A Pharmacovigilance Study of Brain Oedema

NCT ID: NCT04311359

Last Updated: 2020-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9524 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-20

Study Completion Date

2019-11-22

Brief Summary

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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

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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

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Brain Edema Brain Edema Caused by Drugs

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group/Cohort

Brain Oedema induced by drugs reported to the FAERS database from inception till first quarter of 2019

Drugs, Generic

Intervention Type DRUG

All drugs having 19 or more Brain Oedema cases reported to the FAERS database

Interventions

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Drugs, Generic

All drugs having 19 or more Brain Oedema cases reported to the FAERS database

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Peshawar

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Ismail

Assistant Professor, Department of Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Peshawar

Peshawar, KPK, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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PV-BO

Identifier Type: -

Identifier Source: org_study_id

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