Trial Outcomes & Findings for Post-marketing Surveillance Study for Evaluation of Dotarem Safety (NCT NCT03048006)
NCT ID: NCT03048006
Last Updated: 2017-05-02
Results Overview
The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded.
Recruitment status
COMPLETED
Target enrollment
44456 participants
Primary outcome timeframe
From the beginning of the MRI procedure to 30-60 min after
Results posted on
2017-05-02
Participant Flow
Participant milestones
| Measure |
All Included Patients
All included patients underwent MRI with Dotarem
|
|---|---|
|
Overall Study
STARTED
|
44456
|
|
Overall Study
COMPLETED
|
44456
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age was missing for 167 patients.
Baseline characteristics by cohort
| Measure |
All Included Patients
n=44456 Participants
All included patients underwent MRI with Dotarem
|
|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 16.9 • n=44289 Participants • Age was missing for 167 patients.
|
|
Age, Customized
<2 years
|
1 Participants
n=44289 Participants • Age was missing for 167 patients.
|
|
Age, Customized
between 2 and 11 years
|
81 Participants
n=44289 Participants • Age was missing for 167 patients.
|
|
Age, Customized
between 12 and 17 years
|
617 Participants
n=44289 Participants • Age was missing for 167 patients.
|
|
Age, Customized
≥18 years
|
43590 Participants
n=44289 Participants • Age was missing for 167 patients.
|
|
Sex: Female, Male
Female
|
24254 Participants
n=43769 Participants • Gender was missing for 687 patients.
|
|
Sex: Female, Male
Male
|
19515 Participants
n=43769 Participants • Gender was missing for 687 patients.
|
|
Risk factors
Known allergies
|
6871 Participants
n=44456 Participants • Out of the 44,456 patients, 11,006 showed at least one risk factor. Several risk factors could be reported for the same patient.
|
|
Risk factors
History of a reaction to a contrast agent
|
176 Participants
n=44456 Participants • Out of the 44,456 patients, 11,006 showed at least one risk factor. Several risk factors could be reported for the same patient.
|
|
Risk factors
Bronchial asthma
|
630 Participants
n=44456 Participants • Out of the 44,456 patients, 11,006 showed at least one risk factor. Several risk factors could be reported for the same patient.
|
|
Risk factors
Beta-blocker treatment
|
648 Participants
n=44456 Participants • Out of the 44,456 patients, 11,006 showed at least one risk factor. Several risk factors could be reported for the same patient.
|
|
Risk factors
Coronary heart disease
|
824 Participants
n=44456 Participants • Out of the 44,456 patients, 11,006 showed at least one risk factor. Several risk factors could be reported for the same patient.
|
|
Risk factors
Heart failure
|
413 Participants
n=44456 Participants • Out of the 44,456 patients, 11,006 showed at least one risk factor. Several risk factors could be reported for the same patient.
|
|
Risk factors
Hypertension
|
2479 Participants
n=44456 Participants • Out of the 44,456 patients, 11,006 showed at least one risk factor. Several risk factors could be reported for the same patient.
|
|
Risk factors
Liver dysfunction
|
121 Participants
n=44456 Participants • Out of the 44,456 patients, 11,006 showed at least one risk factor. Several risk factors could be reported for the same patient.
|
|
Risk factors
Central nervous system disorders
|
560 Participants
n=44456 Participants • Out of the 44,456 patients, 11,006 showed at least one risk factor. Several risk factors could be reported for the same patient.
|
|
Risk factors
Other
|
858 Participants
n=44456 Participants • Out of the 44,456 patients, 11,006 showed at least one risk factor. Several risk factors could be reported for the same patient.
|
PRIMARY outcome
Timeframe: From the beginning of the MRI procedure to 30-60 min afterThe frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded.
Outcome measures
| Measure |
All Included Patients
n=44456 Participants
All included patients underwent MRI with Dotarem
|
|---|---|
|
Frequency of Adverse Events
|
225 adverse events
|
SECONDARY outcome
Timeframe: During MRI procedurePopulation: Diagnostic value was missing for 77 patients.
