a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY (VENDY)

Groupe Hospitalier Pitie-Salpetriere

Status: Completed

Conditions: Encephalopathy; Epilepsy; Neuropathy; Prostate Cancer

Treatments: Drug: Enzalutamide

Study type: Observational

Funder types: Other

Identifiers

NCT04290611

CIC1421-20-02

Details and patient eligibility

About

Enzalutamide may lead to various adverse reactions. This study investigates reports of different neurological toxicities in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Full description

Enzalutamide 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 enzalutamide

Enrollment: 500,000 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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 enzalutamide reported in the WHO database.

Exclusion criteria

• Chronology not compatible between the drug and the toxicity

Trial design

500,000 participants in 1 patient group

Enzalutamide drug-induced toxicity

Description:

Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by enzalutamide, with a chronology compatible with the drug toxicity

Treatment:

Drug: Enzalutamide