COMPARISON OF THE SAFETY OF THE STANDARD-DOSE AND A HIGHER DOSE OF GADODIAMIDE INJECTION FOR MR-IMAGING OF THE CENTRAL-NERVOUS-SYSTEM

This study compared the safety and tolerability of gadodiamide injecti on at the standard dose (0.1 mmol/kg) and at a higher dose (0.3 mmol/k g) in 289 patients participating in a parallel group multiple independ ent trial program. All patients had a known or suspected central nervo us system lesion necessitating investigation with contrast medium-enha nced magnetic resonance imaging. Safety assessments were made before a nd after injection of the contrast medium, and 1 day later. No adverse events were judged to be related to gadodiamide injection. and only 3 .5% of the patients in each dose group reported adverse events that ha d an uncertain relationship to the contrast medium; both doses were th erefore well tolerated. Headache was the most frequently reported even t (2%). There were no significant injection-related changes in neurolo gic status, laboratory test results, or vital signs. The data obtained indicate that the higher dose of gadodiamide injection is as safe and well tolerated as the standard dose.