Cancer
Conditions
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.
Interventions
Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L
Sponsors
University Hospital, Caen
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
No minimum to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events of antineoplastic and immunomodulating agents | Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025 | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
France
Outcome results
None listed