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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.