Diagnostic value was evaluated by answering "yes" or "no" to the following question "Were you able to make a diagnosis based on the test results ?"
Outcome measures
| Measure |
All Included Patients
n=44379 Participants
All included patients underwent MRI with Dotarem
|
|---|---|
|
Diagnostic Value
Diagnosis achieved
|
44312 Participants
|
|
Diagnostic Value
Diagnosis not achieved
|
67 Participants
|
SECONDARY outcome
Timeframe: During MRI procedurePopulation: Image quality was missing for 108 patients.
Image quality was evaluated with a 5-step scale from "excellent" to "very poor" ("excellent/very good"; "good"; "moderate"; "poor" and "very poor")
Outcome measures
| Measure |
All Included Patients
n=44348 Participants
All included patients underwent MRI with Dotarem
|
|---|---|
|
Image Quality
Excellent
|
25580 Participants
|
|
Image Quality
Good
|
18218 Participants
|
|
Image Quality
Moderate
|
516 Participants
|
|
Image Quality
Poor
|
32 Participants
|
|
Image Quality
Very Poor
|
2 Participants
|
Adverse Events
All Included Patients
Serious events: 7 serious events
Other events: 132 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Included Patients
n=44456 participants at risk
All included patients underwent MRI with Dotarem
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
2/44456 • Number of events 2 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
2/44456 • Number of events 2 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Eye disorders
Eye pruritus
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
2/44456 • Number of events 2 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Gastrointestinal disorders
Oral pruritus
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Gastrointestinal disorders
Retching
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
General disorders
Feeling hot
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
Other adverse events
| Measure |
All Included Patients
n=44456 participants at risk
All included patients underwent MRI with Dotarem
|
|---|---|
|
Cardiac disorders
Cardiovascular disorder
|
0.01%
6/44456 • Number of events 6 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Cardiac disorders
Palpitations
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Eye disorders
Eyelid oedema
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Gastrointestinal disorders
Nausea
|
0.16%
69/44456 • Number of events 69 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Gastrointestinal disorders
Retching
|
0.01%
5/44456 • Number of events 5 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Gastrointestinal disorders
Vomiting
|
0.05%
21/44456 • Number of events 21 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
General disorders
Asthenia
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
General disorders
Chest discomfort
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
General disorders
Feeling hot
|
0.01%
3/44456 • Number of events 3 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
General disorders
Injection site erythema
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
General disorders
Injection site extravasation
|
0.00%
2/44456 • Number of events 2 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
General disorders
Injection site irritation
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
General disorders
Injection site pruritus
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
General disorders
Local swelling
|
0.00%
2/44456 • Number of events 2 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
General disorders
Malaise
|
0.01%
5/44456 • Number of events 5 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
General disorders
Oedema mucosal
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
General disorders
Temperature intolerance
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
2/44456 • Number of events 2 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.00%
2/44456 • Number of events 2 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Investigations
Blood pressure decreased
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Nervous system disorders
Dizziness
|
0.02%
9/44456 • Number of events 9 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Nervous system disorders
Headache
|
0.00%
2/44456 • Number of events 2 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Nervous system disorders
Neuralgia
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Nervous system disorders
Paraesthesia
|
0.01%
4/44456 • Number of events 4 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Nervous system disorders
Tremor
|
0.01%
3/44456 • Number of events 3 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Psychiatric disorders
Agitation
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Psychiatric disorders
Anxiety
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.02%
7/44456 • Number of events 7 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.01%
3/44456 • Number of events 3 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
2/44456 • Number of events 2 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.01%
6/44456 • Number of events 6 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
2/44456 • Number of events 2 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.01%
4/44456 • Number of events 4 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.01%
4/44456 • Number of events 4 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
2/44456 • Number of events 2 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.02%
11/44456 • Number of events 11 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Vascular disorders
Flushing
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Vascular disorders
Hypotension
|
0.00%
1/44456 • Number of events 1 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
|
Vascular disorders
Pallor
|
0.00%
2/44456 • Number of events 2 • From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
|
Additional Information
Oliver Heine, MD, Radiology & Scientific Affairs Manager
Guerbet GmbH
Phone: +49 6196 76250
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place