Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)
|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).
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|