CancerAVATARNCT04696250
Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy (AVATAR)
An observational study of Cancer, run by University Hospital, Caen at 1 site in France.
Trial summary
Anticancer drugs can lead to various adverse events. This study analyses reports of adverse events for treatment including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents, endocrine therapy, immunostimulants, and immunosuppressants drugs) in the World Health Organization's (WHO) global… Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cancer
- What is being tested?
- Antineoplastic and Immunomodulating Agents
- How many people
- 5,000,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 1 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with Antineoplastic and immunomodulating agents
Who may be able to join
- Case reported in the World Health Organization (WHO) database of individual safety case reports at the time of the extraction
- Adverse events reported were including in the MedDRA terms. The research could include the report with SOC, HGLT, HLT, or PT MedDRA terms
- Patients treated with Antineoplastic and immunomodulating agents included in the ATC L.
Who cannot join
- Chronology not compatible between the drug and the toxicity
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Alexandre Joachim
Caen, Basse Normandie, 14000
Joachim Alexandre, MD, +33231064670, alexandre-j@chu-caen.fr
About this study
Official title: Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy : an Observational and Retrospective Study Using the WHO Pharmacovigilance Database(AVATAR)
Anticancer drugs can lead to various adverse events. This study analyses reports of adverse events for treatment including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents, endocrine therapy, immunostimulants, and immunosuppressants drugs) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).
Read the detailed description
The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse events following treatment with antineoplastic agents, endocrine therapy, immunostimulants or immunosuppressants drugs.
- Conditions
- Cancer
- Being tested
- Antineoplastic and Immunomodulating Agents
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antineoplastic and Immunomodulating AgentsDrug
Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L
| Study group | Role | What they receive |
|---|---|---|
| Adverse Events associated with Antineoplastic and Immunomodulating Agents | Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by anticancer drugs, with a chronology compatible with the drug toxicity Receives: Drug: Antineoplastic and Immunomodulating Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events of antineoplastic and immunomodulating agents
Identification and report of adverse event of antineoplastic and immunomodulating agents. The research could include the report with SOC, HGLT, HLT, or PT MedDRA terms
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Secondary outcomes (6)
Causality assessment of reported adverse events according to the WHO system
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Description of the type of adverse event depending on the category of antineoplastic and immunomodulating agents
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Description of the time from anticancer drug initiation and the occurrence of the adverse event
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Description of the drug-drug interactions associated with adverse events
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Description of the cancer for which the incriminated drugs have been prescribed
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Description of the population of patients having adverse event
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 5,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696250
- Sponsor's protocol ID
- Pharmaco112020
- Acronym
- AVATAR
- Status last verified
- Nov 2020
- First submitted
- 4 Jan 2021
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Da Silva A, Alexandre J, Bertoletti L, Laneelle D, Biron F, Chretien B, Minoc F, Janson M, Plane AF, Legallois D, Dolladille C. Antineoplastic therapies associated with venous thromboembolism: disproportionality analysis of the WHO database. Blood Vessel Thromb Hemost. 2026 Sep 4;3(4):100212. doi: 10.1016/j.bvth.2026.100212. eCollection 2026 Nov.
PubMed 42960050L'Orphelin JM, Da Silva A, Cabon J, Alexandre J, Dolladille C. Immune checkpoint inhibitor rechallenge after immune-related adverse events: a retrospective study from VigiBase update in 2024 looking for emergent safety signals. BMJ Open. 2024 Dec 3;14(12):e091708. doi: 10.1136/bmjopen-2024-091708.
PubMed 39627133
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy : an Observational and Retrospective Study Using the WHO Pharmacovigilance Database(AVATAR)
- ClinicalTrials.gov ID
- NCT04696250
- Acronym / sponsor ID
- AVATAR / Pharmaco112020
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000,000 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 6 Jan 2021 (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.
Anticancer drugs can lead to various adverse events. This study analyses reports of adverse events for treatment including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents, endocrine therapy, immunostimulants, and immunosuppressants drugs) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).
Detailed description
The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse events following treatment with antineoplastic agents, endocrine therapy, immunostimulants or immunosuppressants drugs.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adverse Events associated with Antineoplastic and Immunomodulating Agents | – | Drug: Antineoplastic and Immunomodulating AgentsCases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by anticancer drugs, with a chronology compatible with the drug toxicity |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with Antineoplastic and immunomodulating agents
Key inclusion criteria (3 listed)
- Case reported in the World Health Organization (WHO) database of individual safety case reports at the time of the extraction
- Adverse events reported were including in the MedDRA terms. The research could include the report with SOC, HGLT, HLT, or PT MedDRA terms
- Patients treated with Antineoplastic and immunomodulating agents included in the ATC L.
Key exclusion criteria (1 listed)
- Chronology not compatible between the drug and the toxicity
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 |
|---|---|---|
| Antineoplastic and Immunomodulating AgentsAntineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L | Drug | Adverse Events associated with Antineoplastic and Immunomodulating Agents |
Primary outcome
Adverse events of antineoplastic and immunomodulating agents
Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Identification and report of adverse event of antineoplastic and immunomodulating agents. The research could include the report with SOC, HGLT, HLT, or PT MedDRA terms
6 secondary outcomes
Causality assessment of reported adverse events according to the WHO system
Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Description of the type of adverse event depending on the category of antineoplastic and immunomodulating agents
Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Description of the time from anticancer drug initiation and the occurrence of the adverse event
Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Description of the drug-drug interactions associated with adverse events
Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Description of the cancer for which the incriminated drugs have been prescribed
Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Description of the population of patients having adverse event
Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Derived from this study: PubMed 42960050Da Silva A, Alexandre J, Bertoletti L, Laneelle D, Biron F, Chretien B, Minoc F, Janson M, Plane AF, Legallois D, Dolladille C. Antineoplastic therapies associated with venous thromboembolism: disproportionality analysis of the WHO database. Blood Vessel Thromb Hemost. 2026 Sep 4;3(4):100212. doi: 10.1016/j.bvth.2026.100212. eCollection 2026 Nov.
- Derived from this study: PubMed 39627133L'Orphelin JM, Da Silva A, Cabon J, Alexandre J, Dolladille C. Immune checkpoint inhibitor rechallenge after immune-related adverse events: a retrospective study from VigiBase update in 2024 looking for emergent safety signals. BMJ Open. 2024 Dec 3;14(12):e091708. doi: 10.1136/bmjopen-2024-091708.
- Individual participant dataSharing planned: No
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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.
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 Cancer, 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 3 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: status not confirmed, as of the sponsor's last update on 6 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events of antineoplastic and immunomodulating agents (time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04696250, which also lists 2 linked publications.
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 6 Jan 2021.