Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy : an Observational and Retrospective Study Using the WHO Pharmacovigilance Database(AVATAR)
Overview
- Phase
- Not Applicable
- Intervention
- Antineoplastic and Immunomodulating Agents
- Conditions
- Cancer
- Sponsor
- University Hospital, Caen
- Enrollment
- 5000000
- Locations
- 1
- Primary Endpoint
- Adverse events of antineoplastic and immunomodulating agents
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
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).
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Chronology not compatible between the drug and the toxicity
Arms & Interventions
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
Intervention: Antineoplastic and Immunomodulating Agents
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
- 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 population of patients having adverse event(Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025)