Skip to main content

Advertisement

Table 1 Time points for data assessment

From: Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study

  Baseline* 1 month 3 months 6 months 12 months 18 months Country-specific LPO
Eligibility criteria(1) X       
Baseline characteristics(2) X       
VTE-related parameters(3) X X§ X§ X§ X§ X§  
Edoxaban therapy(4) X X X X X X  
Concomitant anticoagulants X X X X X X  
Interventions X X X X X X  
Adherence to VTE therapy(5) X X X X X X  
Recurrent VTE(6)   X X X X X X
Other clinical events(7) X X X X X X  
Hospitalisation for cardiovascular disease(8)   X X X X X  
PTS(9) X   X   X X  
Vital signs(10) X X X X X X  
Laboratory parameters(9) X X X X X X  
ADRs(11) X X X X X X  
  1. Legend: VTE, venous thromboembolism; PTS, post-thrombotic syndrome; ADR, adverse drug reaction; LPO, last patient out. (1) Confirmed first or recurrent VTE within the 2 weeks preceding enrolment; treated with edoxaban according to Summary of Product Characteristics; written informed consent; no simultaneous interventional study participation. (2) Age and gender, alcohol consumption, smoking status, frailty, comorbidities, and medical history. (3) Details of past and current VTE risk factors, symptoms, diagnosis, interventions, treatment, and related clinical events (stroke, bleeding events, systemic embolism, non-valvular atrial fibrillation, and malignancies). (4) History and current status, including dose, prescription intervals, and any changes to edoxaban treatment since last data point (including permanent discontinuation, in which case date, reason and subsequent therapy must be provided). (5) Physician judgment only. (6) Timing, diagnosis and interventions. (7)I.e. death, stroke, bleeding events, systemic embolism, non-valvular atrial fibrillation, and malignancies. (8) Admittance and discharge dates, clinical event, and use of the emergency room and/or intensive care unit. (9) If assessed. (10) Including blood pressure, heart rate, height and weight. (11) As per the Guideline on Good Pharmacovigilance Practices (GVP) Module VI (Management and reporting of adverse reactions to medicinal products; EMA/873138/2011 Rev. 1) [16]; coding according to the standardised Medical Dictionary for Regulatory Activities (MedDRA).*Defined as the first day of heparin administration after the index acute VTE event. Since 18-month time point. §Changes in symptoms/diagnosis and any other VTE-relevant information