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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group/Cohort | Brain Oedema induced by drugs reported to the FAERS database from inception till first quarter of 2019 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drugs, Generic | Drug | All drugs having 19 or more Brain Oedema cases reported to the FAERS database |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presented with brain oedema treated for any disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Peshawar | Peshawar | KPK | 25000 | Pakistan |
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| ID | Term |
|---|---|
| D001929 | Brain Edema |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D016568 | Drugs, Generic |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| 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 |