | 17 (14.7%) | 17 (14.3%) | 34 (14.5%) |
| Other | 19 (16.4%) | 19 (16.0%) | 38 (16.2%) |
| Days from BMT to randomization, median (interquartile range) | 36 (24.0-50.0) | 37 (23.0-60.0) | 36 (24.0-55.0) |
| Days from BMT to aGVHD diagnosis, median (interquartile range) | 34 (21-49) | 36 (22-60) | 35 (22-55) |
| Hours from aGVHD diagnosis to randomization, median (interquartile range) | 31 (6-55) | 22 (3-52) | 26 (3-54) |
| Unrelated donor | 66 (56.9%) | 72 (60.5%) | 138 (58.7%) |
| Bone marrow grafts | 23 (19.8%) | 16 (13.4%) | 39 (16.6%) |
| Peripheral blood stem cell grafts | 91 (78.4%) | 102 (85.7%) | 193 (82.1%) |
| Cord blood grafts | 2 (1.7%) | 1(0.8%) | 3 (1.3%) |
| Myeloablative conditioning | 74 (63.8%) | 74 (62.2%) | 148 (63%) |
| Female | 45 (38.8%) | 41 (34.5%) | 86 (36.6%) |
| Male | 71 (61.2%) | 78 (65.5%) | 149 (63.4%) |
| Age, y, median (range, 9.1-76.3) | 54 | 52.9 | 53.8 |
| Patients younger than 18 y of age | 4 (3.4%) | 1 (0.8%) | 5 (2.1%) |
ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; BMT, bone marrow transplantation; CML, chronic myeloid leukemia; MDS, myelodysplastic syndrome.