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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2025
  • participants needed
    5000000
  • sponsor
    University Hospital, Caen
Updated on 28 January 2021

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).

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.

Details
Condition Cancer, Cancer/Tumors, Neoplasms, Cancer (Pediatric), Ewing's Family Tumors, Cancer, Cancer/Tumors, Ewing's Family Tumors, Cancer (Pediatric), Neoplasms, primary cancer, primary malignant neoplasm, malignancy, cancers, malignancies, malignant tumor, malignant tumors
Treatment Antineoplastic and Immunomodulating Agents
Clinical Study IdentifierNCT04696250
SponsorUniversity Hospital, Caen
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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