Clinical trial NCT04696250: Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy (AVATAR)
Official title: Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy : an Observational and Retrospective Study Using the WHO Pharmacovigilance Database(AVATAR)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 5000000
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with Antineoplastic and immunomodulating agents

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.

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

Primary outcomes:
measure: Adverse events of antineoplastic and immunomodulating agents
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Secondary outcomes:
measure: Causality assessment of reported adverse events according to the WHO system
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
measure: Description of the type of adverse event depending on the category of antineoplastic and immunomodulating agents
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
measure: Description of the time from anticancer drug initiation and the occurrence of the adverse event
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
measure: Description of the drug-drug interactions associated with adverse events
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
measure: Description of the cancer for which the incriminated drugs have been prescribed
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
measure: Description of the population of patients having adverse event
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Other outcomes:
Locations:
city: Caen
country: France
facility: Alexandre Joachim
state: Basse Normandie
Study officials:
References: