Encephalopathy, Epilepsy, Neuropathy, Prostate Cancer
Conditions
Keywords
Drug-induced neurotoxicity
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).
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
Interventions
DRUGEnzalutamide
Enzalutamide for the treatment of prostate cancer or other solid tumors
Sponsors
Groupe Hospitalier Pitie-Salpetriere
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with neurological adverse events with significant over-reporting enzalutamide | Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020 | Identification and report of neurological toxiciy of enzalutamdie |
Countries
France
Outcome results
None listed