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

NCT06801158 | Completed FDA Drug

• 1 other identifier: Pharmacol20241101
• Study Type: observational
• Target: 8,804,863
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Effects of Medical Drugs

Keywords

adverse effects; oncology; vigibase

Outcome Measures

Primary Outcomes (1)

• reporting of serious AEs

  1964 to 2024

Study Arms (2)

Patients with an adverse effect of interest (or with a severity criteria of that AE)

Drug: 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)

Drug: use of anticancer drugs in monotherapy or in combination therapy

Interventions

use of anticancer drugs in monotherapy or in combination therapy DRUG

ICSRs involving antineoplastic or immunomodulating agents were included.

Patients with an adverse effect of interest (or with a severity criteria of that AE); Patients without an adverse effect of interest (or without a severity criteria of that AE)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Antidepressants were employed as a proxy for identifying patients experiencing depression. These agents were identified according to the ATC classification for antidepressants (code N06A).

You may qualify if:

• 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)

You may not qualify if:

• Suspect of duplication

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: November 1, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 16, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)