Noninferiority analyses of change in LIC, cardiac T2* MRI, and serum ferritin levels at month 12: ITT population and subpopulations
| . | LS mean (SE) . | 96.01% CI* . | ||||
|---|---|---|---|---|---|---|
| n . | DFP . | n . | DFO . | Difference (DFP − DFO) . | ||
| Change in LIC, mg/g dw | ||||||
| ITT | 133 | −4.04 (0.48) | 69 | −4.45 (0.57) | 0.40 (0.56) | −0.76, 1.57 |
| SCD | 114 | −2.60 (0.43) | 57 | −3.35 (0.56) | 0.74 (0.58) | −0.46, 1.95 |
| Other anemias | 19 | −6.94 (1.19) | 12 | −5.14 (1.50) | −1.79 (1.81) | −5.67, 2.08 |
| Change in log-transformed cardiac T2* MRI, ms | ||||||
| ITT | 133 | −0.023 (0.020) | 69 | −0.022 (0.024) | −0.001 (0.024) | −0.051, 0.049 |
| SCD | 114 | −0.003 (0.018) | 57 | 0.013 (0.024) | −0.017 (0.026) | −0.069, 0.036 |
| Other anemias | 19 | 0.018 (0.050) | 12 | −0.079 (0.063) | 0.097 (0.077) | −0.068, 0.261 |
| Change in serum ferritin, μg/L | ||||||
| ITT | 143 | −414.73 (221.34) | 74 | −749.71 (273.62) | 334.97 (287.75) | −257.63, 927.57 |
| SCD | 122 | 48.16 (229.59) | 62 | −522.57 (298.94) | 570.72 (329.19) | −107.44, 1248.89 |
| Other anemias | 21 | −983.94 (291.01) | 12 | −180.50 (376.32) | −803.45 (439.65) | −1740.50, 133.61 |
| . | LS mean (SE) . | 96.01% CI* . | ||||
|---|---|---|---|---|---|---|
| n . | DFP . | n . | DFO . | Difference (DFP − DFO) . | ||
| Change in LIC, mg/g dw | ||||||
| ITT | 133 | −4.04 (0.48) | 69 | −4.45 (0.57) | 0.40 (0.56) | −0.76, 1.57 |
| SCD | 114 | −2.60 (0.43) | 57 | −3.35 (0.56) | 0.74 (0.58) | −0.46, 1.95 |
| Other anemias | 19 | −6.94 (1.19) | 12 | −5.14 (1.50) | −1.79 (1.81) | −5.67, 2.08 |
| Change in log-transformed cardiac T2* MRI, ms | ||||||
| ITT | 133 | −0.023 (0.020) | 69 | −0.022 (0.024) | −0.001 (0.024) | −0.051, 0.049 |
| SCD | 114 | −0.003 (0.018) | 57 | 0.013 (0.024) | −0.017 (0.026) | −0.069, 0.036 |
| Other anemias | 19 | 0.018 (0.050) | 12 | −0.079 (0.063) | 0.097 (0.077) | −0.068, 0.261 |
| Change in serum ferritin, μg/L | ||||||
| ITT | 143 | −414.73 (221.34) | 74 | −749.71 (273.62) | 334.97 (287.75) | −257.63, 927.57 |
| SCD | 122 | 48.16 (229.59) | 62 | −522.57 (298.94) | 570.72 (329.19) | −107.44, 1248.89 |
| Other anemias | 21 | −983.94 (291.01) | 12 | −180.50 (376.32) | −803.45 (439.65) | −1740.50, 133.61 |
DFO, deferoxamine; DFP, deferiprone.
Data were analyzed using an ANCOVA model, with treatment as the main factor and covariates including overall average transfusional iron input during the study, baseline LIC, cardiac T2* MRI, or serum ferritin levels, as stratification factors. Unless otherwise stated, data are shown as LS mean (SE).