A Pharmacovigilance Study of Brain Oedema

Study Overview
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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.

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

Conditions
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Brain Edema, Brain Edema Caused by Drugs

Intervention / Treatment
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* Drug: Drugs, Generic


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group/Cohort<br>Brain Oedema induced by drugs reported to the FAERS database from inception till first quarter of 2019 | Drug: Drugs, Generic<br>* All drugs having 19 or more Brain Oedema cases reported to the FAERS database<br>|

What is the study measuring?
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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 | Measure Description | 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 |