Post-marketing Surveillance Study for Evaluation of Dotarem Safety

Guerbet

Status: Completed

Conditions: Contrast-enhanced MRI With Dotarem

Treatments: Procedure: MRI with Dotarem

Study type: Observational

Funder types: Industry

Identifiers

NCT03048006

DGD-55-005

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44,456 patients

Sex: All

Ages: Under 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients undergoing routine MRI using the MRI contrast medium Dotarem

Exclusion criteria

Trial design

44,456 participants in 1 patient group

All included patients

Description:

All included patients underwent MRI with Dotarem

Treatment:

Procedure: MRI with Dotarem