NCT05934214View on ClinicalTrials.gov

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

CompletedOBSERVATIONAL
Enrollment

141,630

Participants

Timeline

Start Date

January 1, 2023

Primary Completion Date

December 31, 2023

Study Completion Date

February 29, 2024

Conditions
CancerImmune-related Adverse EventImmune 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"

Trial Locations (2)

75013

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

CIC Paris-Est / Institut Curie, Paris

All Listed Sponsors
collaborator

Institut Curie

OTHER

lead

Groupe Hospitalier Pitie-Salpetriere

OTHER