NCT05934214Completed
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 · Last updated 5 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 141630 (actual)
- First submitted
- 16 Jun 2023
- Start date
- 1 Jan 2023
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Diseases
- Childhood cancers
- NCT number
- NCT05934214
What you commit to
- Study type: Observational
- Participants enrolled: 141630
- From 1 Jan 2023 to the primary completion date, 31 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- ICI not FDA approved
- No irAE identified in report
Who the study is looking for
- Any report with an ICI "Suspect" or "Interacting" with the reported adverse drug reaction.
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CIC Paris-Est / Institut Curie Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM. Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.