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

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

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).

Study Overview

• Status: Completed
• Conditions: Epilepsy; Prostate Cancer; Neuropathy; Encephalopathy
• Intervention / Treatment: Drug: Enzalutamide

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 500000

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with enzalutamide for prostate cancer or other solid tumors

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Enzalutamide drug-induced toxicity; 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	Drug: Enzalutamide; Enzalutamide for the treatment of prostate cancer or other solid tumors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with neurological adverse events with significant over-reporting enzalutamide	Identification and report of neurological toxiciy of enzalutamdie	Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Pitie-Salpetriere

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): April 8, 2023

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Drug-induced neurotoxicity
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Brain Diseases
• Other Study ID Numbers: CIC1421-20-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes