Status:
COMPLETED
a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY
Lead Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Conditions:
Prostate Cancer
Neuropathy
Eligibility:
All Genders
18-100 years
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 c...
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 advers...
Eligibility Criteria
Inclusion
- 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
- Chronology not compatible between the drug and the toxicity
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 8 2023
Estimated Enrollment :
500000 Patients enrolled
Trial Details
Trial ID
NCT04290611
Start Date
January 1 2019
End Date
April 8 2023
Last Update
April 13 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière
Paris, France, 75013