title: Safety assessment of gadoversetamide (OptiMARK) administered by power injector.
abstract: OBJECTIVE
  To evaluate the safety of OptiMARK (gadoversetamide injection) administered via power injector.
  
  
  METHODS
  The study population included 144 healthy volunteers aged 18 years or older randomly assigned to one of seven treatment groups (N = 20/group). The safety assessment was based on changes in physical examination, vital signs, electrocardiograms (ECGs), standard clinical laboratory tests, and adverse events (AEs) through a 24-hour postinjection period.
  
  
  RESULTS
  OptiMARK caused no serious AEs or unexpected changes in physical examinations or laboratory parameters. The changes observed in vital signs and ECG intervals did not vary with changes in injection rate and were not significantly (P < 0.05) different from those elicited by saline administration at the same rates.
  
  
  CONCLUSIONS
  This study demonstrated the safety of OptiMARK when administered via a power injector at rates of 2, 4, and 6 mL/second.
authors.affiliation: Quintiles Phase 1 Services, Lenexa, Kansas, USA.
authors.forename: Nancy
authors.initials: N
authors.lastname: Abdou
authors.forename: Alicia M
authors.initials: AM
authors.lastname: Napoli
authors.forename: Michael R
authors.initials: MR
authors.lastname: Hynes
authors.forename: John C
authors.initials: JC
authors.lastname: Allen
authors.forename: James H
authors.initials: JH
authors.lastname: Wible
mesh_terms: D000704:Analysis of Variance; D003287:Contrast Media / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007275:Injections, Intravenous / Q000379:methods; D008279:Magnetic Resonance Imaging; D008297:Male; D009942:Organometallic Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D016012:Poisson Distribution; D012449:Safety
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; C112666:gadoversetamide