A Pharmacovigilance Study of Torsade de Pointes

University of Peshawar

Status: Completed

Conditions: Torsades de Pointe Caused by Drug

Treatments: Drug: Drugs, Generic

Study type: Observational

Funder types: Other

Identifiers

NCT04293432

PV-TdP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,670 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

6,670 participants in 1 patient group

Group/Cohort

Description:

Torsade de Pointes induced by drugs reported to the FAERS database from inception till first quarter of 2019 (1990-2019)

Treatment:

Drug: Drugs, Generic