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

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).

Study Overview

• Status: Completed
• Conditions: Brain Edema; Brain Edema Caused by Drugs
• Intervention / Treatment: Drug: Drugs, Generic

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 Type: Observational
• Enrollment (Actual): 9524

Contacts and Locations

Study Locations

• Pakistan
  • KPK
    • Peshawar, KPK, Pakistan, 25000
      • University of Peshawar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presented with brain oedema treated for any disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group/Cohort; Brain Oedema induced by drugs reported to the FAERS database from inception till first quarter of 2019	Drug: Drugs, Generic; All drugs having 19 or more Brain Oedema cases reported to the FAERS database

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Stratification of new signals with respect to age	Cases reported to the FAERS database since inception till 31/03/2019
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
Trends of Brain Oedema reports in Google searches	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

Collaborators and Investigators

• Sponsor: University of Peshawar

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2019
• Primary Completion (ACTUAL): November 10, 2019
• Study Completion (ACTUAL): November 22, 2019

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (ACTUAL): March 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Edema; Brain Edema
• Other Study ID Numbers: PV-BO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes