NCT04293432

A Pharmacovigilance Study of Torsade de Pointes

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6,670 (actual)
• Sponsor: University of Peshawar · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Torsades de Pointe Caused by Drug

Interventions

Type	Name	Description
DRUG	Drugs, Generic	All drugs having ≥10 TdP cases reported in the FAERS database

Timeline

• Start date: 2019-05-15
• Primary completion: 2019-12-22
• Completion: 2020-01-01
• First posted: 2020-03-03
• Last updated: 2020-03-03

Locations

1 site across 1 country: Pakistan

Regulatory

• FDA-regulated drug study