Adverse Drug Reactions to Cancer Therapies in Patients with Depression: Insights from VigiBase
NCT ID: NCT06801158
Last Updated: 2025-01-30
Study Results
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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COMPLETED
8804863 participants
OBSERVATIONAL
2024-11-01
2025-01-16
Brief Summary
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Depression is prevalent among oncology patients and may influence the perception, reporting, and severity of adverse events (AEs) related to cancer therapies. Understanding this association is crucial for optimizing treatment outcomes and improving patient quality of life.
Objective:
To evaluate the association between depression and the reporting and severity of AEs among oncology patients using data from VigiBase®, the World Health Organization's global pharmacovigilance database.
Design:
This pharmacovigilance study employed a case/non-case disproportionality analysis using Individual Case Safety Reports (ICSRs) from 1968 to 2024. Multivariable analyses were conducted to adjust for potential confounders, such as age and sex.
Setting:
The study utilized data from VigiBase®, a global pharmacovigilance database containing reports from over 120 countries.
Participants:
ICSRs involving antineoplastic or immunomodulating agents were included. Depression was identified through antidepressant use, yielding 428,102 reports for patients on antidepressants and 8,376,761 for those not on antidepressants.
Exposure:
Oncology patients receiving antidepressant therapy were compared to those not receiving such treatment.
Main Outcome and Measures:
The primary outcome was the reporting of serious AEs (e.g., hospitalization, life-threatening events). Secondary outcomes included the 20 most frequently reported AEs among oncology patients, with comparisons made between those treated with and without antidepressants.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Patients with an adverse effect of interest (or with a severity criteria of that AE)
use of anticancer drugs in monotherapy or in combination therapy
ICSRs involving antineoplastic or immunomodulating agents were included.
Patients without an adverse effect of interest (or without a severity criteria of that AE)
use of anticancer drugs in monotherapy or in combination therapy
ICSRs involving antineoplastic or immunomodulating agents were included.
Interventions
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use of anticancer drugs in monotherapy or in combination therapy
ICSRs involving antineoplastic or immunomodulating agents were included.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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University Hospital, Caen
OTHER
Responsible Party
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Locations
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Caen University Hospital
Caen, , France
Countries
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Other Identifiers
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Pharmacol20241101
Identifier Type: -
Identifier Source: org_study_id
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