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Clinical Trials/NCT00924248
NCT00924248
Completed
Not Applicable

Primovist Regulatory Post Marketing Surveillance

Bayer0 sites4,358 target enrollmentOctober 2007
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ConditionsLiver
InterventionsGadoxetic acid disodium (Primovist, BAY86-4873)
DrugsGadoxetic acid disodium (Primovist, BAY86-4873)

Overview

Phase
Not Applicable
Intervention
Gadoxetic acid disodium (Primovist, BAY86-4873)
Conditions
Liver
Sponsor
Bayer
Enrollment
4358
Primary Endpoint
Safety evaluation in real practice (SAE/AE/ADR collection)
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
October 2007
End Date
May 2011
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bayer

Eligibility Criteria

Inclusion Criteria

  • •Patient who take Primovist for liver MRI

Exclusion Criteria

  • •Patients who belong to the contraindication on the product label

Arms & Interventions

Group 1

Intervention: Gadoxetic acid disodium (Primovist, BAY86-4873)

Outcomes

Primary Outcomes

Safety evaluation in real practice (SAE/AE/ADR collection)

Time Frame: After administration

Secondary Outcomes

  • 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)

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