Abstract
A double-blind, randomized parallel phase III study in MR imaging of the central nervous system was conducted to compare the safety and diagnostic utility of gadodiamide injection and gadopentetate dimeglumine at a dose of 0.1 mmol/kg b.w. in 60 adult patients. Seven patients in the gadodiamide injection group experienced 10 adverse events, 5 of the events possibly related to the contrast agent. in the gadopentetate dimeglumine group 5 patients reported 3 contrast agent-related adverse events out of 8 events. All events were transient and required no treatment. Seven incidents of patient discomfort, and some minor changes in vital signs and laboratory parameters were of no clinical concern. Contrast enhancement was observed in 60% and 44% of the patients with structural abnormalities in the gadodiamide injection group and gadopentetate dimeglumine group, respectively. No difference in overall efficacy was observed. Gadodiamide injection was found to be a safe and effective contrast agent