Pancytopenia Related to PARP Inhibitors (PancytoRIB)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-07

Study Completion Date

2021-03-24

Brief Summary

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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.

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Detailed Description

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Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of pancytopenia related to PARPi.

Conditions

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Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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PARP inhibitor

All patients treated at least with 1 PARPi

Intervention Type DRUG

Other Intervention Names

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olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib

Eligibility Criteria

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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).

Eligible Sex

ALL

Accepts Healthy Volunteers

No