A Pharmacovigilance Study of Torsade de Pointes

Torsades de Pointe Caused by Drug Clinical Trial

Official title:

A Pharmacovigilance Study of Torsade de Pointes in the Food and Drug Administration Adverse Event Reporting System Using Data Mining Algorithms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293432
• Other study ID #: PV-TdP
• Status: Completed
• Start date: May 15, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: February 2020
• Source: University of Peshawar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Drug-induced Torsade de Pointes (TdP) is a serious but an overlooked adverse drug reaction because a wide range of marketed drugs associated with TdP are commonly prescribed in routine practice. Owing to the heightened concern of a vast number of drug-TdP associations including newly approved drugs, the investigators, therefore, aims to investigate drug-TdP associations by performing disproportionality analysis in order to identify new signals of TdP utilizing the individual case reports of TdP in the FAERS database.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6670
• Est. completion date: January 1, 2020
• Est. primary completion date: December 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• TdP cases reported in the FAERS database till 31/03/2019

• Adverse event reported was including the MedDRA term: Torsade de Pointes

Exclusion Criteria:

• Drugs with less than 10 TdP reports

Related Conditions & MeSH terms

• Torsades de Pointe Caused by Drug
• Torsades de Pointes

Intervention

Drug:
• Drugs, Generic
All drugs having =10 TdP cases reported in the FAERS database

Locations

Country	Name	City	State
Pakistan	Department of Pharmacy, University of Peshawar	Peshawar	Khyber Pakhtunkhwa

Sponsors (1)

Lead Sponsor	Collaborator
University of Peshawar

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Identification of new signals of TdP	Signal detection using disproportionality analysis	Cases reported to the FAERS database till 31/03/2019
Secondary	Validation of already known drug-TdP associations		Cases reported to the FAERS database till 31/03/2019
Secondary	Stratification of new signals with respect to age		Cases reported to the FAERS database till 31/03/2019
Secondary	Stratification of new signals with respect to gender		Cases reported to the FAERS database till 31/03/2019
Secondary	Trends of TdP reports in FAERS database		Cases reported to the FAERS database till 31/03/2019
Secondary	Description of the population of patients having TdP		Cases reported to the FAERS database till 31/03/2019