Confirmatory Open-label Saccharated Iron Oxide-controlled Study of NS-32 in Patients with Iron Deficiency Anemia Associated with Menorrhagia (Phase III)

The maximum change in hemoglobin concentration from baseline, as the primary endpoint, was noninferior for NS-32 compared with control. The incidence of TEAEs was lower in the NS-32 group than in the Control group. The incidences of pyrexia and urticaria were higher in the NS-32 group than in the Control group ; both TEAEs are known adverse drug reactions of ferric derisomaltose. No severe TEAEs of pyrexia or urticaria were reported. These TEAEs were effectively managed with standard treatment.