Brain Edema, Brain Edema Caused by Drugs
Conditions
Brief 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).
Detailed 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.
Interventions
DRUGDrugs, Generic
All drugs having 19 or more Brain Oedema cases reported to the FAERS database
Sponsors
University of Peshawar
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of drugs associated with Brain Oedema | 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. |
| Detection of signals of Brain Oedema | Cases reported to the FAERS database since inception till 31/03/2019 | Signal detection using disproportionality analysis |
Secondary
| Measure | Time frame |
|---|---|
| Trends of Brain Oedema reports in FAERS database | Cases reported to the FAERS database since inception till 31/03/2019 |
| Stratification of new signals with respect to age | 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 |
| Trends of Brain Oedema reports in Google searches | 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 |
Countries
Pakistan
Outcome results
None listed