A Pharmacovigilance Study of Brain Oedema

University of Peshawar

Status: Completed

Conditions: Brain Edema; Brain Edema Caused by Drugs

Treatments: Drug: Drugs, Generic

Study type: Observational

Funder types: Other

Identifiers

NCT04311359

PV-BO

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