A Pharmacovigilance Study of Torsade de Pointes
- Conditions
- Torsades de Pointe Caused by Drug
- Interventions
- Drug: Drugs, Generic
- Registration Number
- NCT04293432
- Lead Sponsor
- University of Peshawar
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6670
- TdP cases reported in the FAERS database till 31/03/2019
- Adverse event reported was including the MedDRA term: Torsade de Pointes
- Drugs with less than 10 TdP reports
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group/Cohort Drugs, Generic Torsade de Pointes induced by drugs reported to the FAERS database from inception till first quarter of 2019 (1990-2019)
- Primary Outcome Measures
Name Time Method Identification of drugs associated with TdP Cases reported to the FAERS database till 31/03/2019 The search includes MedDRA (v-22) Preferred Term, "Torsade de Pointes (MedDRA code: 10044066) for the identification of all TdP case reports and drugs.
Identification of new signals of TdP Cases reported to the FAERS database till 31/03/2019 Signal detection using disproportionality analysis
- Secondary Outcome Measures
Name Time Method Validation of already known drug-TdP associations 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 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
Trial Locations
- Locations (1)
Department of Pharmacy, University of Peshawar
🇵🇰Peshawar, Khyber Pakhtunkhwa, Pakistan