N/A
N=44,456
Post-marketing Surveillance Study for Evaluation of Dotarem Safety
Contrast-enhanced MRI With Dotarem
Bottom Line
View on ClinicalTrials.gov: NCT03048006 ↗Enrolled (actual)
44,456
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Frequency of Adverse Events — 225 adverse events
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- MRI with Dotarem (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Guerbet
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Adverse Events |
225 | — |
| SECONDARY Diagnostic Value |
44312; 67 | — |
| SECONDARY Image Quality |
25580; 18218; 516; 32; 2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing routine MRI using the MRI contrast medium Dotarem
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT03048006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.