title: Observational study on the safety profile of gadoterate meglumine in 35,499 patients: The SECURE study.
abstract: To investigate the safety of gadoterate meglumine and identify the incidence of nephrogenic systemic fibrosis (NSF).
  
  
  
  An international prospective observational study was conducted from November 2008 to June 2013. A total of 35,499 adults and children who were scheduled to undergo contrast-enhanced MRI using gadoterate meglumine were analyzed (female, 53.1%; mean age: 49.5 years; range: 0-98 years). At least 3-month follow-up was planned for patients with an estimated creatinine clearance or glomerular filtration rate <60 mL/min (/1.73 m2) to detect any suspicion or occurrence of NSF. Adverse events (AEs) were prospectively recorded. Demographic data, risk factors, indications for MRI examinations, characteristics of gadoterate meglumine administration, and efficacy were documented.
  
  
  
  MRI examinations were mainly for central nervous system (61%). The most frequent risk factor was renal insufficiency (14.7%). Seventy AEs were observed in 44 patients (0.12%). Among the 70 AEs, 38 in 32 patients (0.09% of all patients) were considered related to gadoterate meglumine and classified as adverse drug reaction (ADR).The most frequent ADRs were urticaria (9 patients, 0.03%), nausea (7 patients, 0.02%), and vomiting (4 patients, 0.01%). Within the pediatric population (1,629 patients), only one AE (vomiting) was observed. Nine adult patients (0.03%) experienced serious AEs. Moderate to severe renal insufficiency at inclusion was reported in 514 patients (1.5%). Among them, 476 (92.6%) were followed-up. No patients were suspected of having NSF and no cases of NSF were observed.
  
  
  
  Our study confirms the excellent safety profile of gadoterate meglumine in routine practice.
  
  
  
  1 J. Magn. Reson. Imaging 2017;45:988-997.
authors.affiliation: Department of Body and Interventional Imaging, Hôpital Lariboisiére, AP-HP, Paris, France.|Université Paris-Diderot, Sorbonne-Paris Cité, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Soyer
authors.affiliation: Department of Body and Interventional Imaging, Hôpital Lariboisiére, AP-HP, Paris, France.|Université Paris-Diderot, Sorbonne-Paris Cité, Paris, France.|UMR INSERM 965, Hôpital Lariboisiére, Paris, France.
authors.forename: Anthony
authors.initials: A
authors.lastname: Dohan
authors.affiliation: Department of Radiology, Nanavati Super Specialty Hospital, Mumbai, India.
authors.forename: Deepak
authors.initials: D
authors.lastname: Patkar
authors.affiliation: Central Institute for Radiology and Neuroradiology, Krankenhaus Nordwest, Frankfurt am Main, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Gottschalk
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001208:Asia / Q000453:epidemiology; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000009:adverse effects*; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007089:Image Enhancement; D015994:Incidence; D007223:Infant; D038622:Internationality; D008279:Magnetic Resonance Imaging; D008297:Male; D008536:Meglumine / Q000009:adverse effects*; D008875:Middle Aged; D054989:Nephrogenic Fibrosing Dermopathy / Q000139:chemically induced* / Q000453:epidemiology; D009942:Organometallic Compounds / Q000009:adverse effects*; D011446:Prospective Studies; D012307:Risk Factors; D055815:Young Adult
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; D008536:Meglumine; C072417:gadoterate meglumine
keywords: adverse event; contrast media; gadolinium-based contrast agent; gadoterate meglumine; gadoteric acid; magnetic resonance imaging