Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy (AVATAR)

NCT04696250 | Unknown FDA Drug

• 1 other identifier: Pharmaco112020
• Study Type: observational
• Target: 5,000,000
• Locations: 1 country
• Sites: 1

Brief 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 database of individual safety case reports (VigiBase).

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  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

  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

  Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025

Study Arms (1)

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

Drug: Antineoplastic and Immunomodulating Agents

Interventions

Antineoplastic and Immunomodulating Agents DRUG

Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L

Adverse Events associated with Antineoplastic and Immunomodulating Agents

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with Antineoplastic and immunomodulating agents

You may qualify if:

• 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.

You may not qualify if:

• Chronology not compatible between the drug and the toxicity

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Alexandre Joachim

Caen, Basse Normandie, 14000, France

RECRUITING

Related Publications (1)

• L'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.

  PMID: 39627133 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Antineoplastic Agents; Immunomodulating Agents

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Immunologic Factors; Physiological Effects of Drugs

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2025
• Last Updated: January 6, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)