Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898751
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2021-05-19
Brief Title:
Analysis of Reporting of Cutaneous Toxicities Associated With Immune Checkpoint Inhibitors
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Analysis of Reporting of Cutaneous Toxicities Associated With Immune Checkpoint Inhibitors
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Immune checkpoint inhibitors ICIs are associated with a wide variety of cutaneous immune-related adverse events cirAEs These cirAEs are reported to be the most common immune-related adverse events irAEs and the first to appear This study examines the appearance of cirAEs within the World Health Organization WHO pharmacovigilance database VigiBase
Detailed Description:
ICIs have revolutionized clinical oncologic care The ICIs that are currently FDA approved fall into three main categories those that block the cytotoxic T-lymphocyte-associated antigen-4 anti-CTLA-4 ipilimumab block the programmed cell death protein-1 anti-PD-1 nivolumab pembrolizumab cemiplimab and block the programmed cell death ligand-1 anti-PD-L1 atezolizumab avelumab durvalumab pathway There is a considerable diversity of cirAEs that have been reported with these ICIs in both monotherapy and combination therapy
VigiBase is the WHO pharmacovigilance database that monitors individual case safety reports associated with certain drugs The largest database of its kind in the world VigiBase is managed by the Uppsala Monitoring Center UMC in Sweden and since its inception in 1967 has received over 19 million individual case safety reports ICSRs from over 130 contributing countries In this study the investigators examine the appearance of cutaneous immune related adverse events in the setting of immunotherapy within VigiBase
VigiBase is the WHO pharmacovigilance database that monitors individual case safety reports associated with certain drugs The largest database of its kind in the world VigiBase is managed by the Uppsala Monitoring Center UMC in Sweden and since its inception in 1967 has received over 19 million individual case safety reports ICSRs from over 130 contributing countries In this study the investigators examine the appearance of cutaneous immune related adverse events in the setting of immunotherapy within VigiBase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None