Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia

Exclusion Criteria

• •Previous participation in a FCM trial
• •Known hypersensitivity reaction to FCM
• •Requires dialysis for treatment of chronic kidney disease
• •Current anemia not attributed to iron deficiency
• •Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
• •Anticipated need for surgery
• •AST or ALT greater than 1.5 times the upper limit of normal
• •Received an investigational drug within 30 days of screening
• •Pregnant or sexually-active females who are not willing to use an effective form of birth control