Cancer Clinical Trial
— AVATAROfficial title:
Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy : an Observational and Retrospective Study Using the WHO Pharmacovigilance Database(AVATAR)
Verified date | November 2020 |
Source | University Hospital, Caen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Recruiting |
Enrollment | 5000000 |
Est. completion date | January 1, 2025 |
Est. primary completion date | January 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Alexandre Joachim | Caen | Basse Normandie |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 |
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