Table 4.
Analysis of baseline characteristics in patients with EOS LIC <7 mg Fe/g dw or ≥7 mg Fe/g dw
| Characteristic at baseline | EOS LIC <7 mg Fe/g dw (n = 112) | EOS LIC ≥7 mg Fe/g dw (n = 121) | P-value |
|---|---|---|---|
| Mean age ± SD, yr | 13.7 ± 7.2 | 12.5 ± 6.7 | 0.214 |
| Female/male, n | 54 : 58 | 60 : 61 | 0.834 |
| History of hepatitis B and/or C, n (%) | 28 (25.0) | 43 (35.5) | 0.081 |
| Splenectomy, n (%) | 45 (40.2) | 50 (41.3) | 0.859 |
| Previous chelation therapy, n (%)* | 0.108 | ||
| DFO monotherapy | 87 (77.7) | 99 (81.8) | – |
| Deferiprone monotherapy | 4 (3.6) | 0 (0.0) | – |
| DFO + deferiprone | 21 (18.8) | 22 (18.2) | – |
| Median duration of previous chelation therapy (range), yr1 | 7.9 (0.3–21.0) | 6.5 (0.1–20.6) | 0.228 |
| Mean number of transfusion sessions in the year prior to study entry ± SD2 | 14.6 ± 3.8 | 15.6 ± 4.6 | 0.393 |
| Mean amount transfused in the year prior to study entry ± SD, mL/kg3 | 167.1 ± 65.0 | 175.5 ± 70.4 | 0.471 |
| Mean baseline LIC ± SD, mg Fe/g dw | 14.9 ± 7.9 | 23.9 ± 8.3 | <0.0001 |
| Median baseline serum ferritin (range), ng/mL | 2553 (914–7519) | 4299 (1154–25 008) | <0.0001 |
SD, standard deviation; DFO, deferoxamine; EOS, end-of-study; ITT, intent-to-treat; LIC, liver iron concentrations. LIC at EOS is based on last observation carried forward (LOCF) on the ITT population.
*
P-value calculated for patients receiving previous chelation therapy with any of DFO, deferiprone or DFO/deferiprone.
1
Patients with LIC <7 mg Fe/g dw n = 69, patients with LIC ≥7 mg Fe/g dw n = 102.
2
Patients with LIC <7 mg Fe/g dw n = 101, patients with LIC ≥7 mg Fe/g dw n = 118.
3
Patients with LIC <7 mg Fe/g dw n = 93, patients with LIC ≥7 mg Fe/g dw n = 116.