Clinical trial · Observational
EXploring Immune-related Adverse Events of Immune checkpoinT Inhibitors Using VigiBase, the WHO Pharmacovigilance Database
Immune-related Adverse Events From Immune Checkpoint Inhibitor Characterization Using VigiBase, the WHO Pharmacovigilance Database: An Exploration of Adverse Event Patterns and Signal Detection.
- 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)
This is an observational, retrospective pharmacovigilance study based on reports registered and transmitted in VigiBase®, the WHO's international database. This study includes all reports identified as exposure to an ICI and suspect of inducing adverse drug reaction. The aim of the study is to characterize immune-related adverse reactions associated with immune-checkpoint inhibitors, particularly their time-to-onset, co-occurence, factors associate with their over-report and fatality.
Conditions
Conditions (3)
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 |
| Immune Checkpoint Inhibitor-Related Myocarditis | — | UNRESOLVED | — |
| Immune-related Adverse Event | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immune checkpoint inhibitor | Drug | Immune Checkpoint Inhibitor | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- immune-related adverse event reaction
- description
- Reports of identified immune-related adverse event reaction
- interventionNames
- Drug: Immune checkpoint inhibitor
Primary outcomes (1)
- measure
- Factors associated with an increased rate of fatality among reports with an immune-related adverse event (irAE).
- timeFrame
- any report prior to january 2023
- description
- Reports with a fatal outcome will be compared to reports with no fatal outcome. Odds ratio will be calculated to compare covariates potentially associated with an increase risk of fatality, including irAE type, cancer type reported, patient's age, gender, comorbidities, type of ICI or ICI combination and other treatments.
Secondary outcomes (3)
- measure
- Factors associated with an increased reporting of main irAE types
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Any report with an ICI "Suspect" or "Interacting" with the reported adverse drug reaction. Exclusion Criteria: * ICI not FDA approved * No irAE identified in report
References
Publications (0)
Data not yet available