Status:
COMPLETED
Comparison of Cardiotoxicity Induced by Selective Estrogen REceptor Modulators and aNti-Aromatase
Lead Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Conditions:
Cardiac Affections
Eligibility:
All Genders
18-100 years
Brief Summary
Selective estrogen receptor modulators and aromatase inhibitors for the treatment of breast cancer seems to have an impact on the cardio-vascular system. This study investigates reports of cardiovascu...
Detailed Description
Hormone replacement therapies and contraceptive pills are responsible of a wide range of cardio-vascular side effects, particularly thrombo-embolic disorders and ischemic heart disease. The difference...
Eligibility Criteria
Inclusion
- Case reported in the Eudravigilance from 01/2002 to 08/2017
- Adverse event reported were including the MedDRA terms: SOC Cardiac Affections and the HLT Death and Sudden Death
Exclusion
- \-
Key Trial Info
Start Date :
January 1 2001
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 14 2017
Estimated Enrollment :
20000 Patients enrolled
Trial Details
Trial ID
NCT03259711
Start Date
January 1 2001
End Date
August 14 2017
Last Update
October 18 2018
Active Locations (1)
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1
Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière
Paris, Île-de-France Region, France