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Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine). The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to gain additional insights into the diagnostic efficacy, reliability and safety of Dotarem in routine practice using the most up-to-date MRI techniques and application methods.
Diagnostic efficacy was assessed by the following endpoints: diagnostic value ("yes"/"no") and imaging quality (5-step scale from "excellent" to "very poor"). Safety was evaluated on the basis of the frequency and seriousness of adverse events that occurred following Dotarem injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All included patients | All included patients underwent MRI with Dotarem |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI with Dotarem | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events | The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded. | From the beginning of the MRI procedure to 30-60 min after |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Value | 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 ?" | During MRI procedure |
| Image Quality |
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Inclusion Criteria:
Exclusion Criteria:
-
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Adult and pediatric patients undergoing routine MRI using the MRI contrast medium Dotarem
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| ID | Title | Description |
|---|---|---|
| FG000 | All Included Patients | All included patients underwent MRI with Dotarem |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Included Patients | All included patients underwent MRI with Dotarem |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was missing for 167 patients. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Adverse Events | The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded. | Posted | Number | adverse events | From the beginning of the MRI procedure to 30-60 min after |
|
|
From the beginning of the MRI procedure to 30-60 min after
Several adverse events could be reported for the same patient.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Included Patients | All included patients underwent MRI with Dotarem | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular disorder | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oliver Heine, MD, Radiology & Scientific Affairs Manager | Guerbet GmbH | +49 6196 76250 | oliver.heine@guerbet-group.com |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| C072417 | gadoterate meglumine |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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Image quality was evaluated with a 5-step scale from "excellent" to "very poor" ("excellent/very good"; "good"; "moderate"; "poor" and "very poor")
| During MRI procedure |
| Mean |
| Standard Deviation |
| years |
|
| Age, Customized | Age was missing for 167 patients. | Count of Participants | Participants |
|
| Sex: Female, Male | Gender was missing for 687 patients. | Count of Participants | Participants |
|
| Risk factors | Risk factors were recorded before the MRI examination | Out of the 44,456 patients, 11,006 showed at least one risk factor. Several risk factors could be reported for the same patient. | Count of Participants | Participants |
|
|
| Secondary | Diagnostic Value | 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 ?" | Diagnostic value was missing for 77 patients. | Posted | Count of Participants | Participants | During MRI procedure |
|
|
|
| Secondary | Image Quality | Image quality was evaluated with a 5-step scale from "excellent" to "very poor" ("excellent/very good"; "good"; "moderate"; "poor" and "very poor") | Image quality was missing for 108 patients. | Posted | Count of Participants | Participants | During MRI procedure |
|
|
|
| 44,456 |
| 7 |
| 44,456 |
| 132 |
| 44,456 |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oral pruritus | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Contrast media allergy | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
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| Retching | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Lip swelling | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Retching | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Swollen tongue | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site extravasation | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site irritation | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oedema mucosal | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Temperature intolerance | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Contrast media allergy | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Drug administration error | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
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| Poor |
|
| Very Poor |
|