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| ID | Type | Description | Link |
|---|---|---|---|
| X312141 | Other Identifier | Company internal |
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Assess potential risk for NSF in subjects with renal impairment (moderate) post magnevist injection. Subjects will be screened within 48 hours of previously scheduled MRI, those meeting the enrollment criteria will be enrolled prior to MRI and followed for 2 years post MRI with visits occuring at 1yr and 2 yr timepoints, in addition follow-up phone calls conducted at 1, 3, 6 and 18 months to assess for skin changes suggestive of NSF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gadopentetate dimeglumine (Magnevist, BAY86-4882) | Participants received Magnevist in accordance with its labeling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadopentetate dimeglumine (Magnevist, BAY86-4882) | Drug | Patients will be followed for 2 years after the administration of Magnevist at the approved dose to see if symptoms consistent with NSF develop |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Developed Nephrogenic Systemic Fibrosis (NSF), Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Full Analysis Set | Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d'orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with "tram-tracking," presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement. | Up to 24 months following the administration of Magnevist |
| Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-full Analysis Set | Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d'orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with "tram-tracking," presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement. | Up to 24 months following the administration of Magnevist |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Full Analysis Set | Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d'orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with "tram-tracking," presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who are scheduled to undergo CE-MRI with Magnevist and for which the inclusion and exclusion criteria are fulfilled are eligible for enrolment into the study.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85008 | United States | |||
A total of 168 participants were enrolled.
The first participant's first visit was on 21 Nov 2008. Nineteen study centers in the United States screened and enrolled participants scheduled to undergo contrast enhanced magnetic resonance imaging (CE-MRI) with Magnevist within the approved indications at the recommended dose of 0.1 mmol/kg body weight.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gadopentetate Dimeglumine (Magnevist, BAY86-4882) | Participants received Magnevist in accordance with its labeling. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Serum creatinine must be obtained within 6 weeks of the administration of Magnevist, or as currently recommended by the American College of Radiology. At the Baseline within 48 hrs. pre-injection a chemistry panel will be obtained in all patients after intravenous access has been obtained.
| Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Per Protocol Set | Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d'orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with "tram-tracking," presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement. | Up to 24 months following the administration of Magnevist |
| Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-per Protocol Set | Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d'orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with "tram-tracking," presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement. | Up to 24 months following the administration of Magnevist |
| Up to 24 months following the administration of Magnevist |
| Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-full Analysis Set | Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d'orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with "tram-tracking," presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy. | Up to 24 months following the administration of Magnevist |
| Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Per Protocol Set | Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d'orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with "tram-tracking," presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy. | Up to 24 months following the administration of Magnevist |
| Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-per Protocol Set | Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d'orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle ore epithelioid cells in a reticular or parallel arrangement with "tram-tracking," presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy. | Up to 24 months following the administration of Magnevist |
| Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Full Analysis Set | Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded. | Up to 24 months following the administration of Magnevist |
| Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-full Analysis Set | Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded. | Up to 24 months following the administration of Magnevist |
| Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Per Protocol Set | Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded. | Up to 24 months following the administration of Magnevist |
| Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-per Protocol Set | Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded. | Up to 24 months following the administration of Magnevist |
| Chula Vista |
| California |
| 91910 |
| United States |
| Los Angeles | California | 90033 | United States |
| Santa Rosa | California | 95405 | United States |
| Pueblo | Colorado | 81008 | United States |
| New Haven | Connecticut | 06520--804 | United States |
| Jacksonville | Florida | 32209-6595 | United States |
| Honolulu | Hawaii | 96813 | United States |
| Honolulu | Hawaii | 96859 | United States |
| Topeka | Kansas | 66604 | United States |
| Baltimore | Maryland | 21287 | United States |
| Boston | Massachusetts | 02114 | United States |
| Boston | Massachusetts | 02118 | United States |
| Boston | Massachusetts | 02215 | United States |
| Brooklyn | New York | 11219 | United States |
| New York | New York | 10016 | United States |
| Stony Brook | New York | 11790 | United States |
| Cleveland | Ohio | 44195 | United States |
| Danville | Pennsylvania | 17822-2001 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia | Pennsylvania | 19141 | United States |
| Memphis | Tennessee | 38104 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78229 | United States |
| Charlottesville | Virginia | 22908 | United States |
| Tacoma | Washington | 98321 | United States |
| Treatment Received |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mild Renal Impairment | Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment. |
| BG001 | Extended Moderate Renal Impairment | Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment. |
| BG002 | Moderate Renal Impairment | Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment. |
| BG003 | Severe Renal Impairment | Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Overall number of baseline participants for moderate cohort is 107 | Mean | Standard Deviation | Kilograms |
| ||||||||||||||
| Years since renal diagnosis | Number of participants with information available: mild cohort is 5;extended moderate cohort is 1; moderate cohort is 38 ; severe cohort 3. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Cause of renal disease | Participants might have more than one cause of renal disease reported. | Number | Participants |
