Demographic and baseline patient characteristics
Characteristic . | Cardiac iron reduction arm (n = 114) . | Prevention arm (n = 78) . |
---|---|---|
Age, y, mean ± SD | 20.9 ± 7.3 | 20.2 ± 7.5 |
Age group, n (%) | ||
10 to < 16 y | 31 (27.2) | 26 (33.3) |
≥ 16 y | 83 (72.8) | 52 (66.7) |
Female:male, n | 60:54 | 43:35 |
Race (White: Asian: other), n | 39:69:6 | 30:45:3 |
History of hepatitis B and/or C, n (%) | 33 (28.9) | 16 (20.5) |
Splenectomy, n (%) | 55 (48.2) | 37 (47.4) |
Previous chelation therapy, n (%) | ||
Deferoxamine monotherapy | 78 (68.4) | 54 (69.2) |
Deferoxamine + deferiprone | 36 (31.6)* | 22 (28.2) |
Other | 1 (0.9) | |
None | 2 (2.6) | |
Duration of previous chelation therapy, y, mean ± SD | 14.1 ± 7.6 | 10.0 ± 6.8 |
Baseline cardiac T2*, ms, geometric mean ± CV% | 11.2 ± 40.5 | 32.0 ± 25.6 |
No. of transfusion sessions in the year prior to study entry, mean ± SD | 16.4 ± 7.1 | 15.2 ± 8.5 |
Total amount transfused in the year prior to study entry, mL/kg, mean ± SD | 184.9 ± 215.7 | 133.7 ± 77.4 |
Baseline LIC, mg Fe/g dw, mean ± SD | 28.2 ± 10.0 | 28.8 ± 10.2 |
Baseline serum ferritin, ng/mL median (range) | 5235 (1643-16 944) | 4367 (1627-10 528) |
Characteristic . | Cardiac iron reduction arm (n = 114) . | Prevention arm (n = 78) . |
---|---|---|
Age, y, mean ± SD | 20.9 ± 7.3 | 20.2 ± 7.5 |
Age group, n (%) | ||
10 to < 16 y | 31 (27.2) | 26 (33.3) |
≥ 16 y | 83 (72.8) | 52 (66.7) |
Female:male, n | 60:54 | 43:35 |
Race (White: Asian: other), n | 39:69:6 | 30:45:3 |
History of hepatitis B and/or C, n (%) | 33 (28.9) | 16 (20.5) |
Splenectomy, n (%) | 55 (48.2) | 37 (47.4) |
Previous chelation therapy, n (%) | ||
Deferoxamine monotherapy | 78 (68.4) | 54 (69.2) |
Deferoxamine + deferiprone | 36 (31.6)* | 22 (28.2) |
Other | 1 (0.9) | |
None | 2 (2.6) | |
Duration of previous chelation therapy, y, mean ± SD | 14.1 ± 7.6 | 10.0 ± 6.8 |
Baseline cardiac T2*, ms, geometric mean ± CV% | 11.2 ± 40.5 | 32.0 ± 25.6 |
No. of transfusion sessions in the year prior to study entry, mean ± SD | 16.4 ± 7.1 | 15.2 ± 8.5 |
Total amount transfused in the year prior to study entry, mL/kg, mean ± SD | 184.9 ± 215.7 | 133.7 ± 77.4 |
Baseline LIC, mg Fe/g dw, mean ± SD | 28.2 ± 10.0 | 28.8 ± 10.2 |
Baseline serum ferritin, ng/mL median (range) | 5235 (1643-16 944) | 4367 (1627-10 528) |
LIC and serum ferritin were calculated for 105 patients in the cardiac substudy and 75 patients in the cardiac prevention arm (per-protocol population).
One patient receiving deferoxamine + deferiprone also received concomitant deferasirox.