Status:
COMPLETED
Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases: Evaluation of Reporting of Adverse Events
Lead Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Conditions:
Adverse Drug Reactions
Cancer
Eligibility:
All Genders
Up to 100 years
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...
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 id...
Eligibility Criteria
Inclusion
- 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
- Chronology not compatible between the drug and the toxicity
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 8 2023
Estimated Enrollment :
100000 Patients enrolled
Trial Details
Trial ID
NCT04279470
Start Date
January 1 2019
End Date
April 8 2023
Last Update
April 13 2023
Active Locations (1)
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1
Hôpital Pitié-Salpêtrière
Paris, France, 75013