Primovist Regulatory Post Marketing Surveillance (PMS)

This study has been completed.
Information provided by:
Bayer Identifier:
First received: June 17, 2009
Last updated: September 18, 2012
Last verified: September 2012
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Primovist Regulatory Post Marketing Surveillance

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Safety evaluation in real practice (SAE/AE/ADR collection) [ Time Frame: After administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of contrast effect by imaging after administration [ Time Frame: Before administration ] [ Designated as safety issue: No ]
  • Overall contrast effects by combining individual assessment [ Time Frame: Before administration ] [ Designated as safety issue: No ]
  • Assessment of contrast enhancement effect [ Time Frame: After administration ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Enrollment: 4358
Study Start Date: October 2007
Study Completion Date: May 2011
Groups/Cohorts Assigned Interventions
Group 1 Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)
Patients in daily life clinical practice treatment receiving Primovist according to indication on the label.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Korean who take Primovist for liver MRI

Inclusion Criteria:

  • Patient who take Primovist for liver MRI

Exclusion Criteria:

  • Patients who belong to the contraindication on the product label
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00924248

Korea, Republic of
Many Locations, Korea, Republic of
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Director, Bayer Healthcare AG Identifier: NCT00924248     History of Changes
Other Study ID Numbers: 14332, PR0810KR
Study First Received: June 17, 2009
Last Updated: September 18, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Bayer:
Liver MRI

Additional relevant MeSH terms:
Gadolinium ethoxybenzyl DTPA
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions processed this record on December 01, 2015