| |||||||||||||||
| Receiving dialysis | Not all participants were receiving dialysis at baseline. | Number | Participants |
| |||||||||||||||
| Vascular injuries | Participants reporting more than one injury per injury type were counted only once for each type. Not all patients had vascular injuries reported. | Number | Participants |
| |||||||||||||||
| MRI region of main interest | Number | Participants |
|
| 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 | Number of Participants Who Developed Nephrogenic Systemic Fibrosis (NSF), Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Full Analysis Set | Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d'orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with "tram-tracking," presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement. | Full Analysis Set | Number | Participants | Up to 24 months following the administration of Magnevist |
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| Primary | Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-full Analysis Set | Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d'orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with "tram-tracking," presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement. | Full Analysis Set | Number | Participants | Up to 24 months following the administration of Magnevist |
|
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| Primary | Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Per Protocol Set | Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d'orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with "tram-tracking," presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement. | Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis. | Number | Participants | Up to 24 months following the administration of Magnevist |
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| Primary | Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-per Protocol Set | Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d'orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with "tram-tracking," presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement. | Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis. | Number | Participants | Up to 24 months following the administration of Magnevist |
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| Secondary | Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Full Analysis Set | Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d'orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with "tram-tracking," presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy. | Full analysis set | Number | Participants | Up to 24 months following the administration of Magnevist |
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| Secondary | Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-full Analysis Set | Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d'orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with "tram-tracking," presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy. | Full analysis set | Number | Participants | Up to 24 months following the administration of Magnevist |
|
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| Secondary | Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Per Protocol Set | Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d'orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with "tram-tracking," presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy. | Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis. | Number | Participants | Up to 24 months following the administration of Magnevist |
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| Secondary | Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-per Protocol Set | Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d'orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle ore epithelioid cells in a reticular or parallel arrangement with "tram-tracking," presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy. | Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis. | Number | Participants | Up to 24 months following the administration of Magnevist |
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| Secondary | Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Full Analysis Set | Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded. | Full analysis set. | Number | Participants | Up to 24 months following the administration of Magnevist |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-full Analysis Set | Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded. | Full analysis set | Number | Participants | Up to 24 months following the administration of Magnevist |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Per Protocol Set | Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded. | Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis. | Number | Participants | Up to 24 months following the administration of Magnevist |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-per Protocol Set | Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded. | Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis. | Number | Participants | Up to 24 months following the administration of Magnevist |
|
|
Up to 24 months following the administration of Magnevist
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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 | Mild Renal Impairment | Participants with eGFR >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment. | 0 | 14 | 0 | 14 | ||
| EG001 | Extended Moderate Renal Impairment | Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment. | 0 | 9 | 3 | 9 | ||
| EG002 | Moderate Renal Impairment | Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment. | 1 | 109 | 12 | 109 | ||
| EG003 | Severe Renal Impairment | Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment. | 0 | 9 | 0 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
|
Bayer HealthCare was informed about the release from the postmarketing surveillance (PMS) for Magnevist with a letter dated 02 JUN 2011. As a consequence Bayer HealthCare stopped enrollment for this study on 01 AUG 2011.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019786 | Gadolinium DTPA |
| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Glomerulonephritis |
|
| Collagen disease |
|
| Hypertension |
|
| Polycystic kidney disease |
|
| Other |
|
| Peritoneal dialysis |
|
| Hemodialysis |
|
| Shunt surgery/repair |
|
| Organ transplant surgery |
|
| Thrombotic events |
|
| Other surgeries |
|
| Other |
|
| Spine |
|
| Liver |
|
| Kidney |
|
| Musculoskeletal |
|
| Other |
|
|
|
Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment. |
| OG002 | Moderate Renal Impairment | Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment. |
| OG003 | Severe Renal Impairment | Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment. |
|
|
| Counts |
|---|
| Participants |
|
|
Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment |
| OG002 | Moderate Renal Impairment | Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment. |
| OG003 | Severe Renal Impairment | Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment. |
|
|
| Participants |
|
|
| Extended Moderate Renal impairmentEdit |
Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment |
| OG002 | Moderate Renal Impairment | Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment. |
| OG003 | Severe Renal Impairment | Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment. |
|
|
|
| Severe Renal Impairment |
Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment. |
|
|
|