Clinical trial · Observational
Cardiovascular and Torsades de Pointes Monitoring for Pazopanib
Postmarketing Cardiovascular Ischemia and Torsades de Pointes Monitoring for Pazopanib Using Observational Databases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Other anti-VEGFs | Drug | — | UNRESOLVED |
| Pazopanib | Drug | Pazopanib | ALIAS |
Design
Arms and outcomes
Arms (4)
- label
- Subjects who experience cardiac ischemia
- description
- Subjects who experience cardiac ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident
- interventionNames
- Drug: Pazopanib
- Drug: Other anti-VEGFs
- label
- Subjects who do not experience cardiac ischemia
- description
- Subjects who do not experience cardiac ischemia
- interventionNames
- Drug: Pazopanib
- Drug: Other anti-VEGFs
- label
- Subjects who experience Torsades de Pointes
- description
- Subjects who experience Torsades de Pointes
- interventionNames
- Drug: Pazopanib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available