A Pharmacovigilance Study of Torsade de Pointes
1 other identifier
observational
6,670
1 country
1
Brief Summary
Many cardiac and non-cardiac drugs are associated with TdP that may constitute a significant problem because of sudden cardiac death. This study aims to present a comprehensive overview and disproportionality analysis of TdP cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) in order to identify new signals of TdP.
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 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 14, 2020
CompletedFirst Posted
Study publicly available on registry
March 3, 2020
CompletedMarch 3, 2020
February 1, 2020
7 months
February 14, 2020
February 28, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Identification of drugs associated with TdP
The search includes MedDRA (v-22) Preferred Term, "Torsade de Pointes (MedDRA code: 10044066) for the identification of all TdP case reports and drugs.
Cases reported to the FAERS database till 31/03/2019
Identification of new signals of TdP
Signal detection using disproportionality analysis
Cases reported to the FAERS database till 31/03/2019
Secondary Outcomes (5)
Validation of already known drug-TdP associations
Cases reported to the FAERS database till 31/03/2019
Stratification of new signals with respect to age
Cases reported to the FAERS database till 31/03/2019
Stratification of new signals with respect to gender
Cases reported to the FAERS database till 31/03/2019
Trends of TdP reports in FAERS database
Cases reported to the FAERS database till 31/03/2019
Description of the population of patients having TdP
Cases reported to the FAERS database till 31/03/2019
Study Arms (1)
Group/Cohort
Torsade de Pointes induced by drugs reported to the FAERS database from inception till first quarter of 2019 (1990-2019)
Interventions
Eligibility Criteria
Patients presented with TdP treated for any disease
You may qualify if:
- TdP cases reported in the FAERS database till 31/03/2019
- Adverse event reported was including the MedDRA term: Torsade de Pointes
You may not qualify if:
- Drugs with less than 10 TdP reports
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pharmacy, University of Peshawar
Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan
Related Publications (1)
Ali Z, Ismail M, Rehman IU, Goh KW, Razi P, Ming LC. Association of anxiolytic drugs with Torsade de Pointes: a pharmacovigilance study of the Food and Drug Administration Adverse Event Reporting System. J Pharm Policy Pract. 2024 Sep 16;17(1):2399716. doi: 10.1080/20523211.2024.2399716. eCollection 2024.
PMID: 39291052DERIVED
MeSH Terms
Interventions
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
February 14, 2020
First Posted
March 3, 2020
Study Start
May 15, 2019
Primary Completion
December 22, 2019
Study Completion
January 1, 2020
Last Updated
March 3, 2020
Record last verified: 2020-02