Results
pallor, skin pallor, koilonychia, cheilitis, TEAEs, glossitis
IRON DEFICIENCY ANEMIA, ADVERSE EVENTS, CHEILITIS, MAY, SECONDARY, GLOSSITIS, REGRESSION, CONJUNCTIVA
The first patient was enrolled on 21 May 2018, and the last visit of the last patient was on 09 October 2020. From 447 patients screened for eligibility, 60 patients were randomized; 30 in the FeSOBaseline characteristics of enrolled patientsAbbreviations: Study flow chart. Abbreviations: Fe-ASP, iron conjugated to The primary study endpoint was successful for non-inferiority between the two groups of treatment in both the absolute and relative change of baseline Hb by week 4 (Fig. Primary study endpoint by week 4. The analysis is presented separately for the intent-to-treat (ITT) population and for the per-protocol population (PP). The predefined secondary endpoints by week 4 did not differ between the two groups (Table Outcomes of the study by week 4*Every variable is calculated as a change per 40mg of elementary FeAbbreviations: Ordinal regression analysis of the global evaluation score of patients. In this score, every participant scores one point for each 10% increase from the baseline of total red blood cell count, hemoglobin, and total reticulocyte count. The assumptions of the ordinal regression were the Goodness-of-fit test with a Impact of iron supplementation on iron deficiency anemia (IDA)-related physical signs. The presence of five physical signs of IDA (skin pallor, pallor at the conjunctiva, glossitis, cheilitis, and koilonychia) was evaluated at baseline and by week 4 by the same evaluators. The rates of patients presenting with these signs are provided; the respective No difference between the two groups of treatment was found for the absolute and relative changes of Hb, RBC count, and reticulocytes at week 12 (Supplementary Fig. No differences were found regarding the safety profile between the two groups (Table Serious and non-serious treatment-emergent adverse events (TEAEs)