LIC and serum ferritin responses over 1 year with deferasirox versus placebo
| . | Deferasirox 5 mg/kg/d (n = 55) . | Deferasirox 10 mg/kg/d (n = 55) . | Placebo 5 and 10 mg/kg/d (n = 56) . |
|---|---|---|---|
| LSM change from baseline in LIC, mg Fe/g dw ± SEM (95% CI)* | |||
| 24 wks | −0.87 ± 0.45 (−1.76 to 0.01) | −0.90 ± 0.45 (−1.79 to −0.01) | −0.24 ± 0.44 (−1.10 to 0.63) |
| 52 wks | −1.95 ± 0.50 (−2.94 to −0.96) | −3.80 ± 0.48 (−4.76 to −2.85) | 0.38 ± 0.49 (−0.59 to 1.34) |
| Median change from baseline in serum ferritin, ng/mL (min, max) | |||
| 12 wks | 33 (−531, 688) | −9 (−290, 759) | 27 (−296, 1250) |
| 24 wks | −21 (−520, 1056) | −64 (−833, 1562) | 33 (−620, 1415) |
| 36 wks | −54 (−671, 592) | −103 (−1041, 883) | 87 (−233, 1050) |
| 52 wks | −102 (−839, 376) | −202 (−1407, 988) | 81 (−344, 835) |
| Decrease of ≥ 3 mg Fe/g dw between baseline and wk 52 (LOCF), n (%) | 18 (32.7) | 31 (56.4) | 6 (10.7) |
| Comparison with placebo† | |||
| Estimated odds ratio‡ | 6.7 | 16.3 | |
| 95% CI | 2.1 to 21.1 | 5.2 to 50.8 | |
| Decrease of ≥ 30% in LIC between baseline and wk 52 (LOCF), n (%) | 14 (25.5) | 27 (49.1) | 1 (1.8) |
| . | Deferasirox 5 mg/kg/d (n = 55) . | Deferasirox 10 mg/kg/d (n = 55) . | Placebo 5 and 10 mg/kg/d (n = 56) . |
|---|---|---|---|
| LSM change from baseline in LIC, mg Fe/g dw ± SEM (95% CI)* | |||
| 24 wks | −0.87 ± 0.45 (−1.76 to 0.01) | −0.90 ± 0.45 (−1.79 to −0.01) | −0.24 ± 0.44 (−1.10 to 0.63) |
| 52 wks | −1.95 ± 0.50 (−2.94 to −0.96) | −3.80 ± 0.48 (−4.76 to −2.85) | 0.38 ± 0.49 (−0.59 to 1.34) |
| Median change from baseline in serum ferritin, ng/mL (min, max) | |||
| 12 wks | 33 (−531, 688) | −9 (−290, 759) | 27 (−296, 1250) |
| 24 wks | −21 (−520, 1056) | −64 (−833, 1562) | 33 (−620, 1415) |
| 36 wks | −54 (−671, 592) | −103 (−1041, 883) | 87 (−233, 1050) |
| 52 wks | −102 (−839, 376) | −202 (−1407, 988) | 81 (−344, 835) |
| Decrease of ≥ 3 mg Fe/g dw between baseline and wk 52 (LOCF), n (%) | 18 (32.7) | 31 (56.4) | 6 (10.7) |
| Comparison with placebo† | |||
| Estimated odds ratio‡ | 6.7 | 16.3 | |
| 95% CI | 2.1 to 21.1 | 5.2 to 50.8 | |
| Decrease of ≥ 30% in LIC between baseline and wk 52 (LOCF), n (%) | 14 (25.5) | 27 (49.1) | 1 (1.8) |