Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases: Evaluation of Reporting of Adverse Events

Groupe Hospitalier Pitie-Salpetriere100,000 enrolled

Overview

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).

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

Study Type

OBSERVATIONAL

Enrollment

100,000

Conditions

Adverse Drug Reactions Cancer

Interventions

CAR T-cell and Cellular TherapiesDRUG

Chimeric Antigen Receptor T-cell and Cellular Therapies for the treatment of a cancer either solid or hematologic malignancy

Eligibility

Sex: ALLMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Pitié-Salpêtrière

Paris, France

Outcomes

Primary Outcomes

Number of patients with adverse events with significant over-reporting CAR-T cells and other cellular therapies

Identification and report of various toxicities of cellular therapies.