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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | Enzalutamide for the treatment of prostate cancer or other solid tumors |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with enzalutamide for prostate cancer or other solid tumors
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |