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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adverse Events with cellular therapies | Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by Chimeric Antigen Receptor T-cell and Cellular Therapies, with a chronology compatible with the drug toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR T-cell and Cellular Therapies | Drug | Chimeric Antigen Receptor T-cell and Cellular Therapies for the treatment of a cancer either solid or hematologic malignancy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with cellular therapy for solid or hematologic cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pitié-Salpêtrière | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34057232 | Derived | Dolladille C, Ederhy S, Ezine E, Choquet S, Nguyen LS, Alexandre J, Moslehi JJ, Dechartres A, Salem JE. Chimeric antigen receptor T-cells safety: A pharmacovigilance and meta-analysis study. Am J Hematol. 2021 Sep 1;96(9):1101-1111. doi: 10.1002/ajh.26259. Epub 2021 Jun 23. |
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| 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 |
| 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 |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
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