TabsDetailsBasic DetailsDate Posted: Monday, March 25, 2019Status: CompleteMedical Product: testosteroneHealth Outcome(s): acute myocardial infarction (AMI)strokeDescription: 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. Read More Deliverables (2)Mini-Sentinel Modular Program Report: Acute Myocardial Infarction and Stroke Among Patients with Testosterone-Related Indications, Report 1Mini-Sentinel Modular Program Report: Acute Myocardial Infarction and Stroke Among Patients with Testosterone-Related Indications, Report 2Additional InformationAdditional DetailsFDA Center: CDERTime Period: January 1, 2007 to May 31, 2013Study Type: Modular ProgramAssessment Type: Exploratory AnalysesPopulation / Cohort: Patients with testosterone-related indicationsData Sources: Mini-Sentinel Distributed Database (MSDD)
