Adverse Drug Reactions to Cancer Therapies in Patients with Depression: Insights from VigiBase

Completed

• Conditions: Adverse Effects of Medical Drugs
• Interventions: Drug: use of anticancer drugs in monotherapy or in combination therapy

• Registration Number: NCT06801158
• Lead Sponsor: University Hospital, Caen

Brief Summary

Importance:

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2025-01
• Primary Completion: 2025-01-15
• Study Completion: 2025-01-16
• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-01-24
• Last Update Submitted: 2025-01-24
• Study First Posted: 2025-01-30
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8804863

Inclusion Criteria

• ICSRs were limited to those involving liable antineoplastic or immunomodulating agents (per the Anatomical Therapeutic Chemical (ATC) Classification code L; hereafter referred to as antineoplastics)

Exclusion Criteria

• Suspect of duplication

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
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	-
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	-

Primary Outcome Measures

Name	Time	Method
reporting of serious AEs	1964 to 2024

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France