Table 1.
Patient demographics (safety analysis population)
| Pediatric solid tumor or pediatric brain tumor N = 9 |
Adult malignant lymphoma N = 10 |
|
|---|---|---|
| Sex | ||
| Female, n (%) | 4 (44.4) | 4 (40.0) |
| Male, n (%) | 5 (55.6) | 6 (60.0) |
| Age, years | ||
| Mean (SD) | 7.0 (5.9) | 53.7 (11.6) |
| Median (min, max) | 5.0 (2, 16) | 54.5 (35, 68) |
| Height, cm, mean (SD) | 114.3 (34.4) | 164.7 (10.2) |
| Weight, kg, mean (SD) | 23.0 (14.4) | 60.0 (12.1) |
| Body surface area,a m2, mean (SD) | 0.85 (0.40) | 1.65 (0.20) |
| ECOG performance status,bn (%) | ||
| 0 | 4 (44.4) | 7 (70.0) |
| 1 | 5 (55.6) | 3 (30.0) |
| Primary malignancy, n (%) | ||
| Pediatric solid tumor | 4 (44.4) | 0 |
| Pediatric brain tumor | 5 (55.6) | 0 |
| Malignant lymphoma | 0 | 10 (100.0) |
| Relapse, n (%) | 2 (22.2) | 6 (60.0) |
| Number of previous HSCTs, n (%) | ||
| 0 | 6 (66.7) | 10 (100.0) |
| 1 | 3 (33.3) | 0 |
| Patients with complicationsc | 6 (66.7) | 9 (90.0) |
ECOG Eastern Cooperative Oncology Group, HSCT hematopoietic stem cell transplantation, SD standard deviation
aBody surface area is calculated as a function of age. If age was < 16 years, the Mosteller formula was used ([weight (kg) × height (cm)/3600]0.5). If age was ≥ 16 years, the DuBois formula was used ([weight (kg)0.425 × height (cm)0.725] × 0.007184)
bRange 0–4
cSee Supplementary Table S1 for full list of complications