Clinical trial · Observational
Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy (AVATAR)
Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy : an Observational and Retrospective Study Using the WHO Pharmacovigilance Database(AVATAR)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antineoplastic and Immunomodulating Agents | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adverse Events associated with Antineoplastic and Immunomodulating Agents
- description
- 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
- interventionNames
- Drug: Antineoplastic and Immunomodulating Agents
Primary outcomes (1)
- measure
- Adverse events of antineoplastic and immunomodulating agents
- timeFrame
- Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
- description
- 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 outcomes (6)
- measure
- Causality assessment of reported adverse events according to the WHO system
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDL'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. PMID 39627133