Primovist Regulatory Post Marketing Surveillance (PMS)

Primovist Regulatory Post Marketing Surveillance

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00924248

Enrollment

4358

Registered

2009-06-18

Start date

2007-10-31

Completion date

2011-05-31

Last updated

2012-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver

Keywords

Liver MRI

Brief summary

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

Interventions

DRUGGadoxetic acid disodium (Primovist, BAY86-4873)

Patients in daily life clinical practice treatment receiving Primovist according to indication on the label.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patient who take Primovist for liver MRI

Exclusion criteria

* Patients who belong to the contraindication on the product label

Design outcomes

Primary

Measure	Time frame
Safety evaluation in real practice (SAE/AE/ADR collection)	After administration

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026