Drug Use Investigation of Gadovist.

Completed

• Conditions: Magnetic Resonance Imaging; Image Enhancement
• Interventions: Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)

• Registration Number: NCT02540967
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-04
• Study Start: 2015-10-27
• Primary Completion: 2017-11-02
• Study Completion: 2017-11-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3357

Inclusion Criteria

• Patients who perform contrast enhanced Magnetic Resonance Imaging (MRI) with Gadovist.

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Exclusion Criteria

• Patients who are contraindicated based on approved label.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BAY86-4875	Gadobutrol (Gadavist/Gadovist, BAY86-4875)	Gadovist administration goup

Primary Outcome Measures

Name	Time	Method
Number of episodes of adverse events as a measure of safety and tolerability	Up to 3 days

Secondary Outcome Measures

Name	Time	Method
Number of episodes of adverse drug reactions and adverse events	Up to 3 days	In subpopulations
Contrast enhancement	At the time of MRI	Investigator Discretion as very improved , improved, not changed, degraded, not evaluable.; MRI- Magnetic Resonance Imaging

Trial Locations

Locations (1)

Many Locations; 🇯🇵 Multiple Locations, Japan