Status:
UNKNOWN
Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy (AVATAR)
Lead Sponsor:
University Hospital, Caen
Conditions:
Cancer
Eligibility:
All Genders
Up to 100 years
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...
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, endo...
Eligibility Criteria
Inclusion
- 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
- Chronology not compatible between the drug and the toxicity
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
5000000 Patients enrolled
Trial Details
Trial ID
NCT04696250
Start Date
January 1 2021
End Date
January 1 2025
Last Update
January 6 2021
Active Locations (1)
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1
Alexandre Joachim
Caen, Basse Normandie, France, 14000