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Evaluation of Reporting of Immune Checkpoint Inhibitor Associated Cardio-vascular Adverse Reactions

NCT03387540 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 104

Last updated 2019-09-26

No results posted yet for this study

Summary

Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) on the cardio-vascular system. This study investigates reports of cardio-vascular toxicity with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the World Health Organization (WHO) database VigiBase.

Conditions

Interventions

DRUG

ICI

Immune checkpoint inhibitor targeting either PD-1, PD-L1 or CTLA-4, and included in the following list (ATC classification): Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).

Sponsors & Collaborators

  • Institute of Cardiometabolism and Nutrition, France

    collaborator OTHER

  • Vanderbilt University

    collaborator OTHER

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Groupe Hospitalier Pitie-Salpetriere

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-02
Primary Completion
2017-12-04
Completion
2017-12-31
FDA Drug
Yes

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03387540 on ClinicalTrials.gov