Primovist Regulatory Post Marketing Surveillance (PMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00924248
Recruitment Status : Completed
First Posted : June 18, 2009
Last Update Posted : September 19, 2012
Information provided by:

June 17, 2009
June 18, 2009
September 19, 2012
October 2007
Not Provided
Safety evaluation in real practice (SAE/AE/ADR collection) [ Time Frame: After administration ]
Safety and efficacy evaluation in real practice [ Time Frame: After administration ]
Complete list of historical versions of study NCT00924248 on Archive Site
  • Assessment of contrast effect by imaging after administration [ Time Frame: Before administration ]
  • Overall contrast effects by combining individual assessment [ Time Frame: Before administration ]
  • Assessment of contrast enhancement effect [ Time Frame: After administration ]
  • Demography [ Time Frame: Before administration ]
  • Medical History/Background [ Time Frame: Before administration ]
  • Dose [ Time Frame: At point of administration ]
  • Concomitant medication [ Time Frame: At point of administration ]
  • Facility [ Time Frame: At point of administration ]
  • Diagnosis [ Time Frame: After administration ]
  • Serious Adverse Event /Adverse Event collection [ Time Frame: At the point of the occurence ]
  • Overall evaluation [ Time Frame: After administration ]
Not Provided
Not Provided
Primovist Regulatory Post Marketing Surveillance (PMS)
Primovist Regulatory Post Marketing Surveillance
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice
Not Provided
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Non-Probability Sample
Korean who take Primovist for liver MRI
Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)
Patients in daily life clinical practice treatment receiving Primovist according to indication on the label.
Group 1
Intervention: Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2011
Not Provided

Inclusion Criteria:

  • Patient who take Primovist for liver MRI

Exclusion Criteria:

  • Patients who belong to the contraindication on the product label
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
PR0810KR ( Other Identifier: company internal )
Not Provided
Not Provided
Medical Director, Bayer Healthcare AG
Not Provided
Study Director: Bayer Study Director Bayer
September 2012