Rapid Data Analysis – Ceftriaxone and hepatic events

Study identification

• EU PAS number:
  EUPAS38221
• Study ID:
  38276
• Official title and acronym:
  Rapid Data Analysis – Ceftriaxone and hepatic events
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany
• Study description:
  This analysis aims to provide descriptive information on specific hepatic events occurring within 30 days of a prescription in patients using ceftriaxone, stratified by prior history of liver disease or other risk factors for hepatic events. Results are also be stratified by gender, age group, indication, and above or below the mean total dose prescribed on the date of the first prescription. No comparisons to other products will be performed due to the limitations of the data and the low sample size.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 01/09/2020

Actual: 01/09/2020

Study start date

Planned: 01/09/2020

Actual: 01/09/2020

Date of final study report

Planned: 18/11/2020

Actual: 18/11/2020

Sources of funding

EMA

Regulatory

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