Cardiovascular and Torsades de Pointes Monitoring for Pazopanib
- Registration Number
- NCT01446224
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
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
- Patients with multiple primary cancer diagnoses
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects who do not experience cardiac ischemia Other anti-VEGFs Subjects who do not experience cardiac ischemia Subjects who experience Torsades de Pointes Other anti-VEGFs Subjects who experience Torsades de Pointes Subjects who experience cardiac ischemia Other anti-VEGFs Subjects who experience cardiac ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident Subjects who do not experience Torsades de Pointes Other anti-VEGFs Subjects who do not experience Torsades de Pointes Subjects who do not experience cardiac ischemia Pazopanib Subjects who do not experience cardiac ischemia Subjects who experience cardiac ischemia Pazopanib Subjects who experience cardiac ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident Subjects who experience Torsades de Pointes Pazopanib Subjects who experience Torsades de Pointes Subjects who do not experience Torsades de Pointes Pazopanib Subjects who do not experience Torsades de Pointes
- Primary Outcome Measures
Name Time Method Cardiovascular ischemia Over four years from approval of pazopanib Cardiovascular ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident
- Secondary Outcome Measures
Name Time Method Torsades de Pointes Over four years from approval of pazopanib Torsades de Pointes