Trial Condition(s):
Liver
Primovist Regulatory Post Marketing Surveillance (PMS)
Bayer Identifier:
14332
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice
Inclusion Criteria
- Patient who take Primovist for liver MRI
Exclusion Criteria
- Patients who belong to the contraindication on the product label
Trial Summary
Enrollment Goal
4358
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Eovist/Primovist (Gadoxetate disodium, BAY86-4873)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Primovist regulatory Post Marketing Surveillance
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Safety evaluation in real practice (SAE/AE/ADR collection)Timeframe: After administration
Secondary Outcome
- Assessment of contrast effect by imaging after administrationTimeframe: Before administration
- Overall contrast effects by combining individual assessmentTimeframe: Before administration
- Assessment of contrast enhancement effectTimeframe: After administration
Additional Information
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