Sponsor's decision. Termination decision unrelated to safety profile.

Venous Thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is associated with an increase in risk of mortality and long-term disability and is a major contributor to global disease burden. Participants hospitalized with an acute medical illness are at increased risk of VTE.

This study a non-interventional study which analyzes data already collected in the Optum US clinical database. Its aim is to compare conventional versus extended duration prophylaxis with enoxaparin on the incidence of VTE and bleeding events in participants hospitalized for acute medical illness. The first date of enoxaparin treatment will be the index date.

The study population will be developed from the Optum Clinical database in the United States, representing routine clinical practice. Study population will comprise of participants hospitalized for an acute medical illness receiving enoxaparin during hospitalization. The first date of enoxaparin treatment will be the index date. The study period will be from February 2010 to September 2021. Participants will be followed for 90 days.

Inclusion Criteria:

• Hospitalization for the following acute conditions:

  • Infection
  • Respiratory insufficiency
  • Inflammatory condition
  • Cancer
  • Heart failure
  • Ischemic stroke

• Initiation of enoxaparin prophylaxis during hospitalization (index date)

• Age ≥40 years

Exclusion Criteria:

• Symptomatic VTE or major bleeding event 90-days prior to index date
• Major surgery within (+1,-90) days from index date
• Ongoing anticoagulation therapy (medication supply within [-2,-32] days from index date)
• Atrial fibrillation
• Chronic kidney disease (CKD) stages IV and V, or dialysis

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Participants hospitalized for an acute medical illness receiving enoxaparin during hospitalization.

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org