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Post-marketing Surveillance Study for Evaluation of Dotarem Safety

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ClinicalTrials.gov Identifier: NCT03048006
Recruitment Status : Completed
First Posted : February 9, 2017
Results First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Guerbet

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Contrast-enhanced MRI With Dotarem
Intervention Procedure: MRI with Dotarem
Enrollment 44456
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Included Patients
Hide Arm/Group Description All included patients underwent MRI with Dotarem
Period Title: Overall Study
Started 44456
Completed 44456
Not Completed 0
Arm/Group Title All Included Patients
Hide Arm/Group Description All included patients underwent MRI with Dotarem
Overall Number of Baseline Participants 44456
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44289 participants
52.3  (16.9)
[1]
Measure Analysis Population Description: Age was missing for 167 patients.
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
<2 years Number Analyzed 44289 participants
1
   0.0%
between 2 and 11 years Number Analyzed 44289 participants
81
   0.2%
between 12 and 17 years Number Analyzed 44289 participants
617
   1.4%
≥18 years Number Analyzed 44289 participants
43590
  98.4%
[1]
Measure Analysis Population Description: Age was missing for 167 patients.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43769 participants
Female
24254
  55.4%
Male
19515
  44.6%
[1]
Measure Analysis Population Description: Gender was missing for 687 patients.
Risk factors   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Known allergies Number Analyzed 44456 participants
6871
  15.5%
History of a reaction to a contrast agent Number Analyzed 44456 participants
176
   0.4%
Bronchial asthma Number Analyzed 44456 participants
630
   1.4%
Beta-blocker treatment Number Analyzed 44456 participants
648
   1.5%
Coronary heart disease Number Analyzed 44456 participants
824
   1.9%
Heart failure Number Analyzed 44456 participants
413
   0.9%
Hypertension Number Analyzed 44456 participants
2479
   5.6%
Liver dysfunction Number Analyzed 44456 participants
121
   0.3%
Central nervous system disorders Number Analyzed 44456 participants
560
   1.3%
Other Number Analyzed 44456 participants
858
   1.9%
[1]
Measure Description: Risk factors were recorded before the MRI examination
[2]
Measure Analysis Population Description: Out of the 44,456 patients, 11,006 showed at least one risk factor. Several risk factors could be reported for the same patient.
1.Primary Outcome
Title Frequency of Adverse Events
Hide Description The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded.
Time Frame From the beginning of the MRI procedure to 30–60 min after
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Included Patients
Hide Arm/Group Description:
All included patients underwent MRI with Dotarem
Overall Number of Participants Analyzed 44456
Measure Type: Number
Unit of Measure: adverse events
225
2.Secondary Outcome
Title Diagnostic Value
Hide Description 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 ?"
Time Frame During MRI procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Diagnostic value was missing for 77 patients.
Arm/Group Title All Included Patients
Hide Arm/Group Description:
All included patients underwent MRI with Dotarem
Overall Number of Participants Analyzed 44379
Measure Type: Count of Participants
Unit of Measure: Participants
Diagnosis achieved
44312
  99.8%
Diagnosis not achieved
67
   0.2%
3.Secondary Outcome
Title Image Quality
Hide Description Image quality was evaluated with a 5-step scale from "excellent" to "very poor" ("excellent/very good"; "good"; "moderate"; "poor" and "very poor")
Time Frame During MRI procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Image quality was missing for 108 patients.
Arm/Group Title All Included Patients
Hide Arm/Group Description:
All included patients underwent MRI with Dotarem
Overall Number of Participants Analyzed 44348
Measure Type: Count of Participants
Unit of Measure: Participants
Excellent
25580
  57.7%
Good
18218
  41.1%
Moderate
516
   1.2%
Poor
32
   0.1%
Very Poor
2
   0.0%
Time Frame From the beginning of the MRI procedure to 30–60 min after
Adverse Event Reporting Description Several adverse events could be reported for the same patient.
 
