Safety profile of ultrasmall superparamagnetic iron oxide ferumoxtran-10: phase II clinical trial data |
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Authors: | Sharma R Saini S Ros P R Hahn P F Small W C de Lange E E Stillman A E Edelman R R Runge V M Outwater E K Morris M Lucas M |
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Institution: | Department of Radiology, Massachusetts General Hospital, Boston 02114, USA. |
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Abstract: | The safety data from the phase II clinical trial of ferumoxtran-10, an ultrasmall superparamagnetic iron oxide contrast agent, are presented. One hundred and four patients with focal liver or spleen pathologies underwent ferumoxtran-10-enhanced magnetic resonance (MR) imaging at doses of 0.8, 1.1, and 1.7 mg Fe/kg. Overall, 15% patients reported a total of 33 adverse events, regardless of causality. The adverse events most frequently seen were dyspnea (3.8%), chest pain (2.9%), and rash (2.9%). No serious adverse events were reported during the 48 hour observation period. There were no clinically significant effects on vital signs, physical examination, and laboratory results. Ferumoxtran-10 is a safe and well tolerated MR contrast agent. |
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