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The main purpose of this study is to prospectively assess the general safety profile of Dotarem
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events | Adverse Events were notified and described. | During the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Follow-up of at least 3 months after magnetic resonance examination |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients scheduled for a Dotarem®-enhanced MRI over a one year period at each participating radiological site
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano de Buenos Aires | Buenos Aires | Argentina | ||||
| Diagnosticum Gersthof |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36042629 | Derived | Heshmatzadeh Behzadi A, McDonald J. Gadolinium-based contrast agents for imaging of the central nervous system: A multicenter European prospective study. Medicine (Baltimore). 2022 Aug 26;101(34):e30163. doi: 10.1097/MD.0000000000030163. |
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Patients scheduled for a Dotarem-enhanced MRI were recruited in 118 active centers in 10 countries from November 2008 to June 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Included Patients | All patients scheduled for a Dotarem-enhanced MRI with appropriate consent, prospectively enrolled in the study and having reliable data reported. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Included Patients | All patients scheduled for a Dotarem-enhanced MRI with appropriate consent, prospectively enrolled in the study and having reliable data reported. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data were missing for 144 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 | Adverse Events were notified and described. | Posted | Number | 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 recorded during the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination).
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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 | Safety Population | Safety Population included All Included Patients administered with Dotarem. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic diathesis | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corinne Dubourdieu, PharmD, Head of Clinical Projects and Medical Writing | Guerbet | +33 (0) 1 45 91 51 84 | corinne.dubourdieu@guerbet-group.com |
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| Image Quality |
Image quality was assessed by the radiologist using a scale with five classes: very poor, poor, fair, good and very good. |
| 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). | Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour) |
| Vienna |
| Austria |
| Shanghai Pulmonary Hospital | Shanghai | China |
| Hôpital Necker | Paris | France |
| Universitätskliniken | Cologne | Germany |
| Bombay Hospital Institute of Medical Sciences | Mumbai | India |
| Ospedale Policlinico Giambattista Rossi | Verona | Italy |
| Tabouk Military Hospital | Tabuk | Saudi Arabia |
| Complexo Hospitalario Xeral-Calde | Lugo | Spain |
| Hull Royal Infirmary | Hull | United Kingdom |
| Mean |
| Standard Deviation |
| years |
|
| Age, Customized | Data were missing for 75 patients. | Number | participants |
|
| Gender | Data were missing for 41 patients. | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. | Patients of the Safety Population with moderate to severe impaired renal function. | Posted | Number | participants | Follow-up of at least 3 months after magnetic resonance examination |
|
|
|
| Secondary | Image Quality | Image quality was assessed by the radiologist using a scale with five classes: very poor, poor, fair, good and very good. | Data were missing for 164 patients. | Posted | Number | participants | Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour) |
|
|
|
| Secondary | Diagnostic Quality | Diagnostic quality was assessed by the radiologist by answering the question "could you come to a diagnostic ?" (answer : yes or no). | Data were missing for 308 patients. | Posted | Number | participants | Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour) |
|
|
|
| 9 |
| 35,474 |
| 35 |
| 35,474 |
| Cardiac failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Adverse event | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| General physic health deterioration | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Candida sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Angiopathy | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Extravasation | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site extravasation | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Clonus | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
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| Title | Measurements |
|---|
|
| good |
|
| very good |
|