We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Liver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01043523
Recruitment Status : Completed
First Posted : January 6, 2010
Results First Posted : June 3, 2014
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Conditions Liver Neoplasms
Adenoma
Carcinoma
Liver Abscess
Intervention Drug: Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Enrollment 52
Recruitment Details Pediatric subjects (> 2 months and < 18 years of age), who underwent a contrast-enhanced (CE) liver magnetic resonance imaging (MRI) with Eovist/Primovist because of suspected or known focal liver lesions, and who had evaluable safety and efficacy data.
Pre-assignment Details Of the 52 subjects that were identified by the investigators for participation in this observational/retrospective study, 51 were included in the efficacy analysis. One subject (22001-0005) did not have unenhanced images. The safety analysis was performed on all 52 subjects.
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Period Title: Overall Study
Started 52
Participants With Unenhanced Images 51
Completed 52
Not Completed 0
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Baseline Participants 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 52 participants
>2 months to ≤2 years 14
>2 years to ≤12 years 25
>12 years to <18 years 13
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Female
28
  53.8%
Male
24
  46.2%
Indication for magnetic resonance imaging (MRI)  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 52 participants
Suspected or known focal liver lesions 49
Cystic fibrosis 1
Biliary atresia 1
No clinical indication 1
Physical examination performed at preinjection timepoint   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 52 participants
Yes 36
No 16
[1]
Measure Description: Number of participants received physical examination within14 days prior to injection.
Physical examination performed at postinjection timepoint   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 52 participants
Yes 35
No 17
[1]
Measure Description: Number of participants received physical examination up to 24 hours after injection of Eovist/Primovist. Changes in the physical examination were recorded as adverse events (AEs).
1.Primary Outcome
Title Percentage of Participants With Overall Change in Additional Diagnostic Information Obtained When Comparing the Combined Precontrast/Postcontrast Images With the Precontrast Images.
Hide Description Overall Change in additional diagnostic information was defined as a change in at least 1 of the 5 variables below obtained from the combined precontrast and postcontrast images as compared with the precontrast images: 1. Change in number of lesions: greater or fewer 2. Improved border delineation of the primary lesion 3. Increased contrast of primary lesion versus. background 4. Change in size of the primary lesion: larger or smaller 5. Change in information about lesion characterization (lesion type): improved, unchanged, worsened
Time Frame When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
86.3
(73.7 to 94.3)
2.Primary Outcome
Title Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point
Hide Description Laboratory parameters analyzed: Hematology: leukocytes, erythrocytes, hematocrit, platelets, hemoglobin, prothrombin time and differential counts (neutrophils total, neutrophils segmented and lymphocytes); Chemistry: lactate dehydrogenase (LDH), alkaline phosphatase (AKP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), sodium, potassium, blood urea nitrogen (BUN), glucose, creatinine, bilirubin:, direct bilirubin, indirect bilirubin, total protein, albumin, estimated glomerular filtration rate (eGFR), and α-fetoprotein levels.
Time Frame 14 days prior to Eovist/Primovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
The laboratory analyses were performed on participants in the Full Analysis Set (FAS) who had laboratory values collected
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: Participants
Increased AST, BUN 1
Increased AST, AKP 1
High liver values due to gastrointestinal (GI) 1
3.Primary Outcome
Title Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities 24 Hours Post-injection
Hide Description The following parameters were analyzed: Hematology: leukocytes, erythrocytes, hematocrit, platelets, hemoglobin, prothrombin time and differential counts (neutrophils total, neutrophils segmented and lymphocytes) Clinical chemistry: lactate dehydrogenase (LDH), alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), sodium, potassium, blood urea nitrogen (BUN), glucose, creatinine, total bilirubin, direct bilirubin, indirect bilirubin, total protein, albumin, eGFR, and α-fetoprotein levels.
