| Project Title | Acute Myocardial Infarction and Stroke Among Patients with Testosterone-Related Indications |
| Date Posted | Monday, March 25, 2019 |
| Project ID | to09y05_mpr_wp27_v02 |
| Status | Complete |
| Deliverables | |
| 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. |
| Medical Product | testosterone |
| Health Outcome | acute myocardial infarction (AMI) stroke |
| Population / Cohort | Patients with testosterone-related indications |
| Time Period | January 1, 2007 to May 31, 2013 |
| Assessment Type | Exploratory Analyses |
| Study Type | Modular Program |
| Data Sources | Mini-Sentinel Distributed Database (MSDD) |
| FDA Center | CDER |
