Contrast Media
Conditions
Keywords
Nephrogenic Systemic Fibrosis (NSF), Primovist / Eovist
Brief summary
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate. The administration of contrast agents that contain gadolinium such as Primovist/Eovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Primovist/Eovist. Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.
Detailed description
Adverse events data will be reported in Adverse Events section.
Interventions
Primovist/Eovist in approved indications at approved dosages
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be scheduled for Contrast enhanced magnetic resonance imaging (CE-MRI) of the liver with Primovist/Eovist based on careful risk/benefit evaluation at the recommended dose in one of the approved indications * Patient must fulfill criteria for moderate (Estimated glomerular filtration rate \[eGFR\] 30 - 59 mL/min/1.73 m\^2) to severe (eGFR \< 30 mL/min/1.73 m\^2) renal impairment.
Exclusion criteria
* Gadolinium based contrast agent (GBCA)-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Primovist/Eovist within 12 months prior to administration of Primovist/Eovist * History of existing NSF
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information | Up to 24 months following the administration of Primovist/Eovist | A diagnosis of NSF was assumed for subjects with a minimum combined clinical (scale: 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent) and histopathological score (same scale as clinical score). Either the clinical score or the histopathology score had to be at least 2, and the other at least 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score | Up to 24 months following the administration of Primovist/Eovist | Participants in whom no biopsy was obtained with a clinical score of 4 on a scale comprising 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent. |
| Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | Immediately after Primovist/Eovist-enhanced MRI | The investigator was to record his / her confidence in making a diagnosis using a 4 point scale (Very high confidence / High confidence / Moderate / Low confidence). For some participants the values were not collected. |
| Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Immediately after Primovist/Eovist-enhanced MRI | The investigator was to record the imaging efficacy by evaluation of lesion detection using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected. |
| Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Immediately after Primovist/Eovist-enhanced MRI | The investigator was to record the imaging efficacy by evaluation of lesion delineation using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected. |
| Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Immediately after Primovist/Eovist-enhanced MRI | The investigator was to record the imaging efficacy by evaluation of lesion characterization using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected. |
Countries
Australia, Austria, Germany, Italy, South Korea, Spain, Thailand, United Kingdom, United States
Participant flow
Recruitment details
The first participant's first visit was on 21 May 2009. 35 study centers in Australia, Austria, Germany, Italy, Spain, South Korea, UK, USA, and Thailand screened and enrolled participants scheduled to undergo contrast enhanced magnetic resonance imaging (CE-MRI) of the liver with Primovist/Eovist within the approved indications.
Pre-assignment details
A total of 364 participants were enrolled. Of these, 4 were withdrawn prior to magnetic resonance imaging (MRI) already since they failed to meet the study entrance criteria, and 3 were withdrawn for other reasons. Participants had to have moderate to severe renal impairment (estimated glomerular filtration rate \[eGFR\] 65 mL/min/1.73 m\^2 or less).
Participants by arm
| Arm | Count |
|---|---|
| Gadoxetic Acid Disodium - Mild Renal Impairment Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection \>65 mL/min/1.73 m\^2. Participants received Primovist/Eovist as part of their routine medical care. | 47 |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Participants with eGFR prior to Primovist/Eovist injection between \> 59 and ≤ 65 mL/min/1.73 m\^2. Participants received Primovist/Eovist as part of their routine medical care. | 32 |
| Gadoxetic Acid Disodium - Moderate Renal Impairment Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m\^2. Participants received Primovist/Eovist as part of their routine medical care. | 193 |
| Gadoxetic Acid Disodium - Severe Renal Impairment Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection \< 30 mL/min/1.73 m\^2. Participants received Primovist/Eovist as part of their routine medical care. | 85 |
| Total | 357 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 5 | 57 | 32 |
| Overall Study | Lost to Follow-up | 0 | 1 | 12 | 4 |
| Overall Study | Other reasons | 46 | 6 | 2 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 3 | 1 |
Baseline characteristics
| Characteristic | Gadoxetic Acid Disodium - Mild Renal Impairment | Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Gadoxetic Acid Disodium - Moderate Renal Impairment | Gadoxetic Acid Disodium - Severe Renal Impairment | Total |
|---|---|---|---|---|---|
| Age, Continuous | 65.3 Years STANDARD_DEVIATION 9.55 | 65.3 Years STANDARD_DEVIATION 12.03 | 65.5 Years STANDARD_DEVIATION 10.88 | 62.2 Years STANDARD_DEVIATION 13.83 | 64.7 Years STANDARD_DEVIATION 11.56 |
| Race/Ethnicity, Customized Asian | 27 Participants | 16 Participants | 56 Participants | 8 Participants | 107 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 1 Participants | 6 Participants | 2 Participants | 11 Participants |
| Race/Ethnicity, Customized Caucasian | 15 Participants | 9 Participants | 101 Participants | 63 Participants | 188 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized other | 3 Participants | 5 Participants | 27 Participants | 12 Participants | 47 Participants |
| Sex: Female, Male Female | 20 Participants | 7 Participants | 46 Participants | 30 Participants | 103 Participants |
| Sex: Female, Male Male | 27 Participants | 25 Participants | 147 Participants | 55 Participants | 254 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 47 | 1 / 32 | 7 / 193 | 6 / 85 |
| serious Total, serious adverse events | 0 / 47 | 0 / 32 | 0 / 193 | 1 / 85 |
Outcome results
Primary
Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information
A diagnosis of NSF was assumed for subjects with a minimum combined clinical (scale: 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent) and histopathological score (same scale as clinical score). Either the clinical score or the histopathology score had to be at least 2, and the other at least 3.
