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 Type
OBSERVATIONAL
Enrollment
17,562
identification of cases of immune-related adverse events due to immune checkpoint inhibitors. Among these cases, identification and description of those with immune checkpoint inhibitor rechallenge.
Alexandre Joachim
Caen, Basse Normandie, France
RECRUITINGRate of occurrence of second immune-related adverse events (irAEs)
percentage of cases experiencing a second irAE among the rechallenged cases
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).
Description of cases experiencing an initial irAEs
description of clinical features of cases experiencing an initial 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)..
Description of the rechallenge cases
description of clinical features of the rechallenged cases
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)..
Description of the clinical features of cases experiencing a second irAEs
Description of the clinical features of cases experiencing a second 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)..
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