Bleeding Events and Venous Thromboembolism (VTE) following Enoxaparin Use: A Descriptive Analysis

In this request, we examined bleeding (hospitalized bleeding and major bleeding) and venous thromboembolism (VTE) events following incident use of enoxaparin in the Mini-Sentinel Distributed Database (MSDD). This analysis includes three reports:

• Report 1: We investigated the use of enoxaparin, by manufacturer (Sanofi, Sandoz, or Amphastar). Bleeding events and venous thromboembolism (VTE) events were used to define incidence. In this report, specifications for bleeding events were relaxed to a seven day period; Report 3 restricts the definition to an inpatient stay.
• Report 2: We investigated bleeding (hospitalized bleed and major bleed) and VTE events following incident use of enoxaparin (regardless of manufacturer).
• Report 3: We investigated the use of enoxaparin, by manufacturer (Sanofi, Sandoz, or Amphastar). Bleeding events and venous thromboembolism (VTE) events were used to define incidence. In this report, specifications for bleeding events were restricted to an inpatient stay; Report 1 relaxes the definition to a seven day period.

This analysis was distributed to 15 Data Partners in the MSDD on April 29, 2015. The query period for this request was August 1, 2010 to December 31, 2013.