Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04774627
Status:
COMPLETED
Last Update Posted:
2021-09-23
First Post:
2021-02-25
Brief Title:
Pancytopenia Related to PARP Inhibitors PancytoRIB
Sponsor:
University Hospital Caen
Organization:
University Hospital Caen
Study Overview
Official Title:
Pancytopenia Related to PARP Inhibitors in Cancer Patients an Observational and Retrospective Study Using the WHOs Pharmacovigilance Database PancytoRIB
Status:
COMPLETED
Status Verified Date:
2021-02
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:
Although PARP inhibitors PARPi have proved effective in treating many cancers few patients receiving PARPi may experience rare but serious adverse events such as pancytopenia Today data about pancytopenia are scarce
The objective was to investigate reports of pancytopenia adverse events related to PARPi including olaparib rucaparib niraparib talazoparib veliparib and pamiparib using the World Health Organizations WHO pharmacovigilance database VigiBase
The objective was to investigate reports of pancytopenia adverse events related to PARPi including olaparib rucaparib niraparib talazoparib veliparib and pamiparib using the World Health Organizations WHO pharmacovigilance database VigiBase
Detailed Description:
Here investigators use the World Health Organizations WHO database of individual safety case reports to identify cases of pancytopenia related to PARPi
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?:
None
Is an FDA AA801 Violation?:
None