Use of ondansetron in pregnant female patients in the IMS Disease Analyzer databases in France and Germany (Ondansetron use pregnancy)

Study identification

• EU PAS number:
  EUPAS34908
• Study ID:
  34909
• Official title and acronym:
  Use of ondansetron in pregnant female patients in the IMS Disease Analyzer databases in France and Germany (Ondansetron use pregnancy)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany
• Study description:
  Pregnancy was identified on the basis of diagnosis codes for pregnancy, and possible time of pregnancy was derived from the pregnancy code and the date when the code was recorded. Use of ondansetron was then identified during the time interval of possible pregnancy.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 01/04/2019

Actual: 01/04/2019

Study start date

Planned: 01/04/2019

Actual: 01/04/2019

Data analysis start date

Planned: 01/04/2019

Actual: 01/04/2019

Date of final study report

Planned: 02/05/2019

Actual: 02/05/2019

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