a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY

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).

Completed

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Key information

Conditions

Prostate Cancer Brain Diseases Central Nervous System Diseases Encephalopathy Epilepsy Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Nervous System Diseases Neuropathy Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière

Paris, 75013, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enzalutamide

Drug

Enzalutamide for the treatment of prostate cancer or other solid tumors

Primary outcomes

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

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

Identification and report of neurological toxiciy of enzalutamdie

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Official study title

Monitoring the Neurological Toxicity of Enzalumatide Through VigiBase, a Pharmacovigilance Study

Acronym: VENDY

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Mar 2, 2020
Registry last updated: Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed