Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility (SAVE-VEMED)

• Percentage of Participants Who Experienced Venous Thromboembolism Event (VTE) or VTE-related Death [ Time Frame: From randomization up to 15 days after randomization or the day of the mandatory Compression Ultrasound (CUS), whichever came first ] [ Designated as safety issue: No ]

  VTE included:

  • asymptomatic proximal Deep Vein Thrombosis (DVT) detected by the mandatory CUS and confirmed by a Compression Ultrasound Adjudication Committee (CUSAC) after central and blind review of the mandatory CUS;
  • symptomatic DVT and non-fatal Pulmonary Embolism (PE) reported by the investigator and confirmed by a Central Independent Adjudication Committee (CIAC) after central and blind review of diagnosis tests.

  VTE-related Death included fatal PE and unexplained deaths.

  
  

• Percentage of Participants Who Experienced asymptomatic proximal DVT [ Time Frame: From randomization up to 15 days after randomization or the day of the mandatory CUS, whichever came first. ] [ Designated as safety issue: No ]
  
• Percentage of Participants Who Experienced Clinically Relevant Bleedings [ Time Frame: From 1st study drug injection up to 3 days after last study drug injection ] [ Designated as safety issue: Yes ]

  Bleedings were centrally and blindly reviewed by the CIAC and classified as:

  • "major" (fatal, symptomatic in a critical area/organ, causing a post-operative drop in hemoglobin ≥2 g/dL or requiring post-operative transfusion ≥2 units of blood);
  • "clinically relevant non-major" (overt bleeding requiring medical intervention and not meeting criteria for major bleeding);
  • "Non-clinically relevant bleeding".
  
  
• Percentage of Participants Who Required the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment [ Time Frame: From randomization up to 15 days after randomization or the day of mandatory CUS, whichever came first ] [ Designated as safety issue: No ]
  Initiation of curative anticoagulant or thrombolytic treatment after VTE assessment was defined from investigator's answer to the question "was the subject treated for VTE?" asked after the diagnostic tests for suspected VTE and after the mandatory CUS.
  
  

Randomization had to take place just prior to the first study drug injection.

The total duration of observation per participant was 35-42 days from randomization broken down as follows:

• 10 to 14-day double-blind treatment period;
• 25 to 32-day follow-up period.

Mandatory bilateral compression ultrasound [CUS] had to be performed between 10 to 15 days after randomization.