Adverse Drug Reactions, Cancer
Conditions
Keywords
CAR-T cell, Cellular Therapies
Brief summary
CAR-T cells and cellular therapies may lead to various adverse reactions. This study investigates reports of different toxicities for cellular therapies in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).
Detailed description
CAR-T cells and cellular therapies are responsible of a wide range of side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse drug reactions following treatment with cellular therapies
Interventions
Chimeric Antigen Receptor T-cell and Cellular Therapies for the treatment of a cancer either solid or hematologic malignancy
Sponsors
Groupe Hospitalier Pitie-Salpetriere
Study design
Observational model
CASE_CONTROL
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 to 01/01/2020 * Adverse events reported were including any MedDRA terms * Patients treated with cellular therapies reported in the WHO database.
Exclusion criteria
* Chronology not compatible between the drug and the toxicity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events with significant over-reporting CAR-T cells and other cellular therapies | Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020 | Identification and report of various toxicities of cellular therapies. |
Secondary
| Measure | 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 2020 |
| Description of the type of adverse event depending on the class and the target of cellular therapy | Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020 |
| 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 2020 |
| Description of the pathologies (cancer) for which the incriminated drugs have been prescribed | Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020 |
| Description of the population of patients having an adverse event | Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020 |
| Description of the duration of treatment when the toxicity happens and the time to onset | Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020 |
Countries
France
Outcome results
None listed