NCT04774406

Brief Summary

Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious (or not) adverse events such as hypertension whose data are scarce. The objective was to investigate reports of hypertension related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, and fluzoparib using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,336

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

June 6, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

February 25, 2021

Last Update Submit

June 5, 2023

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • hypertension reports related to PARPi.

    Identification of the hypertension adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports.

    From inception to 16 Feb, 2023

Study Arms (1)

parp inhibitors

All patients treated at least with 1 PARPi

Drug: olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib

Interventions

olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparibDRUG

All patients treated at least with 1 PARPi (alone or in combination)

parp inhibitors

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients treated with PARPi and experiencing hypertension.

You may qualify if:

  • 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, pamiparib, fluzoparib (none).

You may not qualify if:

  • chronology not compatible between the PARPi and adverse event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandre Joachim

Caen, Basse Normandie, 14000, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

olaparibrucaparibniraparibtalazoparibveliparibpamiparibfluzoparib

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 1, 2021

Study Start

February 24, 2021

Primary Completion

May 9, 2021

Study Completion

September 1, 2022

Last Updated

June 6, 2023

Record last verified: 2023-05

Locations

FR(1)