Time frame: Up to 24 months following the administration of Primovist/Eovist
Population: Full Analysis Set: all participants who were enrolled and received Primovist/Eovist
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadoxetic Acid Disodium - Mild Renal Impairment | Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information | 0 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information | 0 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information | 0 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information | 0 Participants |
Secondary
Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)
The investigator was to record his / her confidence in making a diagnosis using a 4 point scale (Very high confidence / High confidence / Moderate / Low confidence). For some participants the values were not collected.
Time frame: Immediately after Primovist/Eovist-enhanced MRI
Population: Full Analysis Set: all participants who were enrolled and received Primovist/Eovist
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium - Mild Renal Impairment | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | Very high | 26 Participants |
| Gadoxetic Acid Disodium - Mild Renal Impairment | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | High | 15 Participants |
| Gadoxetic Acid Disodium - Mild Renal Impairment | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | Moderate | 5 Participants |
| Gadoxetic Acid Disodium - Mild Renal Impairment | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | Low | 1 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | High | 13 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | Moderate | 3 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | Low | 0 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | Very high | 16 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | Moderate | 12 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | High | 80 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | Low | 2 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | Very high | 98 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | Low | 1 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | High | 38 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | Very high | 33 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | Moderate | 4 Participants |
Secondary
Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization
The investigator was to record the imaging efficacy by evaluation of lesion characterization using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
Time frame: Immediately after Primovist/Eovist-enhanced MRI
Population: Full Analysis Set: all participants who were enrolled and received Primovist/Eovist
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium - Mild Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Excellent | 30 Participants |
| Gadoxetic Acid Disodium - Mild Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Good | 12 Participants |
| Gadoxetic Acid Disodium - Mild Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Adequate | 2 Participants |
| Gadoxetic Acid Disodium - Mild Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Insufficient | 1 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Good | 16 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Adequate | 3 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Insufficient | 0 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Excellent | 13 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Adequate | 14 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Good | 79 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Insufficient | 2 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Excellent | 93 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Insufficient | 2 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Good | 34 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Excellent | 33 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization | Adequate | 5 Participants |
Secondary
Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation
The investigator was to record the imaging efficacy by evaluation of lesion delineation using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
Time frame: Immediately after Primovist/Eovist-enhanced MRI
Population: Full Analysis Set: all participants who were enrolled and received Primovist/Eovist
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium - Mild Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Excellent | 27 Participants |
| Gadoxetic Acid Disodium - Mild Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Good | 15 Participants |
| Gadoxetic Acid Disodium - Mild Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Adequate | 3 Participants |
| Gadoxetic Acid Disodium - Mild Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Insufficient | 0 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Good | 16 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Adequate | 0 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Insufficient | 0 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Excellent | 16 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Adequate | 16 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Good | 77 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Insufficient | 1 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Excellent | 94 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Insufficient | 3 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Good | 34 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Excellent | 31 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation | Adequate | 6 Participants |
Secondary
Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection
The investigator was to record the imaging efficacy by evaluation of lesion detection using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
Time frame: Immediately after Primovist/Eovist-enhanced MRI
Population: Full Analysis Set: all participants who were enrolled and received Primovist/Eovist
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium - Mild Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Insufficient | 0 Participants |
| Gadoxetic Acid Disodium - Mild Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Adequate | 1 Participants |
| Gadoxetic Acid Disodium - Mild Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Excellent | 29 Participants |
| Gadoxetic Acid Disodium - Mild Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Good | 15 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Good | 12 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Excellent | 20 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Adequate | 0 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Insufficient | 0 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Adequate | 15 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Insufficient | 1 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Good | 74 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Excellent | 99 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Insufficient | 2 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Excellent | 34 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Good | 29 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection | Adequate | 8 Participants |
Secondary
Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score
Participants in whom no biopsy was obtained with a clinical score of 4 on a scale comprising 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent.
Time frame: Up to 24 months following the administration of Primovist/Eovist
Population: Full Analysis Set: all participants who were enrolled and received Primovist/Eovist
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadoxetic Acid Disodium - Mild Renal Impairment | Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score | 0 Participants |
| Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score | 0 Participants |
| Gadoxetic Acid Disodium - Moderate Renal Impairment | Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score | 0 Participants |
| Gadoxetic Acid Disodium - Severe Renal Impairment | Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score | 0 Participants |