Adverse Drug Reactions to Cancer Therapies in Patients wi... | NCT06801158

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

NCT06801158

Sponsor

University Hospital, Caen

Status

Completed

Last Update Posted

Jan 30, 2025Actual

Enrollment

8,804,863Actual

Phase

Not provided

Conditions

Adverse Effects of Medical Drugs

Interventions

use of anticancer drugs in monotherapy or in combination therapy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Actual

Primary Completion Date

Jan 15, 2025Actual

Completion Date

Jan 16, 2025Actual

First Submitted Date

Jan 24, 2025

First Submission Date that Met QC Criteria

Jan 24, 2025

First Posted Date

Jan 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2025

Last Update Posted Date

Jan 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8,804,863Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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)

Measure	Description	Time Frame
reporting of serious AEs		1964 to 2024

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Caen University Hospital		Caen			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Data belong to the WHO Uppsala Monitoring Center

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided