Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine). The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to gain additional insights into the diagnostic efficacy, reliability and safety of Dotarem in routine practice using the most up-to-date MRI techniques and application methods.
Diagnostic efficacy was assessed by the following endpoints: diagnostic value ("yes"/"no") and imaging quality (5-step scale from "excellent" to "very poor"). Safety was evaluated on the basis of the frequency and seriousness of adverse events that occurred following Dotarem injection.
Study Type
OBSERVATIONAL
Enrollment
44,456
Frequency of Adverse Events
The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded.
Time frame: From the beginning of the MRI procedure to 30-60 min after
Diagnostic Value
Diagnostic value was evaluated by answering "yes" or "no" to the following question "Were you able to make a diagnosis based on the test results ?"
Time frame: During MRI procedure
Image Quality
Image quality was evaluated with a 5-step scale from "excellent" to "very poor" ("excellent/very good"; "good"; "moderate"; "poor" and "very poor")
Time frame: During MRI procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.