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

Nephrogenic Systemic Fibrosis Incidence

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.

Time frame: Follow-up of at least 3 months after magnetic resonance examination

Image Quality

Image quality was assessed by the radiologist using a scale with five classes: very poor, poor, fair, good and very good.

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

Diagnostic quality was assessed by the radiologist by answering the question "could you come to a diagnostic ?" (answer : yes or no).

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)