Deaths and life-threatening events associated with paliperidone palmitate in France

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37271
• EU PAS number:
  EUPAS37270
• Study ID:
  37271
• Official title and acronym:
  Deaths and life-threatening events associated with paliperidone palmitate in France
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Our aim was to describe paliperidone palmitate-related adverse drug reactions (ADRs) leading to death or life-threatening events, specifying their main clinical and pharmacological characteristics.This observational study was a retrospective review of French pharmacovigilance database cases in patients treated with PP between January 1, 2013, and December 31, 2019.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual: 06/01/2020

Study start date

Actual: 15/01/2020

Data analysis start date

Actual: 20/01/2020

Date of final study report

Planned: 15/09/2020

Actual: 15/09/2020

Sources of funding

Other

More details on funding

Nantes University hospital

Regulatory

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