a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY

NCT04290611 | Completed FDA Drug

• 1 other identifier: CIC1421-20-02
• Study Type: observational
• Target: 500,000
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Prostate Cancer; Neuropathy; Epilepsy; Encephalopathy

Keywords

Drug-induced neurotoxicity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Enzalutamide DRUG

Enzalutamide for the treatment of prostate cancer or other solid tumors

Enzalutamide drug-induced toxicity

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with enzalutamide for prostate cancer or other solid tumors

You may qualify if:

• 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.

You may not qualify if:

• Chronology not compatible between the drug and the toxicity

Sponsors & Collaborators

• Groupe Hospitalier Pitie-Salpetriere: lead

Study Sites (1)

Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Epilepsy; Brain Diseases

Interventions

enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: January 1, 2019
• Primary Completion: January 1, 2023
• Study Completion: April 8, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)