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NCT Number: NCT04311359

A Pharmacovigilance Study of Brain Oedema

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).

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Key information

Conditions

Brain Edema Brain Diseases Brain Edema Caused by Drugs Central Nervous System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Peshawar

Peshawar, KPK, 25000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drugs, Generic

Drug

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

Primary outcomes

  1. Identification of drugs associated with Brain Oedema

    Time frame: 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.

  2. Detection of signals of Brain Oedema

    Time frame: Cases reported to the FAERS database since inception till 31/03/2019

    Signal detection using disproportionality analysis

Secondary outcomes

  1. Stratification of new signals with respect to age

    Time frame: Cases reported to the FAERS database since inception till 31/03/2019

  2. Stratification of new signals with respect to gender

    Time frame: Cases reported to the FAERS database since inception till 31/03/2019

  3. Trends of Brain Oedema reports in FAERS database

    Time frame: Cases reported to the FAERS database since inception till 31/03/2019

  4. Trends of Brain Oedema reports in Google searches

    Time frame: Cases reported to the FAERS database since inception till 31/03/2019

  5. Description of the population of patients having Brain Oedema

    Time frame: Cases reported to the FAERS database since inception till 31/03/2019

Sponsors and collaborators

Lead sponsor

University of Peshawar

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 17, 2020
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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