Cardiovascular and Torsades de Pointes Monitoring for Pazopanib

Study Overview
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Brief Summary
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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.

Official Title
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Postmarketing Cardiovascular Ischemia and Torsades de Pointes Monitoring for Pazopanib Using Observational Databases

Conditions
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Carcinoma, Renal Cell

Intervention / Treatment
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* Drug: Pazopanib
* Drug: Other anti-VEGFs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects who experience cardiac ischemia<br>Subjects who experience cardiac ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident | Drug: Pazopanib<br>* Patients treated with pazopanib<br>Drug: Other anti-VEGFs<br>* Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib<br>|
| Subjects who do not experience cardiac ischemia<br>Subjects who do not experience cardiac ischemia | Drug: Pazopanib<br>* Patients treated with pazopanib<br>Drug: Other anti-VEGFs<br>* Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib<br>|
| Subjects who experience Torsades de Pointes<br>Subjects who experience Torsades de Pointes | Drug: Pazopanib<br>* Patients treated with pazopanib<br>Drug: Other anti-VEGFs<br>* Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib<br>|
| Subjects who do not experience Torsades de Pointes<br>Subjects who do not experience Torsades de Pointes | Drug: Pazopanib<br>* Patients treated with pazopanib<br>Drug: Other anti-VEGFs<br>* Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular ischemia | Cardiovascular ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident | Over four years from approval of pazopanib | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Torsades de Pointes | Torsades de Pointes | Over four years from approval of pazopanib | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pazopanib, adverse events, Torsades des Pointes, renal cell carcinoma, anti-VEGF agents, observational data, cardiac ischemia