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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune Checkpoint Modulator | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of occurrence of second immune-related adverse events (irAEs) | percentage of cases experiencing a second irAE among the rechallenged cases | Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Description of cases experiencing an initial irAEs | description of clinical features 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with immune checkpoint inhibitors and experiencing irAEs
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joachim Alexandre, MD | Contact | +33231064670 | alexandre-j@chu-caen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandre Joachim | Recruiting | Caen | Basse Normandie | 14000 | France |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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description of clinical features of the rechallenged 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 | 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).. |