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EXploring Immune-related Adverse Events of Immune checkpoinT Inhibitors Using VigiBase, the WHO Pharmacovigilance Database

NCT05934214 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 141630

Last updated 2024-03-05

No results posted yet for this study

Summary

This is an observational, retrospective pharmacovigilance study based on reports registered and transmitted in VigiBase®, the WHO's international database.

This study includes all reports identified as exposure to an ICI and suspect of inducing adverse drug reaction.

The aim of the study is to characterize immune-related adverse reactions associated with immune-checkpoint inhibitors, particularly their time-to-onset, co-occurence, factors associate with their over-report and fatality.

Conditions

  • Cancer
  • Immune-related Adverse Event
  • Immune Checkpoint Inhibitor-Related Myocarditis

Interventions

DRUG

Immune checkpoint inhibitor

Reports associated with an an Immune checkpoint inhibitor with a status of "Suspect" or "Interacting" ICI will include the following list of FDA-apporved ICIs: nivolumab, pembrolizumab, cemiplimab, dostarlimab, durvalumab, atezolizumab, avelumab, ipilimumab, tremelimumab, relatlimab

Sponsors & Collaborators

  • Institut Curie

    collaborator OTHER

  • Groupe Hospitalier Pitie-Salpetriere

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-12-31
Completion
2024-02-29
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 NCT05934214 on ClinicalTrials.gov