A Pharmacovigilance Study of Brain Oedema
1 other identifier
observational
9,524
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2019
CompletedFirst Submitted
Initial submission to the registry
March 12, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedMarch 17, 2020
March 1, 2020
6 months
March 12, 2020
March 12, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
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
Study Arms (1)
Group/Cohort
Brain Oedema induced by drugs reported to the FAERS database from inception till first quarter of 2019
Interventions
All drugs having 19 or more Brain Oedema cases reported to the FAERS database
Eligibility Criteria
Patients presented with brain oedema treated for any disease
You may qualify if:
- Brain Oedema cases reported in the FAERS database till 31/03/2019
- Adverse event reported was included using the MedDRA term: Brain Oedema
You may not qualify if:
- Drugs with less than 19 brain oedema reports
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Peshawar
Peshawar, KPK, 25000, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Department of Pharmacy
Study Record Dates
First Submitted
March 12, 2020
First Posted
March 17, 2020
Study Start
May 20, 2019
Primary Completion
November 10, 2019
Study Completion
November 22, 2019
Last Updated
March 17, 2020
Record last verified: 2020-03