Arm/Group Title All Included Patients
Hide Arm/Group Description All included patients underwent MRI with Dotarem
All-Cause Mortality
All Included Patients
Affected / at Risk (%)
Total   0/44456 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
All Included Patients
Affected / at Risk (%) # Events
Total   7/44456 (0.02%)    
Eye disorders   
Eye pruritus  1  1/44456 (0.00%)  1
Gastrointestinal disorders   
Vomiting  1  1/44456 (0.00%)  1
Oral pruritus  1  1/44456 (0.00%)  1
Retching  1  1/44456 (0.00%)  1
Nausea  1  1/44456 (0.00%)  1
General disorders   
Feeling hot  1  1/44456 (0.00%)  1
Immune system disorders   
Contrast media allergy  1  1/44456 (0.00%)  1
Nervous system disorders   
Paraesthesia  1  1/44456 (0.00%)  1
Renal and urinary disorders   
Renal failure  1  1/44456 (0.00%)  1
Respiratory, thoracic and mediastinal disorders   
Nasal congestion  1  1/44456 (0.00%)  1
Cough  1  2/44456 (0.00%)  2
Sneezing  1  1/44456 (0.00%)  1
Skin and subcutaneous tissue disorders   
Swelling face  1  2/44456 (0.00%)  2
Urticaria  1  2/44456 (0.00%)  2
Erythema  1  1/44456 (0.00%)  1
1
Term from vocabulary, MedDRA 16.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Included Patients
Affected / at Risk (%) # Events
Total   132/44456 (0.30%)    
Cardiac disorders   
Cardiovascular disorder  1  6/44456 (0.01%)  6
Palpitations  1  1/44456 (0.00%)  1
Eye disorders   
Eyelid oedema  1  1/44456 (0.00%)  1
Gastrointestinal disorders   
Abdominal discomfort  1  1/44456 (0.00%)  1
Gastrointestinal pain  1  1/44456 (0.00%)  1
Lip swelling  1  1/44456 (0.00%)  1
Nausea  1  69/44456 (0.16%)  69
Retching  1  5/44456 (0.01%)  5
Swollen tongue  1  1/44456 (0.00%)  1
Vomiting  1  21/44456 (0.05%)  21
Hypoaesthesia oral  1  1/44456 (0.00%)  1
General disorders   
Asthenia  1  1/44456 (0.00%)  1
Chest discomfort  1  1/44456 (0.00%)  1
Feeling hot  1  3/44456 (0.01%)  3
Injection site erythema  1  1/44456 (0.00%)  1
Injection site extravasation  1  2/44456 (0.00%)  2
Injection site irritation  1  1/44456 (0.00%)  1
Injection site pruritus  1  1/44456 (0.00%)  1
Local swelling  1  2/44456 (0.00%)  2
Malaise  1  5/44456 (0.01%)  5
Oedema mucosal  1  1/44456 (0.00%)  1
Temperature intolerance  1  1/44456 (0.00%)  1
Immune system disorders   
Hypersensitivity  1  2/44456 (0.00%)  2
Contrast media allergy  1  1/44456 (0.00%)  1
Injury, poisoning and procedural complications   
Drug administration error  1  2/44456 (0.00%)  2
Investigations   
Blood pressure decreased  1  1/44456 (0.00%)  1
Nervous system disorders   
Dizziness  1  9/44456 (0.02%)  9
Dizziness postural  1  1/44456 (0.00%)  1
Headache  1  2/44456 (0.00%)  2
Loss of consciousness  1  1/44456 (0.00%)  1
Neuralgia  1  1/44456 (0.00%)  1
Paraesthesia  1  4/44456 (0.01%)  4
Tremor  1  3/44456 (0.01%)  3
Psychiatric disorders   
Agitation  1  1/44456 (0.00%)  1
Anxiety  1  1/44456 (0.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  7/44456 (0.02%)  7
Nasal congestion  1  1/44456 (0.00%)  1
Respiratory distress  1  1/44456 (0.00%)  1
Sneezing  1  3/44456 (0.01%)  3
Throat irritation  1  1/44456 (0.00%)  1
Throat tightness  1  1/44456 (0.00%)  1
Skin and subcutaneous tissue disorders   
Cold sweat  1  2/44456 (0.00%)  2
Dermatitis allergic  1  1/44456 (0.00%)  1
Erythema  1  6/44456 (0.01%)  6
Hyperhidrosis  1  2/44456 (0.00%)  2
Pruritus  1  4/44456 (0.01%)  4
Rash  1  4/44456 (0.01%)  4
Rash papular  1  1/44456 (0.00%)  1
Skin reaction  1  2/44456 (0.00%)  2
Urticaria  1  11/44456 (0.02%)  11
Vascular disorders   
Flushing  1  1/44456 (0.00%)  1
Hypotension  1  1/44456 (0.00%)  1
Pallor  1  2/44456 (0.00%)  2
1
Term from vocabulary, MedDRA 16.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Oliver Heine, MD, Radiology & Scientific Affairs Manager
Organization: Guerbet GmbH
Phone: +49 6196 76250
Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT03048006     History of Changes
Other Study ID Numbers: DGD-55-005
First Submitted: February 1, 2017
First Posted: February 9, 2017
Results First Submitted: March 22, 2017
Results First Posted: May 2, 2017
Last Update Posted: May 2, 2017