The primary efficacy endpoint of this study for FDA is the proportion of subjects who achieved a > 2.0 g/dL increase in hemoglobin at any time from baseline to week 5; the primary efficacy endpoint for European Union (EU) regulators is the mean change in hemoglobin from baseline to week 5. In the AUB subgroup analysis, 87.3% of ferumoxytol-treated patients achieved an increase of > 2.0 g/dL in hemoglobin compared to 3.6% of patients who received placebo, meeting the protocol defined measure of superiority (p<0.0001). The mean change in hemoglobin in ferumoxytol-treated AUB patients was 2.8 g/dL, compared to no increase (0.0 g/dL) in AUB patients receiving placebo (p<0.0001). These results paralleled those in the total study population.
In the AUB sub-group, the rate of reported adverse events (AEs) was higher among ferumoxytol-treated patients (47.7%) than in patients that received placebo (46.4%), although no new safety signals, outside those described in the current FDA-approved label for ferumoxytol, were observed in this study.
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