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PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diagnostic Imaging

Intervention: Ultravist (Iopromide, BAY86-4877) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

The purpose of this study is to obtain data on the safety and efficacy of Ultravist application in usual daily use. The radiologist will administer the contrast medium to the patient as he/she would have done without the study. No other examinations will be performed than would have been done routinely.

Clinical Details

Official title: Post-marketing Surveillance Study Ultravist®-IMAGE IoproMide (UltrAvist®) to Gain Further Information on Tolerability and Safety in X-ray Examination

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Occurrence of adverse events

Secondary outcome: General contrast quality in the region of interest as assessed by physicians

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with indication for an X-ray examination and for whom the radiologist has

decided to use the contrast medium Ultravist. Exclusion Criteria:

- No exclusion criteria besides the contraindications for the use of Ultravist as

mentioned in the product information.

Locations and Contacts

Many Locations, Bosnia and Herzegovina

Many Locations, China

Many Locations, Germany

Many Locations, Hungary

Many Locations, Indonesia

Many Locations, Iran, Islamic Republic of

Many Locations, Italy

Many Locations, Korea, Republic of

Many Locations, Malaysia

Many Locations, Moldova, Republic of

Many Locations, Pakistan

Many Locations, Philippines

Many Locations, Poland

Many Locations, Romania

Many Locations, Russian Federation

Many Locations, Saudi Arabia

Many Locations, Singapore

Many Locations, Taiwan

Many Locations, Thailand

Many Locations, Ukraine

Many Locations, Vietnam

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: March 2008
Last updated: February 25, 2011

Page last updated: August 23, 2015

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