Clinical trial · Observational
a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY
Monitoring the Neurological Toxicity of Enzalumatide Through VigiBase, a Pharmacovigilance Study
NCT04290611CI-TRIAL-00065629VENDYcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Encephalopathy | — | UNRESOLVED | — |
| Epilepsy | — | UNRESOLVED | — |
| Neuropathy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enzalutamide | Drug | Enzalutamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Enzalutamide drug-induced toxicity
- description
- 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
- interventionNames
- Drug: Enzalutamide
Primary outcomes (1)
- measure
- Number of patients with neurological adverse events with significant over-reporting enzalutamide
- timeFrame
- Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
- description
- Identification and report of neurological toxiciy of enzalutamdie
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.