NCT04311359

A Pharmacovigilance Study of Brain Oedema

A Pharmacovigilance Study of Brain Oedema in the Food and Drug Administration Adverse Event Reporting System Using Data Mining Algorithms

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9,524 (actual)
• Sponsor: University of Peshawar · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Brain Edema
• Brain Edema Caused by Drugs

Interventions

Type	Name	Description
DRUG	Drugs, Generic	All drugs having 19 or more Brain Oedema cases reported to the FAERS database

Timeline

• Start date: 2019-05-20
• Primary completion: 2019-11-10
• Completion: 2019-11-22
• First posted: 2020-03-17
• Last updated: 2020-03-17

Locations

1 site across 1 country: Pakistan

Regulatory

• FDA-regulated drug study