Drug Use Investigation of Gadovist.

Bayer

Status: Completed

Conditions: Image Enhancement; Magnetic Resonance Imaging

Treatments: Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)

Study type: Observational

Funder types: Industry

Identifiers

NCT02540967

17512

Details and patient eligibility

About

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

Full 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).

Enrollment: 3,357 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients who are contraindicated based on approved label.

Trial design

3,357 participants in 1 patient group

BAY86-4875

Description:

Gadovist administration goup

Treatment:

Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)