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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adverse Events associated with Antineoplastic and Immunomodulating Agents | Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by anticancer drugs, with a chronology compatible with the drug toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antineoplastic and Immunomodulating Agents | Drug | Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of antineoplastic and immunomodulating agents | 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 | Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 type of adverse event depending on the category of antineoplastic and immunomodulating agents |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with Antineoplastic and immunomodulating agents
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandre Joachim | Recruiting | Caen | Basse Normandie | 14000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39627133 | Derived | L'Orphelin JM, Da Silva A, Cabon J, Alexandre J, Dolladille C. Immune checkpoint inhibitor rechallenge after immune-related adverse events: a retrospective study from VigiBase update in 2024 looking for emergent safety signals. BMJ Open. 2024 Dec 3;14(12):e091708. doi: 10.1136/bmjopen-2024-091708. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000970 | Antineoplastic Agents |
| D000091369 | Immunomodulating Agents |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007155 | Immunologic Factors |
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| 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 |
| 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 |
| 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 |
| D045505 |
| Physiological Effects of Drugs |