General Safety Profile of DOTAREM
Conditions
Brief summary
The main purpose of this study is to prospectively assess the general safety profile of Dotarem
Interventions
None listed
Sponsors
Guerbet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nephrogenic Systemic Fibrosis Incidence | 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 | 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 | 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). |
Countries
Argentina, Austria, China, France, Germany, India, Italy, Saudi Arabia, Spain, United Kingdom
Participant flow
Recruitment details
Patients scheduled for a Dotarem-enhanced MRI were recruited in 118 active centers in 10 countries from November 2008 to June 2013.
Participants by arm
| Arm | Count |
|---|---|
| All Included Patients All patients scheduled for a Dotarem-enhanced MRI with appropriate consent, prospectively enrolled in the study and having reliable data reported. | 35,499 |
| Total | 35,499 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 422 |
Baseline characteristics
| Characteristic | All Included Patients |
|---|---|
| Age, Continuous | 49.5 years STANDARD_DEVIATION 17.9 |
| Age, Customized <18 years | 1631 participants |
| Age, Customized ≥65 years | 7735 participants |
| Age, Customized from 18 to 64 years | 26058 participants |
| Gender Female | 18838 Participants |
| Gender Male | 16620 Participants |
| Region of Enrollment Argentina | 43 participants |
| Region of Enrollment Austria | 703 participants |
| Region of Enrollment China | 7064 participants |
| Region of Enrollment France | 7692 participants |
| Region of Enrollment Germany | 9988 participants |
| Region of Enrollment India | 6803 participants |
| Region of Enrollment Italy | 328 participants |
| Region of Enrollment Saudi Arabia | 372 participants |
| Region of Enrollment Spain | 1039 participants |
| Region of Enrollment United Kingdom | 1467 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 35 / 35,474 |
| serious Total, serious adverse events | 9 / 35,474 |
Outcome results
Primary
Frequency of Adverse Events
Adverse Events were notified and described.
Time frame: During the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Safety Population | Frequency of Adverse Events | 70 Adverse Events |
Secondary
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)
Population: Data were missing for 308 patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Safety Population | Diagnostic Quality | No | 343 participants |
| Safety Population | Diagnostic Quality | Yes | 33921 participants |
Secondary
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)
Population: Data were missing for 164 patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Safety Population | Image Quality | very poor | 6 participants |
| Safety Population | Image Quality | poor | 52 participants |
| Safety Population | Image Quality | fair | 341 participants |
| Safety Population | Image Quality | good | 10268 participants |
| Safety Population | Image Quality | very good | 23741 participants |
Secondary
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
Population: Patients of the Safety Population with moderate to severe impaired renal function.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Safety Population | Nephrogenic Systemic Fibrosis Incidence | 0 participants |