Prediction
**Modified Eligibility Criteria:**
### **Study Design and Methods:**
The study is designed as a prospective transversal observational study with longitudinal safety follow-ups.
The primary objective is to estimate the incidence of NSF in patients with moderate to severe renal impairment following DOTAREM® administration.
Secondary objectives include collecting data on the general safety profile of DOTAREM®, MRI indication, and conditions of use/administration of the product in this specific population of patients.
Additionally, efficacy data will be recorded and described.
### **Safety Follow-Up and Procedures for Reporting Serious Adverse Events (SAE):**
For any patient included in this study, the radiologist will notify any adverse event occurring during the MRI examination or during the time of usual follow-up post DOTAREM® administration.
A Serious Adverse Event (SAE) is any untoward medical occurrence or effect that at any dose:
- Results in death
- Is life-threatening
- Requires hospitalization or prolongation of existing inpatients' hospitalization,
- Results in persistent or significant disability or incapacity
- Is a congenital anomaly or birth defect
- Is medically significant
### **Statistics / Data Analysis:**
Quantitative variables will be summarized in tables including sample sizes, means, standard deviations and extreme values as well as medians and percentiles when appropriate.
Qualitative variables will be described in terms of frequencies and percentages of the number of individuals considered.
### **Population Definitions:**
All-included-Patients (AIP):
- Includes all patients enrolled in the study and having a questionnaire partially or fully filled in.
- Used for describing demographic data and medical history of patients and the indication for MRI.
Safety Population (SP):
- Includes all patients exposed to the contrast product and having received at least one injection of contrast agent, regardless of the quantity.
- Described for all safety parameters, administration modalities, adverse events and laboratory data.
Efficacy Population (EP):
- Includes all patients who have been imaged and who have an available diagnostic assessment.
- Described for image quality and diagnostic quality.
### **Data Analysis:**
- All the data will be collected in electronic format.
- Any electronic database provided will be compatible with an SAS format for statistical analysis.
- The following section summarizes the statistical analysis method which will be fully described in the Statistical Analysis Plan.
### **Potential Number of Patients Lost to Follow-Up:**
The potential number of patients lost to follow-up was estimated by considering that a loss of 10% of the sample size would be acceptable (100 subjects), corresponding to a minimum observable frequency of 0.111%.
If the number of patients lost to follow-up exceeds 100 subjects, the protocol will be amended to revise the sample size.
### **Information About the Study Results:**
The study report will include all the study analysis performed and will be provided to the participating investigators if needed.
### **Publication Requirements:**
The study data are the exclusive property of the Sponsor.
No data can be published by the physician without prior approval by the Sponsor in writing.
The modalities concerning the publications and the presentations about the study results will be defined by the Sponsor.
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Nephrol Dial Transplant 2006; 21:697-700
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Cowper:** Gadolinium-based MR Contrast Agents and Nephrogenic Systemic Fibrosis.
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