Evaluation of Reporting of Vascular Endothelial Growth Factor and Vascular Endothelial Growth Factor Receptor Inhibitors Associated Cardiovascular Adverse reactioN.

NCT03413176 | Completed FDA Drug

• 1 other identifier: CIC1421-18-02
• Study Type: observational
• Target: 150,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Complication; Vascular Diseases

Keywords

VEGFR; VEGF; antiangiogenics; angiogenesis

Outcome Measures

Primary Outcomes (1)

• Cardio-vascular toxicity of AAs

  Identification and report of the cardio-vascular toxicity of AAs. The research includes the report with MedDRA terms: SOC Cardiac Disorders, SOC Vascular Disorders, Sudden death (PT). Drugs investigated are: sorafenib, sunitinib, pazopanib, vandetanib, axitinib, regorafenib, nintedanib, lenvatinib, ceritinib, bevacizumab, ramucirumab, aflibercept.

  Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018

Secondary Outcomes (6)

• Causality assessment of reported cardiovascular events according to the WHO system

  Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018

• Description of the type of cardiotoxicity depending on the category of AAs

  Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018

• Description of the duration of treatment when the toxicity happens (role of cumulative dose)

  Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018

• Description of the drug-drug interactions associated with adverse events

  Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018

• Description of the pathologies (cancer) for which the incriminated drugs have been prescribed

  Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018

Interventions

Cardiac complication induced by VEGF/VEGFR inhibitor DRUG

Case reported in the World Health Organization (WHO) of cardiac complication of patient treated by AAs, with a chronology compatible with the drug toxicity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with an AA for a cancer

You may qualify if:

• 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:

You may not qualify if:

• Chronology not compatible between the drug and the toxicity

Sponsors & Collaborators

• Groupe Hospitalier Pitie-Salpetriere: lead

Study Sites (1)

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.

Paris, 75013, France

Location

Related Publications (2)

• 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.

  PMID: 29698683 BACKGROUND

• 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.

  PMID: 28916378 BACKGROUND

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 29, 2018
• Study Start: January 1, 2018
• Primary Completion: January 15, 2018
• Study Completion: January 31, 2018
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

FR (1)