The OptiMARK clinical development program: summary of safety data.
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.
Brown
Jeffrey J
JJ
Mallinckrodt Institute of Radiology, St. Louis, Missouri 63110, USA. brownj@mfr.wustl.edu
Kristy
Rita M
RM
Stevens
Gary R
GR
Pierro
Joseph A
JA
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
D003287:Contrast Media; D009942:Organometallic Compounds; D019786:Gadolinium DTPA; C112666:gadoversetamide