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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04774627

Enrollment

200

Registered

2021-03-01

Start date

2021-02-07

Completion date

2021-03-24

Last updated

2021-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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 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.

Interventions

DRUGPARP inhibitor

All patients treated at least with 1 PARPi

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* 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 criteria

chronology not compatible between the PARPi and adverse event.

Design outcomes

Primary

Measure	Time frame	Description
Pancytopenia reports related to PARPi.	From inception to Feb, 2021	Identification of the pancytopenia adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports.

Secondary

Measure	Time frame
Description of the latency period since first PARPi exposure.	From inception to Feb, 2021
Description of the fatality rate.	From inception to Feb, 2021
Description of patients who experienced co-reported adverse events	From inception to Feb, 2021

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026