Cardiovascular and Torsades de Pointes Monitoring for Pazopanib

GlaxoSmithKline1 enrolled

Overview

This observational study is conducted as part of a systematic pharmacovigilance activity, to provide a population-based context for Pazopanib use outside of the clinical trial setting. The aims of the study are to examine the incidence of cardiovascular ischemia (including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident) and cardiac arrhythmia (Torsades de Pointes) in renal cell carcinoma patients treated with marketed anti-VEGF agents \[Pazopanib (VOTRIENT), Bevacizumab (AVASTIN), Sorafenib (NEXAVAR), and Sunitinib (SUTENT)\]. Two databases will be utilized for this study: a large healthcare claims database in the U.S. and the Dutch linked medical registries (PHARMO RLS). The databases will provide large, geographically varied, non-trial populations in which to examine the incidence of the stated cardiovascular ischemic events and Torsades des Pointes.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Carcinoma, Renal Cell

Interventions

PazopanibDRUG

Patients treated with pazopanib

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: The anti-VEGF cohorts will include patients with the following characteristics: * Adult patients (age ≥18 years) * Prescribed or administered an anti-VEGF agent: Pazopanib, Bevacizumab, Sorafenib or Sunitinib on or after approval date of Pazopanib * Diagnosed with renal cell cancer Exclusion Criteria: * Patients with multiple primary cancer diagnoses

Outcomes

Primary Outcomes

Cardiovascular ischemia

Cardiovascular ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident

Time frame: Over four years from approval of pazopanib

Secondary Outcomes

Torsades de Pointes

Time frame: Over four years from approval of pazopanib