Clinical trial NCT03413176: Evaluation of Reporting of Vascular Endothelial Growth Factor and Vascular Endothelial Growth Factor Receptor Inhibitors Associated Cardiovascular Adverse reactioN.
Official title: Evaluation of Reporting of VEGF Inhibitors Associated Cardiovasclular Adverse reactioNs Using International Pharmacovigilance Database.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Complication
Vascular Diseases
Keywords: VEGFR
VEGF
antiangiogenics
angiogenesis
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 150000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with an AA for a cancer

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 investigates reports of cardio-vascular toxicity with treatment including VEGF and VEGFR inhibitors using the World Health Organization (WHO) database VigiBase.

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 investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify cases of cardiovascular adverse drug reaction following treatment with AAs.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* Chronology not compatible between the drug and the toxicity

Primary outcomes:
measure: Cardio-vascular toxicity of AAs
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
Secondary outcomes:
measure: Causality assessment of reported cardiovascular events according to the WHO system
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
measure: Description of the type of cardiotoxicity depending on the category of AAs
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
measure: Description of the duration of treatment when the toxicity happens (role of cumulative dose)
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
measure: Description of the drug-drug interactions associated with adverse events
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
measure: Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
measure: Description of the population of patients having a cardio-vascular adverse event
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.
Study officials:
References:
citation: Alexandre J, Moslehi JJ, Bersell KR, Funck-Brentano C, Roden DM, Salem JE. Anticancer drug-induced cardiac rhythm disorders: Current knowledge and basic underlying mechanisms. Pharmacol Ther. 2018 Sep;189:89-103. doi: 10.1016/j.pharmthera.2018.04.009. Epub 2018 Apr 24.
citation: Gougis P, Wassermann J, Spano JP, Keynan N, Funck-Brentano C, Salem JE. Clinical pharmacology of anti-angiogenic drugs in oncology. Crit Rev Oncol Hematol. 2017 Nov;119:75-93. doi: 10.1016/j.critrevonc.2017.08.010. Epub 2017 Sep 1.