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Primovist Regulatory Post Marketing Surveillance (PMS)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00924248
First received: June 17, 2009
Last updated: September 18, 2012
Last verified: September 2012
History of Changes

June 17, 2009
September 18, 2012
October 2007
Not Provided
Safety evaluation in real practice (SAE/AE/ADR collection) [ Time Frame: After administration ] [ Designated as safety issue: Yes ]
Safety and efficacy evaluation in real practice [ Time Frame: After administration ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00924248 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Demography [ Time Frame: Before administration ] [ Designated as safety issue: No ]
  • Medical History/Background [ Time Frame: Before administration ] [ Designated as safety issue: No ]
  • Dose [ Time Frame: At point of administration ] [ Designated as safety issue: No ]
  • Concomitant medication [ Time Frame: At point of administration ] [ Designated as safety issue: No ]
  • Facility [ Time Frame: At point of administration ] [ Designated as safety issue: No ]
  • Diagnosis [ Time Frame: After administration ] [ Designated as safety issue: No ]
  • Serious Adverse Event /Adverse Event collection [ Time Frame: At the point of the occurence ] [ Designated as safety issue: Yes ]
  • Overall evaluation [ Time Frame: After administration ] [ Designated as safety issue: Yes ]
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

n.a.
Non-Probability Sample

Korean who take Primovist for liver MRI
Liver
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4358
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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00924248
14332, PR0810KR
No
Medical Director, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP