PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Post-marketing Surveillance Study Ultravist®-IMAGE IoproMide (UltrAvist®) to Gain Further Information on Tolerability and Safety in X-ray Examination|
- Occurrence of adverse events [ Time Frame: During and after Ultravist application on the day of examination ] [ Designated as safety issue: Yes ]
- General contrast quality in the region of interest as assessed by physicians [ Time Frame: On the day of examination ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Drug: Ultravist (Iopromide, BAY86-4877)
Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876083
Show 21 Study Locations
|Study Director:||Bayer Study Director||Bayer|