a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY

Groupe Hospitalier Pitie-Salpetriere500,000 enrolled

Overview

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).

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

Study Type

OBSERVATIONAL

Enrollment

500,000

Conditions

Prostate Cancer Neuropathy Epilepsy Encephalopathy

Interventions

EnzalutamideDRUG

Enzalutamide for the treatment of prostate cancer or other solid tumors

Eligibility

Sex: ALLMin age: 18 YearsMax 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 enzalutamide reported in the WHO database. Exclusion Criteria: * Chronology not compatible between the drug and the toxicity

Locations (1)

Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière

Paris, France

Outcomes

Primary Outcomes

Number of patients with neurological adverse events with significant over-reporting enzalutamide

Identification and report of neurological toxiciy of enzalutamdie

Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020

Data from ClinicalTrials.gov

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