ClinicalTrials.Veeva

Menu

A Pharmacovigilance Study of Brain Oedema

U

University of Peshawar

Status

Completed

Conditions

Brain Edema
Brain Edema Caused by Drugs

Treatments

Drug: Drugs, Generic

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

Literature reports the development of brain oedema following the use of certain drugs. Therefore, this study aims to present a comprehensive disproportionality analysis of brain oedema cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS).

Full description

Brain oedema is a serious neurological condition, as it possesses a significant impact on the functional abilities of an individual by causing irreversible brain damage and potentiates the risk of mortality. Apart from a number of medical conditions causing brain oedema, evidence suggests the association of various drugs with brain oedema. Therefore, this study aims to provide a comprehensive disproportionality analysis of the drug-induced brain oedema reports in the FAERS database.

Enrollment

9,524 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Brain Oedema cases reported in the FAERS database till 31/03/2019
  • Adverse event reported was included using the MedDRA term: Brain Oedema

Exclusion criteria

  • Drugs with less than 19 brain oedema reports

Trial design

9,524 participants in 1 patient group

Group/Cohort
Description:
Brain Oedema induced by drugs reported to the FAERS database from inception till first quarter of 2019
Treatment:
Drug: Drugs, Generic

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems