Trial Information
Postmarketing Cardiovascular Ischemia and Torsades de Pointes Monitoring for Pazopanib Using Observational Databases
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Cardiovascular ischemia
Outcome Description:
Cardiovascular ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident
Outcome Time Frame:
Over four years from approval of pazopanib
Safety Issue:
Yes
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: No Health Authority
Study ID:
114428
NCT ID:
NCT01446224
Start Date:
December 2010
Completion Date:
December 2014
Related Keywords:
- Carcinoma, Renal Cell
- cardiac ischemia
- adverse events
- Torsades des Pointes
- renal cell carcinoma
- anti-VEGF agents
- observational data
- pazopanib
- Carcinoma
- Carcinoma, Renal Cell
- Torsades de Pointes