A Pharmacovigilance Study of Torsade de Pointes

Study Overview
=================
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.

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.

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

Conditions
-----------------
Torsades de Pointe Caused by Drug

Intervention / Treatment
-----------------
* Drug: Drugs, Generic


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group/Cohort<br>Torsade de Pointes induced by drugs reported to the FAERS database from inception till first quarter of 2019 (1990-2019) | Drug: Drugs, Generic<br>* All drugs having ≥10 TdP cases reported in the FAERS database<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |