Dihydropyrimidine dehydrogenase deficiency related toxicities to fluorouracil and fluorouracil related substances containing medicinal products - EudraVigilance analysis and literature review

Study identification

• EU PAS number:
  EUPAS39122
• Study ID:
  39123
• Official title and acronym:
  Dihydropyrimidine dehydrogenase deficiency related toxicities to fluorouracil and fluorouracil related substances containing medicinal products - EudraVigilance analysis and literature review
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  This study included a descriptive analysis of case reports to fluorouracil and related substances in EudraVigilance that could have resulted from dihydropyrimidine dehydrogenase deficiency (DPD). The study included several different potential case definitions of DPD including probabilistic phenotyping.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 26/03/2019

Actual: 26/03/2019

Study start date

Planned: 26/03/2019

Actual: 26/03/2019

Data analysis start date

Planned: 26/03/2019

Actual: 26/03/2019

Date of final study report

Actual: 19/06/2019

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable