Table 1. Baseline characteristics of the study cohort by allocation.
| Placebo, N=110 (%) | Caphosol, N=110 (%) | |
|---|---|---|
| Median age in years (range) | 13.7 (4.1–21.9) | 13.7 (4.0–20.9) |
| Sex | ||
| Male | 56 (50.9) | 62 (56.4) |
| Female | 54 (49.1) | 48 (43.6) |
| Diagnosis | ||
| Malignant conditions | 99 (90.0) | 99 (90.0) |
| Nonmalignant conditions | 11 (10.0) | 11 (10.0) |
| Transplant type | ||
| Autologous | 28 (25.5) | 29 (26.4) |
| Allogeneic | 82 (74.5%) | 81 (73.6) |
| Graft source | ||
| Bone marrow | 49 (44.6) | 57 (51.8) |
| Peripheral blood stem cells | 47 (42.7) | 44 (40.0) |
| Umbilical cord blood | 14 (12.7) | 9 (8.2) |
| Conditioning with TBI or melphalan | 70 (63.6) | 71 (64.5) |
| Characteristics in allogeneic group | n=82 | n=81 |
| Matched related donor | 26 (31.7) | 31 (38.3) |
| Mismatched related donor | 0 (0) | 1 (1.2) |
| Matched unrelated donor | 33 (40.2) | 28 (34.6%) |
| Mismatched unrelated donor | 9 (11) | 12 (14.8) |
| Matched or partially mismatched cord blood | 14 (17.1) | 9 (11.1) |
| GVHD prophylaxis with methotrexate | 46/72a (63.9) | 50/72a (69.4) |
| Mean day of engraftment (range) | 14.3 (9–34) | 14.3 (8–24) |
Abbreviations: GVHD=graft vs host disease; TBI=total body irradiation.
a
Patients without data on GVHD prophylaxis data were excluded.