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NCT04311359 Clinical Trial

A Pharmacovigilance Study of Brain Oedema

Brain Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04311359
Other study ID # PV-BO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 20, 2019
Est. completion date November 22, 2019

Study information
Verified date March 2020
Source University of Peshawar
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 9524
Est. completion date November 22, 2019
Est. primary completion date November 10, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Drugs, Generic
All drugs having 19 or more Brain Oedema cases reported to the FAERS database

Locations
Country Name City State
Pakistan University of Peshawar Peshawar KPK

Sponsors (1)
Lead Sponsor Collaborator
University of Peshawar

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Detection of signals of Brain Oedema Signal detection using disproportionality analysis Cases reported to the FAERS database since inception till 31/03/2019
Secondary Stratification of new signals with respect to age Cases reported to the FAERS database since inception till 31/03/2019
Secondary Stratification of new signals with respect to gender Cases reported to the FAERS database since inception till 31/03/2019
Secondary Trends of Brain Oedema reports in FAERS database Cases reported to the FAERS database since inception till 31/03/2019
Secondary Trends of Brain Oedema reports in Google searches Cases reported to the FAERS database since inception till 31/03/2019
Secondary Description of the population of patients having Brain Oedema Cases reported to the FAERS database since inception till 31/03/2019
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