check_circleStudy Completed
Liver
Bayer Identifier:
14332
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Primovist Regulatory Post Marketing Surveillance (PMS)
Trial purpose
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice
Key Participants Requirements
Sex
BothAge
0 - N/ATrial summary
Enrollment Goal
4358Trial Dates
October 2007 - May 2011Phase
N/ACould I Receive a placebo
NoProducts
Eovist/Primovist (Gadoxetate disodium, BAY86-4873)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Korea, Republic Of |
Primary Outcome
- Safety evaluation in real practice (SAE/AE/ADR collection)date_rangeTime Frame:After administrationenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Assessment of contrast effect by imaging after administrationdate_rangeTime Frame:Before administrationenhanced_encryptionNoSafety Issue:
- Overall contrast effects by combining individual assessmentdate_rangeTime Frame:Before administrationenhanced_encryptionNoSafety Issue:
- Assessment of contrast enhancement effectdate_rangeTime Frame:After administrationenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A