The following definitions were applied by the central independent adjudication committee to confirm a suspected episode of symptomatic recurrent DVT or PE:

1. Suspected (recurrent) DVT with one of the following findings:
   1. abnormal compression ultrasound (CUS) where compression had been normal or, if non-compressible during screening, a substantial increase (4 mm or more) in diameter of the thrombus during full compression
   2. an extension of an intraluminal filling defect, or a new intraluminal filling defect or an extension of non-visualization of veins in the presence of a sudden cut-off on venography.
      or
2. Suspected PE with one of the following findings:
   1. a (new) intraluminal filling defect in segmental or more proximal branches on spiral computed tomography scan
   2. a (new) intraluminal filling defect or an extension of an existing defect or a new sudden cut-off of vessels more than 2.5 mm in diameter on the pulmonary angiogram
   3. a (new) perfusion defect of at least 75% of a segment with a local normal ventilation result (high probability) on ventilation/perfusion lung scintigraphy
   4. inconclusive spiral computed tomography, pulmonary angiography, or lung scintigraphy with demonstration of DVT in the lower extremities by CUS or venography.
3. Fatal PE was:
   1. PE based on objective diagnostic testing, autopsy
   2. death which cannot be attributed to a documented cause and for which DVT/PE cannot be ruled out (unexplained death).

Without objective testing (see Section 3), a suspected episode of DVT or PE was to be considered as confirmed if it led to a change in anticoagulant treatment at therapeutic dosages for more than 48 hours.