NCT02540967

Drug Use Investigation of Gadovist.

Drug Use Investigation of Gadovist

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,357 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Magnetic Resonance Imaging
• Image Enhancement

Interventions

Type	Name	Description
DRUG	Gadobutrol (Gadavist/Gadovist, BAY86-4875)	Gadovist dosage following summary of product characteristics

Timeline

• Start date: 2015-10-27
• Primary completion: 2017-11-02
• Completion: 2017-11-02
• First posted: 2015-09-04
• Last updated: 2023-11-07

Locations

1 site across 1 country: Japan