Post-marketing Surveillance Study for Evaluation of Dotarem Safety
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|ClinicalTrials.gov Identifier: NCT03048006|
Recruitment Status : Completed
First Posted : February 9, 2017
Results First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Information provided by (Responsible Party):
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.
|Condition or disease||Intervention/treatment|
|Contrast-enhanced MRI With Dotarem||Procedure: MRI with Dotarem|
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|
|Actual Enrollment :||44456 participants|
|Official Title:||Evaluation of Dotarem Safety|
|Study Start Date :||January 2011|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
All included patients
All included patients underwent MRI with Dotarem
Procedure: MRI with Dotarem
Other Name: MRI with gadoteric acid/gadoterate meglumine
Primary Outcome Measures :
- Frequency of Adverse Events [ Time Frame: From the beginning of the MRI procedure to 30-60 min after ]The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded.
Secondary Outcome Measures :
- Diagnostic Value [ Time Frame: During MRI procedure ]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 ?"
- Image Quality [ Time Frame: During MRI procedure ]Image quality was evaluated with a 5-step scale from "excellent" to "very poor" ("excellent/very good"; "good"; "moderate"; "poor" and "very poor")
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