Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)
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|ClinicalTrials.gov Identifier: NCT01523873|
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : January 22, 2016
Last Update Posted : February 24, 2017
|Condition or disease|
|General Safety Profile of DOTAREM|
|Study Type :||Observational|
|Actual Enrollment :||35921 participants|
|Official Title:||Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
- Frequency of Adverse Events [ Time Frame: During the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination). ]Adverse Events were notified and described.
- Nephrogenic Systemic Fibrosis Incidence [ Time Frame: Follow-up of at least 3 months after magnetic resonance examination ]For any patient identified with moderate to severe impaired renal function at the time of inclusion, a specific safety follow-up was performed in order to detect any suspicion of Nephrogenic Systemic Fibrosis.
- Image Quality [ Time Frame: Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour) ]Image quality was assessed by the radiologist using a scale with five classes: very poor, poor, fair, good and very good.
- Diagnostic Quality [ Time Frame: Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour) ]Diagnostic quality was assessed by the radiologist by answering the question "could you come to a diagnostic ?" (answer : yes or no).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523873
|Hospital Italiano de Buenos Aires|
|Buenos Aires, Argentina|
|Shanghai Pulmonary Hospital|
|Bombay Hospital Institute of Medical Sciences|
|Ospedale Policlinico Giambattista Rossi|
|Tabouk Military Hospital|
|Tabouk, Saudi Arabia|
|Complexo Hospitalario Xeral-Calde|
|Hull Royal Infirmary|
|Hull, United Kingdom|