Safety profile of Ultravist in patients with different sexes, races and from different countries/regions

Study identification

• EU PAS number:
  EUPAS47805
• Study ID:
  47806
• Official title and acronym:
  Safety profile of Ultravist in patients with different sexes, races and from different countries/regions
• DARWIN EU® study:
  No
• Study countries:
  China

  Germany

  Korea, Democratic People's Republic of
• Study description:
  The research question of this analysis is to describe the relative risk / odds ratio of HSRs after Ultravist administrations in patients of different sexes, different races (e.g. Asian, White, Black, other, not specified ) and in patients from 37 countries or summarized in global regions (e.g. Europe, North America, Asia w/wo China, Africa).
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual: 28/03/2022

Study start date

Planned: 30/06/2022

Actual: 30/06/2022

Date of final study report

Planned: 21/12/2022

Actual: 28/03/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable