NCT04169503UnknownNot Applicable
Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events in Patients With Cancer: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database
University Hospital, Caen1 site in 1 country17,562 target enrollmentStarted: October 14, 2019Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University Hospital, Caen
- Enrollment
- 17,562
- Locations
- 1
- Primary Endpoint
- Rate of occurrence of second immune-related adverse events (irAEs)
Study Overview
Brief Summary
Although immune checkpoint inhibitors (ICIs) have proved effective in treating many cancers, patients receiving ICIs may experience immune-related adverse events (irAEs). Little evidence exists on the safety of resuming these treatments after an irAE.
Our objective was to investigate the safety of ICI rechallenge after an irAE using the WHO pharmacovigilance database
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
- •consecutive individual case safety reports present in VigiBase reporting an irAEs associated to at least one immune checkpoint inhibitor.
Exclusion Criteria
- •Chronology not compatible between the drug and the toxicity.
Outcomes
Primary Outcomes
Rate of occurrence of second immune-related adverse events (irAEs)
Time Frame: Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months).
percentage of cases experiencing a second irAE among the rechallenged cases
Secondary Outcomes
- Description of cases experiencing an initial irAEs(Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..)
- Description of the rechallenge cases(Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..)
- Description of the clinical features of cases experiencing a second irAEs(Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..)
Investigators
Study Sites (1)
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