Primovist Regulatory Post Marketing Surveillance (PMS)

Tracking Information
First Submitted Date	June 17, 2009
First Posted Date	June 18, 2009
Last Update Posted Date	September 19, 2012
Study Start Date	October 2007
Primary Completion Date	Not Provided
Current Primary Outcome Measures; (submitted: September 18, 2012)	Safety evaluation in real practice (SAE/AE/ADR collection) [ Time Frame: After administration ]
Original Primary Outcome Measures; (submitted: June 17, 2009)	Safety and efficacy evaluation in real practice [ Time Frame: After administration ]
Change History	Complete list of historical versions of study NCT00924248 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: September 18, 2012)	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 ]
Original Secondary Outcome Measures; (submitted: June 17, 2009)	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 ]
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Primovist Regulatory Post Marketing Surveillance (PMS)
Official Title	Primovist Regulatory Post Marketing Surveillance
Brief Summary	The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: None Retained; Description: n.a.
Sampling Method	Non-Probability Sample
Study Population	Korean who take Primovist for liver MRI
Condition	Liver
Intervention	Drug: Gadoxetic acid disodium (Primovist, BAY86-4873); Patients in daily life clinical practice treatment receiving Primovist according to indication on the label.
Study Groups/Cohorts	Group 1; Intervention: Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: September 18, 2012)	4358
Original Estimated Enrollment; (submitted: June 17, 2009)	4500
Actual Study Completion Date	May 2011
Primary Completion Date	Not Provided
Eligibility Criteria	Inclusion Criteria: Patient who take Primovist for liver MRI Exclusion Criteria: Patients who belong to the contraindication on the product label
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Korea, Republic of
Removed Location Countries
Administrative Information
NCT Number	NCT00924248
Other Study ID Numbers	14332; PR0810KR ( Other Identifier: company internal )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Medical Director, Bayer Healthcare AG
Study Sponsor	Bayer
Collaborators	Not Provided
Investigators	Study Director: Bayer Study Director Bayer
PRS Account	Bayer
Verification Date	September 2012