Time Frame Up to 24 hours post-Eovist/Primovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
The laboratory analyses were performed on participants in the Full Analysis Set (FAS) who had laboratory values collected
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
0
4.Primary Outcome
Title Vital Signs: Mean Change From Baseline in Heart Rate
Hide Description [Not Specified]
Time Frame 14 days prior to and up to 24 hours post-Eovist/Primovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: beats/min
-4.17  (16.86)
5.Primary Outcome
Title Vital Signs: Mean Change From Baseline in Systolic Blood Pressure
Hide Description [Not Specified]
Time Frame 14 days prior to and up to 24 hours post-Eovist/Primovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mmHg
-1.76  (17.10)
6.Primary Outcome
Title Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure
Hide Description [Not Specified]
Time Frame 14 days prior to and up to 24 hours post-Eovist/Primovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: mmHg
-0.46  (17.00)
7.Secondary Outcome
Title Change in Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Hide Description [Not Specified]
Time Frame When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Participants
Relevant change in diagnosis 25
No change in diagnosis 26
8.Secondary Outcome
Title Change in Confidence of Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Hide Description [Not Specified]
Time Frame When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Participants
Blinded reader was confident in the diagnosis 10
Blinded reader was not confident in the diagnosis 41
9.Secondary Outcome
Title Change in Number of Nonmalignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Hide Description Change in number of nonmalignant lesions was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images
Time Frame When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Participants
Change in the number of non-malignant lesions 18
No change in the number of non-malignant lesions 33
10.Secondary Outcome
Title Change in Number of Malignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Hide Description Change in number of malignant lesions was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images
Time Frame When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Participants
Change in the number of malignant lesions 11
No change in the number of malignant lesions 40
11.Secondary Outcome
Title Change in Recommended Next Course of Subject Management/Therapy Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Hide Description [Not Specified]
Time Frame When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Participants
Change from subject management therapy 45
No change in subject management therapy 6
12.Secondary Outcome
Title Change in Recommended Next Course of Subject Management / Therapy - Comparison of Precontrast Versus Combined Precontrast/Postcontrast Images (Only Subjects for Whom a Change Was Documented)
Hide Description [Not Specified]
Time Frame When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
45 subjects had a change from additional imaging with contrast-enhanced MRI based on the precontrast images to definitive therapy.
Arm/Group Title Precontrast Combined Precontrast / Postcontrast
Hide Arm/Group Description:
45 subjects had a change based on the Precontrast image read
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
Overall Number of Participants Analyzed 45 45
Measure Type: Number
Unit of Measure: Participants
Ultrasound 7 1
Biopsy 0 26
Follow-up examination 1 13
Other 37 2
No action 0 3
13.Secondary Outcome
Title The Overall Image Quality for the Postcontrast Image Only
Hide Description [Not Specified]
Time Frame When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Participants
Satisfactory 34
Excellent 8
Poor 9
14.Secondary Outcome
Title Final Diagnosis (SoT) by Clinical Investigator
Hide Description [Not Specified]
Time Frame When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Participants
Benign Lesions 27
Malignant Lesions 24
15.Secondary Outcome
Title Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis.
Hide Description Sensitivity is the probability that a test indicates there is disease when there is disease. Specificity is the probability that a test indicates there is no disease when there is no disease. Accuracy is the probability that a test is correct: the test indicates there is no disease when there is no disease and it indicates there is disease when there is disease.
Time Frame When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Arm/Group Title Precontrast Combined Precontrast / Postcontrast
Hide Arm/Group Description:
51 eligible for accuracy, 24 eligible for sensitivity, 27 eligible for specificity
51 eligible for accuracy, 24 eligible for sensitivity, 27 eligible for specificity
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: Percentage points
Sensitivity [%] 66.7 70.8
Specificity [%] 88.9 66.7
Accuracy [%] 78.4 68.6
16.Other Pre-specified Outcome
Title Change in Number of Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Hide Description [Not Specified]
Time Frame When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Participants
Less 3
Equal 34
More 14
17.Other Pre-specified Outcome
Title Improved Border Delineation of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Hide Description [Not Specified]
Time Frame When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Participants
Yes 36
No 15
18.Other Pre-specified Outcome
Title Increased Contrast of Primary Lesion vs Background Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Hide Description [Not Specified]
Time Frame When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Participants
Yes 40
No 11
19.Other Pre-specified Outcome
Title Change in Size of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Hide Description [Not Specified]
Time Frame When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Participants
Larger 12
No change 38
Smaller 1
20.Other Pre-specified Outcome
Title Change in Information About Lesion Characterization Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Hide Description [Not Specified]
Time Frame When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description:
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Participants
Improved 39
Unchanged 12
Worsened 0
Time Frame Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Hide Arm/Group Description Participants have received Primovist/Eovist for liver MRI as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records.
