Status:
COMPLETED
Pancytopenia Related to PARP Inhibitors (PancytoRIB)
Lead Sponsor:
University Hospital, Caen
Conditions:
Cancer
Eligibility:
All Genders
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 pan...
Detailed Description
Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of pancytopenia related to PARPi.
Eligibility Criteria
Inclusion
- case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
- patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib (none) and pamiparib (none).
Exclusion
- chronology not compatible between the PARPi and adverse event.
Key Trial Info
Start Date :
February 7 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 24 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04774627
Start Date
February 7 2021
End Date
March 24 2021
Last Update
September 23 2021
Active Locations (1)
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1
Alexandre Joachim
Caen, Basse Normandie, France, 14000