title: The OptiMARK clinical development program: summary of safety data.
abstract: OBJECTIVE
  To describe and summarize the safety data from the OptiMARK clinical development program.
  
  
  METHODS
  In the 18 clinical studies comprising the clinical program, doses ranging from 0.1 to 0.7 mmol/kg were administered to healthy adult volunteers, patients with hepatic or renal impairment, and patients with confirmed or highly suspected central nervous system (CNS), liver, breast, vascular, bone, or soft tissue pathologies. A total of 2038 injections of OptiMARK, Magnevist, or placebo were administered to 1684 subjects. Safety assessments were performed at appropriate intervals during all Phase 1, 2, and 3 studies.
  
  
  RESULTS
  Of the 1684 subjects exposed to a study drug or placebo in the clinical development program, 646 subjects experienced 1293 adverse events. Thirty-one percent of the OptiMARK injections were associated with an adverse event. In comparison, 35% of Magnevist injections and 48% of placebo injections were associated with at least one adverse event.
  
  
  CONCLUSIONS
  OptiMARK was safe and well-tolerated with a safety profile similar to that of Magnevist.
authors.affiliation: Mallinckrodt Institute of Radiology, St. Louis, Missouri 63110, USA. brownj@mfr.wustl.edu
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Brown
authors.forename: Rita M
authors.initials: RM
authors.lastname: Kristy
authors.forename: Gary R
authors.initials: GR
authors.lastname: Stevens
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Pierro
mesh_terms: D000328:Adult; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects; D004361:Drug Tolerance; D005260:Female; D019786:Gadolinium DTPA / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007674:Kidney Diseases / Q000503:physiopathology; D008107:Liver Diseases / Q000503:physiopathology; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000009:adverse effects; D012449:Safety
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; D019786:Gadolinium DTPA; C112666:gadoversetamide