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Table 3 Overview of data collection procedures

From: XALIA: rationale and design of a non-interventional study of rivaroxaban compared with standard therapy for initial and long-term anticoagulation in deep vein thrombosis

Scheduled procedure

Initial visit (baseline)

After 1 month

Quarterly

Final assessment

Visit date

X

X

X

X

Demographic data

X

   

Medical/surgical history

X

   

Concomitant diseases

X

 

X*

X*

Concomitant medication/treatment

X

 

X*

X*

Physical examination

X

   

Laboratory results (if available)

X

X

X

X

Diagnosis of current DVT

X

   

Previous VTE

X

   

Current VTE treatment regimen

X

 

X

X

Initial phase treatment

 

X

  

Dose reduction (twice daily to once daily)

 

X

  

Assessment of therapy

   

X

Patient satisfaction and adherence with treatment (optional, only in a sub-sample of patients)

 

X*

X*

X*

Adverse events†

 

X

X

X

  1. *Only documented if new information is available from regular practice. No additional diagnostics are required for the study; †serious adverse events must be reported to the sponsor within 24 hours.
  2. DVT, deep vein thrombosis; VTE, venous thromboembolism.
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Thrombosis Journal

ISSN: 1477-9560

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