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Acute Myocardial Infarction and Stroke Among Patients with Testosterone-Related Indications

Basic Details
Date Posted
Status
Complete
Medical Product
testosterone
Health Outcome(s)
acute myocardial infarction (AMI)
stroke
Description

This request analyzed acute myocardial infarction (AMI) and stroke among members with a pre-existing condition that is indicated for testosterone use. This request contained two reports. Report 1 investigated new diagnoses for a testosterone-related indication and those who received a testosterone product in the following six months. Report 2 analyzed acute myocardial infarction (AMI) and stroke among members overall and among those with a pre-existing condition of one of the specified testosterone indications.

Data from January 1, 2007 through May 31, 2013 from 18 Data Partners contributing to the Mini-Sentinel Distributed Database (MSDD) were included in this report. This request was distributed to 18 Data Partners on March 28, 2014.

Deliverables (2)
Mini-Sentinel Modular Program Report: Acute Myocardial Infarction and Stroke Among Patients with Testosterone-Related Indications, Report 1 Mini-Sentinel Modular Program Report: Acute Myocardial Infarction and Stroke Among Patients with Testosterone-Related Indications, Report 2
Additional Details
FDA Center
CDER
Time Period
January 1, 2007 to May 31, 2013
Analysis Type
Mini-Sentinel
Population / Cohort
Patients with testosterone-related indications
Data Sources
Mini-Sentinel Distributed Database (MSDD)