Pancytopenia Related to PARP Inhibitors (PancytoRIB)

Sponsor

University Hospital, Caen (Other)

Overall Status

Completed

CT.gov ID

NCT04774627

Collaborator

(none)

200

Enrollment

Location

1.5

Actual Duration (Months)

135.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: PARP inhibitor

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.

Study Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Feb 7, 2021

Actual Primary Completion Date :

Feb 27, 2021

Actual Study Completion Date :

Mar 24, 2021

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.