Trial Outcomes & Findings for Primovist / Eovist in Renally Impaired Patients (NCT NCT00908596)
NCT ID: NCT00908596
Last Updated: 2015-07-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
357 participants
Primary outcome timeframe
Up to 24 months following the administration of Primovist/Eovist
Results posted on
2015-07-23
Participant Flow
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.
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 Of these, 4 were withdrawn prior to magnetic resonance imaging (MRI) already since they failed to meet the study entrance criteria, and 3 were withdrawn for other reasons.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).
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
32
|
193
|
85
|
|
Overall Study
COMPLETED
|
0
|
19
|
119
|
48
|
|
Overall Study
NOT COMPLETED
|
47
|
13
|
74
|
37
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Other reasons
|
46
|
6
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
12
|
4
|
|
Overall Study
Death
|
0
|
5
|
57
|
32
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
3
|
1
|
Baseline Characteristics
Primovist / Eovist in Renally Impaired Patients
Baseline characteristics by cohort
| Measure |
Gadoxetic Acid Disodium - Mild Renal Impairment
n=47 Participants
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.
|
Gadoxetic Acid Disodium - Extended Moderate Renal Impairment
n=32 Participants
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.
|
Gadoxetic Acid Disodium - Moderate Renal Impairment
n=193 Participants
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.
|
Gadoxetic Acid Disodium - Severe Renal Impairment
n=85 Participants
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.
|
Total
n=357 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.3 Years
STANDARD_DEVIATION 9.55 • n=5 Participants
|
65.3 Years
STANDARD_DEVIATION 12.03 • n=7 Participants
|
65.5 Years
STANDARD_DEVIATION 10.88 • n=5 Participants
|
62.2 Years
STANDARD_DEVIATION 13.83 • n=4 Participants
|
64.7 Years
STANDARD_DEVIATION 11.56 • n=21 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
254 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
188 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
27 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
other
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 24 months following the administration of Primovist/EovistPopulation: Full Analysis Set: all participants who were enrolled and received 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.
Outcome measures
| Measure |
Gadoxetic Acid Disodium - Mild Renal Impairment
n=47 Participants
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.
|
Gadoxetic Acid Disodium - Extended Moderate Renal Impairment
n=32 Participants
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.
|
Gadoxetic Acid Disodium - Moderate Renal Impairment
n=193 Participants
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.
|
Gadoxetic Acid Disodium - Severe Renal Impairment
n=85 Participants
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.
|
|---|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months following the administration of Primovist/EovistPopulation: Full Analysis Set: all participants who were enrolled and received 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.
Outcome measures
| Measure |
Gadoxetic Acid Disodium - Mild Renal Impairment
n=47 Participants
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.
|
Gadoxetic Acid Disodium - Extended Moderate Renal Impairment
n=32 Participants
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.
|
Gadoxetic Acid Disodium - Moderate Renal Impairment
n=193 Participants
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.
|
Gadoxetic Acid Disodium - Severe Renal Impairment
n=85 Participants
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.
|
|---|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediately after Primovist/Eovist-enhanced MRIPopulation: Full Analysis Set: all participants who were enrolled and received Primovist/Eovist
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.
Outcome measures
| Measure |
Gadoxetic Acid Disodium - Mild Renal Impairment
n=47 Participants
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.
|
Gadoxetic Acid Disodium - Extended Moderate Renal Impairment
n=32 Participants
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.
|
Gadoxetic Acid Disodium - Moderate Renal Impairment
n=193 Participants
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.
|
Gadoxetic Acid Disodium - Severe Renal Impairment
n=85 Participants
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.
|
|---|---|---|---|---|
|
Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)
Very high
|
26 Participants
|
16 Participants
|
98 Participants
|
33 Participants
|
|
Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)
High
|
15 Participants
|
13 Participants
|
80 Participants
|
38 Participants
|
|
Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)
Moderate
|
5 Participants
|
3 Participants
|
12 Participants
|
4 Participants
|
|
Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)
Low
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Immediately after Primovist/Eovist-enhanced MRIPopulation: Full Analysis Set: all participants who were enrolled and received Primovist/Eovist
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.
Outcome measures
| Measure |
Gadoxetic Acid Disodium - Mild Renal Impairment
n=47 Participants
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.
|
Gadoxetic Acid Disodium - Extended Moderate Renal Impairment
n=32 Participants
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.
|
Gadoxetic Acid Disodium - Moderate Renal Impairment
n=193 Participants
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.
|
Gadoxetic Acid Disodium - Severe Renal Impairment
n=85 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection
Excellent
|
29 Participants
|
20 Participants
|
99 Participants
|
34 Participants
|
|
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection
Good
|
15 Participants
|
12 Participants
|
74 Participants
|
29 Participants
|
|
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection
Adequate
|
1 Participants
|
0 Participants
|
15 Participants
|
8 Participants
|
|
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection
Insufficient
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Immediately after Primovist/Eovist-enhanced MRIPopulation: Full Analysis Set: all participants who were enrolled and received Primovist/Eovist
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.