All-Cause Mortality
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Affected / at Risk (%)
Total   21/52 (40.38%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/52 (1.92%) 
Febrile neutropenia * 1  7/52 (13.46%) 
Thrombocytopenia * 1  1/52 (1.92%) 
Gastrointestinal disorders   
Abdominal pain * 1  2/52 (3.85%) 
Caecitis * 1  1/52 (1.92%) 
Small intestinal obstruction * 1  1/52 (1.92%) 
Vomiting * 1  1/52 (1.92%) 
Pneumatosis intestinalis * 1  1/52 (1.92%) 
General disorders   
Gait disturbance * 1  1/52 (1.92%) 
Pyrexia * 1  3/52 (5.77%) 
Device occlusion * 1  1/52 (1.92%) 
Hepatobiliary disorders   
Cholangitis acute * 1  1/52 (1.92%) 
Infections and infestations   
Appendicitis * 1  1/52 (1.92%) 
Bacteraemia * 1  1/52 (1.92%) 
Bronchitis * 1  1/52 (1.92%) 
Clostridium difficile colitis * 1  1/52 (1.92%) 
Enterococcal bacteraemia * 1  1/52 (1.92%) 
Gastroenteritis rotavirus * 1  1/52 (1.92%) 
Herpes zoster * 1  1/52 (1.92%) 
Lobar pneumonia * 1  1/52 (1.92%) 
Pneumonia * 1  1/52 (1.92%) 
Sepsis * 1  1/52 (1.92%) 
Septic shock * 1  1/52 (1.92%) 
Tracheitis * 1  1/52 (1.92%) 
Upper respiratory tract infection * 1  1/52 (1.92%) 
Staphylococcal infection * 1  1/52 (1.92%) 
Rhinovirus infection * 1  2/52 (3.85%) 
Parainfluenzae virus infection * 1  1/52 (1.92%) 
Metabolism and nutrition disorders   
Feeding disorder * 1  1/52 (1.92%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Hepatocellular carcinoma * 1  1/52 (1.92%) 
Nervous system disorders   
Headache * 1  1/52 (1.92%) 
Intracranial aneurysm * 1  1/52 (1.92%) 
Neuropathy peripheral * 1  1/52 (1.92%) 
Renal and urinary disorders   
Renal tubular acidosis * 1  1/52 (1.92%) 
Surgical and medical procedures   
Portal shunt * 1  1/52 (1.92%) 
Vascular disorders   
Hypertension * 1  1/52 (1.92%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Affected / at Risk (%)
Total   1/52 (1.92%) 
Surgical and medical procedures   
Benign tumour excision * 1  1/52 (1.92%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (16.0)
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayerhealthcare.com
Publications of Results:
Geller J, Kasahara M, Martinez M, Soresina A, Kashanian F, Endrikat J. Safety and Efficacy of Gadoxetate Disodium-Enhanced Liver MRI in Pediatric Patients Aged >2 Months to <18 Years-Results of a Retrospective, Multicenter Study. Magn Reson Insights. 2016 Jul 21;9:21-8. doi: 10.4137/MRI.S39091. eCollection 2016.
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01043523    
Other Study ID Numbers: 13729
First Submitted: January 4, 2010
First Posted: January 6, 2010
Results First Submitted: February 24, 2014
Results First Posted: June 3, 2014
Last Update Posted: November 28, 2016