N/A
Completed N=35,921
Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)
General Safety Profile of DOTAREM
Source: ClinicalTrials.gov NCT01523873 ↗
Enrolled (actual)
35,921
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Frequency of Adverse Events — 70 Adverse Events
Summary
The main purpose of this study is to prospectively assess the general safety profile of Dotarem
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Adverse Events |
70 | — |
| SECONDARY Nephrogenic Systemic Fibrosis Incidence |
— | — |
| SECONDARY Image Quality |
6; 52; 341; 10268; 23741 | — |
| SECONDARY Diagnostic Quality |
343; 33921 | — |
Eligibility Criteria
Inclusion Criteria
- patient scheduled for a Dotarem®-enhanced MRI
Exclusion Criteria
- patient with a contra-indication to MR examination
- patient with a contra-indication to Dotarem® injection as per local SPC
Data sourced from ClinicalTrials.gov (NCT01523873). 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. Informational only — not medical advice.