Brain EdemaNCT04311359
A Pharmacovigilance Study of Brain Oedema
An observational study of Brain Edema and Brain Edema Caused by Drugs, run by University of Peshawar at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Edema, Brain Edema Caused by Drugs
- What is being tested?
- Drugs, Generic
- How many people
- 9,524 participants
- Where
- 1 sitePakistan
- Study dates
- 20 May 2019to 22 Nov 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presented with brain oedema treated for any disease
Who may be able to join
- Brain Oedema cases reported in the FAERS database till 31/03/2019
- Adverse event reported was included using the MedDRA term: Brain Oedema
Who cannot join
- Drugs with less than 19 brain oedema reports
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacovigilance Study of Brain Oedema in the Food and Drug Administration Adverse Event Reporting System Using Data Mining Algorithms
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).
Read the 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.
- Conditions
- Brain Edema, Brain Edema Caused by Drugs
- Being tested
- Drugs, Generic
- Medical subject headings
- Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drugs, GenericDrug
All drugs having 19 or more Brain Oedema cases reported to the FAERS database
| Study group | Role | What they receive |
|---|---|---|
| Group/Cohort | Brain Oedema induced by drugs reported to the FAERS database from inception till first quarter of 2019 Receives: Drug: Drugs, Generic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Cases reported to the FAERS database since inception till 31/03/2019
Detection of signals of Brain Oedema
Signal detection using disproportionality analysis
Measured: Cases reported to the FAERS database since inception till 31/03/2019
Secondary outcomes (5)
Stratification of new signals with respect to age
Measured: Cases reported to the FAERS database since inception till 31/03/2019
Stratification of new signals with respect to gender
Measured: Cases reported to the FAERS database since inception till 31/03/2019
Trends of Brain Oedema reports in FAERS database
Measured: Cases reported to the FAERS database since inception till 31/03/2019
Trends of Brain Oedema reports in Google searches
Measured: Cases reported to the FAERS database since inception till 31/03/2019
Description of the population of patients having Brain Oedema
Measured: Cases reported to the FAERS database since inception till 31/03/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start20 May 2019
- Primary completion10 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 9,524 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Peshawar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Ismail, University of Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311359
- Sponsor's protocol ID
- PV-BO
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacovigilance Study of Brain Oedema in the Food and Drug Administration Adverse Event Reporting System Using Data Mining Algorithms
- ClinicalTrials.gov ID
- NCT04311359
- Acronym / sponsor ID
- PV-BO
- Conditions
- Brain Edema, Brain Edema Caused by Drugs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,524 participants (actual)
- Lead sponsor
- University of PeshawarUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group/Cohort | – | Drug: Drugs, GenericBrain Oedema induced by drugs reported to the FAERS database from inception till first quarter of 2019 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presented with brain oedema treated for any disease
Key inclusion criteria (2 listed)
- Brain Oedema cases reported in the FAERS database till 31/03/2019
- Adverse event reported was included using the MedDRA term: Brain Oedema
Key exclusion criteria (1 listed)
- Drugs with less than 19 brain oedema reports
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drugs, GenericAll drugs having 19 or more Brain Oedema cases reported to the FAERS database | Drug | Group/Cohort |
Primary outcome
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.
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
5 secondary outcomes
Stratification of new signals with respect to age
Time frame: Cases reported to the FAERS database since inception till 31/03/2019
Stratification of new signals with respect to gender
Time frame: Cases reported to the FAERS database since inception till 31/03/2019
Trends of Brain Oedema reports in FAERS database
Time frame: Cases reported to the FAERS database since inception till 31/03/2019
Trends of Brain Oedema reports in Google searches
Time frame: Cases reported to the FAERS database since inception till 31/03/2019
Description of the population of patients having Brain Oedema
Time frame: Cases reported to the FAERS database since inception till 31/03/2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Brain Edema
Not yet recruitingObservational study
Decompressive Craniectomy After Aneurysmal Subarachnoid Hemorrhage (DECIDE-SAH)
Aneurysmal Subarachnoid Hemorrhage
Not yet recruiting
Modulating Inflammation in Neuro-Trauma
Traumatic Brain Injury
Not yet recruitingPhase 2
Early Prophylactic Versus Late Salvage Recombinant Human Endostatin in Managing Radiosurgery-Induced Brain Injury for NSCLC Brain Metastases
Lung Cancer (Non-Small Cell), Radiation
RecruitingObservational study
Chinese Multicenter Cohort Study of Intracerebral Hemorrhage
Intracerebral Hemorrhage
Not yet recruitingObservational study
Transcranial Doppler Evaluation After Endovascular Thrombectomy for Acute Ischemic Stroke (PRECISE-TCD)
Anterior Cerebral Artery Syndrome, Anterior Cerebral Artery Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Edema and Brain Edema Caused by Drugs, run by University of Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of drugs associated with Brain Oedema (time frame: Cases reported to the FAERS database since inception till 31/03/2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.