Informations générales (source: ClinicalTrials.gov)
Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy : an Observational and Retrospective Study Using the WHO Pharmacovigilance Database(AVATAR) (AVATAR)
Observational
University Hospital, Caen (Voir sur ClinicalTrials)
janvier 2021
janvier 2025
04 janvier 2025
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).
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Alexandre Joachim - 14000 - Caen - Basse Normandie - France | Joachim Alexandre, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- Chronology not compatible between the drug and the toxicity