Adverse Effects of Medical DrugsNCT06801158
Adverse Drug Reactions to Cancer Therapies in Patients with Depression: Insights from VigiBase
An observational study of Adverse Effects of Medical Drugs, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Effects of Medical Drugs
- What is being tested?
- use of anticancer drugs in monotherapy or in combination therapy
- How many people
- 8,804,863 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2024to 16 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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).
Who may be able to join
- 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)
Who cannot join
- Suspect of duplication
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- use of anticancer drugs in monotherapy or in combination therapy
- Keywords
- adverse effects, oncology, vigibase
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of anticancer drugs in monotherapy or in combination therapyDrug
ICSRs involving antineoplastic or immunomodulating agents were included.
| Study group | Role | What they receive |
|---|---|---|
| Patients with an adverse effect of interest (or with a severity criteria of that AE) | Not described Receives: 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) | Not described Receives: Drug: use of anticancer drugs in monotherapy or in combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
reporting of serious AEs
Measured: 1964 to 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Nov 2024
- Primary completion15 Jan 2025
- Study completion16 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Effects of Medical DrugsStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 8,804,863 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801158
- Sponsor's protocol ID
- Pharmacol20241101
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data belong to the WHO Uppsala Monitoring Center
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Drug Reactions to Cancer Therapies in Patients with Depression: Insights from VigiBase
- ClinicalTrials.gov ID
- NCT06801158
- Acronym / sponsor ID
- Pharmacol20241101
- Conditions
- Adverse Effects of Medical Drugs
- Keywords
- adverse effects, oncology, vigibase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,804,863 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 16 Jan 2025 (actual)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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).
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Suspect of duplication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of anticancer drugs in monotherapy or in combination therapyICSRs involving antineoplastic or immunomodulating agents were included. | Drug | 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) |
Primary outcome
reporting of serious AEs
Time frame: 1964 to 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No. Data belong to the WHO Uppsala Monitoring Center
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Effects of Medical Drugs, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reporting of serious AEs (time frame: 1964 to 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.