A Pharmacovigilance Study of Brain Oedema

Completed

• Conditions: Brain Edema; Brain Edema Caused by Drugs
• Interventions: Drug: Drugs, Generic

• Registration Number: NCT04311359
• Lead Sponsor: University of Peshawar

Brief 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.

Study Timeline

• Study Start: 2019-05-20
• Primary Completion: 2019-11-10
• Study Completion: 2019-11-22
• Status Verified: 2020-03
• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-12
• Last Update Submitted: 2020-03-12
• Study First Posted: 2020-03-17
• Last Update Posted: 2020-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9524

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Identification of drugs associated with Brain Oedema	Cases reported to the FAERS database since inception till 31/03/2019	The search includes MedDRA (v-22) Preferred Term, "Brain Oedema (MedDRA code: 10048962) for the identification of all Brain Oedema case reports and drugs.
Detection of signals of Brain Oedema	Cases reported to the FAERS database since inception till 31/03/2019	Signal detection using disproportionality analysis

Secondary Outcome Measures

Name	Time	Method
Stratification of new signals with respect to gender	Cases reported to the FAERS database since inception till 31/03/2019
Trends of Brain Oedema reports in FAERS database	Cases reported to the FAERS database since inception till 31/03/2019
Description of the population of patients having Brain Oedema	Cases reported to the FAERS database since inception till 31/03/2019
Stratification of new signals with respect to age	Cases reported to the FAERS database since inception till 31/03/2019
Trends of Brain Oedema reports in Google searches	Cases reported to the FAERS database since inception till 31/03/2019

Trial Locations

Locations (1)

University of Peshawar; 🇵🇰 Peshawar, KPK, Pakistan