Outcome measures
| Measure |
Gadoxetic Acid Disodium - Mild Renal Impairment
n=47 Participants
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.
|
Gadoxetic Acid Disodium - Extended Moderate Renal Impairment
n=32 Participants
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.
|
Gadoxetic Acid Disodium - Moderate Renal Impairment
n=193 Participants
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.
|
Gadoxetic Acid Disodium - Severe Renal Impairment
n=85 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation
Excellent
|
27 Participants
|
16 Participants
|
94 Participants
|
31 Participants
|
|
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation
Good
|
15 Participants
|
16 Participants
|
77 Participants
|
34 Participants
|
|
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation
Adequate
|
3 Participants
|
0 Participants
|
16 Participants
|
6 Participants
|
|
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation
Insufficient
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Immediately after Primovist/Eovist-enhanced MRIPopulation: Full Analysis Set: all participants who were enrolled and received Primovist/Eovist
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.
Outcome measures
| Measure |
Gadoxetic Acid Disodium - Mild Renal Impairment
n=47 Participants
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.
|
Gadoxetic Acid Disodium - Extended Moderate Renal Impairment
n=32 Participants
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.
|
Gadoxetic Acid Disodium - Moderate Renal Impairment
n=193 Participants
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.
|
Gadoxetic Acid Disodium - Severe Renal Impairment
n=85 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Characterization
Excellent
|
30 Participants
|
13 Participants
|
93 Participants
|
33 Participants
|
|
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Characterization
Good
|
12 Participants
|
16 Participants
|
79 Participants
|
34 Participants
|
|
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Characterization
Adequate
|
2 Participants
|
3 Participants
|
14 Participants
|
5 Participants
|
|
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Characterization
Insufficient
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Gadoxetic Acid Disodium - Mild Renal Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gadoxetic Acid Disodium - Extended Moderate Renal Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Gadoxetic Acid Disodium - Moderate Renal Impairment
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Gadoxetic Acid Disodium - Severe Renal Impairment
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gadoxetic Acid Disodium - Mild Renal Impairment
n=47 participants at risk
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.
|
Gadoxetic Acid Disodium - Extended Moderate Renal Impairment
n=32 participants at risk
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.
|
Gadoxetic Acid Disodium - Moderate Renal Impairment
n=193 participants at risk
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.
|
Gadoxetic Acid Disodium - Severe Renal Impairment
n=85 participants at risk
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.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/47 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/32 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/193 • Up to 24 months following the administration of Primovist/Eovist
|
1.2%
1/85 • Up to 24 months following the administration of Primovist/Eovist
|
Other adverse events
| Measure |
Gadoxetic Acid Disodium - Mild Renal Impairment
n=47 participants at risk
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.
|
Gadoxetic Acid Disodium - Extended Moderate Renal Impairment
n=32 participants at risk
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.
|
Gadoxetic Acid Disodium - Moderate Renal Impairment
n=193 participants at risk
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.
|
Gadoxetic Acid Disodium - Severe Renal Impairment
n=85 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/47 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/32 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/193 • Up to 24 months following the administration of Primovist/Eovist
|
1.2%
1/85 • Up to 24 months following the administration of Primovist/Eovist
|
|
Infections and infestations
Cellulitis
|
0.00%
0/47 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/32 • Up to 24 months following the administration of Primovist/Eovist
|
1.0%
2/193 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/85 • Up to 24 months following the administration of Primovist/Eovist
|
|
Infections and infestations
Erysipelas
|
0.00%
0/47 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/32 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/193 • Up to 24 months following the administration of Primovist/Eovist
|
1.2%
1/85 • Up to 24 months following the administration of Primovist/Eovist
|
|
Infections and infestations
Rash pustular
|
0.00%
0/47 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/32 • Up to 24 months following the administration of Primovist/Eovist
|
0.52%
1/193 • Up to 24 months following the administration of Primovist/Eovist
|
1.2%
1/85 • Up to 24 months following the administration of Primovist/Eovist
|
|
Musculoskeletal and connective tissue disorders
Extremity contracture
|
0.00%
0/47 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/32 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/193 • Up to 24 months following the administration of Primovist/Eovist
|
1.2%
1/85 • Up to 24 months following the administration of Primovist/Eovist
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/47 • Up to 24 months following the administration of Primovist/Eovist
|
3.1%
1/32 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/193 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/85 • Up to 24 months following the administration of Primovist/Eovist
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/47 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/32 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/193 • Up to 24 months following the administration of Primovist/Eovist
|
1.2%
1/85 • Up to 24 months following the administration of Primovist/Eovist
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/47 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/32 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/193 • Up to 24 months following the administration of Primovist/Eovist
|
1.2%
1/85 • Up to 24 months following the administration of Primovist/Eovist
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/47 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/32 • Up to 24 months following the administration of Primovist/Eovist
|
2.1%
4/193 • Up to 24 months following the administration of Primovist/Eovist
|
2.4%
2/85 • Up to 24 months following the administration of Primovist/Eovist
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/47 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/32 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/193 • Up to 24 months following the administration of Primovist/Eovist
|
1.2%
1/85 • Up to 24 months following the administration of Primovist/Eovist
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/47 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/32 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/193 • Up to 24 months following the administration of Primovist/Eovist
|
1.2%
1/85 • Up to 24 months following the administration of Primovist/Eovist
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/47 • Up to 24 months following the administration of Primovist/Eovist
|
3.1%
1/32 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/193 • Up to 24 months following the administration of Primovist/Eovist
|
0.00%
0/85 • Up to 24 months following the administration of Primovist/Eovist
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60