Drug Use Investigation of Gadovist.

Bayer3,357 enrolled

Overview

The objectives of this study are to investigate the safety and effectiveness of Gadovist.

This is a prospective, non-interventional, continuous submission safety study that includes patients who planned Gadolinium (Gd) contrast enhanced Magnetic Resonance Imaging (MRI) in accordance with approved label. The investigator will have made the choice of Gd enhanced MRI (the decision to use Gadovist according the Japanese Package Insert prior to enrolling the patient in this study). The study period is 3 years. Data analysis period is 1 year. In total, 3300 patients will be recruited. For each patient, data are collected as defined in the case report form (CRF) at the visit for MRI examination (as per investigators routine practice).

Study Type

OBSERVATIONAL

Enrollment

3,357

Conditions

Magnetic Resonance Imaging Image Enhancement

Interventions

Gadobutrol (Gadavist/Gadovist, BAY86-4875)DRUG

Gadovist dosage following summary of product characteristics

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who perform contrast enhanced Magnetic Resonance Imaging (MRI) with Gadovist. Exclusion Criteria: * Patients who are contraindicated based on approved label.

Locations (1)

Many Locations

Multiple Locations, Japan

Outcomes

Primary Outcomes

Number of episodes of adverse events as a measure of safety and tolerability

Time frame: Up to 3 days

Secondary Outcomes

Number of episodes of adverse drug reactions and adverse events

In subpopulations

Time frame: Up to 3 days

Contrast enhancement

Investigator Discretion as very improved , improved, not changed, degraded, not evaluable. MRI- Magnetic Resonance Imaging

Time frame: At the time of MRI

Data from ClinicalTrials.gov

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