NCT04774627

Pancytopenia Related to PARP Inhibitors (PancytoRIB)

Pancytopenia Related to PARP Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database (PancytoRIB)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 Organization's (WHO) pharmacovigilance database: VigiBase.

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	PARP inhibitor	All patients treated at least with 1 PARPi

Timeline

• Start date: 2021-02-07
• Primary completion: 2021-02-27
• Completion: 2021-03-24
• First posted: 2021-03-01
• Last updated: 2021-09-23

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study