Primovist Regulatory Post Marketing Surveillance (PMS)

Completed

• Conditions: Liver
• Interventions: Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)

• Registration Number: NCT00924248
• Lead Sponsor: Bayer

Brief Summary

The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-17
• Study First Posted: 2009-06-18
• Study Completion: 2011-05
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-18
• Last Update Posted: 2012-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4358

Inclusion Criteria

• Patient who take Primovist for liver MRI

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Exclusion Criteria

• Patients who belong to the contraindication on the product label

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Gadoxetic acid disodium (Primovist, BAY86-4873)	-

Primary Outcome Measures

Name	Time	Method
Safety evaluation in real practice (SAE/AE/ADR collection)	After administration

Secondary Outcome Measures

Name	Time	Method
Assessment of contrast effect by imaging after administration	Before administration
Overall contrast effects by combining individual assessment	Before administration
Assessment of contrast enhancement effect	After administration