Status:
COMPLETED
Evaluation of Reporting of Vascular Endothelial Growth Factor and Vascular Endothelial Growth Factor Receptor Inhibitors Associated Cardiovascular Adverse reactioN.
Lead Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Conditions:
Cardiac Complication
Vascular Diseases
Eligibility:
All Genders
18+ years
Brief Summary
Antiangiogenics (AAs) which are vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR) inhibitors might have high grade adverse events (AEs) on the cardio-vascular system. This study inves...
Detailed Description
AAs have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and used in combination. However, AEs can occur. Here the invest...
Eligibility Criteria
Inclusion
- Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
- Adverse event reported were including the MedDRA terms: Cardiac disorders (SOC), Vascular disorders (SOC), Sudden death (PT)
- Patients treated with antiangiogenics included in the following list:
Exclusion
- Chronology not compatible between the drug and the toxicity
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2018
Estimated Enrollment :
150000 Patients enrolled
Trial Details
Trial ID
NCT03413176
Start Date
January 1 2018
End Date
January 31 2018
Last Update
September 26 2019
Active Locations (1)
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1
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.
Paris, France, 75013